>>WELCOME EVERYONE.
THANK YOU SO MUCH FOR JOINING US
THIS AFTERNOON FOR OUR ANNUAL
WORKSHOP FOR THE NIH PRAGMATIC
TRIALS COLLABRATORY.
WE'VE DONE VIDEO CAST OUT TO THE
BROADER AUDIENCE AND IN THE LAST
TWO YEARS, WE'VE DONE OUR
WORKSHOPS WITH A SERIES OF GRAND
ROUNDS OVER A SERIES OF
DIFFERENT MONTHS WITH A TOTAL OF
FOUR OR FIVE AND THIS MONTH
WE'RE TRYING SOMETHING NEW SO WE
CAN ACCOMMODATE BOTH OUR WEST
COAST AND EAST COAST COLLEAGUES
HERE IN THE U.S. AND ANY
INTERNATIONAL COLLEAGUES WE HAVE
AROUND THE WORLD WHO ARE
PARTICIPATING TODAY.
SO WELCOME TO EVERYONE.
THIS YEAR, WE'RE SECELEBRATING E
FIRST DECADES OF THE HEALTH
SYSTEMS COLLABORATORY WHICH
WE'VE REBRANDED.
AND IN PREPARING FOR THIS YEAR'S
WORKSHOP, WE THOUGHT WE'D TALK
TO A LOT OF OUR INVESTIGATORS TO
ASK THEM WHAT WOULD THEY DO
DIFFERENTLY?
WHAT WOULD THEY LEARN DOING
THESE PRAGMATIC TRIALS EMBEDDED
IN THE HEALTH ANTERIOR SYSTEMS,
WHAT WOULD THEY SHARE IN DOING
THIS RESEARCH?
AND OUR CORE LEADERSHIP FOUND A
FEW THINGS.
ONE OF THEM WAS THE FACT THAT
EVERYBODY'S USING ELECTRONIC
HEALTH RECORDS AND A LOT HAS
CHANGED IN THE LAST DECADE.
SO WE'RE GOING TO HAVE A SESSION
TODAY ABOUT ELECTRONIC HEALTH
RECORD DATA AND HOW WE MIGHT BE
ABLE TO USE IT AND MAYBE EVEN
USE IT BETTER IN THE FUTURE.
WE'VE LEARNED A LOT ABOUT
DIFFERENT STUDY DESIGNS AND HOW
YOU SELECT THE RIGHT STUDY
DESIGN AND ANSWER THE RESEARCH
QUESTION THAT YOU HAVE.
AND MANY OF OUR INVESTIGATORS,
WE'VE ASKED THEM THE QUESTION
WOULD YOU DO IT THE SAME WAY
THAT YOU'VE ENDED UP DOING IT?
AND SO I'M LOOKING FORWARD TO
THEIR DISCUSSION AND THOUGHTS
ABOUT WHAT THEY DO THE TRIAL THE
SAME WAY AND HAVE THEY LEARNED
SOME THINGS OR MAYBE WOULD HAVE
ANSWERED THEIR QUESTIONS A
LITTLE BIT DIFFERENT HAD THEY
DONE THE STUDY DESIGN.
ONE OF THE THINGS THAT'S UNIQUE
ABOUT THE PRAGMATIC TRIALS
COLLABORATORY IS WE'VE LAUNCHED
22 TRIALS ACROSS THE COUNTRY AND
THEY'VE UTE ILLIZED A 1,000 AT
THAT TIME.
SOME OF OUR INVESTIGATORS ARE
GOING TO TELL US ABOUT WHAT WAS
USEFUL AND HELPFUL IN THAT
PLANNING PERIOD AND WHAT WAS
REALLY MAYBE SOMETHING THEY
WISHED THINKING BACK THAT WOULD
HAVE BEEN HELPFUL IF THEY HAD
DONE AND SO WE'RE GOING TO HAVE
A NICE DISCUSSION AROUND THAT.
AND OUR LAST PANEL IS ONE THAT
HAS BECOME MORE AND MORE OF AN
ISSUE OVER TIME IS THE HUGE
IMPLEMENTATION AND DELIVERING
THESE IN THE HEALTH CARE CENTER
AND WORKING WITH OUR COLLEAGUES
DOING IMPLEMENTATION SCIENCE
AROUND WHAT CAN WE LEARN FROM
THEIR METHODS DOING PRAGMATIC
TRIALS IN THOSE HEALTH CARE
SYSTEMS SO WE CAN TEST WHETHER
INTERVENTION WORKS AND THE
BIGGEST THING IS LOGISTICS.
LOTS OF LOGISTICS TO OVERCOME.
SO I'M LOOKING FORWARD TO
HEARING FROM ALL OF OUR
INVESTIGATORS ABOUT WHAT THEY'VE
LEARNED ABOUT SOME OF THE
IMPLEMENTATION TRIALS.
BECAUSE THE HEALTH KERR SYSTEMS
REALLY VARY.
EVERYTHING FROM YOUR ACADEMIC
HEALTH CARE SETTING TO MANAGED
CARE TYPESETTING AND EVEN
COMMUNITY BASED CLINICS.
SO WE HAVE A BIG RANGE OF
DIFFERENT LESSONS ACROSS THESE
DIFFERENT HEALTH CARE SETTINGS.
SO WE KNOW WE HAVE A BROAD
AUDIENCE HERE ON OUR VIDEO CAST.
WE CERTAINLY KNOW WE HAVE OTHER
RESEARCH FUNDERS THAT ARE HERE
AND WE HOPE YOU CAN LEARN THINGS
ABOUT HOW TO DO THESE TYPE OF
RESEARCH AND ANSWER QUESTIONS
ABOUT DO INTERVENTIONS WORK WHEN
THEY'RE ACTUALLY IN THE HEALTH
CARE SETTING AS WELL AS
IMPLEMENTATION QUESTIONS SUCH AS
HOW DO YOU GET INTERVENTIONS
INTO THE HEALTH CARE SETTING AND
WHAT'S THE BEST WAY TO DO THAT.
CERTAINLY, WE KNOW WE HAVE MANY
INVESTIGATORS AND RESEARCHERS ON
THIS MEETING AND WE HOPE THAT
YOU CAN BENEFIT FROM THE
EXPERIENCE OF THE INVESTIGATORS
YOU'RE GOING TO HEAR FROM TODAY
AND TOMORROW ABOUT THEIR
EXPERIENCE CONDUCTING THESE
TRIALS AND HEALTH CARE SYSTEMS.
WE ALSO KNOW THAT YOU BRING A
LOT OF YOUR OWN EXPERIENCE TO
THIS DISCUSSION AND TO THIS
VIDEO CAST AND TO THIS WORKSHOP
OVER THE NEXT TWO DAYS.
AND SO WE CERTAINLY WELCOME
OPPORTUNITIES FOR YOU TO ASK
QUESTIONS AS WELL AS TO GIVE
YOUR INPUT AND THOUGHTS AND
IDEAS AS WELL.
AND THEN, FINALLY, WE KNOW WE
HAVE MANY STAKEHOLDERS WHO'VE
PARTICIPATED IN THESE WORKSHOPS
AND WANT TO KNOW ABOUT WHAT
WE'RE DOING HERE AT NIH WHETHER
YOU'RE ON THE PATIENT'S SIDE,
THE PROVIDER'S SIDE, HOW TO DO
RESEARCH THAT INFORMS YOUR
DECISIONS ABOUT WHAT CARE IS
RIGHT FOR YOU, WHAT CARE IS BEST
FOR YOUR PATIENTS, OR WHAT CARE
IS BEST FOR YOUR BENEFICIARIES.
SO WE'RE LOOKING FORWARD TO ALL
OF YOUR PERSPECTIVES AS WELL.
IF YOU CAN GO TO THE NEXT SLIDE
FOR ME, MARY JOE.
I HAVE JUST ARE A COUPLE OF
MINOR LITTLE HOUSEKEEPING NOTES.
ONE IS AS I MENTIONED, WE HAVE
AN ACTIVE E-MAIL THAT YOU CAN
SUBMIT QUESTIONS TO AND WE WILL
BE MONITORING THAT E-MAIL BOX
THROUGHOUT THE WORKSHOP TODAY
AND TOMORROW.
SO PLEASE DO SEND YOUR QUESTIONS
IN AS YOU THINK OF THEM AND WE
WILL TRY OUR BEST TO GET TO AS
MANY OF THEM AS POSSIBLE.
WE DO HAVE A ZOOM PLATFORM FOR
OUR SPEAKERS AND SO FOR THE
SPEAKERS, WE ARE ASKING YOU TO
KEEP YOUR CAMERAS OFF UNLESS
YOU'RE ACTUALLY SPEAKING,
OTHERWISE YOU'RE GOING TO SHOW
UP IN THE LIVE VIDEO CAST FEED
AS YOUR CAMERA IS ON.
WE ALSO DO HAVE THE CHAT
AVAILABLE TO US, BUT PLEASE DO
REMEMBER ONCE WE GET TO THE
DISCUSSION, I ENCOURAGE YOU TO
RAISE YOUR HAND OR TURN YOUR
CAMERA ON IF YOU WANT TO
PARTICIPATE IN THE DISCUSSION SO
WE CAN GET TO YOUR QUESTIONS.
OUR AUDIENCE, MOST OF OUR
AUDIENCE IS HERE VIA VIDEO CAST
AND THEY CANNOT SEE THE ZOOM
DISCUSSION.
SO WE'LL DEFINITELY WANT TO
BRING THOSE QUESTIONS UP IN THE
LIVE DISCUSSION AND WE SHOULD
HAVE PLENTY OF TIME FOR IN ALL
OF OUR SESSIONS.
WE'RE LOOKING FORWARD TO A
SERIES OF MODERATED DISCUSSIONS
AS I MENTIONED ON THOSE FOUR
DIFFERENT TOPICS, BUT BEFORE WE
LAUNCH INTO THAT, I'M VERY
EXCITED TO INTRODUCE DR. ELAN
LONGEVAN.
AND SHE IS ALSO THE CO-CHAIR OF
THE COLLABORATORY PROGRAM AND
SHE IS HERE AND WE'VE BEEN LUCKY
IN DOING THIS AMAZING PROGRAM
WITH AN AMAZING SET OF PEOPLE AT
OUR COORDINATING CENTER AT DUKE
AS WELL AS ALL OF OUR
INVESTIGATORS AND ALL OF OUR
COLLABORATORS IN THE COORDINATED
CENTER ACROSS MANY INSTITUTIONS
ACROSS THE COUNTRY.
SO DR. LANGEVIN I'M GOING TO
INTRODUCE YOU TO OUR KEYNOTE
WHICH WE'RE EXCITED TO HAVE
DR. SHANNON ZENK AS WELL.
>> IT'S REALLY MY GREAT PLEASURE
TO INTRODUCE OUR KEYNOTE SPEAKER
DR. SHANNON ZENK WHO IS THE
DIRECTOR OF NATIONAL INSTITUTE
NURSING RESEARCH.
DR. ZENK JOINED NNR IN 2020.
HER LEADERSHIP IN NINR'S LEADING
NURSING RESEARCH TO SOLVE
CRITICAL HEALTH CHALLENGES,
INFORMING PRACTICE AND POLICY
AND ADVANCING HEALTH.
BEFORE LEAVING NINR, DR. ZENK
WAS THE LEADING PROFESSOR IN THE
HEALTH SCIENCES AT THE
UNIVERSITY OF CHICAGO COLLEGE OF
NURSING.
AND, A FELLOW IN THE UIC
INSTITUTE FOR HEALTH RESEARCH
AND POLICY.
SHE EARNED A BACHELOR'S IN
NURSING FROM ILLINOIS WESLEY
UNIVERSITY.
MASTERS IN NURSING AND HEALTH
FROM THE UNIVERSITY OF ILLINOIS.
AND A DOCTORATE IN HEALTH
BEHAVIOR AND HEALTH EDUCATION
FROM THE UNIVERSITY OF MICHIGAN.
DR. ZENK WAS ELECTED AS A FELLOW
OF THE AMERICAN ACADEMY OF
NURSING IN 2013.
RECEIVED AWARDS FROM THE
NATIONAL INSTITUTE OF NURSING
RESEARCH IN 2018.
WAS INDUCTED INTO THE
INTERNATIONAL NURSE'S
RESEARCHER'S HALL OF FAME IN
2019, AND, ELECTED AS A MEMBER
OF THE NATIONAL ACADEMY OF
MEDICINE IN 2021.
HER RESEARCH FOCUSES ON SOCIAL
INEQUITIES AND HEALTH WITH A
GOAL OF IDENTIFYING EFFECTIVE
MULTI-LEVEL APPROACHES TO
IMPROVE HEALTH AND ELIMINATE
RACIAL AND ETHNIC AND SOCIAL
ECONOMIC HEALTH DISPARITIES.
HER RESEARCH PORTFOLIO HAS
INCLUDED NIH SUPPORTED WORK IN
URBAN FOOD ENVIRONMENTS,
COMMUNITY HEALTH SOLUTIONS, AND
VETERANS' HEALTH THROUGH
PIONEERING RESEARCH ON THE BUILT
ENVIRONMENT AND FOOD DESERTS,
DR. ZENK AND HER COLLEAGUES
INCREASED NATIONAL ATTENTION TO
THE PROBLEM OF INADEQUATE ACCESS
TO FOOD IN LOW-INCOME AND BLACK
NEIGHBORHOODS.
DR. ZENK AND HER COLLEAGUES HAVE
STUDIED YOU ENVIRONMENTAL AND
PERSONAL FACTORS INTERACT TO
AFFECT HEALTH AS WELL AS THE
EFFECTIVENESS OF BEHAVIORAL CAN
VARY IN ENVIRONMENTAL CONTEXT.
HER WORK HAS LEVERAGED A VARIETY
OF TECHNOLOGIES AND EMERGING
DATA RESEARCH SUCH AS ELECTRONIC
HEALTH RECORDS.
FIRST OFF, SHE WAS AN EARLY
ADOPTER OF GPS TRACKING TO STUDY
ENVIRONMENTS IN RELATION TO
HEALTH BEHAVIORS.
SHE RECOGNIZED THAT PEOPLE NOT
ONLY SPEND TIME IN THE
COMMUNITIES WHERE THEY LIVE BUT
ALSO IN MANY OTHER PLACES WHICH
IS CRUCIAL WHEN IMPLEMENTING
INTERVENTIONS IN THE CONTEXT OF
HEALTH DISPARITIES.
I HOPE YOU CAN AGREE WITH ME
THAT MANY OF THESE TOPICS ARE
RELEVANT NOT ONLY TO THIS
WORKSHOP BUT ALSO TO THE
PRAGMATIC TRIALS GOAL.
WE ALL LOOK FORWARD TO YOUR
PRESENTATION.
WELCOME, SHANNON.
>> THANK YOU, HELENE.
I'M LOOKING FORWARD TO OUR
CONVERSATION TODAY.
I'M GOING TO SHARE MY SCREEN.
ALL RIGHT.
SO, AGAIN, GOOD AFTERNOON
EVERYONE.
THANK YOU FOR INVITING ME TO
TODAY'S WORKSHOP MARKING THE
FIRST TEN YEARS OF THE PRAGMATIC
CLINICAL TRIALS COLLABORATORY AT
NIH.
CONGRATULATIONS TO ALL.
AND, I DO WANT TO THANK MY
COLLEAGUE DR. HELENE LANGEVIN
FOR RECOMMENDING ME TO JOIN YOU
TODAY.
SO I'M EXCITED TO TELL YOU ABOUT
N
NINR, NURSING SCIENCE, AND
IMPLEMENT OF PRAGMATIC CLINICAL
TRIALS.
SO I'LL START BY SHARING SOME
BACKGROUND ON NINR AND OUR NEW
STRATEGIC PLAN INCLUDING
THOUGHTS ON OUR MOST PRESSING
HEALTH CHALLENGES.
CHIEF AMONG THEM HEALTH
INEQUITIES.
AND THE MANY WAYS THAT NURSING
AND NURSING SCIENCE CAN
CONTRIBUTE TO PRAGMATIC CLINICAL
TRIALS AND I'M CERTAINLY LOOKING
FORWARD TO DISCUSSION ON HOW WE
CAN BETTER WORK TOGETHER IN
THESE AREAS.
NOW, BEFORE I BEGIN THOUGH, I DO
WANT TO TELL YOU A LITTLE BIT
ABOUT NINR AND THE IMPORTANCE OF
NURSING SCIENCE TO HEALTH AND
WELL-BEING.
NINR WAS FOUNDED AS AN NIH
CENTER IN 1985 AND BECAME AN
INSTITUTE IN 1993.
SINCE ITS FOUNDING, NINR HAS
SUPPORTED RESEARCH THAT DEVELOPS
THE SCIENTIFIC BASIS FOR
CLINICAL PRACTICE AS WELL AS
POLICY.
ECHOING THE PRAGMATIC TRIAL'S
COLLABORATORY VISION OF
GENERATING RELIABLE EVIDENCE
WITH REAL WORLD DATA.
NOW, WE THINK WHAT SETS NINR
APART FROM OTHER NIH INSTITUTES
IS THAT OUR RESEARCH WITH
NURSING'S % AT ITS CORE IS
FOCUSED ON HEALTH SOLUTIONS FOR
PEOPLE IN THE CONTEXT OF THEIR
LIVES AND LIVING CONDITIONS.
NURSES ARE EVERYWHERE.
CERTAINLY, WE THINK ABOUT
HOSPITALS AND CLINICS, BUT
NURSES ARE ALSO IN OUR SCHOOLS,
IN OUR WORK PLACES, IN HOMES AND
LONG-TERM CARE FACILITIES, IN
JUSTICE SETTINGS AND REALLY
THROUGHOUT OUR COMMUNITIES.
WE APPROACH PREVENTION,
TREATMENT, AND CARE HOLISTICALLY
AND IN CONTEXT.
AND THE SCOPE OF OUR PRACTICE
AND DISCIPLINE AND THE BREATH OF
OUR KNOWLEDGE SPANS THE LIFE
COURSE, CROSSES DISEASES AND
CONDITIONS, AND EXTENDS FROM
IMPROVING THE HEALTH OF
INDIVIDUALS TO THAT OF ENTIRE
POPULATIONS.
IT'S THIS UNIQUE PERSPECTIVE AND
POSITIONING THAT MAKES NURSING
SCIENCE SO WELL-SITUATED TO LEAD
RESEARCH ON THE WHOLE PICTURE OF
HEALTH FROM THE BIOLOGY OF A
PERSON'S CELLS AND GENES TO
THEIR WHOLE SELF, THEIR FAMILY
AND RESOURCES, AND THE COMMUNITY
AND SOCIETY IN WHICH THEY LIVE.
SO, WITH THAT, NURSING AND
NURSING SCIENCE CONTEXT IN MIND,
LET ME TELL YOU ABOUT NINR'S
STRATEGIC PLAN.
WE LAUNCHED A 20222026 STRATEGIC
PLAN LAST NO AND I THINK YOU'LL
SEE A NUMBER OF PARALLELS
BETWEEN OUR STRATEGIC DIRECTION
AND THAT OF THE COLLABORATORY.
AT NINR AS DR. LANGEVIN
MENTIONED, WE ARE COMMITTED TO
LEADING NURSING SCIENCE TO SOLVE
PRESSING HEALTH CHALLENGES AND
PRACTICING POLICY.
OPTIMIZING HEALTH AND ADVANCING
HEALTH EQUITY INTO THE FUTURE.
OUR MISSION STATEMENT REFLECTS
OUR BELIEF THAT NURSING RESEARCH
IS THE KEY TO UNLOCKING THE
POWER AND POTENTIAL OF NURSING.
IN OUR STRATEGIC PLAN DESCRIBES
HOW WE WANT TO LEVERAGE THE
STRENGTHS AND UNIQUE KNOWLEDGE
AND PERSPECTIVES INHERENT TO THE
DISCIPLINE TO THE BENEFIT OF ALL
PEOPLE.
THE STRATEGIC PLAN INCLUDES
GUIDEN PRINCIPLES THAT IMPORTANT
QUALITIES THAT NINR SUPPORTIVE
WORK SHOULD HAVE GOING FORWARD.
IN CONSIDERING GRANT
APPLICATIONS FOR FUNDING, THE
EXTENT TO WHICH REFLECT THESE
PRINCIPLES WILL BE A FACTOR IN
OUR DECISIONS.
WE NEED TO SUPPORT RESEARCH THAT
ADDRESSES TODAY'S CHALLENGES AND
HELPS US BE BETTER PREPARED FOR
THE FUTURE.
DISCOVER SOLUTIONS TO OPTIMIZE
HEALTH ACROSS CLINICAL,
COMMUNITY, AND POLICY SETTINGS.
ADVANCES EQUITY, DIVERSITY,
INCLUSION, AND ACCESSIBILITY AND
IS INNOVATIVE DEVELOPS OR
APPLIES RESEARCH METHODS AND HAS
THE POTENTIAL FOR SIGNIFICANT
IMPACT ON HEALTH AND WELL-BEING.
SO I ENCOURAGE ALL INVESTIGATORS
TO THINK ABOUT IMPLEMENTATION
FROM THE START.
ANOTHER COMMONALITY WITH THE
COLLABORATORY.
THE PLAN ALSO INCLUDES FIVE
RESEARCH LENSES.
AGAIN, I THINK YOU'LL SEE
PARALLELS IN HOW THESE LENSES
CAN BE APPLIED TO PRAGMATIC
CLINICAL TRIALS.
SO WHEN WE SAY "LENS" WE ARE
DESCRIBING A PERSPECTIVE THROUGH
WHICH TO EXAMINE A HEALTH
CHALLENGE.
IN DEVELOPING OUR SCIENTIFIC
STRATEGY, NINR IDENTIFIED FIVE
LENSES THAT WE THINK BEST
LEVERAGE THE STRENGTHS INHERENT
TO OUR DISCIPLINE AND PUSHED
NURSING SCIENCE TO INNOVATE,
THINK BIGGER, AND GREATLY
INCREASE OUR IMPACT.
THE LENSES IN THE STRATEGIC PLAN
ARE HEALTH EQUITY, SOCIAL
DETERMINENCE OF HEALTH, SYSTEMS
AND MODELS OF CARE.
LET ME GIVE YOU A CLOSER LOOK AT
EACH OF THESE LENSES.
OUR HEALTH EQUITY LENS AIMS TO
REDUCE AND ULTIMATELY ELIMINATE
THE SYSTEMIC AND STRUCTURAL
INEQUITIES THAT PLACE SOME
POPULATION GROUPS AT AN UNFAIR,
UNJUST, AND AVOIDABLE
DISADVANTAGE AND ATTAINING THEIR
FULL HEALTH POTENTIAL.
FROM NINR'S PERSPECTIVE, HEALTH
INEQUITIES ARE ROOTED IN
SYSTEMIC AND STRUCTURAL FACTORS
THAT LIMIT ACCESS TO POWER,
OPPORTUNITIES, AND RESOURCES.
THESE FACTORS INCLUDE STRUCTURAL
RACISM AND CREATE BARRIERS TO
HEALTH AND CAN LEAD TO
PERSISTENT HEALTH INEQUITIES.
WE ARE INTERESTED IN SUPPORTING
NURSING RESEARCH THAT IMPROVES
HEALTH AND WELL-BEING FOR ALL
THROUGH STRUCTURAL INTERVENTIONS
THAT REMOVE OBSTACLES TO HEALTH,
INCREASE AVAILABILITY AND
ACCESSIBILITY OF RESOURCES AND
ALTER ARE SOCIAL AND
INSTITUTIONAL NORMS.
OUR SOCIAL DETERMINANTS AS WELL
AS INDIVIDUAL AND FAMILY SOCIAL
AND ECONOMIC CIRCUMSTANCES.
SO WE'RE INTERESTED IN
SUPPORTING NURSING RESEARCH THAT
IDENTIFIES AND SUPPORTS
INTERVENTIONS DELIVERED AT THE
RIGHT PLACE AND THE RIGHT TIME
TO TARGET THESE SOCIAL FACTORS.
WE WANT OUR INVESTIGATORS TO
DISCOVER CREATIVE SOLUTIONS TO
ADDRESS UPSTREAM AND MIDSTREAM
CAUSES OF HEALTH OUTCOMES.
IDENTIFY ON HOW TO LIMIT
EXPOSURES TO ADVERSE AND
ECONOMIC CONDITIONS.
AND CONSIDER HOW TO LIMIT
SUSCEPTIBILITY TO BIOLOGICAL
EMBEDDING OF DETERMINANTS OVER
THE LIFE COURSE AND ACROSS
GENERATIONS.
OUR POPULATION AND COMMUNITY
HEALTH LENS AIMS TO ADDRESS
CRITICAL HEALTH CHALLENGES AT A
MACRO LEVEL THAT PERSISTENTLY
AFFECTS GROUPS OF PEOPLE WITH
SHARED CHARACTERISTICS.
WE'RE INTERESTED IN SUPPORTING
NURSING RESEARCH THAT USES ETIO
LOGIC.
TESTS AND EVALUATES PLANNED AS
WELL AS NATURAL EXPERIMENTS OF
MACRO-LEVEL INTERVENTIONS AND
USES COMMUNITY ACTION AND
PARTNERSHIPS IN THE MANY
SETTINGS IN WHICH NURSES WORK.
THE NEXT LENS AIMS TO PREVENT
DISEASE AND PROMOTE HEALTH
THROUGH THE CONTINUUM OF
PREVENTION.
THROUGH THE NINR'S PERSPECTIVE,
PREVENTION ACT OF RISK OF
DISEASE, DISABILITY OR INJURY
ALONG WITH THE CONTINUUM THAT
BEGINS WITH PRIMORTIAL AND
CONTINUES TO TERTIARY
PREVENTION.
HEALTH PROMOTION INCLUDES
EFFORTS TO FACILITATE HEALTHY
BEHAVIORS THAT REDUCE RISK,
IMPROVE HEALTH, MANAGE DISEASE,
AND ENHANCE WELL-BEING.
WE ARE INTERESTED IN SUPPORTING
NURSE RESEARCH THAT TESTS
INTERVENTIONS AND IDENTIFIES THE
MECHANISMS THROUGH WHICH
INTERVENTIONS WORK.
MORE OVER, PREVENTION AND HEALTH
PROMOTION EFFORTS MUST AIM TO
ELIMINATE HEALTH INEQUITIES BY
ACCOUNTING FOR THE MYRIAD OF
INFLUENCES ON RISK FROM
BIOLOGICAL TO SOCIETAL.
AND OUR LAST LENS AIMS TO
ADDRESS CLINICAL,
ORGANIZATIONAL, AND POLICY
CHALLENGES THROUGH NEW SYSTEMS
AND MODELS OF CARE.
WE DO NEED INNOVATIVE SYSTEMS
AND MODELS OF CARE MADE UP OF
COALITIONS AND PARTNERSHIPS THAT
SPAN CLINICAL AND COMMUNITY
SETTINGS AND ADDRESS SOCIAL
FACTORS AND NEEDS FOR
POPULATIONS AND INDIVIDUALS.
WE ENCOURAGE NURSE-LED SYSTEMS
AND MODELS OF CARE THAT CONSIDER
HOW TO LEVERAGE THE PUBLIC'S
TRUST IN AND THE EXPERTISE OF
THE NURSING WORK FORCE TO EMPLOY
SOLUTIONS INFORMED BY NURSES'
PERSPECTIVE AND EXPERIENCES AND
TO FOCUS ON HEALTH PROMOTING
CARE THAT ENCOMPASSES THE WHOLE
PERSON IN THE CONTEXT OF THEIR
LIVES AND LIVING CONDITIONS.
SO WE ARE INTERESTED IN
SUPPORTING NURSING RESEARCH THAT
INFORMS THE DEVELOPMENT,
DESEMINATION, AND IMPLEMENTATION
OF SYSTEMS AND MODELS OF CARE
AND GRAPPLES WITH CHALLENGES
SUCH AS COORDINATING CARE AND
INTEGRATING DATA ACROSS CLINICAL
AND COMMUNITY SETTINGS.
TESTING MODELS OF CONTEXTUALIZED
CARE AND UNDERSTANDING THE
IMPACTS OF ORGANIZATIONAL
PRACTICES AND POLICY ON QUALITY
OF CARE AND ITS OUTCOMES.
NOW, YOU'VE PROBABLY NOTICED
THESE LENSES ARE COMPLEMENTARY.
SO IN ADDITION TO LEVERAGING THE
STRENGTHS OF NURSING RESEARCH,
THE LENSES PROMOTE MULTI-LEVEL
APPROACHES, CROSS-DISCIPLINARY,
AND CROSS SEC. TOIRL
COLLABORATION AND COMMUNITY
ENGAGEMENT AND RESEARCH.
AND NINR SUPPORT INVESTIGATORS
TO HAVE THE FLEXIBILITY TO APPLY
A SINGLE LENS OR A COMBINATION
OF LENSES IN THEIR STUDY DESIGNS
AND TRAINING PROGRAMS.
WE ENCOURAGE RESEARCHERS TO VIEW
THE HEALTH EQUITY AND SOCIAL
DETERMINANTS OF HEALTH LENSES AS
PRIMARY TO SIDE TO CONSIDER THE
OTHER THREE LENSES.
THIS IS BECAUSE WE STRONGLY
BELIEVE THAT NURSES NEED TO BE
AT THE TABLE AND THAT NURSING
SCIENCE NEEDS TO BE IT AT THE
FOREFRONT IN DISCOVERING
SOLUTIONS TO ADDRESS OUR
NATION'S DEEPLY ROOTED SYSTEMIC
AND STRUCTURAL INEQUITIES AND TO
ULTIMATELY ACHIEVE HEALTH
EQUITY.
NINR'S RESEARCH LENSES WILL
ALLOW INVESTIGATORS TO CONSIDER
A FULL SPECTRUM OF NURSING
RESEARCH TOPICS THAT ENCOMPASSED
HEALTH AND ILLNESS WITHIN THE
CONTEXT OF PEOPLES' LIVED
EXPERIENCES.
THUS, THESE LENSES WILL ALLOW
NURSE INVESTIGATORS AND OTHERS
TO EXAMINE NEW TOPICS WHILE ALSO
ALLOWING THOSE WITH LONG
STANDING PROGRAMS OF RESEARCH TO
TAKE A DIFFERENT LOOK AT THEIR
AREAS OF INTEREST.
FOR EXAMPLE, 43% OF NINR'S
BUDGET FOCUSES ON LENS RESEARCH.
30% FOCUSES ON RESEARCH.
AND 26% OF OUR BUDGET FOCUSES
ALREADY ON SOCIAL DETERMINANTS
OF HEALTH.
SO YOU CAN FIND THE FULL
STRATEGIC PLAN ON OUR WEBSITE.
THAT ALLOWS US TO MERGE.
AS A RESULT, WE'RE GOING TO KEEP
IT ON OUR WEBSITE AND YOU CAN
ALWAYS FIND THE LATEST THERE.
SO LET ME TRANSITION.
WHAT DO WE MEAN WHEN WE AT NINR
SAY WE WANT TO ADDRESS PRESSING
HEALTH CHALLENGES?
NOW, WE MEAN THAT PRESSING THAT
UNDER LINE HEALTH INEQUITIES.
SO I'LL SHARE A FEW EXAMPLES TO
ILLUSTRATE SOME OF THE
CHALLENGES THAT REQUIRE URGENT
SOLUTIONS AND THAT I THINK ARE
RELEVANT TO THOSE INVOLVED IN
PRAGMATIC CLINICAL TRIALS.
PEOPLE WHO ARE HISPANIC, BLACK,
AND AMERICAN INDIAN ARE MORE
LIKELY TO DIE FROM COVID-19 AS
THAN PEOPLE WHO ARE WHITE.
WITH NEARLY THREE QUARTERS OF
THOSE REPORTING MORE THAN ONE
EXPERIENCE.
BLACK INDIVIDUALS ARE 22% LESS
LIKELY THAN WHITE INDIVIDUALS TO
RECEIVE ANY PAIN MEDICATION FOR
SIMILAR PAINFUL CONDITIONS.
IN THE UNITED STATES, SIX IN
SEVEN ADULTS HAVE A CHRONIC
DISEASE AND FOUR IN TEN HAVE TWO
OR MORE LEADING DRIVERS OF THE
NATION'S $3.8 TRILLION ANNUAL
HEALTH CARE COST.
SO SPEAKING OF CHRONIC DISEASE,
PEOPLE OF COLOR ARE SUFFERING
FROM DISEASE MORE THAN PEOPLE
WHO ARE WHITE.
U.S. ADULTS DIAGNOSED WITH
DIABETES IS MUCH HIGHER FOR
PEOPLE WHO ARE AMERICAN INDIAN
OR CAN NATIVE, BLACK, OR
HISPANIC AND LATINO THAN OF
THOSE WHO ARE WHITE.
THESE ARE JUST A FEW EXAMPLES OF
THE ALARMING AND TRAGIC HEALTH
INEQUITIES THAT OUR NATION
FACES.
SO, HOW CAN NURSES AND NURSING
SCIENCE CONTRIBUTE TO PRAGMATIC
CLINICAL TRIALS.
THREE KEY ATTRIBUTES ARE
SUMMARIZED IN THE COMMON SENSE
DEFINITION HERE.
IN DETAIL, THESE ATTRIBUTES
INCLUDE INFORM DECISION MAKERS
INSTEAD OF EXPLAINING A
BIOLOGICAL OR SOCIAL MECHANISM.
AN INTENT TO ENROLL A
REPRESENTATIVE POPULATION IN
RELEVANT SETTINGS, AND, AN
INTENT TO EITHER STREAMLINE
PROCEDURES AND DATA COLLECTION
OR MEASURE A BROAD RANGE OF
OUTCOMES.
IN OUR GUIDING PRINCIPLES
INCLUDE DISCOVERING SOLUTIONS TO
OPTIMIZE HEALTH.
ADVANCING EQUITY, DIVERSION, AND
INCLUSION AND ACCESSIBILITY, AND
SIGNIFICANTLY IMPACTING ON
HEALTH AND WELL BEING.
IN USING THE GRAPHIC FROM THE
COLLABORATORY'S LIVING TEXTBOOK,
IT'S EASY TO SEE WHERE NURSING
AND NURSING RESEARCH CAN FIT
WITH AN EMBEDDED PRAGMATIC
CLINICAL TRIALS.
NURSES MAKE UP THE LARGEST
SEGMENT OF THE HEALTH CARE WORK
FORCE AND ARE ALREADY IN EVERY
SETTING WHERE PEOPLE RECEIVE
CARE.
IMPORTANTLY, AS THE
COLLABORATORY INTENSIFIES ITS
EFFORTS TO ADDRESS HEALTH
INEQUITIES, NURSES ARE IN A WIDE
RANGE OF NOT ONLY CLINICAL
SETTINGS, BUT ALSO IN COMMUNITY
SETTINGS PROVIDING CARE.
THESE COMMUNITY SETTINGS ARE
CRITICAL FOR REACHING
POPULATIONS AND WHO ARE
DISCONNECTED FROM TRADITIONAL
HEALTH CARE SETTINGS.
MORE OVER, NURSES KNOW THAT
PATIENTS IN THE CONTEXT OF THEIR
WHOLE LIVES AND CAN USE THAT
KNOWLEDGE TO DEVELOP SOLUTIONS
AND IDENTIFY BARRIERS TO
PARTICIPATION AND STUDIES.
NURSES ALSO ARE INTIMATELY
FAMILIAR WITH THE NUANCES OF
ELECTRONIC HEALTH RECORDS, A
VITAL SOURCE OF DATA FOR
PRAGMATIC TRIALS AND OUR EXPERT
USERS.
AND NURSES ARE DECISION-MAKERS
IN THEIR OWN RIGHT AND ALSO
SERVE AS A VITAL LINK BETWEEN
OTHER DECISION MAKER, PATIENTS,
AND HEALTH CARE PROVIDERS TO
NAME JUST A FEW.
AND I AM PROUD THAT NINR IS
SHARING ITS EXPERTISE WITH
COLLABORATORY PROJECTS.
DR. KAREN KALE SERVES AS THE
NINR REPRESENTATIVE TO THE
COLLABORATORY STEERING COMMITTEE
AND I THANK HER FOR REPRESENTING
NINR'S PERSPECTIVE.
ADDITIONALLY, DR. KALE SERVES AS
THE PROGRAM OFFICIAL FOR THE
COLLABORATORY'S BEAT PAYING UTAH
PROJECT FOR WHICH NINR PROVIDES
OVERSIGHT.
AND, DR. LYNN ADAMS AND
DR. JERRY MILLER HAVE ALSO
SERVED AS PROJECT SCIENTISTS FOR
SEVERAL ONGOING AND COMPLETED
PRAGMATIC CLINICAL TRIAL
DEMONSTRATION PROJECTS.
SO AS PARTS OF THE NIH HEAL
INITIATIVE TO SPEED SCIENTIFIC
SOLUTIONS FOR THE NATIONAL
OPIOID PUBLIC HEALTH CRISIS,
NINR PARTICIPATED IN THE PRISM
PROJECT.
PRISM AS YOU MAY KNOW STANDS FOR
THE PRAGMATIC AND IMPLEMENTATION
STUDIES FOR THE MANAGEMENT OF
PAIN TO REDUCE OPIOID
PRESCRIBING.
IN FACT, JUST LAST MONTH
DR. KALE PRESENTED A CONCEPT TO
NINR'S OF CHRONIC PAIN IN RURAL
POPULATIONS.
THIS CONCEPT WHICH IS SPONSORED
BY NCCIH WOULD BE INCLUDED IN
PRISM AND WOULD AIM TO
ACCELERATE IMPLEMENTATION OF
EVIDENCE-BASED, NONOPIOID PAIN
CARE IN RURAL POPULATIONS TO
OPTIMIZE HEALTH, ADDRESS
DISPARITIES AND ADVANCE HEALTH
EQUITY.
AS DR. KALE EXPLAINED IN HER
PRESENTATION TO NINR'S COUNCIL,
IN RURAL AND REMOTE SETTINGS,
PRIMARY CARE PROVIDERS INCLUDING
NURSE PRACTICIONERS, CLINICAL
NURSE SPECIALISTS, AND CERTIFIED
NURSE MID WIVES ARE RESPONSIBLE
FOR MANAGING CHRONIC PAIN AND
FOR ADHERING TO GUIDELINES TO
REDUCE OPIOID USE OFTEN WITH
LIMITED RESOURCES.
WHILE THERE ARE EFFECTIVE
EVIDENCE-BASED NONOPIOID
INTERVENTIONS FOR CHRONIC PAIN,
THEY HAVE NOT BEEN WIDELY
IMPLEMENTED IN RURAL AND REMOTE
AREAS.
THE CONCEPT FOCUSES ON
IMPLEMENTATION IN COMMUNITY
SETTINGS AND BUILDING
PARTNERSHIPS BETWEEN
INVESTIGATORS, LOCAL PROVIDERS
AND COMMUNITY ORGANIZATIONS.
NOW, AS YOU KNOW, CONCEPTS MAY
OR MAY NOT TURN INTO FUNDING
OPPORTUNITY ANNOUNCEMENTS
DEPENDING ON A WIDE VARIETY OF
FACTORS.
I DO WANT TO THANK DR. KALE,
NCCIH AND THE MANY OTHER
INSTITUTE CENTERS AND OFFICES
WHO HAVE EXPRESSED INTEREST IN
COLLABORATING ON THIS PROJECT.
BEFORE I WRAP UP, I'D LIKE TO
SHARE MY THOUGHTS ON TWO
STRENGTHS THAT NURSES AND
NURSING RESEARCH CAN BRING TO
COLLABORATORY EFFORTS.
FIRST IS OUR KNOWLEDGE OF SOCIAL
DETERMINANTS OF HEALTH WITH THE
CONDITIONS IN WHICH PEOPLE ARE
BORN, LIVE, LEARN, WORK, PLAY,
AND AGE.
NURSING'S EARLIEST PIONEERS
RECOGNIZE THAT HEALTH MUST BE
CONSIDERED WITHIN THE CONTEXT OF
PEOPLES' LIVES AND LIVING
CONDITIONS.
IN OTHER WORDS, THEY WERE AMONG
THE EARLIEST TO INCORPORATE
SOCIAL DETERMINANTS INTO THEIR
SOLUTIONS TO HEALTH PROBLEMS.
AND THE TASK OF ELIMINATING
INEQUITIES CAUSED BY SOCIAL
DETERMINANTS IS NOTHING NEW TO
NURSES.
AT NINR, WE CONTINUE TO BUILD ON
THIS RICH HISTORY THROUGH
NURSE-LED EFFORTS TO ADDRESS
INEQUITIES AND SOCIAL
DETERMINANTS OF HEALTH.
IN FACT, A RECENT FUTURE OF
NURSING REPORT MAKES A
COMPELLING CASE FOR NEW
NURSE-LED MODELS TO ADDRESS
SOCIAL DETERMINANTS OF HEALTH
AND SOCIAL NEEDS ALL WITH THE
GOAL OF ACHIEVING HEALTH EQUITY.
WE CAN'T UNDERESTIMATE THE
IMPACT OF SOCIAL DETERMINANTS
AND INDIVIDUALS' ABILITY AND
INTEREST IN PARTICIPATING IN
RESEARCH.
EVEN A PRAGMATIC CLINICAL TRIAL
THAT'S DESIGNED TO BE AS
INCLUSIVE AS POSSIBLE.
MORE OVER, I WOULD ARGUE THAT
PRAGMATIC TRIALS IN HEALTH CARE
SETTINGS THAT SEEK TO ADDRESS
HEALTH INEQUITIES ARE MORE
LIKELY TO BE SUCCESSFUL IF THEY
INCORPORATE AND ADDRESS SOCIAL
NEEDS AND SOCIAL DETERMINANTS OF
HEALTH.
AND, OF COURSE, WE HAVE TO
CONSIDER COMMUNITY ENGAGEMENT
WHICH IS CRUCIAL FOR DESIGNING,
IMPLEMENTING, AND SUSTAINING
INTERVENTIONS.
WHEN COMMUNITY MEMBERS ARE
INCLUDED EQUITABLY FROM THE
OUTSET, WE CAN BETTER UNDERSTAND
WHAT PEOPLE NEED AND WHAT THEY
WANT.
AND WE CAN CO-CREATE AND
CO-EVALUATE INTERVENTIONS THAT
TRULY RESPOND TO THE ISSUES AND
IMPORTANT TO THE COMMUNITY AND
ARE MORE LIKELY TO WORK.
MORE OVER, BUILDING THIS TRUST
AND ENSURING COMMUNITY BUY-IN
HELPS TO SUSTAIN EFFORTS LONG
AFTER GRANT FUNDING HAS ENDED.
AND NURSES MAKE UP NOT ONLY THE
LARGEST SEGMENT OF THE HEALTH
CARE WORK FORCE, BUT ALSO ARE
THE MOST TRUSTED.
SO I ENCOURAGE YOU ALL TO
CONSIDER HOW YOU CAN INCLUDE
NURSES THROUGHOUT THE PROCESS OF
TRIAL DESIGN AND IMPLEMENTATION
TO CAPITALIZE ON THIS TRUST AND
TRULY ENGAGE COMMUNITY PARTNERS
AT ALL LEVELS.
NOW, I MUST POINT OUT THOUGH
THAT COMMUNITY ENGAGEMENT IS
ONLY ONE PART OF THE EQUATION.
WE AS RESEARCHERS MUST BE AND
STAY ENGAGED TOO.
NO HOARDING OF RESEARCH
RESOURCES POWER OR CONTROL, NO
PARACHUTE OR HELICOPTER RESEARCH
AND NO RESEARCH TOURISM.
WE MUST HAVE A COMMITMENT TO
BUILDING MUTUALLY BENEFICIAL
RELATIONSHIPS, BENEFITTING
COMMUNITIES, AND SUSTAINING
EVIDENCE-BASED SOLUTIONS.
SO, THANK YOU AGAIN FOR INVITING
ME TO JOIN YOU TODAY.
I WISH YOU MUCH CONTINUED
SUCCESS IN THE COLLABORATORY'S
NEXT TEN YEARS INCLUDING THROUGH
AN EVEN KEENER FOCUS ON HOW THE
COLLABORATORY CAN IDENTIFY
SOLUTIONS TO ELIMINATE HEALTH
DISPARITIES AND ADVANCE HEALTH
EQUITY.
I LOOK FORWARD TO YOUR
QUESTIONS.
I'D LOVE TO HEAR YOUR THOUGHTS
ON HOW NURSES AND NURSING
RESEARCH CAN ENHANCE PRAGMATIC
CLINICAL TRIALS AT NIH AND
THROUGHOUT THE BIO MEDICAL
ENTERPRISE.
PLEASE DO NOTE THE E-MAIL
ADDRESS HERE, IF THERE'S
ANYTHING WE DON'T GET TO DISCUSS
TODAY OR ANY PROGRAM YOU'D LIKE
MORE INFORMATION ON PLEASE FEEL
FREE TO REACH OUT TO US AND
WE'LL GET YOU THE INFORMATION
YOU NEED.
SO THANK YOU AGAIN.
>> WOW, DR. ZENK, THAT WAS
AMAZING.
THANK YOU SO MUCH FOR THAT
WONDERFUL KEYNOTE AND IT'S SO
GREAT TO SEE HOW YOUR NEW
PRIORITIES AND YOUR NEW
STRATEGIC PLAN REALLY SORT OF
OVERLAP AND, YOU KNOW, SO WELL
FIT WITH WHAT WE'RE DOING HERE
IN THE COLLABORATORY PROGRAM.
I'LL ENCOURAGE EVERYONE IN THE
AUDIENCE, IF YOU HAVE QUESTIONS,
YOU CAN SEND THEM TO THE E-MAIL
THAT YOU SEE POPPING UP ON YOUR
SCREEN NOW.
MARY JOE, IF YOU CAN SWITCH THE
DISPLAY IT WILL BE A LITTLE BIT
BIGGER SO YOU CAN SEE IT AND ALL
OF OUR PANELISTS THAT ARE PART
OF THE ZOOM, YOU CAN PUT THEM
INTO THE CHAT OR JUST RAISE YOUR
HAND IF YOU'D LIKE TO ASK A
QUESTION.
I'LL START OFF, WE CERTAINLY
HAVE HAD MANY TRIALS ACROSS THE
COLLABORATORY THAT HAVE INCLUDED
NURSES IN ONE WAY OR ANOTHER
WHETHER IT'S, YOU KNOW, I'M
THINKING OF THE ABATE TRIAL
WHERE THE NURSES WERE THE ONES
DELIVERING AND DOING THE BATHING
PROCEDURES IN THE HOSPITAL
SETTINGS AND IT WAS PART OF
THEIR CHECKLIST AS TO WHETHER
THEY WERE DOING THE BATHING
PROCEDURES TO REDUCE SUBSEQUENT
INFECTIONS AND A WHOLE RANGE OF
OTHER THINGS AND ONE OF THE
THINGS THAT OUR INVESTIGATORS
HAVE STRUGGLED WITH IS THE
RESEARCH BURDEN THAT'S PUT ON
PROVIDERS, WHATEVER THE PROVIDER
IS, THEY HAVE SO MUCH ALREADY
GOING ON IN THE CLINICAL CARE
SETTING.
ANY ADVICE YOU HAVE ON HOW TO
MAYBE ENGAGE THE NURSING
COMMUNITY POTENTIALLY AS
STAKEHOLDERS OR HOW DO WE WORK
TOGETHER BECAUSE IT'S OFTEN THE
IMPLEMENTATION OF THESE
INTERVENTIONS INTO THE HEALTH
CARE SETTING IS OFTEN A REALLY
BIG CHALLENGE.
SO ANY ADVICE THAT YOU HAVE
THERE?
>> YEAH.
I THINK THAT'S A REALLY
IMPORTANT ISSUE AND YOU POINT
OUT THE HEALTH CARE WORKFORCE
INCLUDING NURSES ARE VERY
STRETCHED AND SO TRYING TO COME
UP WITH SOLUTIONS THAT ARE
FEASIBLE AND IMPLEMENTABLE IS
KEY.
SO I THINK, YOU KNOW, IT'S THE
SAME AS ENGAGING THE COMMUNITY
TO REALLY UNDERSTAND AND ENGAGE
NURSES RIGHT FROM THE START.
THEY KNOW WHAT WORKS, WHAT IS,
YOU KNOW, MORE CHALLENGING AND
SO I'M GLAD TO HEAR THAT NURSES
HAVE BEEN INCLUDED AND I THINK
THERE ARE MANY MORE
OPPORTUNITIES TO EXPAND THEIR
INCLUSION AND THEIR LEADERSHIP
OF THIS TYPE OF RESEARCH.
AND SO WE'RE CERTAINLY
INTERESTED IN AT NINR.
I THINK THERE ARE SO MANY
CHALLENGES OUR HEALTH CARE
SYSTEM BASES IN CLINICAL
SETTINGS AND COMMUNITY SETTINGS
AND THE BRIDGING OF THE TWO THAT
I CERTAINLY HOPE NURSES
INCREASINGLY BECOME MORE ENGAGED
IN THIS AREA OF RESEARCH.
>> THAT'S WONDERFUL.
YEAH.
I KNOW THAT WE REALLY ENJOYED
WORKING WITH KAREN ON THIS NEW
IDEA AROUND HOW TO WE ADDRESS
PAIN MANAGEMENT IN THIS RURAL
AND REMOTE SETTING AND CERTAINLY
MANY OF THE PROVIDERS THAT ARE
SEEN ARE NURSES AND SO HOW DO WE
ENGAGE THEM IN LEADING RESEARCH
IN THAT AREA I THINK IS A REALLY
IMPORTANT ISSUE.
I WILL ENCOURAGE ONCE AGAIN
ANYBODY WHO'S GOT A QUESTION TO
GO AHEAD AND RAISE YOUR HAND OR
OTHERWISE I'M JUST GOING TO TAKE
THE MODERATOR'S PREROGATIVE AND
ASK MY NEXT QUESTION.
SO, I LOVE YOUR NEW LENS LOOKING
AT HEALTH EQUITIES AND THAT IS
AN AREA THAT WE'RE REALLY
ENCOURAGING INVESTIGATORS TO GO
WITH THE NEXT ROUND OF PROJECTS.
DO YOU SEE ANY SORT OF REALLY
GREAT OPPORTUNITIES MAYBE THAT
YOU CAN THINK OF FROM THE
NURSING SCIENCE AREA OF WHERE
THERE WOULD BE OPPORTUNITIES TO
ADDRESS HEALTH INEQUITIES AND
SORT OF THESE HEALTH CARE
SETTINGS THAT ARE JUST, YOU
KNOW, GREAT OPPORTUNITIES THAT
EXIST RIGHT NOW?
>> I MEAN, THE NEEDS AS WE
POINTED OUT IN THE TALK ARE
TREMENDOUS.
THE INEQUITIES WE SEE REALLY ARE
ALARMING, THEY'RE TRAGIC AND
PERSISTENT AND WE URGENTLY NEED
SOLUTIONS AND FROM OUR
PERSPECTIVE, I THINK HOSPITALS
AND CLINICS AND INTERVENTIONS
AND THOSE SETTINGS REMAIN VITAL,
BUT I THINK WE ALSO NEED TO GET
OUT OF THOSE SETTINGS INTO THE
COMMUNITY WHERE PEOPLE LIVE
THEIR LIVES AND WHERE MANY RELY
ON THOSE SETTINGS FOR THEIR CARE
AND TO DISCOVER SOLUTIONS THAT
NOT ONLY ADDRESS IMMEDIATE
HEALTH NEEDS, BUT THAT REALLY
ALSO LOOK UPSTREAM AND INTEGRATE
THOSE FUNDAMENTAL CAUSES OF
HEALTH INEQUITIES.
SO I THINK WE NEED TO BLEND THE
IMMEDIATE NEEDS WITH THE LONGER
TERM, BIGGER PICTURE ISSUES THAT
NEED TO BE TACKLED TO REALLY
MAKE SIZABLE AND MEANINGFUL
DIFFERENCES IN HEALTH
INEQUITIES.
>> WONDERFUL.
I SEE DR. LANGEVIN, DO YOU HAVE
A QUESTION?
>> I DO.
THANK YOU SO MUCH FOR SUCH A
GREAT, WONDERFUL TALK.
ANOTHER THE BEGINNING OF THE
TALK YOU SAID SOMETHING THAT
STUCK WITH ME, YOU SAID NURSES
ARE EVERYWHERE.
IT'S JUST A VERY CENTRAL
CONCEPT.
YOU KNOW, YOU MENTIONED SCHOOLS,
WORK PLACES, YOU MENTIONED
OBVIOUSLY HOSPITALS, CLINICS,
BUT ALSO LONG-TERM CARE
FACILITIES AND A LOT OF THESE
DIFFERENT PLACES WHERE NURSES
ARE ARE NOT NECESSARILY
CONNECTED FROM THE POINT OF VIEW
OF HEALTH RECORDS AND THIS IS A
BIG CHALLENGE BECAUSE WE HAVE
ALL THESE DISCONNECTED SOURCES
OF DATA AND I WAS WONDERING IF
NURSES COULD FUNCTION A LITTLE
BIT IN A SORT OF A GLUE TO
CONNECT ALL THESE.
THIS IS A BIG NEED THAT WE HAVE.
COULD NURSES BE A SOLUTION TO
THIS?
>> I WOULD THINK SO.
THEY ARE A COMMONALITY ACROSS
THOSE SETTINGS AND SPEND SO MUCH
TIME.
I AGREE.
I THINK, HELENE WE'VE TALKED
ABOUT THIS AND THAT WE REALLY
NEED TO BRING DATA TOGETHER
ACROSS THOSE CLINICAL AND
COMMUNITY SETTINGS AND I THINK
IT MAKES SENSE THAT NURSES CAN
PLAY AN IMPORTANT ROLE IN THAT
SENSE AND I'D LOVE TO SEE MORE
DISCUSSION ABOUT THAT.
>> IT'D BE CHALLENGING FOR SURE,
BUT I THINK SO IMPORTANT.
>> TO BE SURE, I THINK THE
REMOTE AND RURAL PAIN CONCEPT
THAT WE'VE BEEN TALKING ABOUT
TOGETHER I THINK ILLUSTRATES THE
NEED FOR THAT KIND OF DATA TO
REALLY MAKE A DIFFERENCE THERE
AS WELL.
>> YES.
ABSOLUTELY.
THANK YOU.
PERHAPS THIS COULD BE A GOOD
TOPIC FOR SOME OF THE
DISCUSSIONS TODAY.
>> YEAH.
ABSOLUTELY.
>> GREAT.
>> WELL, THANK YOU SO MUCH FOR
STARTING US OFF.
WE'RE THRILLED THAT YOU WERE
ABLE TO JOIN US TODAY FOR THE
KEYNOTE LECTURE AND HOPE YOU'LL
BE ABLE TO STAY A LITTLE BIT.
AS ALWAYS, WE ARCHIVE THIS, SO
IT'S AVAILABLE FOR ANYONE TO
TUNE IN IF THEY'VE MISSED
DIFFERENT ELEMENTS.
SO THANK YOU SO MUCH FOR KICKING
US OFF THIS AFTERNOON.
I'M NOW GOING TO TURN THINGS
OVER TO MY COLLEAGUE DR. KEITH
MARSOLO WHO'S GOING TO KICK OFF
OUR FIRST MODERATED DISCUSSION.
KEITH, I'LL TURN THINGS OVER TO
YOU.
>> GREAT.
THANK YOU SO MUCH, WENDY.
SO, THE FIRST PANEL THAT WE'RE
GOING TO TALK ABOUT TODAY THAT
WENDY TEED UP IN HER INTRO
CONVERSATION WAS REALLY AROUND
SQUEEZING MORE VALUE OUT OF THE
ELECTRONIC HEALTH RECORDS.
SO IF WE GO TO THE NEXT
SLIDEMENT JUST AS A WAY OF
BACKGROUND, YOU KNOW, WE'RE
TALKING SORT OF ABOUT THE LAST
TEN YEARS OF SUCCESS WITHIN THE
PRAGMATIC TRIALS COLLABORATORY
AND ACTUALLY OVER THAT SAME
TIME, WE'VE SEEN KIND OF A
SIMILAR CONSISTENT EVOLUTION
WITHIN THE EHR TO BETTER SUPPORT
RESEARCH PROCESSES AND THOSE ARE
RELATED, YOU KNOW, TO COHORT
IDENTIFICATION, RECRUITMENT,
DELIVERY OF INTERVENTIONS,
MONITORING OF OUTCOMES,
MONITORING INTERVENTIONS AND
SORT OF THE WHOLE GAMUT OF
PROCESSES THAT YOU NEED TO
SUPPORT TRIALS.
THERE'S BEEN, YOU KNOW,
CONSISTENT PROGRESS.
NOW, THE CAPABILITIES, THEY DO
VARY ACROSS THE VENDOR AND THEY
VARY WITH SORT OF WITHIN A
VENDOR'S CUSTOMER BASE, SO IT'S
KIND OF THE OLD JOKE THEY USED
TO MAKE ABOUT ACADEMIC MEDICAL
CENTERS WHERE IF YOU'VE SEEN ONE
IT'S KIND OF THE SAME THING
AROUND HEALTH RECORDS
IMPLEMENTATION.
IF YOU'VE SEEN ONE YOU'VE SEEN
ONE.
WE ARE CONSISTENTLY RAISING THE
BAR OR THE BASE OF THAT EVEN IF
THERE'S SORT OF VARYING
CAPABILITY IN SORT OF WHAT WE
CAN DO NOW IS STILL MUCH BETTER
THAN WHAT WE COULD HAVE DONE TEN
YEARS AGO.
SO, EVEN SO, THERE ARE SORT OF
CHALLENGES THAT DO REMAIN.
I THINK THIS IS IN PARTICULAR
SORT OF MODIFYING THE EHR SO
IT'S FIT FOR PURPOSE FOR EVERY
TRIAL OR FOR ANY TRIAL.
SO IT MIGHT WORK FOR MANY, BUT
IT DOESN'T NECESSARILY DO
EVERYTHING FOR EVERYBODY.
YOU KNOW, CHALLENGES REMAIN
AROUND SORT OF COLLECTION AND
SCALE FOR NEW DATA ELEMENTS SUCH
AS SOCIAL DETERMINANTS OF HEALTH
AND, YOU KNOW, AGGREGATING DATA
ACROSS SITES.
THESE ARE AGE-OLD PROBLEMS AND
THINGS GET BETTER, BUT WE SORT
OF COME UP WITH NEW MORE COMPLEX
TRIALS OR PROJECTS THAT WE WANT
TO EXECUTE AND SO WE'VE GOT NEW
PROBLEMS THAT WE NEED TO DEAL
WITH.
IF WE GO TO THE NEXT SLIDE.
SO, YOU KNOW, WHAT WE WANTED TO
REALLY TRY AND DO WITHIN THE
PANEL TODAY IS TOUCH ON A FEW
KEY QUESTIONS THAT WE'RE GOING
TO DIG INTO.
SO, YOU KNOW, GIVEN THE VARIOUS
ACTIVITIES THAT EHR CAN SUPPORT
WITHIN A TRIAL AND I MENTIONED
SOME OF THESE IN THE PREVIOUS
SLIDE, YOU KNOW, IDENTIFYING OR
RECRUITING PATIENTS.
DELIVERING INTERVENTIONS,
MONITORING INTERVENTIONS AND
OUTCOMES.
WHAT WE REALLY WANT TO TRY TO
DIVE INTO IS THE EHR FIT FOR
MORE TASKS HTHAN OTHERS.
THEY'RE A PIECE OF CAKE OR
THINGS THAT ARE JUST KIND OF
GOING TO BE A CHALLENGE KIND OF
NO MATTER WHAT YOU'RE TRYING TO
DO, NO MATTER WHAT YOU'RE
STUDYING WITHIN YOUR TRIAL AND
THEN THE STRATEGIES FOR HEALTH
SYSTEMS TO COLLECT NEW DATA
ELEMENTS AND THEN I THINK, YOU
KNOW, WHAT WE'VE SEEN OVER THE
PAST TEN YEARS SORT OF WHAT'S ON
OUR WISH LIST AND WHAT DO WE
PROJECT WE WOULD LIKE IT TO SEE
OVER THE NEXT TEN YEARS SO WE
CAN CONTINUE TO MAKE PROGRESS.
SO IF WE GO TO THE NEXT SLIDE.
SO I'M JOINED TODAY BY FOUR
PANELI
PANELISTS FOUR SORT OF ALL STARS
FROM THE COLLABORATORY.
MIG
MIGUEL VAZQUEZ, ANDREA CHEVILLE,
JEFFY JARVIK AND GREG SIMON.
EACH OF OUR PANELIST IS GOING TO
BRIEFLY DESCRIBE SORT OF THEIR
TRIAL AND THEIR SORT OF USE OF
THE EHR AND WE'RE REALLY GOING
TO DIVE INTO THOSE QUESTIONS
THAT I HAD ON THE PREVIOUS
SLIDE.
RATHER THAN SPEND THE BULK OF
THE TIME EACH PANELIST SPENDING
TIME TALKING ABOUT THEIR TRIAL,
WE'RE GOING TO MIX IT UP A
LITTLE BIT AND DO A DEEPER DIVE
INTO EACH OF THOSE TASKS, SO
IDENTIFYING AND RECRUITING
PATIENTS AND DRILL DOWN INTO
THAT AND HAVE EACH PANELIST
RESPOND WITH THEIR PERSPECTIVE
SO THAT WAY WE CAN REALLY FOCUS
ON SORT OF THE SPECIFIC TASKS AS
OPPOSED TO SORT OF TAKING IT AS
A SORT OF TRIAL BY TRIAL.
SO WE'LL SEE HOW THIS GOES.
IT WORKED WELL IN SOME OF THE
PREVIOUS PANELS IN THE
COLLABORATORY STEERING
COMMITTEE, AND SO WE'LL SEE IF
WE CAN CONTINUE THAT RECORD OF
SUCCESS.
SO I THINK IF WE GO TO THE NEXT
SLIDE, I BELIEVE WE'VE GOT THE
SPOT TRIALS SO I'LL TURN IT OVER
TO GREG FOR HIS INTRODUCTION.
>> SURE.
THANKS.
AS MANY REMEMBER, THIS TRIAL WAS
A PATIENT LEVEL RANDOMIZED
PRAGMATIC TRIAL.
WE WERE EVALUATING TWO OUTREACH
INTERVENTIONS VERSUS USUAL CARE
FOR PREVENTION OF SELF-HARM
EVENTS OR SUICIDE ATTEMPTS AMONG
OUTPATIENTS WHO REPORTED
FREQUENT SUICIDE.
IT WAS FOUR INTEGRATION SYSTEMS.
BUT NOT THE SAME VERSION.
RELEVANT TO THIS PANEL, WITHIN
THIS TRIAL, THE ELECTRONIC
HEALTH RECORD DATA WERE USED FOR
A VARIETY OF PURPOSES.
FIRST, EHR DATA WERE USED TO
IDENTIFY PEOPLE WHO WERE
ELIGIBLE FOR THE TRIAL.
EACH WEEK IDENTIFYING PEOPLE WHO
HAD MADE AN OUTPATIENT VISIT,
HAD COMPLETED A PHQ 9 DEPRESSION
QUESTIONNAIRE AND ON THAT ITEM
THOUGHTS OF SETH OR SELF-HARM
HAD THOSE THOUGHTS MOST DAYS OR
NEARLY EVERY DAY.
SAME WERE APPLIED TO VARIOUS
OTHER EXCLUSION CRITERIA THAT
PEOPLE DID NOT HAVE DEVELOPMENT
DELAY BECAUSE THE INTERVENTIONS
WOULD NOT BE APPROPRIATE
LIMITING TO PEOPLE WHO WERE AT
LEAST REGISTERED FOR USE OF THE
PATIENT PORTAL BECAUSE THAT'S
HOW INTERVENTIONS WERE LARGELY
DELIVERED LIMITING TO PEOPLE WHO
WERE ENROYALED IN THE
PARTICIPATING HEALTH INSURANCE
PLAN TO MAKE SURE WE WERE ABLE
TO ASCERTAIN OUTCOMES.
SO THAT PROCESS WAS RUN EVERY
WEEK TO IDENTIFY AND
AUTOMATICALLY RANDOMIZE PEOPLE
WHO WERE NEWLY ELIGIBLE.
THE INTERVENTIONS DEPENDING A
LOT ON MESSAGING CAPABILITIES
THROUGH THE PORTAL FOR OUTREACH
AND ONGOING CONTACT.
AND THEN, DATA THAT CAME FROM
THE EHR, BUT ALSO FROM EXTERNAL
INSURANCE CLAIMS CPS FROM STATE
MORTALITY DATA, WE'RE USED TO
IDENTIFY THE PRIMARY OUTCOME,
THAT IS, SELF-HARM EVENTS OR
SUICIDE ATTEMPTS WHICH COULD BE
NONFATAL SELF-HARM EVENTS
PRESENTED FOR HEALTH CARE OR
FATAL EVENTS FROM STATE
MORTALITY DATA.
SO IN THIS, THE EHR DATA WERE
USED AT EVERY STEP IN THE TRIAL
AND WE'LL TALK ABOUT SOME OF
THOSE STEPS.
THANKS.
>> GREAT.
THANKS, GREG.
AND NOW I THINK NEXT IS IF WE GO
TO THE NEXT SLIDE.
JERRY.
>> THANKS, KEITH.
AND GOOD MORNING EVERYONE.
OR GOOD AFTERNOON FROM THE EAST
COAST.
HARD TO BELIEVE IT'S BEEN TEN
YEARS SINCE WE STARTED THINKING
ABOUT THE LEER TRIAL.
SO OURS WAS A CLUSTER RANDOMIZED
TRIAL WHERE WE WERE COMPARING
THE INSERTION OF BENCHMARK
PREVALENCE DATA INTO ROUTINE
RADIOLOGY REPORTS OF PEOPLE WHO
HAVE GOTTEN LUMBAR SPINE
IMAGING.
WE CONDUCTED THIS AT FOUR
INTEGRATED HEALTH SYSTEMS.
ALL OF WHOM WERE EVENTUALLY
USING EPIC, BUT THAT'S ONE OF
THE PROBLEMS THAT WE FACED ALONG
THE WAY WHICH WE CAN TALK ABOUT
LATER.
THE HEALTH SYSTEMS EHRs AND
OTHER INFORMATION SYSTEMS
ACTUALLY IMPORTANTLY WERE USED
FOR A VARIETY OF PURPOSES AND
INCLUDING IDENTIFYING THE
PRIMARY CARE CLINICIANS IN THEIR
CLINICS SINCE IT WAS A CLUSTER
RANDOMIZED TRIAL WITH THE UNIT
OF RANDOMIZATION BEING THE
CLINICS.
WE ALSO USED THE ELECTRONIC
INFORMATION SYSTEMS TO INSERT
THE INTERVENTION TEXT INTO THE
RADIOLOGY REPORTS AND THIS WAS
EITHER DIRECTLY THROUGH THE EHR
OR COULD HAVE ALSO BEEN THROUGH
THE REPORTING SYSTEMS FOR
RADIOLOGY TAILORING THE
INTERVENTION BY MODALITY AND
PATIENT AGE.
SO WE HAD DIFFERENT FLAVORS OF
THE INTERVENTION TEXT DEPENDING
ON EXACTLY WHAT IMAGING TEST
PEOPLE GOT AND HOW THE PATIENT
WAS.
VERIFICATION OF THE INTERVENTION
IMPLEMENTATION.
SO WE DID THIS AT REGULAR
INTERVALS AFTER IT WAS TURNED ON
AND WORKING AND FINALLY THE
ASSESSMENT OF THE OUTCOMES
INCLUDING OUR PRIMARY OUTCOMES
WHICH WERE SPINE-RELATED AND
OPIOID PRESCRIPTIONS
CROSS-SECTIONAL IMAGING, SPINAL
INJECTIONS AND SURGERIES.
THANKS.
>> GREAT.
IF WE GO ON TO THE NEXT SLIDE
WE'VE GOT "NO HARM" WITH ANDREA.
>> THANKS, KEITH.
IT'S A REAL PLEASURE TO BE ON
THE PANEL AND TO JOIN EVERYBODY.
NO HARM STANDS FROM NONCOLLAGIC
OPTIONS AND POST HOSPITAL BASED
AND REHABILITATION PAIN
MANAGEMENT.
HENCE THE NEED FOR AN ACRONYM.
IT IS A CLUSTER RANDOMIZED WEDGE
AND OUR GOAL IS TO MAKE ROBUSTLY
VALIDATED NONPHARMACOLOGIC PAIN
CARE EVALUATING PATIENTS
UNDERGOING SURGERIES IN THE HOPE
OF IMPROVING PAIN AND FUNCTION
WHILE ATTENUATING INAPPROPRIATE
AND PROLONGED OPIOID USE.
THE INTERVENTION IS CONDUCTED
THROUGHOUT SIX FACILITIES OR
SITES WITHIN THE LARGER MAYO
ENTERPRISE AND WE HAVE THE
ADVANTAGE OF USING A SINGULAR
EPIC EHR.
SO WE HAVE A CENTRALIZED EHR,
ANY CHANGES MADE AFFECT ALL THE
SITES AND OVERSIGHT AND
GOVERNANCE OF THE EHR WAS COMMON
ACROSS OUR SITES AND THAT WAS A
TREMENDOUS BOOM.
I MENTIONED IT'S CLUSTER
RANDOMIZED.
WE USED THE EHR RELIED ON IT
VERY HEAVILY FOR INTERVENTION
DELIVERY.
THERE ARE THREE COMPONENTS TO
THE NO-HARM INTERVENTION.
ONE IS A CONVERSATION GUIDE WE
CALL IT THAT'S AUTOMATICALLY
SENT TO PATIENTS PORTAL AND THAT
HAS AN EDUCATION COMPONENT THAT
APPRISES PATIENTS OF THE RISK OF
OPIOIDS, IT NORMS PAIN AND
POST-OPERATIVE PAIN SO PATIENTS
HAVE REALISTIC EXPECTATIONS.
IT ALSO INTRODUCES
NONPHARMALOGICAL IN MANY OF
THESE MODALITIES ARE HIGHLY
EFFECTIVE, EVIDENCE-BASED AND
HAVE BENEFICIAL EFFECTS ON OTHER
PROBLEMATIC SYMPTOMS, ANXIETY,
SLEEP DISTURBANCE AFTER SURGERY.
THE GUIDE THEN EDUCATES PATIENTS
ON THE 13 MODALITIES THAT ARE
SUPPORTED BY THE NO-HARM AND
THEN ENABLES THEM TO SELECT
MODALITIES AND WE ENCOURAGE THEM
TO SELECT THREE.
BUT THAT INFORMATION AND THOSE
PREFERENCES BECOME INTEGRAL
PARTS OF THE EPIC EHR AND ARE
AVAILABLE TO DRIVE CLINICAL
PHYSICIAN SUPPORT.
SO THE CONVERSATION GUIDE IS ONE
ELEMENT.
THE SECOND IS A COLLECTION OF
CLINICAL DECISION SUPPORT THAT
PROMPTS CLINICIANS TO INTRODUCE,
NORMALIZE, VALIDATE, AND SUPPORT
THE USE OF THESE MODALITIES AT
ALL POINTS ALONG THE COMPLEX
TRAJECTORIES, OPERATIVE CARE
TRAJECTORIES AND THE LAST
COMPONENT IS A SWEET OF
SELF-MANAGEMENT TOOLS TO SUPPORT
UPTAKE, PRACTICE, AND USE AND
ADAPTATION OF ALL OF THE
MODALITIES.
SO WE LIKE OTHERS USE THE EHR
FOR TIMELY IDENTIFICATION AND
ENROLLMENT.
SO WE WANTED TO IDENTIFY THEM
IMMEDIATELY ONCE IT WAS DECIDED
THEY WERE GOING TO RECEIVE A
QUALIFYING SURGERY.
WE ALSO USED THE EHR TO ALTHOUGH
IT WAS CLUSTER RANDOMIZED TO
SUPPORT TRANSITIONS FROM CONTROL
TO ACTIVE STATE AS A DIFFERENT
CLUSTERS WENT LIVE.
THE INTERVENTION, THE GROUP
ASSIGNMENT I MENTIONED WAS BASED
ON SITE DATA AND SURGICAL
PROCEDURES.
SO ONCE A PATIENT WAS PLACED ON
AN EPIC INDUSTRY, THEIR GROUP
STATUS WAS DETERMINED THE
CONVERSATION GUIDE WAS
AUTOMATICALLY DELIVERED TO THEIR
PORTAL AND APPROPRIATE PROM
ASSIGNMENTS WERE INITIATED.
THE EPIC EHO IS CENTRAL TO OUR
BUNDLED INTERVENTION DELIVERY.
AS I MENTIONED, THE CONVERSATION
GUIDE WAS DELIVERED TO THE
PATIENT'S PORTAL, BUT SO WERE
TAILORED MESSAGES THAT MATCHED
PATIENT-SPECIFIC PREFERENCES,
THEIR EXPRESSED LEVEL OF
CONFIDENCE AND SELF-EFFICACY TO
UTILIZE THE INTERVENTION.
THE EHR WAS USED TO PROMPT
CLINICIANS ACROSS THE FULL
TRAJECTORY SO THAT THOSE
INCLUDED PATIENTS IN THE
PRE-OPERATIVE OUTPATIENT
CLINICS, HOSPITAL-BASED NURSES,
PHYSICAL AND OCCUPATIONAL
THERAPISTS AS WELL AS THE CARE
TEAMS.
I MENTIONED INTERVENTION
TAILORING.
WE MONITORED INTERVENTION
FIDELITY ACROSS OUR CLUSTERS AND
WE CAN USE THE EHR TO COLLECT
OUR OUTCOMES AND I'LL STOP
THERE.
THANKS.
>> THANKS, ANDREA.
FINALLY, MIGUEL.
>> THANK YOU, KEITH.
GOOD AFTERNOON EVERYONE.
ICD PIECES IS A CLUSTER, A
RANDOMIZED PRAGMATIC TRIAL.
IT COMPARES A MODEL AND INVOLVED
INFORMATION TECHNOLOGY AND
SOFTWARE PLATFORM AND IDENTIFIED
PATIENTS AND ASSIGNED
FACILITATORS TO HELP PRIMARY
PROVIDERS.
THIS WAS TO IMPROVE CARE OF
PATIENT WHO IS HAD A CO-EXISTENT
TRIAL OF CHRONIC KIDNEY DISEASE,
DIABETES.
PATIENTS HAD TO MEET THE
CRITERIA WITH THE THREE
DIAGNOSISES.
IN THIS MODEL OF CARE WAS
COMPARED TOES.
IN THIS MODEL OF CARE WAS
COMPARED TO STANDARD CARE AND
THE MAIN OUTCOME OF THE STUDY
WAS HOSPITALIZATIONS AND THERE
WERE SOME OTHER SECONDARY
OUTCOMES INCLUDING EMERGENCY
VISITS, CARDIOVASCULAR EVENTS --
AS FAR AS THE PARTICIPATING
HEALTH SYSTEMS, THERE WERE FOUR
LARGE HEALTH SYSTEMS WITH VERY
DIFFERENT LEVELS OF INTEGRATION.
ONE OF THEM WAS THE COUNTY
HOSPITAL HEALTH SYSTEM VERY
INTEGRATED FROM THE OUTSIDE
CLINICS ALL THE WAY TO THE MAIN
HOSPITAL WHEN PATIENTS REQUIRED
ADMISSIONS.
AND ALSO THE VA SYSTEM WAS A
PARTICIPANT AND THEN THERE WERE
TWO HEALTH SYSTEMS, ONE
NONPROFIT IN NORTH TEXAS WAS
ONE, ACO -- MUCH LOWER LEVELS OF
INTEGRATION.
SO THERE WAS QUITE A
HETEROGENEITY IN TERMS OF
CHARGE.
TWO OF THE HEALTH SYSTEMS USED
EPIC WITH VARIATIONS.
ONE HEALTH SYSTEM USED ALL THE
SCRIPTS AND ONE HEALTH SYSTEM
USED CPRS.
HEALTH SYSTEM EHRs WERE USED FOR
VARIOUS TASKS.
THE MOST CRITICAL ONE FOR US WAS
TO IDENTIFY POSSIBLE CANDIDATES
AND KNOW WHAT PATIENTS TO
RECRUIT FOR THE STUDY.
THERE WAS ALSO SOME ASSISTANCE
IN TERMS OF THE INTERVENTIONS IN
THE CAPTURE OF SOME OF THE
OUTCOMES.
AND THE MAIN PRIMARY OUTCOME WAS
DATA CLAIMSES, BUT ALSO THERE
WAS SOME CONTRIBUTION FROM THE
--
>> GREAT.
THANK YOU.
YOU BROKE UP BRIEFLY AT LEAST
FOR ME AT THE END OF THAT,
MIGUEL.
BUT I THINK WE HEARD UP UNTIL
THE LAST SENTENCE OR TWO.
SO THANK YOU.
OKAY.
SO THAT'S GREAT.
SORT OF A GREAT SUMMARY FROM OUR
PANELISTS.
I ACTUALLY THINK IT'S KIND OF
NICE EVERYBODY HAS A SORT OF
CLIFF HANGER FROM THEIR STUDY
THAT WE'LL GET INTO IN THESE
NEXT SET OF SLIDES.
AND SO, THE WAY THAT WE'RE GOING
TO DO THIS IS EACH OF OUR
PANELIST IS GOING TO TAKE POINT
ON THE DIFFERENT TASKS THAT WE
SORT OF HIGHLIGHTED FROM THE
EHR.
AND, REALLY SORT OF PROVIDE AN
OVERVIEW OF WHAT KIND OF WHAT
WORKED WELL AND WHAT WERE THE
UNPLEASANT SURPRISES AND OTHER
LESSONS LEARNED JUST TO KEY UP
THE DISCUSSION AND WE'LL HAVE
THE REST OF OUR PANELISTS WEIGH
IN ON EACH TOPIC AS WELL.
SO FIRST UP IS USING THE EHR TO
IDENTIFY OR RECRUIT PATIENTS AND
I THINK, MIGUEL, AS YOU TALKED
ABOUT WITH ICD PIECES THAT WAS
CRUCIAL FOR YOUR STUDY AND SO
WE'LL LEAVE THIS ONE TO YOU TO
GET US STARTED.
>> THANK YOU.
SO AS I MENTIONED IN ICD PIECES,
WE DEPENDED ON THE EHR TO
IDENTIFY POSSIBLE CANDIDATES IF
FOR THE STUDY AND THEN RECRUITED
THOSE AS PARTICIPANTS IN ICD
PIECES.
SO PIECES IS ACTUALLY A SOFTWARE
THAT WAS DEVELOPED BY ONE OF OUR
INVESTIGATORS AND WITH THAT WE
COULD SURVEY THE EHR AND KNOW
WHAT PATIENTS MET CRITERIA AS
CANDIDATES.
OUR STUDIES I MENTIONED THE
TRIAL WAS CHRONIC DIABETES AND
HYPERTENSION.
WE HAD LIKE A PHENO TYPE THEY
NEEDED TO HAVE CHRONIC KIDNEY
DISEASE AND THAT WAS DEFINED ON
OBJECTIVE LABORATORY CRITERIA
DATA AND SO GFRs SO THESE WERE
LABORATORIES FOR DIABETES.
ITS CRITERIA WAS BASED ON
GLUCOSE LEVELS OR THE USE OF
HYPOGLYCEMIC AGENTS OR BLOOD
PRESSURE READINGS OR
HYPERTENSION LIST OR PROBLEM
WITH HYPERTENSION.
SO AN OBJECTIVE CRITERIA TO
CREATE THIS.
SO THE EHR WAS VERY HELPFUL IN
PIECES.
IT WAS ABLE FROM THE CLOUD
INFORMATION FROM THE HEALTH
SYSTEMS WOULD BE THERE AND THEN
IDENTIFY POTENTIAL CANDIDATES.
THEN, A LIST WAS DELIVERED EVERY
WEEK, ONCE A WEEK TO EACH
PARTICIPANT ON SITE TO --
PRACTICES ABOUT POTENTIAL
CANDIDATES FROM THEIR PATIENTS
THAT WERE COMING OFF THAT WEEK.
THEN THAT LIST WOULD BE REVIEWED
AND PATIENTS WOULD BE THEN IN A
DEBT POINT.
THAT PROVIDER OR CLINIC PERSONAL
WOULD THEN INVOLVE THE PATIENT
ACTIVELY INTO THE STUDY.
IT WAS POSSIBLE TO FIND A LARGE
NUMBER OF PATIENTS.
WE INVOLVED 11,000 PATIENTS IN
THE STUDY FOLLOWING THESE
PROTOCOLS.
SO IT WORKED VERY WELL FOLLOWING
PATIENTS.
WHEN WE WERE MAKING PROGRESS TO
GET READY TO LAUNCH THE STUDY,
WE LEARNED THAT TWO OF THE
HEALTH SYSTEMS WOULD NOT ALLOW
THEIR DATA TO COME OUT TO THE
CLOUD SO THIS ALGORITHM COULD
IDENTIFY THE PATIENTS.
SO OUR EEUCHLT T COLLABORATORS
HAD TO GO BACK TO FIND A WAY AND
THEN TO RECREATE THE ALGORITHM
INSIDE THE FIREWALL FOR THESE
TWO SYSTEMS.
SO THAT'S SOMETHING THAT WE HAD
NOT PLANNED AND CAUSED SOME
DELAYS, BUT EVENTUALLY, THERE
WAS A SOLUTION TO BYPASS THAT
OBSTACLE.
ANOTHER SURPRISE WAS THAT WE
NEEDED TO HAVE MORE THAN ONE
LABORATORY FOR SOME OF THE
CRITERIA, FOR EXAMPLE, FOR
CHRONIC OBESITY, WE NEEDED TO
HAVE TWO RATIOS SEPARATED BY AT
LEAST THREE MONTHS.
THEN IT WOULD ALLOW US TO KNOW
WHAT PATIENTS WERE POSSIBLE
CANDIDATES.
THE PLAN OF ENROLLMENT, THESE
LABORATORIES HAD TO BE UPDATED
TO MAKE SURE THE PATIENT STILL
MET CRITERIA AND WAS AN ELIGIBLE
CANDIDATE.
WELL, SOMETIMES THE LABORATORIES
WERE NOT UPDATED INTO THE
ALGORITHM IN PATIENTS COULD NOT
BE IDENTIFIED, POTENTIAL
CANDIDATES.
THAT'S SOMETHING WE LEARNED IN
THE FIRST FEW MONTHS OF THIS
STUDY EVEN THOUGH THE SYSTEM WAS
VERY EFFICIENT TO THE PATIENTS,
THEY NEEDED TO BE THERE.
SOME PATIENTS COULD BE MISSED.
SO WE HAD TO HAVE A SECOND, A
CHECK WITH A MANUAL REVIEW OF
PATIENTS COMING TO THAT
PARTICULAR CLAIM.
SO THAT WAS SOMETHING THAT WE
WERE NOT EXPECTING, BUT, AGAIN,
WE WERE ABLE TO GET AROUND IT
WITH HELP.
AND COLLABORATORS.
WHAT LESSONS HAVE WE LEARNED
BESIDES THOSE FROM THE
SURPRISES, WELL, THE TECHNOLOGY
AND THE EEUCHLT T ARE GREAT, BUT
NOT ENOUGH.
I MENTIONED THE ALGORITHM COULD
WORK VERY WELL.
WE COULD IDENTIFY THE PATIENTS,
WE COULD HAVE A MANUAL REVIEW
WHERE THOSE PATIENTS WERE COMING
UP IN THEIR INDUSTRY OR LIST
THAT WAS PROVIDED EVERY WEEK.
BUT IN THE END, WE REQUIRED
SOMEONE IN THE CLINIC, IDEALLY
THE PROVIDER OR IN SOME CASES,
SOME CLINIC PERSON ASSIGNED TO
THIS TASK TO ACTUALLY MANUALLY
OR ACTIVELY ENROLL THE PATIENT
SO THAT ALL INTERVENTIONS WOULD
THEN BECOME RELEVANT FOR THE
PATIENT.
BUT THAT LAST STEP WAS NOT
HAPPENING, THEN THE PATIENTS
WOULD COME THROUGH CLINIC AND
WOULD BE MISSED EVEN -- THOUGH
THERE WAS A LESSON ALSO THAT WE
LEARNED.
WE WERE ABLE TO ADDRESS TO SOME
DEGREE BUT NEVER OVERCOME 100%
THAT PARTICULAR LIMITATION THAT
SOME PATIENTS, THEY WERE NOT
BEING ACTIVATED BY THE CLINIC.
BUT IN GENERAL TERMS, WE WERE
VERY HAPPY ABOUT HOW EHR WORKED
TO ALLOW US TO IDENTIFY
CANDIDATES AND TO RECRUIT
PATIENTS.
SO I WILL STOP AT THIS POINT.
>> GREAT.
THAT'S A REALLY FANTASTIC
SUMMARY I THINK OF SORT OF WHAT
MANY OF THE PROJECTS GO THROUGH.
ARE THERE ANY PANELISTS THAT
WANT TO WAVE SORT OF TO SPEAK
NEXT?
OTHERWISE I CAN JUST CALL ON
FOLKS.
JERRY'S GOT HIS HAND UP.
JERRY, WOULD YOU LIKE TO ADD ON
THERE?
>> SURE.
KEITH, JUST TO CONTINUE WITH AN
ISSUE THAT MIGUEL RAISED ABOUT
NEEDING TO UPDATE CERTAIN
ASPECTS OF INFORMATION AS YOU
WENT ALONG, ONE OF THE, YOU
KNOW, I THINK PREVALENT THEMES
WE FACE AS FAR AS SURPRISES OR
LESSONS LEARNED IS THAT THE
SYSTEMS WEREN'T AS STATIC AS WE
ASSUMED AT FIRST AND THAT WE
WERE CONSTANTLY NEEDING TO
ADJUST TO A VARIETY OF CHANGES
AS WE WENT ALONG.
YOU KNOW, I THINK ONE EXAMPLE OF
THAT FOR US SO WE COULD DEFINE
WHO OUR CLINICS WERE BECAUSE
THEY WERE OUR UNIT OF
RANDOMIZATION.
AND THAT'S JUST ONE EXAMPLE OF A
VARIETY OF THINGS THAT WE NEEDED
TO MONITOR AND UPDATE AS WE WENT
FORWARD WITH THE TRIAL.
>> YEAH.
THAT'S A GREAT POINT.
GREG, ARE YOU RAISING YOUR HAND
THERE.
>> YEAH.
IN TERMS OF THINGS THAT WENT
WELL AND SORT OF AVOIDED
SURPRISES MOST OF THE SURPRISES
ARE NOT PLEASANT SURPRISES.
FORTUNATELY, WE WERE ABLE TO
LOOK VERY CAREFULLY BEFORE THE
TRIAL STARTED ACTUALLY ALL THE
POTENTIAL PARTICIPATING SITES IN
TERMS OF HOW CONSISTENT WERE THE
PHQ 9 MEASURES BEING USED.
WHAT WAS THE VOLUME.
WHAT PROPORTION OF THEM WERE
REPORTING SUICIDAL THOUGHTS AND
THAT WAS A KEY POINT IN
SELECTING SITES.
THERE WERE SOME SITES WHERE THE
QUESTIONNAIRES WERE NOT BEING
USED CONSISTENTLY AND THE VOLUME
WAS JUST TOO LOW.
AND THEN THE OTHER IN TERMS OF
DEALING WITH SURPRISES, YOU
KNOW, THE ROUTINE THAT WAS SET
UP WHICH ACTUALLY FOR
CONFIDENTIALITY CONDITION THE AT
EACH SITE.
FOLKS AT KP WASHINGTON WOULD
GENERATE WHAT MOST PEOPLE WOULD
CALL A WATERFALL DIAGRAM.
THIS WAS A PROPORTION FILLED OUT
A PHQ 9.
THIS WAS THE PROPORTION WHO HAD
ALREADY BEEN ENROLLED IN THE
TRIAL AND ALL THE EXCLUSION
CRITERIA.
AND THEN THE SORT OF LOG OF THAT
PROCESS WAS THEN JUST
AUTOMATICALLY E-MAILED TO THE
CENTRAL SITE EVERY WEEK AND
THERE WERE A FEW SURPRISES ALONG
THE WAY IN TERMS OF SOMETHING
JUST NOT LOOKING RIGHT, BUT
GENERATING THAT LOG FILE AND
LOOKING AT THE WATERFALL EVERY
WEEK ALLOWED YOU TO QUICKLY
PINPOINT HERE'S WHAT IT IS.
SOMETHING IS BROKEN ABOUT THE
PATIENT REPORTED OUTCOME DATA
GETTING LOADED INTO THE DATA
WAREHOUSE THIS WEEK OR SOMETHING
IS BROKEN ABOUT FAR TOO MANY
PEOPLE OR FAR TOO FEW PEOPLE
BEING EXCLUDED FOR THIS REASON,
LET'S TRACK THAT DOWN.
SO THOSE THINGS CERTAINLY DID
HAPPEN.
THESE INEVITABLE THOSE THINGS
HAPPENED, BUT HAVING A PROCESS
IN PLACE THAT ALLOWS YOU TO
QUICKLY PINPOINT WHERE DID IT
HAPPEN AND THEN TRACK THAT DOWN
AND FIX IT, THAT WORKED PRETTY
WELL.
>> YEAH.
GREAT POINT PLANNING FOR SOME
RESILIENCY THERE BECAUSE THE
SYSTEM WILL BREAK AT SOME POINT.
ANYTHING TO ADD OVER WHAT'S BEEN
SAID?
>> YEAH.
JUST A COUPLE OF POINTS.
I THINK IN OUR STUDY, ENROLLMENT
WAS TIME SENSITIVE BECAUSE MANY
OF THE PATIENTS, THE INTERVAL
BETWEEN ORDERING THE SURGERY AND
THE SURGERY OCCURRING, IT COULD
BE DAYS.
AND SO THIS IS WHERE THE H R
SERVED US INCREDIBLY WELL.
WE WERE ABLE TO VERY PRECISELY
PINPOINT THE TIME AT WHICH A
PATIENT BECAME ELIGIBLE AND, FOR
US, THAT ELECTRONIC EVENT WAS
THE ENTRY OF AN ORDER, THE
SURGICAL ORDER INTO THE SYSTEM.
LITERALLY, WE HAVE A PRECISE
TIME STAMP AND WE WERE ABLE TO
DEVELOP FAIRLY NOT OVERLY
CONVOLUTED, BUT NOT SIMPLE LOGIC
THAT
TRIANGULATE TO IDENTIFY THOSE
PATIENTS WHO SHOULD BE CONTROL
VERSUS INTERVENTION.
AND SO BY TWEAKING THAT LOGIC
THROUGHOUT A VERY GEOGRAPHICALLY
DISBURSED HEALTH SYSTEM, WE WERE
ABLE TO SHIFT ON A DIME.
PATIENTS EXPOSURE TO CERTAIN
INTERVENTION ELEMENTS.
SO THAT WORKED WELL.
ONE SOURCE OF FILIBUSTER
REGISTRATION, WE USED A INDUSTRY
FOR DRIVING A LOT OF ELEMENTS
OUT.
THAT WAS NOT UPDATED UNTIL AFTER
24 HOURS.
THE LIGHTS DIM AND THE AIR
CONDITIONER.
IT TAKES SO MUCH POWER THAT IT'S
NOT COMPATIBLE TO UPDATE
INDUSTRIES DURING BUSINESS
HOURS.
SO THE KNOWLEDGE THAT A PATIENT
OR EVEN THE EHR'S AWARENESS THAT
A PATIENT WAS ASSIGNED TO THE
INTERVENTION DID NOT OCCUR UNTIL
MIDNIGHT AND THAT HAD SOME
SUBTLE REPERCUSSIONS.
UNMREZN'T SURPRISES AND THESE
WEREN'T REALLY EHR SURPRISES.
WHAT WE DISCOVERED WAS
HETEROGENEITY OF WORK FLOWS.
WE FOUND THAT THE OBSTETRICIANS
INCLUDING C-SECTIONS IN THE
TRIAL THE OBSTETRICIANS IN
ROCHESTER KEEP A PAPER LOG.
IT'S LITERALLY ALMOST A
PARCHMENT BOOK WHERE THEY LOG
PLANNED C-SECTIONS.
THEY DON'T SCHEDULE THEM USING
THE EHR, SO THAT WAS A
DISCOVERY.
WE ALSO DISCOVERED THAT SOME
GROUPS EVEN THOUGH A PATIENT
DOESN'T REALIZE THEY'RE HAVING
THE SURGERY, THEY PLACED THE
ORDER.
SO THE UNCOMFORTABLE TENSION
AROSE WHEN PATIENTS WERE GETTING
OUR MATERIAL AND THEY DIDN'T YET
KNOW HE WERE GOING TO HAVE
SURGERY.
I THINK OTHER THE HAVE HOW MUCH
GOOD WILL WE GAINED BY INCLUDING
PROCEDURES THAT WE HAD NOT
ALREADY DECIDED ON BUT
CLINICIANS FELT STRONGLY ABOUT
INCLUDING.
SOME OF THEM WE WILL INCLUDE IN
THE ANALYSIS, BUT IT WAS VERY
IMPORTANT TO THE CLINICIANS AND
IT WAS EASY TO DO AND A LOT OF
ENTHUSIASM AND THAT'S ALL I'VE
GOT.
.
>> GREAT.
OKAY.
SO LET'S GO AHEAD AND MOVE ON TO
THE NEXT SORT OF TASK.
SO SAME QUESTIONS.
NOW WE'RE MOVING ON.'
WE'VE IDENTIFIED PATIENTS.
WE'VE RECRUITED PATIENTS AND NOW
WE'RE DELIVERING INTERVENTIONS
TO THE PATIENTS THEMSELVES.
JERRY HAD VOLUNTEERED TO GET US
STARTED WITH THIS ONE.
>> SO THIS IS SOMETHING THAT
ACTUALLY WORKED QUITE WELL WITH
OUR INTERVENTION.
REMEMBER, OUR INTERVENTION WAS
ESSENTIALLY A CLINICAL DECISION
SUPPORT TYPE OF INTERVENTION
WHERE WE WERE PUTTING PREVALENCE
INFORMATION DIRECTLY INTO THE
CLINICAL RADIOLOGY REPORT AND WE
NEEDED THIS TO BE AUTOMATED AND
CUSTOMIZED TO THE AGE OF THE
PATIENT AND WORKING WITH
PROGRAMMERS AT EACH OF THE SITES
WHO WERE FAMILIAR WITH THE EHR
AND REALLY ALLOWED US TO HAVE A
LIGHT TOUCH INTERVENTION AND PUT
US ON THE FAR END OF THE
SPECTRUM.
YOU KNOW, ONE OF THE, YOU AGAIN,
I WOULDN'T NECESSARILY CALL IT
AN UNPLEASANT SURPRISE, BUT IT
WAS SOMETHING THAT WE HAD TO
DEAL WITH WAS THE FACT THAT NOT
ALL THE SO THE WAY WE DESIGNED
THE TRIAL THEN GOING FROM THE
REPORTING SYSTEM TO THE EHR AND
THEN THE INTERVENTION TEXT BEING
INSERTED THERE.
ONE OF OUR HEALTH SYSTEMS DIDN'T
WANT TO DO IT THAT WAY.
THEY WANTED TO INSERT THE
INTERVENTION AS POP-UPS AS THESE
POP-UP ALERTS THAT CLINICIANS
GET AND SO IT WASN'T PERMANENTLY
ATTACHED TO THE REPORT, BUT IT
APPEARED WHEN THE REPORT WAS
OPENED AND THIS PRESENTED SOME
CHALLENGES BECAUSE DEPENDING ON
WHO OPENED THE REPORT, THEY
MIGHT OR MIGHT NOT SEE THE
POP-UP AND, YOU KNOW, SO THERE
WERE ADDITIONAL SORT OF THINGS
TO WORK THROUGH JUST BECAUSE
THEIR APPROACH WAS SLIGHTLY
DIFFERENT.
THEN, AS I MENTIONED BEFORE,
SOME OF THE SITES INSERTED THE
INTERVENTION AT THE LEVEL OF THE
RADIOLOGY REPORTING SYSTEM AND
WHILE YOU MIGHT NOT THINK THAT
WOULD MAKE A BIG DIFFERENCE, IT
DID ALLOW THE RADIOLOGIST WHO
WAS DICTATING TO SEE THE
INTERVENTION TEXT AND TO REMOVE
IT IF THEY WANTED TO AND WHILE
NOT A LOT OF THEM DID, SOME OF
THEM DID AND SOME OF THEM DID
CONSISTENTLY AND SO THAT
PRESENTED CHALLENGES WHERE WE
WOULD HAVE TO WORK WITH OUR SITE
DIRECTORS FOR EXAMPLE TO GO AND
TO TALK TO THOSE INDIVIDUALS AND
SEE WHY THEY WERE DOING WHAT
THEY WERE DOING AND SORT OF
RE-EXPLAIN THE STUDY TO THEM
AND, AGAIN, IT TOOK SORT OF TIME
AND EFFORT.
ONCE WE HAD THOSE SORT OF KINKS
WORKED OUT, THINGS WERE, YOU
KNOW, I WOULD SAY VERY WELL AND
THE INTERVENTION WAS INSERTED AS
WE HAD THOUGHT IT SHOULD BE
INSERTED AND STAYED THERE
APPROPRIATELY.
SO, YOU KNOW, I THINK SORT OF
THE LESSONS LEARNED AS ANDREA
AND OTHERS HAVE ALLUDED TO IS
THAT THERE'S A LOT OF
HETEROGENEITY TO THE ACTUAL
IMPLEMENTATION AND YOU JUST NEED
TO BE ABLE TO BE AGILE AND
ADJUST AND ADAPT TO THAT.
>> GREAT.
ANYONE WANT TO GO -- WANT TO
VOLUNTEER TO GO NEXT?
ANY HANDS AT ALL?
MIGUEL, WOULD YOU LIKE TO GO?
>> I'LL BE HAPPY TO MAKE SOME
COMMENTS.
FOR US, AS FAR AS DELIVERING
INTERVENTIONS, SOME THINGS
WORKED WELL.
WE HAD A SMART SET AVAILABLE SO
SOME PROVIDERS WERE HAPPY WITH
THE SMART SETS.
HOWEVER, MOST OF THEM PREFERRED
TO STILL MAKE ADJUSTMENTS TO
FOLLOW -- RATHER THAN USING THE
SMART SETS THAT WERE PROVIDED.
ONE OF THE THINGS THAT ALSO
BECAME, YOU KNOW, VERY CLEAR TO
US WE HAD ANTICIPATED THAT SOME
OF THEM WOULD PREPARE LIKE A
MORE STRUCTURED TYPE OF TOOL
SUCH AS THERAPY PLAN OR
SOMETHING MORE COMPREHENSIVE IN
THE PROVIDERS TOLD US VERY
CLEARLY THAT THAT WAS NOT WHAT
THEY WANTED.
THERE WAS SOME RESISTANCE TO
THAT SO WE WENT WITH A SOFTER
TOUCH THAN WAS HAVING THE
PROTOCOLS, THE OPTIONS, EVEN THE
SMART SET, BUT NOT REQUIRING TO
GO THROUGH A THERAPY PLAN OR
THROUGH A MORE STRUCTURED TYPE
OF TOOL.
OTHER THINGS THAT WE LEARNED WAS
HOW THE CHANGES TO THE STUDY
AFFECTED OUR INTERVENTIONS AND
THAT HAPPENED AT THE LEVEL OF
THE OVERALL STRUCTURE AND THE
LEVEL OF INTERVENTIONS.
SO, FOR EXAMPLE, WE WANTED TO
DELIVER INTERVENTIONS BASED UPON
THE ASSIGNMENT AND, OF COURSE,
IT WAS AN INTENTION TO TREAT
STUDY, BUT SOME OF THE
PRACTICIONERS LEFT.
SOME RETIRED.
SOME UNEXPECTED CHANGES.
US, AS FAR AS SPECIFIC
INTERVENTIONS WERE MANY CHANGES
IN THE PRACTICE OF CARE FOR
PATIENTS WITH THIS TRIAL.
FOR EXAMPLE, MANY CHANGES WE
APPROACHED ESPECIALLY WITH THE
COMBINATION WE MENTIONED, THERE
WERE NEW HYPERTENSION GUIDELINES
WITH THE STUD, WITH OUR DATA
SAFETY MONITORING BOARD IN TERMS
OF HOW THEY WOULD AFFECT OUR
STUDYING PROGRESS.
IN THE AREA OF DIABETES, THERE
WAS AN EXPLOSION OF NEW
TREATMENTS, NEW MEDICATIONS TO
TREAT DIABETES THAT WERE NOT
PRESENT WHEN THE STUDY FIRST
STARTED.
SO, AGAIN, THERE WERE SURPRISES.
I WOULDN'T SAY THEY WERE
UNPLEASANT, BUT CERTAINLY
SURPRISES AND IT WOULD REQUIRE
FOR US TO ADJUST AND LEARN HOW
TO BE FLEXIBLE THROUGHOUT THE
STUDY.
>> GREAT.
GREG, I THOUGHT YOU HAD YOUR
HAND UP ALSO.
DO YOU WANT TO GO NEXT?
>> YEAH.
SURE.
SO WE WERE IT TESTING TWO
DIFFERENT OUTREACH INTERVENTIONS
AND ONE OF THEM WORKED REALLY
WELL SORT OF WITHIN THE
CONTAINER OF STANDARD PATIENT
PORTAL.
THAT WAS A SORT OF CARE
MANAGEMENT INTERVENTION WHERE
THE PRIMARY ACTIVITIES WERE
SYSTEMATICALLY REACHING OUT TO
PEOPLE VIA MESSAGING SENDING
THEM QUESTIONNAIRES TO COMPLETE,
INTERACTING WITH THEM BACK AND
FORTH VIA MESSAGING
COMMUNICATING WITH THEIR USUAL
OUTPATIENT PROVIDERS AND HAVING
ALL OF THIS BEING VISIBLE TO THE
CARE TEAM, THAT WORKED REALLY
WELL AND THAT'S SORT OF WHAT
PATIENT PORTAL COMMUNICATION IS
BUILT FOR.
THE OTHER INTERVENTION INVOLVES
SORT OF BOTH THAT KIND OF TEXT
BASED COMMUNICATION, BUT ALSO
DELIVERY OF MORE SORT OF
INTERACTIVE KIND OF EDUCATION ON
SELF-MANAGEMENT MATERIAL,
WATCHING VIDEOS, DOING HOMEWORK,
THINGS WHICH ARE CLEARLY OUTSIDE
SORT OF THE STANDARD KIND OF
PATIENT PORTAL COMMUNICATION.
SO THE CHALLENGE THERE IS IT
REQUIRES SORT OF I DON'T KNOW
WHAT TO SAY EXCEPT A
DISCONTINUITY BETWEEN THESE WAYS
YOU'RE INTERACTING WITH PEOPLE
AND THE CLUNKINESS OF SHIFTING
FROM ONE MODE TO THE OTHER.
WE TRIED TO HANDLE THAT BY USING
THE PORTAL TO SEND MESSAGES THAT
WOULD INCLUDE UNDER THE COVERS
LENGTH THAT WOULD TAKE PEOPLE
STRAIGHT TO THE CONTENT WE WERE
TRYING TO REFER THEM TOO, BUT IT
WAS A BIT CLUNKY.
YOU KNOW, I THINK THIS IS A SORT
OF GENERAL ISSUE ABOUT, YOU
KNOW, HOW WE DELIVER RICHER,
MORE INTERACTIVE CONTENT TO
PEOPLE SORT OF WHAT THE
BOUNDARIES OF PATIENT PORTAL
COMMUNICATION ARE AND THEN WHEN
YOU SORT OF MOVE OVER TO SOME
OTHER SORT OF SEPARATE WEBSITE
OR APP-BASED COMMUNICATION AND
HOW THOSE TWO THINGS INTERACT
WITH EACH OTHER.
HOW THEY CONNECT OR SOMETIMES
DON'T CONNECT WELL WITH EACH
OTHER.
>> GREAT POINT.
ANDREA, ANYTHING TO ADD?
>> YEAH.
ACTUALLY FOLLOWING UP PRECISELY
ON THAT ISSUE ONE OF THE THINGS
THAT WORKED VERY NICELY WAS THIS
HIGH FIDELITY OF DELIVERY TO
CONVERSATION GUIDE WE
EXPERIMENTED WITH LOT OFFICER
OPTIONS REALIZING OUR GOAL OF
AND ULTIMATELY, WE WOUND UP
GOING WITH EPIC QUESTIONNAIRE
FUNCTIONALITY AND WE WERE
PLEASANTLY SURPRISED OF THE
ABILITY TO EMBED HTML.
WE DID OUR BEST TO NOT MAKE IT
LOOK LIKE A QUESTIONNAIRE
BECAUSE PATIENTS DON'T HAVE WARM
AND FUZZY ASSOCIATIONS WITH
THOSE.
WE HAD WEB DESIGNERS WORK WITH
US.
SO THE END PRODUCT LOOKS VERY
PROFESSIONAL.
IT DOESN'T LOOK LIKE A
QUESTIONNAIRE.
THERE ARE BEAUTIFUL IMAGES.
HTML EMBEDDED IN THE
CONVERSATION GUIDE THE PATIENTS
CAN WORK WITH.
THAT WAS A GREAT DISCOVERY AND
EPIC WAS VERY HELPFUL THERE.
WHAT WAS A LITTLE BIT
FRUSTRATING IS ANY INTERACTION
WITH THE HTML, WE CAN TELL IF
PATIENTS ARE INTERACTING WITH IT
AND WE CAN TELL FOR HOW LONG,
BUT NONE OF THE DATA THAT
RESULTS FROM THAT INTERACTION
BEING COLLECTED.
WE HAVE TO USE.
SO IF YOU THINK OF THE
CONTAINER, THE EPIC
QUESTIONNAIRE AS A CONTAINER
ONLY LANGUAGE AND SELECTION
OPTIONS IN THE CONTAINER HAVE
THE CAPABILITY TO BE STORED
PERMANENTLY IN THE EPIC EHR.
SO A LITTLE BIT OF FANCY
FOOTWORK WAS REQUIRED TO MAKE
THAT HTML SINK NICELY WITH THE
QUESTIONNAIRE BUILD.
THE OTHER UNPLEASANT DISCOVERY
WE HAD WAS WE WERE LOCKED IN TO
SOME EPIC QUESTIONNAIRE TITLE
FORMAT.
IF WE CHANGED IT FOR OUR
QUESTIONNAIRE, WE WOULD OF HAD
TO CHANGE IT FOR ALL
QUESTIONNAIRES THROUGHOUT THE
ENTERPRISE.
AND THAT SEEMS SO SILLY BUT IT
WAS ACTUALLY QUITE AN
IMPEDIMENT.
SO THE ABILITY TO CREATE
APPROPRIATELY TAILORED
EXPERIENCES USING QUESTIONNAIRE
FUNCTIONALITY ARE LIMITED.
ANOTHER NICE THING THAT WORKED
WELL WAS TAILORING INTERVENTION
DELIVERY AND I'VE ALLUDED TO
THIS A LITTLE BIT EARLIER.
WE IN THE CONVERSATION GUIDE, WE
HAD A HEALTH COACH WORK WITH US
AND WE WERE ABLE TO SOLICIT
WHETHER PATIENTS HAD LOW
CONFIDENCE THAT THEY WERE GOING
TO BE ABLE TO USE THE
INTERVENTION MODALITIES, LEARN
HOW TO USE THEM, SO IF THEY
SELECTED YES, I ACTUALLY THINK
IT WAS A ORDINAL RESPONSE
OPTION, IF THEY SELECTED THEY
HAD ISSUES, WE TAILORED THE
SUBSEQUENT MESSAGING AND
SUBSEQUENT CONTENT WE DELIVERED
TO THEM TO ADDRESS LOW
CONFIDENCE.
FOR FOLKS THAT REQUESTED POST
DISMISSAL HOSPITAL OPIOID
DISCHARGE REFILLS, WE WERE ABLE
TO SEND VERY TAILORED MESSAGING,
SUPPORTIVE MESSAGING TO THEIR
PORTAL REDIRECTING THEM TO THE
MODALITIES.
AND WE WERE ABLE CONTINGENT ON
HOSPITAL DISCHARGE LOCATION
DEPENDING ON WHICH PACK THAT
POST ACUTE CARE SETTING THEY
MIGHT BE GOING TO, WE WERE ABLE
TO USE LOGIC TO PRECISELY TAILOR
THE INFORMATION, THE MODALITY
SPECIFIC INFORMATION PROVIDED AT
DISCHARGE TO THEIR SETTING AND
WE EVEN USED ZIP CODE BASED
LOGIC TO LINK THEM TO LOCAL
RESOURCES.
UNPLEASANT SURPRISES, THESE
AGAIN WERE NOT SO MUCH EHR.
THERE WAS A MARKET SHIFT AWAY
FROM OVERNIGHT STAYS TO SAME-DAY
SURGERIES DURING THE TRIAL -- IT
WAS DURING OUR UG 3 YEAR SO THAT
NECESSITATED A VERY AGILE SHIFT
AND LEVERAGING, DEVELOPING BUILT
SPECIFIC TO PACK DISMISSALS,
POST ACUTE CARE AND THAT WORKED
QUITE WELL.
AND A NOT SO PLEASANT DISCOVERY
WAS A FREQUENCY OF CANCELLATIONS
AND RESCHEDULING.
AND THAT NECESSITATED THE BUILD
OF SURVEILLANCE ALGORITHMS TO
IDENTIFY THESE EVENTS AND HANDLE
THEM.
AND THAT'S -- THOSE WERE OUR
MAJOR OBSERVATIONS.
>> ALL RIGHT.
SO I THINK WE'LL NOW MOVE ON TO
MONITORING THE INTERVENTION
DELIVERY AND I THINK ANDREA,
WE'RE GOING TO GO BACK TO YOU TO
KICK US OFF ON THIS ONE.
>> SURE.
MANY THINGS WORKED WELL HERE.
WE WERE ABLE TO THE ACTIVITIES
OF MULTIPLE GROUPS.
FOR PATIENTS, WE WERE ABLE TO
CERTAINLY MONITOR, WAS THE
CONVERSATION GUIDE DELIVERED,
WAS IT OPENED?
FOR HOW LONG WAS IT OPENED?
WHICH ELEMENTS OF THE
CONVERSATION GUIDE DID PATIENTS
INTERACT WITH AND FOR HOW LONG
WHICH WE PLAN TO CAPITALIZE ON A
MEDIATOR ANALYSES AND TRY TO
UNDERSTAND WHAT WORKED AND WHAT
WORKED FOR WHOM.
WE WERE ABLE TO ASK -- THE
VISION INITIALLY WAS FOR THE
CONVERSATION GUIDE TO SERVE AS
AN EVER PRESENT RESOURCE FOR THE
PATIENT SO THAT THEY COULD
RETURN TO THAT REPEATEDLY
THROUGHOUT THEIR JOURNEY TO
TROUBLESHOOT, LEARN ABOUT
DIFFERENT MODALITIES IF THEIR
INITIAL SELECTIONS DIDN'T WORK.
SO WE WERE ABLE TO MONITOR
PATTERNS OF USE WITH THE
CONVERSATION GUIDE.
DID THEY RETURN, DID THEY CHANGE
THEIR SELECTIONS.
WE WERE ALSO ABLE TO ASCERTAIN
WHETHER THEY RECEIVED PPC
NONPHARMACOLOGIC PAIN CARE
WHETHER THEY RECEIVED IT
SPECIFIC TO THE MODALITIES THEY
SELECTED.
EPIC HAS A FAIRLY MATURE SYSTEM.
SO ON THE PART OF NURSES, WE
WERE ABLE TO CAPTURE HOW THEY
RESPONDED.
WE USED ALERTS TO LET PATIENTS
KNOW THIS IS A PATIENT WHO'S
HAVING PAIN.
THESE ARE THEIR PREFERENCES AND
WE COULD VERY PRECISELY
DETERMINE HOW A GIVEN NURSE
RESPONDED TO THAT.
DID SHE TELL IT TO GO AWAY.
DID SHE SAY YES?
I'LL CHANGE THE ORDERS OR I'M
DOING IT RIGHT NOW.
WE WERE BY VIRTUE COLLECTING
FLOW SHEETS.
AND ALSO THE EXTENT VERY
PRECISELY WHAT EDUCATION NURSES
DELIVERED TO PATIENTS ABOUT THE
MODALITIES.
AND THE SAME APPLIES TO PHYSICAL
AND OCCUPATIONAL THERAPISTS.
WE CAN DETERMINE WHETHER
MODALITY EDUCATION WAS DELIVERED
IN PRE-OPERATIVE CLASSES WHICH
IS NOW THE NORM IN MANY PLACES
PRIOR TO HIP AND KNEE.
WHETHER THERAPISTS INTEGRATED
MODALITIES INTO THEIR
HOSPITAL-BASED CARE.
THAT WAS RECORDED.
SO MANY OF THESE KEY ELEMENTS OF
THE INTERVENTION WE WILL BE ABLE
TO DETERMINE WHETHER THEY WERE
DELIVERED, WHO DELIVERED THEM
AND IN WHAT WAY.
ONE OTHER THING THAT WAS NICE IN
TERMS OF THE ALERTS, WE WERE
ABLE TO CON FIGURE THE ALERTS SO
IT WAS SPECIFIC TO WHAT STAGE A
PATIENT WAS, WHERE THEY WERE IN
THIS INTERVENTION CONTINUUM AND
I'LL DESCRIBE THAT.
SOME PATIENTS ARRIVED AT THE
HOSPITAL NOT HAVING SELECTED ANY
MODALITIES AND WHEN A PATIENT
HAD PAIN, WE WOULD LET THE NURSE
KNOW, THIS PATIENT NEEDS
SELECTIONS.
SOME PATIENTS HAD SELECTED
MODALITIES, BUT NOT RECEIVED ANY
EDUCATION.
WE LET THE NURSE KNOW YOU NEED
TO EDUCATE.
SO WE WERE ABLE TO TARGET
NURSES' ACTIVITIES IN A
PATIENT-SPECIFIC WAY BASED ON
WHERE THEY WERE IN THIS
CONTINUUM OF THE INTERVENTION.
UNPLEASANT SURPRISES.
ONE THING WE WOULD HAVE LOVED TO
BE ABLE TO DO IS TO DETERMINE
THE DEGREE TO WHICH PHYSICIANS,
APPs AND ALLIED HEALTH WERE
USING THE NO-HARM INTERFACES,
THAT WE CREATED TO HELP THEM
UNDERSTAND THE INTERVENTION.
A DATA SET THAT CAPTURES USERS
ENGAGEMENT WITH CERTAIN
FUNCTIONALITY BUT IT'S NOT AS
GRANULAR AS SOMEONE WOULD LIKE.
WE WOULD HAVE LIMITED POSSIBLY
TO DETERMINE THAT USAGE AND I
WILL PASS THE MIC.
>> GREAT.
THANKS.
ANYBODY WANT TO GO NEXT FROM OUR
PANELISTS?
GREG.
>>.
>> IN SOME WAYS SIMILAR TO WHAT
ANDREA WAS TALKING ABOUT BUT
SIMILAR TO OUR TRIAL.
ONE OF THE KEY QUESTIONS WE WERE
INTERESTED IN DOING THIS WAS
ABOUT THE VALUE OR EFFECTIVENESS
OF OUTREACH TO PEOPLE WHO WERE
NOT NECESSARILY SEEKING ANY SORT
OF MENTAL HEALTH CARE AND
CERTAINLY NOT SEEKING CARE
RELATED TO SUICIDE PREVENTION.
MUCH OF THE PREVIOUS RESEARCH
ABOUT THE EFFECTIVENESS OF
INTERVENTIONS VOLUNTEERED TO
RECEIVE A PREVENTION
INTERVENTION WHICH AS YOU MIGHT
IMAGINE PROBABLY NOT THE
QUESTION WE SHOULD BE ASKING
BECAUSE THE PEOPLE WHO VOLUNTEER
TO RECEIVE A SUICIDE PREVENTION
PROGRAM ARE PROBABLY PEOPLE WHO
MAY HAVE LOWER RISK.
WHAT THAT MEANT WAS THE DESIGN
WE CHOSE DID NOT ACTUALLY ASK
PEOPLE UPFRONT AT ALL WHETHER
THEY WERE AT ALL INTERESTED IN
ANY OF THESE PROGRAMS.
PEOPLE WERE ASSIGNED TO BE
OFFERED THE PROGRAM OR NOT AND
THE OFFER WAS DELIVERED
INITIALLY, YOU KNOW, VIA PATIENT
PORTAL MESSAGING.
AND, IT WAS INTERESTING THE
EXPERIENCE OF OUR FRONT LINE
CLINICIANS IN TERMS OF TRYING TO
REACH OUT TO PEOPLE IN THIS WAY
AND WHEN THERE WAS SILENCE,
KNOWING THAT THAT COULD MEAN
VERY DIFFERENT THINGS, YOU KNOW,
THAT THE FAVOR TO RESPOND COULD
MEAN THAT PEOPLE WELCOMED AN
EXPRESSION OF CARING OR IT COULD
MEAN WE WERE IRRITATING PEOPLE
AND MAKING THINGS WORSE.
AND WE SUSPECTED BOTH THINGS
MIGHT HAVE BEEN HAPPENING.
THE CHALLENGE WAS KNOWING WHEN
IT WAS ONE AND WHEN IT WAS THE
OTHER AND HOW YOU MIGHT RESPOND
TO THAT.
WE EVEN DID THINGS FOR INSTANCE
WHEN WE WOULD TALK TO OUR
INTERVENTION STAFF ABOUT WHAT
ARE ARE THE HINTS.
FOR INSTANCE, IT'S POSSIBLE TO
KNOW WHEN YOU SEND SOMEONE A
MESSAGE.
HAVE THEY READ IT OR NOT.
HAVE THEY DELETED IT.
WE SORT OF JOKINGLY TALKED ABOUT
WE WISHED IT WERE POSSIBLE TO
MESSAGE THE VIGOR WITH WHICH
THEY HIT THE DELETE KEY, YOU
KNOW.
IS SOMEONE'S RESPONSE TO THIS
SORT OF, YOU KNOW, LINGERING FOR
A LONG TIME OVER THAT SAYING
THAT'S NICE, MAYBE I SHOULD GET
BACK TO THAT NICE PERSON, VERSUS
WILL THEY LEAVE ME ALONE PLEASE.
AND SINCE WE ACTUALLY DID
OBSERVE EVIDENCE POSSIBLY THAT
ONE OF THE INTERVENTIONS MAY
HAVE HAD NEGATIVE EFFECTS OR
BEEN HARMFUL IN SOME PEOPLE,
THAT WAS AN IMPORTANT QUESTION
WE WERE NOT ABLE TO ANSWER.
I'M NOT SURE THERE IS ANY ANSWER
TO THAT QUESTION.
I THINK IT'S AN INEVITABLE
CHALLENGE OF TRYING TO DELIVER
INTERVENTIONS IN THIS WAY WHEN
NOT ONLY DO YOU HAVE THE
NONVERBAL CUES, YOU DON'T EVEN
HAVE TONE OF VOICE IN TERMS OF
HOW IT THIS COMING ACROSS.
>> THAT'S REALLY FASCINATING.
I'M SORT OF THINKING TO LIKE
SOME OF THE SOCIAL MEDIA
COMPANIES THAT ARE OUT THERE
THAT CAN TELL HOW LONG YOU HOVER
OVER AN IMAGE ON YOUR SCREEN WE
PROBABLY FOR BETTER, WE DON'T
NECESSARILY HAVE THAT WITH THE
EHR, BUT CERTAINLY THAT COULD
COME IN HANDY WITH SOME OF THESE
THINGS.
IT'S REALLY FASCINATING.
>> IT'S POSSIBLE SOME OF THOSE
THINGS ARE KNOWABLE.
AND, YOU'RE RIGHT, IT IS AN
INTERESTING QUESTION.
CERTAINLY THIS VERGES INTO
REALMS THAT MANY PEOPLE WOULD
CONSIDER CREEPY, BUT, YOU KNOW,
I WOULD LIKE TO SAY OUR MOTIVES
ARE NOT CREEPY.
WE WOULD LIKE TO KNOW WHEN THE
THINGS WE'RE DOING ARE HELPFUL
AND SUPPORTED AND WHEN THEY'RE
BEING PERCEIVED ADDS IRRITATING
AND UNCARING AND HOW ARE WE TO
KNOW?
>> THAT'S A GREAT POINT.
JERRY OR MIGUEL, ANYTHING TO ADD
ON THIS TOPIC?
>> I HAVE SOME MORE MUNDANE
EXAMPLES.
WE DID REGULAR DATA POLLS AFTER
EACH WAVE JUST TO ASSURE THAT
THE TEXT WAS BEING APPROPRIATELY
INSERTED INTO THE RADIOLOGY
REPORT AND THEN WE ASSUMED
EVERYTHING STAYED THE SAME UNTIL
THE NEXT WAVE WHEN WE WOULD DO
ANOTHER DATA POLL.
WE ACTUALLY FOUND OUT THROUGH
THIS SORT OF MONITORING THAT ONE
OF THE SITES HAD AN UPGRADE TO
THEIR SOFTWARE, A DICTATION
SOFTWARE WHICH BROKE THE LINK
THAT INSERTED THE INTERVENTION
TEXT AND WE DIDN'T FIND OUT
ABOUT THAT UNTIL OUR NEXT
ROUTINE DATA POLL FROM THE SITE.
SO THAT WAS AN UNPLEASANT
SURPRISE SINCE WE ESSENTIALLY
HAD UNINTENTIONAL CROSS-OVER FOR
SEVERAL WEEKS AND, YOU KNOW, IF
THERE'S A LESSON LEARNED FROM
THAT, IT WOULD BE TO INCREASE
THE FREQUENCY THAT WE MONITORED
THE FIDELITY OF THE INTERVENTION
SO THAT WE DIDN'T GO WEEKS WITH
THIS UNKNOWN CROSS-OVER.
>> YEAH.
I THINK I IMAGINE SORT OF I CAN
SPEAK FOR ALL THE PANELISTS WHEN
SYSTEM UPGRADES ARE THE BANE OF
EVERYONE'S EXISTENCE.
THEY CAUSE ALL SORTS OF
PROBLEMS.
>> JUST TO BRING IT BACK, THAT
FITS WITH THIS THEME THAT
SYSTEMSES DON'T REMAIN STATIC
OVER TIME AND YOU HAVE TO BE
VIGILANT ABOUT CHANGES.
>> ABSOLUTELY.
MIGUEL.
>> YES.
FROM OUR PERSPECTIVE FOR US IT
WAS MANAGEMENT OF THE CONDITIONS
-- BUT AT THE SAME TIME SINCE WE
WERE A PRAGMATIC TRIAL,
SPECIFIED CLINIC VISITS OR QUOTE
UNQUOTE A STUDY INTERVENTION.
SO WE CAPTURED WHAT WAS
AVAILABLE IN THE EHR AND WE
LEARNED SOME OF THE METRICS THAT
WERE HELPFUL AS FAR AS
INTERVENTION DELIVERY WOULD NOT
BE MADE AVAILABLE BECAUSE
PATIENTS MIGHT NOT HAVE A GIVEN
TEST WHEN THEY SAY WHAT HAD BEEN
REQUIRED AS PART OF THE STUDY.
ANOTHER THING IS THAT ONE OF THE
LIMITATIONS WE HAD, WE WERE NOT
ABLE TO ALTERNATE WHEN THE TOOLS
WERE USED.
SO WE DID HANDWRITING REVIEWS
AND ONE OF THE THINGS IS IT
WOULD BE IMPORTANT TO USE MANUAL
REVIEWS WITH THE STUDY WHEN THE
STUDY HAS BEEN ONGOING.
BUT THESE ARE THINGS WE HAD NOT
ANTICIPATED AND WE LEARNED AS WE
WENT ALONG.
>> GREAT.
OKAY.
ALL RIGHT.
SO THE LAST -- MOVING ON TO THE
LAST.
NOW, WE'RE MONITORING OUR
INTERVENTION AND NOW WE'RE
ASSESSING OUTCOMES.
GREG, I THINK YOU WERE GOING TO
LEAD THE WAY ON THIS ONE.
>> SURE.
SO IN OUR TRIAL, THE PRIMARY
OUTCOME WAS A SELF-HARM EVENT,
ARE THE SUICIDE ATTEMPT WHICH
WOULD INCLUDE NONFATAL SELF-HARM
EVENTS AND FATAL SELF-HARM
EVENTS.
WE ASCERTAINED FROM ENCOUNTER
DIAGNOSIS IN THE ELECTRONIC
HEALTH RECORDS AND IN SOME CASES
INSURANCE CLAIMS WHEN PEOPLE
WERE RECEIVING CARE FROM SOME
OUTSIDE FACILITY.
PROBABLY WORTH MENTIONING WHY WE
CHOSE, WHY WE WENT THIS ROUTE AS
OPPOSED IT WOULD NOT HAVE BEEN
POSSIBLE TO SAY SURVEY PEOPLE OR
SEND THEM A QUESTIONNAIRE ABOUT
THAT.
BUT EVEN THOUGH THAT'S SOMETHING
THAT'S OFTEN DONE IN TRIALS OF
SUICIDE PREVENTION PROGRAMS, I
THINK IT'S PROBLEMATIC FOR TWO
REASONS.
IN OUR POPULATION, THIS IS A
RELATIVELY FORTUNATELY LOW
FREQUENCY EVENT.
WE WERE EXPECTING A RATE OF 4%
TO 5% OF SUICIDE ATTEMPTS.
IF THE OUTCOME IS OCCURRING 4%
TO 5% OF THE TIME IF EVEN IF YOU
HAVE 90% RESPOND TO A SURVEY,
THAT'S NOT GOOD ENOUGH, YOU
DON'T KNOW WHAT YOU'RE MISSING.
AND WE WOULD CERTAINLY NOT
EXPECT THAT WILLINGNESS TO
PARTICIPATE IN A SURVEY ABOUT
SUICIDAL BEHAVIOR IS UNRELATED
TO THE EXISTENCE OF SUICIDAL
BEHAVIOR.
JUST A COUPLE OF NONRESPONSE, WE
COULD NOT ASSUME THAT
NONRESPONSE WAS RANDOM.
SO IT WAS REALLY NECESSARY TO
USE RECORDS DATA.
OF THIS WAS NOT A CASE OF LETS
USE RECORDS DATA BECAUSE IT'S
CHEAPER OR LET'S USE RECORDS
DATA BECAUSE IT'S EASY.
IT WAS LET'S USE IT BECAUSE WE
THINK IT'S THE ONLY RIGHT AND
FAIR WAY TO DO IT.
TWO ISSUES WE HAD TO DEAL WITH.
ONE WAS AS YOU MAY REMEMBER
THERE WAS A TRANSITION RIGHT
BEFORE OUR TRIAL WENT INTO THE
FIELD.
AND WE'D ACTUALLY DONE FOR OTHER
REASONS BECAUSE WE'VE BEEN DOING
RESEARCH IN THIS AREA FOR A
WHILE.
WE'VE DONE SOME WORK AND WHEN
YOU LOOKED AT THE CLINICAL TEXT,
HOW OFTEN COULD YOU TRUST OR
WHEN COULD YOU TRUST RECORDED
DIAGNOSES OF SELF-HARM.
ONE OF THE BIG QUESTIONS WAS THE
CATEGORY OF THINGS WHERE THINGS
WERE SAID TO HAVE UNDETERMINED
INTENT AND DO YOU COUNT THOSE OR
NOT COUNT THOSE AS SELF-HARM
EVENT.
THERE WAS A MAJOR CHANGE IN THE
CODING, SO WE HAD SORT OF SOME
IDEAS ABOUT HOW THINGS WOULD
CROSS OVER, BUT IT WAS NECESSARY
IN THE TRIAL ACTUALLY TO DO SOME
SORT OF NEW VALIDATION WORK AND
WE REALLY FOCUSED ON SELF-HARM
EVENTS THAT MIGHT BE MISSED.
THOSE INCLUDED INJURIES AND
POISONINGS THAT WERE SAID TO
HAVE UNDETERMINED INTENT.
THEY INCLUDED CERTAIN CATEGORIES
OF EVENTS THAT INCLUDED CERTAIN
ACCIDENTS, BUT BASED ON OUR
JUDGMENT, WE NEEDED TO LOOK
THERE, FOR INSTANCE IN PEOPLE IN
SELF-HARM, WE MIGHT SAY WE
SHOULD CHECK THAT OUT.
OR THERE STILL ARE IN ICD SOME
KIND OF CODING INTENT THAT'S NOT
REQUIRED.
SO THERE WERE INJURIES.
SO WE HAD TO DO SOME CHART WORK.
AND WE SET UP A ROBUST PROCESS
FOR DOING THAT AND WHAT WE DID
FIND WAS THERE WERE SOME EVENTS
WHICH WERE NOT CODED TO
SELF-HARM THAT ADDED TO THE
TOTAL NUMBER OF OUTCOMES OF ONLY
ABLE 10%.
SO IT WOULD NOT HAVE
SUBSTANTIALLY CHANGED THE
RESULTS OF THE TRIAL TO INCLUDE
OR EXCLUDE THOSE.
SO WE THOUGHT WE CAME UP WITH
SOME EXTRA WORK, BUT A SORT OF
REASONABLE SOLUTION TO THAT.
THE THING WE STILL, THERE IS NO
GOOD WAY TO ADDRESS IS THE IDEA
THAT CERTAINLY ASCERTAINMENT OF
SELF-HARM EVENTS USING RECORDS
MEANS WE.
SO, WE DO NOT KNOW ABOUT
SELF-HARM EVENTS WHERE PEOPLE
NEVER WENT TO THE EMERGENCY
DEPARTMENT OR EVER TOLD A DOCTOR
ABOUT IT.
IT CERTAINLY IS PLAUSIBLE THAT
PARTICIPATING IN INTERVENTION
THAT'S INTENDED TO PREVENT OR
REDUCE SELF-HARM MIGHT INFLUENCE
THE LIKELIHOOD THAT PEOPLE WOULD
SEEK CARE FOR SELF-HARM.
WE LOOKED AT THAT THAT.
THE IDEA OR LIKELIHOOD THAT THE
INTERVENTION WOULD BE LESS.
WHEN YOU SAY THE EVENT WAS SORT
OF LESS DISCRETIONARY OR MORE
SEVERE AND ALTHOUGH THERE WERE A
SMALLER NUMBER OF EVENTS IN THAT
CATEGORY, SO STATISTICAL POWER
WAS LOWER, THE PATTERN OF
RESULTS WAS THE SAME.
THAT WAS STILL A BIG CAVEAT IN
INTERPRETING THE RESULTS OF THE
TRIAL AND SAYING WE CANNOT BE
SURE THAT THE INTERVENTION MIGHT
HAVE CHANGED THE PROCESS OF
ASCERTAINMENT.
>> GREAT.
REALLY FASCINATING CHALLENGES TO
WORK THROUGH.
ANY OTHER PANELISTS WANT TO ADD
ON?
IF YOU WANT TO RAISE A HAND.
ANDREA.
>> I'LL JUST ADD A FEW QUICK
POINTS.
ONE, WE TALKED A LITTLE BIT
ABOUT IN THE LOVELY PRESENTATION
ABOUT THE CHALLENGES OF
ACCESSING RURAL POPULATIONS.
WE'RE ABLE TO VERY ACCURATELY
DETERMINE PATIENTS PORTAL
STATUS.
DO THEY HAVE AN ACCOUNT, ARE
THEY USING THEIR PORTAL AND IF
NOT, WE'RE ABLE TO DETERMINE
WHETHER THEY'RE IN A BROAD BAND,
INACCESSIBLE ZIP CODE.
WE SEND THEM PAPER AND I DON'T
KNOW IF THIS IS UNIQUE TO MAIL,
BUT WE'VE DEVELOPED A WAY BY
WHICH WE AUTOMATICALLY SEND THEM
A PRINTED MAILED PROM IN LIEU OF
ADMINISTERING IT VIA THE PORTAL.
WE'VE ALLEGATION BEEN ABLE TO
CONTINGENT ON RESPONSE RATES, WE
WERE ABLE TO ADD PEOPLE
AUTOMATICALLY TO PRINT LISTS SO
THAT THEY'RE SENT PRINT VERSIONS
AND WE FOUND THAT INCREASE OUR
RESPONSE RATES AMONG RURAL
SITUATED PATIENTS.
WE HAD A VERY HEART STOPPING
EVENT.
WE BLATANTLY DISCOVERED HOW
VULNERABLE SOME OF THIS LOGIC IS
TO SYSTEM UPGRADES AND TWICE NOW
HAVE HAD EVENTS WHERE PROMS WERE
NOT BEING SENT OUT ALTHOUGH THE
PROXY MEASURES THAT WE WERE
USING TO MONITOR FIDELITY
SUGGESTED THEY WERE.
SO WE HAD GAPS IN DATA
COLLECTION AND SIMILAR TO
JERRY'S EXPERIENCE, IT TAUGHT US
VALIDATE, MONITOR CLOSELY AND
UNTIL YOU LOOK AT THE ACTUAL
DATA, DON'T BELIEVE ANYTHING.
AND, ACTUALLY, THAT EXPERIENCE
LED US TO TWO I THINK TWO
DISCOVERIES, ONE, BECAUSE THE
PROMISE MEASURES ARE BEING
ENCOURAGED THROUGHOUT THE MAYO
ENTERPRISE, A LOT OF OTHER
RESEARCH AND CLINICAL
INITIATIVES WERE COLLECTING
PROMISE DATA.
SO WE WERE ABLE TO SCAVENGE
THEIR RESULTS AND THAT PROVED
VERY EFFECTIVE.
THE OTHER THING IS THAT WE
BROADENED OUR CLINIC BASED
ASSIGNMENT OF PROMS TO ANY
HEALTH CARE ENCOUNTER TO MAKE
SURE THAT IF RURALLY PORTAL
NONUSERS CAME DURING THE
FOLLOWUP INTERVAL FOR CARE AT A
BRICKS AND MORTAR ENCOUNTER,
THEY WERE VERY LIKELY TO BE
ADMINISTERED OUR STUDY PROMS.
>> GREAT.
OKAY.
JERRY OR MIGUEL, ANYTHING TO
ADD?
OTHERWISE WE CAN MOVE ON TO THE
NEXT QUESTION.
JERRY.
>> YEAH.
I HAVE JUST A COUPLE OF QUICK
POINTS.
YOU KNOW, ARE AS A REMINDER, WE
RELIED ON CPT AND ICD CODES TO
ASSESS OUR OUTCOMES AND, YOU
KNOW, WE ALSO HAD THE JOY AND
PRIVILEGE OF LIVING THROUGH THE
ICD 9 TO ICD 10 TRANSITION WHICH
I GUESS UNLIKE GREG'S TRIAL
WHICH WAS RIGHT AT THE BEGINNING
OF HIS DATA COLLECTION, FOR US,
IT WAS RIGHT IN THE MIDDLE.
AND SO WE HAD TO GO THROUGH A
VARIETY OF TRANSLATION
GYMNASTICS IN ORDER TO COME UP
AND ASSESS OUR FINAL OUTCOMES
BECAUSE OF THIS.
SO I GUESS ONE LESSON LEARNED IS
IF YOU CAN ANTICIPATE THE NEXT
ICD ITERATION, AVOID DOING YOUR
TRIAL IN THE MIDDLE OF IT.
BUT EVEN IF THE CODES ARE THE
SAME FROM DIFFERENT SITES,
BEWARE THAT THEY MAY BE USED
DIFFERENTLY AND THAT CODING
PRACTICES ARE NOT IDENTICAL AND
SO EVEN THOUGH YOU THINK YOU'RE
GETTING THE SAME DATA FROM SITE
A AND SITE B, IN FACT, YOU MAY
BE GETTING DIFFERENT INFORMATION
AND SO IT TAKES SOME
INVESTIGATIVE WORK TO MAKE SURE
THAT SITES ARE CODING THE SAME
PROCESSES AND THE SAME DISEASES
SIMILARLY.
AND THEN, OF COURSE, THERE, WE
CAME ACROSS ONE SITE WHICH
DIDN'T USE THE SAME CODE, SO
THEY HAD THEIR OWN PROPRIETARY
SET OF CODES THAT THEY USED AND
SO THAT REQUIRED YET ANOTHER
TRANSLATION EFFORT.
AND SO CODES ARE NOT WHAT THEY
SEEM TO BE ALWAYS.
>> ALSO THE CAPTURE OF OUTCOMES
FROM THE EHR WORKED WELL FOR ALL
OF THE SITES.
IT WAS VERY CLEAR WHAT WE NEE
ALSO STRAIGHT FORWARD.
IN THE OTHER ONE -- BUT THE
ORIGINAL INTERMEDIARY THAT WAS
GOING TO SUPPLY THE DATA WAS
CHANGED IN THE MIDDLE OF THE
PROCESS APPROVED THE SHARING OF
DATA.
THE AGREEMENT HAD BEEN INITIALLY
FOR THE DATE.
IT WAS FOR CARING FOR DATA OF
CLINICAL OPERATIONS, BUT NOT FOR
RESEARCH.
SO WE HAD TO GO BACK TO NUMEROUS
PRIVACY OFFICERS INTO THE HEALTH
SYSTEM UNTIL FINALLY THERE WAS A
WAY TO ALLOW FOR THE SHARING OF
DATA FOR RESEARCH PURPOSES.
SO THERE WAS A DELAY IN ALLOWING
THAT TO BE SHARED WITH US FOR
THE PURPOSES OF RESEARCH SO IT
WAS AN UNPLEASANT SURPRISE, BUT
CERTAINLY BROUGHT SOME DELAYS.
>> GREAT.
I THINK WE HAVE A COUPLE
QUESTIONS LEFT.
I KNOW GREG AND ANDREA, BOTH OF
YOU HAVE SOME NICE ANECDOTES OF
WHAT CAN GO WRONG OR NOT GO
WRONG WITH THIS.
WOULD ANY OF YOU LIKE TO START?
>> SURE.
AT LEAST IN TERMS OF WHAT'S
HAPPENING WITH THE HEALTH
SYSTEMS I KNOW BEST KAISER,
WASHINGTON, BUT ALSO THE OTHER
HEALTH SYSTEMS IN OUR NETWORK, I
THINK, YOU KNOW IN TERMS OF
COLLECTING AND RECORDING
INFORMATION ABOUT GENDER
IDENTITY, WE'RE SAYING WE THINK
WE KNOW HOW TO DO THIS.
WE'VE CREATED THE RIGHT
INFRASTRUCTURE TO DO THIS AND
GETTING UP TO SPEED ON
SYSTEMATICALLY DOING IT.
AT THIS POINT, WE'RE STILL ON
HOW WELL IS THAT.
WE'RE STILL PROBABLY IN THE
SINGLE DIGITS OF PERCENTAGES AND
I THINK THE HEALTH SYSTEMS ARE
PROCEEDING A LITTLE BIT
CAUTIOUSLY AND I CAN TELL YOU IN
TERMS OF ASKING THESE QUESTIONS
ESPECIALLY TO OUR YOUNGER
MEMBERS, THERE HAS BEEN A LITTLE
BIT OF PUSHBACK ABOUT THAT, SO
WE HAVE TO TREAD CAREFULLY.
ALTHOUGH I'LL SAY AT KAISER
WASHINGTON, WE'VE BEEN ASKING
PEOPLE NOW FOR WELL OVER A
DECADE WHETHER THEY HAVE ACCESS
TO FIREARMS.
YOU KNOW, WE'RE NOT UNACCUSTOMED
TO TRYING TO TREAD INTO SOMEWHAT
CHALLENGING TERRITORY.
SO I THINK THAT IS MOVING ALONG
NOW.
TO BE CLEAR, I SHOULD HAVE SAID
AT THE BEGINNING, THIS IS
CLEARLY A CASE WHERE HEALTH
SYSTEMS MAKE THE DECISIONS ABOUT
WHETHER THEY WANT TO DO THIS IN
TERMS OF DELIVERING BETTER
HEALTH CARE.
DOING IT FOR RESEARCH, NO ONE IS
EVER GOING TO DO THIS FOR THE
PURPOSES OF MAKING RESEARCH
EASIER.
THIS IS ABOUT DELIVERING HEALTH
CARE.
IF YOU'RE IN A MEETING IN THE
HEALTH SYSTEM TALKING ABOUT
THIS, DIFFERENT PEOPLE MEAN
REALLY DIFFERENT THINGS WHEN
THEY SAY THAT AND YOU WOULD ASK
ABOUT DIFFERENT THINGS DEPENDING
ON YOUR PURPOSE AND THERE I
THINK IT'S AN INTERESTING
CHALLENGE BECAUSE I'M NOT SURE
WE'RE AT THE PLACE WHERE WE HAVE
A CLEAR ENOUGH CONSENSUS ABOUT
WHAT QUESTIONS SHOULD BE ASKED
OF WHOM AND WHEN TO BE ABLE TO
SAY IT'S TIME TO GO ON THAT.
AND I THINK, YOU KNOW, WHEN I AS
A RESEARCHER HAVE THE PRIVILEGE,
YOU KNOW, BECAUSE IT IS A
PRIVILEGE OF BEING IN ON THOSE
MEETINGS AND BEING ABLE TO
APINE, YOU KNOW, MY ROLE IS MORE
ALONG THE LINES OF, OKAY, ARE WE
CLEAR WHAT QUESTION WE'RE ASKING
HERE AND TO TEAR OUT MY THREE
REMAINING HAIRS WHEN ANYBODY
SUGGESTIONS WE RECORD SOMETHING
AS FREE TEXT.
>> ANYONE WANT TO ADD?
ANDREA.
>> I COULDN'T AGREE WITH GREG
MORE ABOUT FREE TEXT.
WE WANT YOUR HAIRS TO SURVIVE.
ONE ANECDOTE ABOUT THE SOGI
QUESTIONS, MAYO TURNED THOSE ON
ABOUT 18 MONTHS AGO AND I THINK
OUR EXPERIENCE HIGHLIGHTS AN
IMPORTANT CHALLENGE.
THEY DECIDED TO MAKE THE
QUESTIONS PERMANENTLY AVAILABLE
TO PATIENTS SHOULD THEY DECIDE
TO CHANGE THEM, THEIR RESPONSES.
THIS CREATED A FATHERER BECAUSE
THEY NEVER WENT AWAY AND
PATIENTS ASSUMED THEY HAD TO
KEEP REPORTING THAT MAYO IN A
VERY BENEGATIVE SIT WAY WAS
CHECKING ON THEIR GENDER
IDENTITY AND SEXUAL ORIENTATION.
WE WENT THROUGH THIS ISSUE TOO
WITH OUR CONVERSATION GUIDE.
WE WANT IT TO BE PERMANENTLY
AVAILABLE, BUT PATIENTS
MISINTERPRETED THAT AS WE WANTED
TO COMPLETE AND REAFFIRM THEIR
MODALITY SELECTIONS AND THERE
REALLY ISN'T ANY NICE WAY OF --
WE ULTIMATELY CREATED TWO
CONVERSATION GUIDES.
ONE IS THE INITIAL AND ONE AS
THE FOLLOWUP.
IT WAS JUST EASY TO COPY AND
CREATE ANOTHER VERSION.
BUT EPIC CURRENTLY DOESN'T HAVE
ANY NICE WAY TO HAVE SENSITIVE
QUESTIONNAIRES LIKE THAT THAT
YOU'D LIKE IT TO BE OPEN ENDED.
SO INTIMATE PARTNER VIOLENCE OR
ANY INSTANT SITUATION THAT MIGHT
SOMEONE MIGHT LIKE TO USE THIS
TYPE OF REPORTING TO CALL TO THE
HEALTH CARE SYSTEM'S ATTENTION:
THERE'S NO EASY WAY TO MAKE
THOSE ITEMS AVAILABLE IN A
SUBTLE AND ONGOING BASIS.
THE OTHER THING I'D LIKE TO
POINT OUT, IT'S NOW BEEN ABOUT
TWO AND A HALF YEARS SINCE WE'VE
BEEN COLLECTING EPIC'S SOCIAL
DETERMINANTS OF HEALTH DATA ON
AN ENTERPRISE WIDE BASIS.
THIS IS FROM A POLL AT THE END
OF MARCH.
WE'VE HAD ROUGHLY BUT ONLY A
MILLION RESPONSES.
AND IT SEEMS IN A DEMOGRAPHIC
ASSESSMENT THE FOLKS THAT YOU
MOST WANT TO LEARN ABOUT ARE NOT
THE ONES THAT ARE ANSWERING THE
QUESTION.
AND I THINK TO GREG'S POINT,
WHAT ITEMS WE USE, THE
CONSTRUCTS THAT WE THINK ARE
CLINICALLY ACTIONABLE, WHICH
ONES WE SELECT AND THE ITEMS WE
SELECT TO QUERY THOSE, SOME OF
THE SDOH DOE MAINS IN EPIC HAVE
FIVE OR SIX ITEMS.
SO IT BECOMES A FAIRLY PREDIJOUS
QUESTIONNAIRE, A LONG ONE WHEN
ALL OF THOSE ARE ADDED UP.
SO I THINK THERE ARE SOME VERY
IMPORTANT ONGOING CHALLENGES.
>> ALL RIGHT.
SO I THINK A REALLY FANTASTIC
RESPONSE.
IN THE INTEREST OF TIME, I THINK
WE'LL JUST MOVE ON TO THE FINAL
QUESTION.
REAL QUICK LIGHTNING ROUND PART
TWO, WHAT'S ON YOUR WISH LIST
FOR THE NEXT TEN YEARS?
ANDREA, SINCE YOU SPOKE LAST,
I'LL GO TO YOU NEXT IF YOU WANT
TO RUN DOWN YOUR LIST.
>> I WANT PARAMETERIZABLE
QUESTIONNAIRES SO IT'S NOT A
ONE-SIZE-FITS-ALL FOR THE
INTERINTERVAL.
AUTO MATED TOOLS.
IT TOOK A HUGE AMOUNT OF BUILD
TO BE ABLE TO AUTOMATICALLY
RESPOND TO PATIENTS
QUESTIONNAIRE CHOICES IN THE
CONVERSATION GUIDE AND THAT'S A
BARRIER.
THE COST OF THIS BUILD IS
PROHIBITIVE.
SO IF THEY HAD SOME SIMPLE
FOUNDATION SYSTEM TOOLS FOR
RESPONDING TO PATIENT
INFORMATION, NOT NAMELY PROM
RESPONSES, ALSO, MORE EASILY
PROGRAMTIZABLE TOOLS FOR THE
TYPE OF CO-HOHORT IDENTIFICATIO
AND FUNDING WITH A LESSER TRIAL.
SO THOSE WOULD BE MYS AND.
>> GREG.
YOU'RE NEXT ON MY LIST.
I'LL GO TO YOU.
>> YEAH.
THIS IS MAYBE A LITTLE NEARBY
FOR HOW WE SPECIALIZE, BUT I'M
INTERESTED IN TRYING TO
UNDERSTAND MORE ABOUT PEOPLES'
NEGATIVE EXPERIENCES WITH
MEDICATIONS AND WE JUST DON'T
HAVE
>> AS A CLINICIAN YOU CERTAINLY
LEARN YOU WOULD NEVER EVER
REPORT THE REASON SOMEBODY
STOPPED MAKING A MEDICINE IS
BECAUSE OF AN ADVERSE EFFECT
WHEN YOU SUBSEQUENTLY PRESCRIPT
ANOTHER YOU'D HAVE TO CLICK
THROUGH THREE WARNINGS ON A
SUPPOSED CLASS INTOLERANCE.
I'M GETTING ON A SOAPBOX.
THE CURRENT PROCESS FOR
RECORDING THAT DISCOURAGES
RECORDING ANY USEFUL
INFORMATION.
THAT'S SOMETHING I'D LIKE TO SEE
US DO BETTER.
>> MIGUEL.
>> A WAY OF INTERVENTIONS
WITHOUT AN EXPENSIVE BILL AND TO
CAPTURE THIS ACROSS MULTIPLE
HEALTH SYSTEMS.
I THINK WE REALIZE MANY PATIENTS
GO THROUGH MANY PLACES AND WE'RE
MISSING IMPORTANT DATA WHEN WE
JUST LOOK AT THE E.H.R. OF THE
HEALTH SYSTEM.
SOME TOOLS ALLOW FOR SHARING BUT
THERE'S STILL INCOMPLETE AND
REQUIRE LEVELS OF ACTIVATION AND
DO NOT WORK ACROSS ALL SITES.
THAT HAS TO BE NEEDS TO BE
FIXED.
>> LAST BUT NOT LEAST, TERRY.
>> I'M WITH MIGUEL AND ANDREA
AND MAKING IT EASY TO
INCORPORATE STANDARDIZED PRONGS
AND CUSTOMIZABLE FOR THE PURPOSE
OF CARE AND ADMINISTER THEM NOT
ONLY AT SCHEDULED VISITS BUT AT
REGULAR FOLLOW-UP INTERVALS
APART FROM PATIENT CARE
ENCOUNTERS.
THE ISSUE OF CAPTURING CARE
OUTSIDE YOUR OWN HEALTH STUCK IS
CRITICALLY IMPORTANT FOR CLINIC
CARE AS WELL AS RESEARCH.
>> THANK YOU ALL.
THAT WAS OUR PREPARED LIST.
NOW WE HAVE TIME FOR QUESTIONS.
I DON'T KNOW THERE'S ANYTHING
FROM THE GROUP.
I DO HAVE BASED ON WHAT JERRY
JUST MENTIONED I HAVE A
FOLLOW-UP QUESTION MAYBE I'LL
POSE IT BECAUSE I DON'T SEE
ANYTHING IMMEDIATELY.
THE QUESTION OF CARE OUTSIDE THE
HEALTH CARE SYSTEM AND ONE WAY
TO GET AT THAT WITH THE
LIMITATIONS AND E.H.R. HAS
CAPABILITIES WHERE YOU CAN START
TO PULL IN INFORMATION FROM CARE
AND THE RULES OF THE ROAD ARE
SUCH YOU CAN'T LEVERAGE THE DATA
FOR RESEARCH.
IT'S COME UP IN SEVERAL TRIALS
CAN WE QUERY THEM AND ABSTRACT
THEM FROM THE CHART.
THERE'S DIFFERENT THOUGHTS HOW
THAT GOES OR MIGHT GO.
I DON'T KNOW IF THE PANELISTS
HAVE ANY THOUGHTS AROUND WHETHER
WE CAN PIGGY BACK ON THE
INTEROPERABILITY, HEALTH
EXCHANGE MECHANISMS THAT MAY BE
IN PLACE.
>> THIS MAY ANSWER YOUR
QUESTION, TECHNICALLY HOW THAT'S
WORKED OUT AT MY HEALTH SYSTEM
AND THE HEALTH SYSTEMS WE WORK
ON WITH THE POLICIES ABOUT USING
THAT INFORMATION IS THAT
INFORMATION THAT WE WOULD ACCESS
VIA CARE EVERYONE OR WHATEVER
THE BRAND NAME OF SUCH ANOTHER
SYSTEM IS TO USE THOSE IDENTIFY
RESEARCH PARTICIPANTS OR
SOMETHING ELSE LIKE THAT IS
CONSIDERED OUT OF BOUNDS.
BUT ONCE EVEN IN THE CONTEXT OF
A RESEARCH PROJECT, ONCE ONE
CROSSES OVER THE BOUNDARY TO
BECOME A CARE PROVIDER YOU'RE
NOW A PROVIDER OF CARE AND THIS
IS PART OF THE PERSON'S CARE AND
YOU SHOULD OFFER THE BEST CARE
AVAILABLE AND THAT'S USING THE
RECORDS AND THAT'S THE BOUNDARY
ESTABLISHED.
THIS CAME UP SPECIFICALLY IN OUR
TRIAL IT WAS NOT OKAY TO USE
THOSE DATA OR TRY TO USE THE
DATA TO IDENTIFY POTENTIAL
PARTICIPANTS OR ASCERTAIN
OUTCOMES BUT WHEN A CARE MANAGER
WAS TRYING TO PROVIDER CARE
MANAGEMENT AND MAKE SURE PEOPLE
WERE GET APPROPRIATE MEDICAL
HEALTH CARE FOR SUICIDE ATTEMPTS
THAT WAS CONSIDERED INBOUNDS FOR
THAT.
>> THAT'S A REALLY IMPORTANT
NUANCE ON HOW THAT MIGHT GO.
WE DO HAVE A QUESTION FROM
WENDY.
SO HAS ANYTHING EXCHANGED IN THE
E.H.R. SYSTEM AT YOUR
INSTITUTIONS SINCE YOU STARTED
YOUR TRIALS THAT WOULD HAVE MADE
IT EASIER DO COLLECT THE DATA
THAT YOU NEEDED?
ANYONE?
>> I'M CONCERNED HOW QUICKLY THE
SYSTEMS ARE EVOLVING AND IF
THERE'S THINGS THAT ALREADY
CHANGED NOW THAT ESPECIALLY LIKE
JERRY AND GREG YOU STARTED YOUR
TRIALS A WHILE AGO AND HAD TO
USE THE SYSTEM YOU USED THAT THE
POINTS.
HAVE THINGS IMPROVED.
IS IT EASIER TO LAUNCH YOUR
TRIAL THAN WHEN YOU ACTUALLY
LAUNCHED?
ANDREA TALKED ABOUT SOME WAYS WE
WERE DELIVERING INTERVENTIONS
VIA THE PORTAL WERE PRETTY
CLUNKY AT THE BEGINNING, GOT
BETTER IN TERMS OF WHAT YOU
COULD EMBED IN MESSAGES AND NOW
ARE EVEN BETTER.
ANDREA MENTIONED THE BETTER
CAPABLEABILITIY -- CAPABILITIES
THAT CAME THROUGH AND THAT COULD
IMPROVE AND DO BETTER THERE.
AND IT'S BEEN AS I SAID OVER A
DECADE SINCE WE STARTED THINKING
ABOUT OUT SO OUR SYSTEMS HAVE
NOT EVOLVED QUICKLY BUT THEY'RE
EVOLVING NONETHELESS AND WE'RE
ABOUT TO HOPEFULLY IMPLEMENT
UNIFORM COLLECTION OF THE
PROMISED PAIN MEASURES FOR
EXAMPLE IN CERTAIN CLINICS AND
THAT IDEALLY WOULD BE HELPFUL IN
GETTING SOME INFORMATION THAT WE
WERE NOT ABLE TO GET THAT WE
WANTED TO GET AS PART OF OUR
TRIAL.
SO I THINK WE'RE MAYBE AT THE
CUSP OF A SLOW EVOLUTION THAT
WILL HELP.
>> TWO INNOVATIONS.
EPIC HAS RECEIVED PRESSURE TO
IMPROVE CAPABILITY TO PRESENT
PATIENTS WITH THEIR OWN PROM
SCORES AND MEANS OF TRACKING
THEM AND LINKING INTERVENTION TO
THEIR PROMPT SCORES.
THAT OPENS A HUGE OPPORTUNITY
FOR US TO EMBED MATERIAL.
IT'S EASIER IF SOMETHING IS A
FUNCTIONALITY IN THE FOUNDATION
SYSTEM WE JUST NEED TO TWEAK
PARAMETERS.
I'M VERY EXCITED AND OPTIMISTIC
ABOUT THIS CAPABILITY TO CUSTOM
I'M PATIENT INDIVIDUAL LEVEL
PRESENTATION OF PRONG DATA TO
PATIENTS.
I THINK THAT'S REALLY GOING TO
BE EXCITING THE SECOND IS A
FUNCTIONALITY CALLED COMPASS
ROSE ONE FOR ACTIVE CARE AND
COPD BUT COMMONLY TROD PATHWAYS
APPRECIATES WITH FAIRLY
CONSISTENT MILESTONES OR STAGES
AND THEY ARE AN AGGREGATE OF
PROMS, VIDEOS, PATIENT EDUCATION
MATERIALS AND THERE'S ONE FOR
SLEEP DISTURBANCE.
THEY'RE NOT TRIVIAL TO BUILD BUT
I DON'T THINK THEY'RE NEARLY THE
HEAVY LIFT WE WENT THROUGH AT
THE BEGINNING OF NO HARM.
THESE ARE EMERGENT CAPABILITIES
WE CAN LOOK FORWARD TO IN THE
NOT TOO DISTANT FUTURE.
>> IN CONVERSATIONS SEVEN YEARS
AGO IT WOULD HAVE BEEN SHORT AND
THE RESEARCH IS PROBABLY NOT
GOING TO BE POSSIBLE AND NOW
THERE'S MUCH MORE WILLINGNESS TO
DO A BUILD AND HIGHER COMFORT
LEVEL TO SAY YES, WE CAN MAKE
THEM WORK IN THE SYSTEM IT'S
GOING TO TAKE EXTRA WORK AND
RESOURCES.
WE CAN WORK AND
>> E.H.R.'S WERE NOT DEVELOPED
FOR RESEARCH
THEY WERE DESIGNED TO SUPPORT
BILLING.
WHAT WE HAVE DONE IS LEVERAGED
THE TOOLS FOR OUR PURPOSES AND
RECONFIGURE THEM BECAUSE THERE'S
REVENUE CYCLE FOLKS AND CODES
AND WITH HOSPITALIZATIONS
WHETHER IMPORTANT CLINICAL
EVENTS OCCURRED THAT ARE NOT
ALWAYS ABLE TO QUERY.
>> THE LAST POINT IS E.H.R.s FOR
THE MOST PART UPGRADE CYCLE IS
GETTING FASTER.
AND EVERY THREE AND FIVE AND 10
YEARS BEFORE PEOPLE WOULD
UPGRADE AND NOW THEY'RE PUSHING
IT ON A CYCLE.
THAT GETS EVERYBODY AND FOR
SMALLER UPGRADES PUT IT'S A MORE
OF THINGS TO BREAK BUT NOT
NECESSARILY WAITING FOR THE NEXT
PIECE OF FUNCTIONALITY.
IT COULD BE DELIVERED MORE
FREQUENTLY THAN YOU MIGHT HAVE
OTHERWISE HAVE SEEN.
>> THINK WE'RE AT TIME AND THANK
YOU FOR RESPONDING TO THE
QUESTIONS.
I FOUND THIS VERY ENLIGHTENING.
AM I TURNING THIS BACK OVER TO
YOU?
>> YES.
WE ARE GOING TO TAKE BRIEF
BREAK.
WE ARE PLANNING TO COME BACK AT
3:20 SO PLEASE GET UP AND
STRETCH AND WE'LL SEE YOU BACK
IN 10 MINUTES TO START OUR NEXT
PANEL ABOUT TALKING ABOUT
DIFFERENT STUDY DESIGNS.
WE'LL SEE YOU ALL BACK SHORTLY.
>>GREETINGS
>>SHOWS UP IN THE SIGNS AND
LOTS OF RANDOMIZED DESIGNS.
IT'S PRAGMATIC WHICH WE CAN LOOK
UP THE DEFINITION BUT IN MY
SIMPLE THINKING, PRAGMATIC MEANS
THERE'S GOING TO BE VARIATION
IT'S FLEXIBLE IN ELIGIBILITY FOR
SUBJECTS AND FLEXIBLE IN
INTERVENTION AND MAYBE SOMETIMES
TOO FLEXIBILITY IN STUDY
CONDUCT.
AT THE DESIGN STAGE HOW DO YOU
ADDRESS AND THINK ABOUT AND
IDENTIFY THOSE IMPORTANT DESIGN
AND ANALYSIS AND AS WE'LL SEE IN
THE PRESENTATIONS THAT FOLLOW,
THESE SOURCES OF VARIATION ARE
SOMETIMES NOT JUST HARMLESS OR
IMPACTFUL BUT CAN LEAD TO BIAS
AND NEED TO ADDRESS REMOVAL OF
BIAS.
ANOTHER WE DISCUSSED IS THE
CRITICAL ELEMENT OF TIME AND THE
EARLIER PANEL TALKED ABOUT ALL
THE CHANGES THAT CAN HAPPEN OVER
TIME.
THAT'S A PROMINENT FEATURE AND
MANY ASPECT TO THINK ABOUT TO
HELP STRUCTURE AND WE SAW THAT
IN COVID AND CHANGES IN STANDARD
OF CARE AND THE CATCH-ALL BUCKET
OF WHAT I PICKED UP FROM A
GUIDANCE DOCUMENT INTERCURRENT
FORCES.
MAYBE THEY'RE INTRINSIC CHANGES
IN TERMS OF NATIONAL POLICIES
AND CODING ISSUES.
WE WANTED TO HIGHLIGHT FOUR
SPECIFIC TRIALS WE WANTED A
STRUCTURED FRAMEWORK FOR
THINKING ABOUT THOSE AND DRAW
OUT THESE THREE ELEMENTS IT'S
PRAGMATIC AND LONGITUDINAL
ELEMENTS AND IF WERE HELPING
FOLKS I WOULD FIRST SAY, I
SYSTEMATIC WAY IS TO THINK ABOUT
THE CLINICAL RESEARCH QUESTION
AND THERE'S SCAFFOLDING FRAME
WORKS THAT HELP AND THE
COMPARISON AND OUTCOMES TIMING
AND THE HEALTH CARE DELIVERY AND
CONTEXT SETTING.
WE ALSO RECOGNIZED THAT THIS
STRUCTURED THINKING HAS NAME
THAT'S BEEN PICKED UP IN
REGULATORY GUIDANCE DOCUMENTS.
I'LL SHOW A GLIMPSE OF THAT AND
CLEAR THINKING ABOUT THE
ESTIMATE.
THEN I WANT TO GIVE A SHOUT OUT
TO THE DESIGN PROCESS.
WE CAN TALK ABOUT THE DESIGN.
HOW ARE YOU ON YOUR OWN OR WHAT
THE PEERS YOU CAN TAP INTO OR
EXPERTISE OR EXPERTISES YOU CAN
TAP INTO TO AND THE
COLLABORATORY WAS UNIQUE IN
TAPPING INTO PEERS AND EXPERTS
AND THEY'VE BEEN INCREDIBLY
VALUABLE AND INFECTIOUS TO OTHER
NETWORKS THAT WE HAVE
REPRESENTED LEADERSHIP IN OUR
PANELISTS.
THE NIH IMPACT COLLABORATORY IS
ONE.
I'VE INVOLVED IN THE NHLBI
DECIPHER AND THE DOD PAIN
MANAGEMENT.
THESE ARE ALL OTHER GROUPS THAT
HAVE RECOGNIZED A GOOD THING
FROM THE COLLABORATORY THE
PROCESS FOR DESIGNING A NEW
TRIAL AND SHEPHERDING THAT
FORWARD.
I DO WANT TO CALL THAT OUT NOW.
THE NEXT IS STRUCTURE OF THIS
AND WE'LL TOUCH OR LEAN ON THESE
IN THE SUBSEQUENT TALKS.
WE HAVE THIS CONCEPT THAT
CRITICALLY GUIDES I THINK
CLARIFYING A RESEARCH QUESTION
AND THE RESEARCH QUESTION THEN
LEADS TO DESIGN CONSIDERATION.
DESIGN CONSIDERATION AND
FIDELITY TO THE QUESTION AND
THEN ADDRESSING SOURCES OF
VARIATION.
THIS IS CODIFIED IN THE R01
DOCUMENT THEY SAY TREATMENT AND
ALTERNATIVE.
IT'S BASICALLY TREATMENT AND
COMPARATOR ESSENTIALLY.
THEY TALK ABOUT POPULATION.
I WANT TO CALL OUT THE CONCEPT
OF POPULATION FOR EMBEDDED
TRIALS TAKES ADDITIONAL
DIMENSIONS AND WE THINK OF IT AS
POPULATION AS GUIDANCE DOCUMENT
HERE BUT WE'RE OFTEN THINKING
WHEN EVALUATING IMPLEMENTATION
OPTIONS MAYBE IT'S THE HEALTH
CARE DELIVERY AGENTS.
THAT'S WHERE WE WANT TO
CHARACTERIZE WHAT WHAT'S
HAPPENING THERE.
WE MAKE INFERENCE ON STRATEGY TO
IMPACT THAT PATIENT POPULATION.
SORRY, THAT TARGET POPULATION
THE POPULATION OF FOCUS FOR THE
RESEARCH QUESTION AT HAND.
VERY CLEARLY ONCE IT'S EMBEDDED,
POPULATION CAN TAKE NEW MEANING
IN TERMS OF PATIENTS, PROVIDERS,
CLINICS, OTHER HEALTH CARE
DELIVERY STRUCTURES OR PEOPLE.
THIS GETS IN THE SPECIFIC
INTERCURRENT EVENT ISSUES AS
WELL AND THE NEXT SLIDE ROUNDS
THAT OUT TO SAY THE OUTCOME OR
IN THIS PARLANCE THE VARIABLE OF
INTEREST.
CLARITY ON WHAT IS THAT VARIABLE
AND SEE ON THE EMBEDDED
PRAGMATIC TRIALS CONTEXT WHAT
ARE FACTORS ASSOCIATED WITH
VARIABILITY.
THE EARLIER SESSION WAS
WONDERFUL AT HIGHLIGHTING
CHANGES OVER TIME IN HOW
VARIABLES ARE CAPTURED OR
CHANGES OVER SETTING AN CAPTURED
AND WHAT'S THE DESIGN ANALYSIS
IN THE PRAGMATIC TRIALS AND
THERE'S A SUMMARY THAT'S A
CONCEPTUAL THOUGHT HOW WOULD YOU
AVERAGE THE OUTCOME.
HOW WOULD YOU COMPARE IT ACROSS
THE TWO GROUPS WHAT IS THAT
SPECIFIC AND FINAL ANALYTICAL
SUMMARY THAT WOULD ADDRESS THE
PRIMARY AND SECONDARY RESEARCH
QUESTIONS.
I THINK WE'RE GOING TRY AND
TOUCH ON IN FOUR SEQUENTIAL
STUDY SPECIFIC PRESENTATIONS
WHAT WAS GOING ON INITIALLY,
WHAT ARE THE CONSIDERATIONS THAT
MOTIVATED THE STUDY DESIGN.
NOW THAT YOU'RE SO MUCH SMARTER,
IN HINDSIGHT WHAT MIGHT YOU DO
DIFFERENTLY OR WHAT MIGHT YOU
ADVISE SOMEONE ELSE TO THINK
ABOUT AS THEY EMBARK ON A
SIMILAR ENDEAVOR AND THEN ARE
THERE ALTERNATIVE DESIGNS FROM
THE ONE YOU STARTED WITH THAT
YOU MIGHT CONSIDER FOR A FUTURE
TRIAL.
IN FACT I KNOW AT LEAST TWO OF
THE TRIALS WE'LL TALK ABOUT
CHANGE THEIR DESIGN EITHER EARLY
OR LATER IN THE PROCESS OF DOING
THE RESEARCH.
THE NEXT SLIDE SHOWS THE FOUR
STELLAR PEOPLE THAT ARE GOING TO
GIVE THEIR INSIGHTS INTERN AND
THEN WE'LL WRAP UP AND LEAVE I
THINK PLENTY OF TIME FOR
QUESTIONS.
SO IF YOU HAVE QUESTIONS AS THE
TALKS GO, PLEASE JUST PUT THEM
IN THE CHAT AND I'LL TRACK THEM
AND COME BACK TO THEM.
BUT I THINK WE'LL LET THE FOUR
PROJECTS SUMMARIZE THEIR STUDIES
AND LEARNINGS AND ADVICE AND
THEN WE'LL RETURN TO AN OPEN
TIME FOR QUESTIONS.
WITH THAT I'LL TURN IT OVER TO
DOUG ZATZICK.
>> THANK YOU.
I'LL GIVE A BRIEF OVERVIEW AND
WHAT CAME OUT IN THE ROLLOUT OF
THE TRIAL THAT CAME UP AND
BRIEFLY GO OVER DESIGN
CONSIDERATIONS HOPEFULLY GETTING
TO A RICH DISCUSSION ON THE
PANEL AND WITH OTHERS.
BASICALLY THE RESEARCH QUESTION
WAS WILL THE INTERVENTION SHOW
REDUCTIONS OF POST-TRAUMATIC
STRESS DISORDER COMPARED TO THE
USUAL INTERVENTION.
WITH THE POPULATION OF SURVIVORS
OF INTENTIONAL AND UNINTENTIONAL
HAD PHARMACOLOGY AND ELEMENTS
AND PTSD SYSTEMS WERE ASSESSED
AT TRAUMA CENTER SETTINGS OR
DEPARTMENTS AND NEW OF INTEREST
TO US, AFTER THE INJURY AS
ASSESSED AND POSTSTATE OF
EMERGENCY AND THE TRAUMA CENTER
SITES WHICH WAS THE CLUSTER.
THIS IS A COMPLEX SLIDE AND WE
BASICALLY HAVE UNEXPOSED IS THE
DOTTED LINE OR CONTROL GROUP TO
START RECRUITMENT AND WE HAVE
THE INTERVENTION GROUP YOU
SWITCH ON IN THE STEP WEDGE
DESIGN OF THE INTERVENTION GROUP
RECRUITMENT.
EACH OF THE SITES RANDOMIZED TO
ONE OF FOUR WAVES.
THERE'S FIVE PERIODS, STEP
WEDGE, CLUSTER RANDOMIZED
DESIGN.
THERE WERE A LOT OF EVENTS AT
TSOS AND THE OTHER EVENTS CAN
OCCUR FREQUENTLY AND MAKE YOU
THINK ABOUT YOUR ORIGINAL DESIGN
AND PERHAPS SIMPLICITY.
WE HAD A REGULATORY PAUSE IN OUR
FINAL PERIOD WHEN WE WERE ONLY
RECRUITING INTERVENTION
SUBJECTS.
AND IT TURNS OUT IN THE STEP
WEDGE DESIGN IT'S HARD TO
OVERCOME SOMETHING LIKE THIS FOR
A VARIETY OF REASONS.
AND OTHERS THINK MAYBE WE SHOULD
HAVE GONE WITH OR STUCK WITH A
PARALLEL GROUP RANDOMIZED DESIGN
BASED ON THE ONE SORT OF EVENT
THAT OCCURRED DURING THE TRIAL.
IN THE TSOS THE CONTROL PATIENTS
WERE INTERVENTED FIRST AND THE
STEP WEDGE WAS TURNED ON.
AT EACH SITE ACROSS THE SITES
THERE WAS A STATISTICALLY AND
CLINICALLY SIGNIFICANT INCREASE
IN PTSD SYMPTOMS IN INTERVENTION
SYSTEMS WHO RECRUITED LATER THAN
CONTROL PATIENTS.
MAYBE ANOTHER DESIGN WOULD HAVE
BEEN BETTER THAN THE STEP WEDGE.
WE ALSO SAW TREMENDOUS SITE
HETEROGENEITY AND AT BASELINE WE
KNEW SOME OF OUR CENTERS HAD
HIGHER RATES OF INJURY LIKE
FIREARM THAN OTHERS AND
ADMISSION VOLUME WAS DIFFERENT.
A SLEW OF VARIABLES BETWEEN THE
SITES.
EACH SITE CONTRIBUTES TO THE
CONTROL AND INTERVENTION GROUP.
THERE'S A METHODS LIKE EXTREME
RANDOMIZATION AND OTHERS CAN
OFFSET BUT WHAT'S CHALLENGING IS
THE NOTION OF DIFFERENTIAL
HETEROGENEITY OVER TIME.
WE SAW A TREMENDOUS AMOUNT IN
TERMS OF RECRUITMENT RATES,
REGULATORY LAPSES, LEADERSHIP
TURNOVER AND THE FUNDAMENTAL
QUALITY OF THE INTERVENTION OF
DELIVERY AND TREMENDOUS
VARIABILITY ACROSS THE SITES.
IT TURNS OUT THAT THIS
DIFFERENTIAL SITE VARIABILITY
OVER TIME WAS A KEY FACTOR
INFLUENCING ENROLLMENT.
WITH THE PATIENTS THERE'S A
BASELINE SIGNIFICANT INCREASE IN
PTSD SYSTEMS AND THE
INTERVENTION CONTROL.
WHEN YOU TAKE INTO ACCOUNT THE
SITES THAT RECRUITED FEWER
PATIENTS THAT HAD MORE
REGULATORY LAPSES AND GREATER
LEADERSHIP TURNOVER AND DIDN'T
DO AS GOOD AN A JOB INTERVENING
IT'S AMPLIFIED AND COHORT INTO
GROUPS.
POOR IMPLEMENTERS AND THE OTHERS
DON'T HAVE SIGNIFICANT
DIFFERENCES.
THE INTERVENTION STILL HAS
HIGHER PTSD SYMPTOMS BUT THE
DIFFERENCE NO LONGER
SIGNIFICANT.
I'LL BE PROVOCATIVE AND
HOPEFULLY THIS WILL INSPIRE
DISCUSSION AMONGST THE PANEL AND
EVERYONE ELSE BUT MAYBE THE TSOS
LESSON IS SITE VARIABILITY
CONSIDERATION BOTH AT BASELINE
AND LONGITUDINALLY
DIFFERENTIALLY OVER TIME FAVOR
RANDOMIZATION WHEN POSSIBLE.
THANK YOU.
>> WE'LL COME BACK TO THAT.
IT'S A GREAT COMMENT TO LEAD
WITH.
THE FOLLOW-UP AS WELL WHAT IF
YOU CAN'T DO IT SO WE CAN GO
THERE LATER.
I'LL TRANSITION NOW TO MYLES
WOLF TALKING ABOUT HIGH LOW.
IT'S STILL IN PROCESS AND IN
PROGRESS.
IT'S A DIFFERENT STAGE AND THEN
ADDRESSING DIFFERENT ELEMENTS OF
DESIGN.
MYLES.
>> THANK YOU, PATRICK.
THANKS EVERYBODY FOR JOINING AND
FOR INVITING ME TO SPEAK ABOUT
THIS.
SO IT'S A DIALYSIS BASED TRIAL.
I'M A NEPHROLOGIST.
SO WE TAKE CARE OF PATIENTS WITH
RENAL AND END STAGE KIDNEY
DISEASE THAT REQUIRE DIALYSIS TO
STAY ALIVE.
WHEN YOU DON'T HAVE KIDNEY
FUNCTION YOU DEVELOP A
LIMITATION IN YOUR ABILITY TO
SECRETE PHOSPHORUS THAT COMES
INTO YOUR BODY FROM YOUR DIET
BUT MUST GET OUT THROUGH YOUR
KIDNEY.
SO PEOPLE WITHOUT KIDNEY
FUNCTION ACCUMULATE PHOSPHATE IN
THE BLOOD AND THE SERUM
PHOSPHATE RISES.
THE DIALYSIS CONTRIBUTE TO
REMOVING SOME OF IT BUT STILL
INSUFFICIENT SO WE HAVE AN
ARMAMENTARIAN OF DRUGS CALLED
DIETARY PHOSPHATE BINDERS BUT
HAVE NEVER BEEN PROVEN INFLUENCE
CLINICAL OUTCOMES IN PATIENTS
WITH KIDNEY DISEASE AND WE HAVE
EVIDENCE SUGGESTING THE HIGHER
THE SERUM PHOSPHATE THE WORSE
THE SURVIVAL IS IN DIALYSIS AND
THIS HAS TURNED INTO
OPINION-BASED GUIDELINES
RECOMMENDED GETTING THE
PHOSPHATE TO THE LEVEL OF LESS
THAN 5 1/2.
FOR PEOPLE WHO DON'T THINK IN
TERMS OF PHOSPHATE MUCH, THE
NORMAL RANGE IS MORE LIKE 4 OR 3
1/2.
GETTING 5 1/2 IS ACCEPTING SOME
DEGREE OF ELEVATION AND PATIENTS
CAN BE TREATED AT LEVELS OF 6,
7, 8, 9, 10.
SO THERE'S NO PROOF, NUMBER ONE,
THE PHOSPHATE BINDERS INFLUENCE
OUTCOMES AND THERE'S NO PROOF
THAT TAKING AN INDIVIDUAL
PATIENT'S SERUM PHOSPHATE THAT'S
HIGH AND LOWERING IT WILL
ACTUALLY IMPROVE THE OUTCOMES.
WE JUST HAVE OBSERVATIONAL DATA
THAT ASSOCIATED A HIGH PHOSPHATE
WITH WORSE OUTCOMES.
GETTING CLINICAL TRIAL GRADE
EVIDENCE IN THIS AREA ONE WAY OR
THE OTHER WAS OUR GOAL.
I SHOULD ALSO ADD THAT THE
PHOSPHATE BINDER MEDICINES HAVE
SIDE EFFECTS AND THEORETICAL
TOXICITIES THAT IN THE ABSENCE
OF CLINICAL TRIALS CREATE A
SITUATION WHERE WE THINK WE'RE
DOING GOOD TRYING TO LOWER
PEOPLE PHOSPHATE INTO THE
OPINION-BASED RANGE BUT FIT
REQUIRES USING A HOST OF
MEDICATIONS AND DIETARY
RESTRICTION THE ADVERSE EFFECTS
OF WHICH WE DON'T REALLY KNOW
FROM CLINICAL TRIALS WE DON'T
KNOW IF WE'RE ACTUALLY DOING
HARM, GOOD OR ARE COMPLETELY
NEUTRAL IN HAVING NO EFFECT IN
WHICH CASE PERHAPS WE SHOULD BE
USING OUR TIME AND ENERGY IN
OTHER ASPECTS OF DIALYSIS
MANAGEMENT OF WHICH THERE ARE
MANY.
SO ENTER THIS HILO TRIAL AS A
GOAL HAS TO COMPARE TWO
DIFFERENT PHOSPHATE TARGET
PATIENTS ON HEMODIALYSIS THE
MOST COMMONLY USED MODALITY OF
DIALYSIS IN THE UNITED STATES.
SO THE TWO THERAPEUTIC TARGETS
WE'RE AIMING FOR THE LOW ARM IS
THE STANDARD OF CARE EFFECTIVELY
THAT HAS NO EVIDENTIARY BASIS IT
HAS OBSERVATIONAL EVIDENCE.
AGAINST THAT WE'RE COMPARING
LESS STRICT PHOSPHATE CONTROL
ALLOWING THE SERUM PHOSPHATE TO
DRICHT TO ONE MILLIGRAM PER DES
LITER ACROSS THE TARGET RATE.
THERE'S A HIERARCHICAL COMPOSITE
OUTCOME AND I'LL TALK ABOUT IT
MORE.
ALL-CAUSE MORTALITY IS THE FIRST
IN THE HIERARCHY AND THE SECOND
IS ALL-CAUSE HOSPITALIZATION.
I THINK EVERYBODY WOULD
RECOGNIZE THESE ARE IMPORTANT
HEALTH OUTCOMES BUT AS WE'LL
DISCUSS THEY'RE EASY TO
ASCERTAIN FROM THE ELECTRONIC
HEALTH RECORD.
WHEN WE SET OUT TO DO THE TRIAL
FOR OPERATIONAL REASONS AND EASE
OF ADMINISTRATION IN THE
PARTICIPATING DIALYSIS
FACILITIES WE WERE STRONGLY
ENCOURAGED WITH OUR PARTNERS AND
AGGRADE TO DO THIS AS A CLUSTER
RANDOMIZED TRIAL.
THAT IS RANDOMIZED IN FACILITIES
AND EVERYBODY WHO PARTICIPATES
WOULD BE IN THE HIGH AR LOW.
AND THE CLINICAL TRIAL PART OF
PRAGMATIC TRIALS AND HAVE RISK
IN INTERVENTION.
THAT IS, WE'RE GOING AGAINST THE
GUIDELINES AND WE'RE ASKING
PEOPLE TO DO SO AND THERE'S A
POSSIBILITY I'LL BE SUPERIOR ON
MORTALITY OR LOW WILL BE
SUPERIOR ON MORTALITY.
CLEARLY THE OUTCOME IS A SERIOUS
HEALTH OUTCOME AND WE'RE
ANTICIPATING THIS INTERVENTION
WILL INFLUENCE THE OUTCOME ONE
WAY OR THE OTHER.
WE BELIEVE PATIENTS NEED TO
PROVIDE WRITTEN INFORMED CONSENT
TO PARTICIPATE IN THE STUDY
VERSUS, FOR EXAMPLE, VERSUS
ANOTHER IMPLEMENTATION.
THIS IS IN TWO BITES TRYING TO
ANSWER A SCIENTIFIC AND
IMPLEMENTATION QUESTION.
SO WE HAD THIS INFORMED CONSENT
BIT AND THAT REALLY COMPLICATES
OUR APPROACH AND AS PATRICK
ALLUDED TO IN HIS INTRODUCTORY
COMMENTS, WE'RE ONE OF THE
STUDIES THAT HAD TO MAKE SOME
CHANGES LATER ON I'LL WALK YOU
THROUGH HOW THE CLUSTER
RANDOMIZATION PLUS INFORMED
CONSENT IS A BIG CHALLENGE.
I TRIED TO ORGANIZATION THIS TO
TOUCH ON THE KEY POINTS.
I MENTIONED SOME FROM THE
FRAMEWORK AND THE POPULATION OF
END STAGE KIDNEY DISEASE IN
DIALYSIS AND FROM A PRAGMATIC
TRIAL PERSPECTIVE IT'S A DREAM
COME TRUE POPULATION.
THEY COME TO A FIXED PLACE.
THEY COME TO THE HEALTH CARE
SYSTEM THREE TIMES A WEEK AT A
KNOWN TIME ON SCHEDULE VERY
FREQUENT INTERACTIONS.
THERE'S ALSO GREAT DATA
COLLECTION IN THE ELECTRONIC
HEALTH RECORDS BECAUSE OF THE
MANDATES BY THE FEDERAL
GOVERNMENT WHICH AS YOU KNOW
PAYS FOR THE VAST MAJORITY OF
DIALYSIS AND THERE'S THE BURDEN
OF DOCUMENTATION WHICH BECOMES
USEFUL FOR CLINICAL TRIALS.
THE INTERVENTION TWO
THERAPEUTICS IN THIS CASE, AND
WHAT WE'RE ASKING PEOPLE TO DO
IS GET TO THE TARGET AND THEY
CAN USE WHATEVER WORKS IN THEIR
LOCAL SETTING.
THAT COULD BE BETWEEN THE
PATIENT AND HEALTH CARE FOLKS.
THE COMPARISON IS THE COMPARISON
BETWEEN THE TWO INTERVENTIONS ON
CLINICAL OUTCOMES AND THE
HIERARCHICAL OF ALL-CAUSE
MORTALITY AND HOSPITALIZATION.
IN THIS CASE, ALL CAUSE
MORTALITY IS TIME TO EVENT
MEASUREMENT AND ALL-CAUSE
HOSPITALIZATION IS COUNTS PER
UNIT TIME INCLUDING RECURRENT
EVENTS.
YOU CAN SEE IT'S TRYING TO ADD
TWO THINGS IN THE COMPOSITE
MEASURED AT DIFFERENT SCALES.
MAKING A TRADITIONAL TYPE OF
JOINT TIME TO FIRST DEATH OR
CARDIOVASCULAR EVENT WON'T WORK
IN THIS BECAUSE YOU HAVE GOT
THINGS MEASURED ON TWO SCALES
AND THAT'S WHERE THE
HIERARCHICAL OUTCOME AND
STATISTICS FOR THAT COME IN
HANDY.
I'LL SHOW IN A BIT.
THE TIMING, I THINK IF I
UNDERSTAND CORRECTLY THIS IS
PATIENTS PREVALENT TO DIALYSIS
AT LEAST THREE MONTHS ON AND
GOING TO BE FOLLOWED FOR UP TO
THREE TO FOUR YEARS AFTER WHICH
I MENTIONED DIALYSIS IS A
PRAGMATIC SETTING, FREQUENT
ENCOUNTERS THAT ARE PREDICTABLE
AND GRANULAR DATA COLLECTION,
LOTS OF LAB TESTING DONE ON A
MONTHLY BASIS.
THIS IS ALL MANDATED BY FEDERAL
REIMBURSEMENT.
A LOT OF THE VARIABILITY OTHER
STUDIES FACE IS MITIGATED IN
THIS POPULATION WE'RE WORKING
WITH OUR DIALYSIS PARTNER WHO
EMPLOYED DIETICIANS A MANDATE OF
THE FEDS.
THAT IS TO HAVE DIETICIANS WHO
ARE INTEGRALLY INVOLVED IN
MANAGING AND TRI TATING
PHOSPHATED THERAPIES WHETHER
THEY'RE ON THE TRIAL NOT.
THEY'RE A NATURE GROUP MOTIVATED
AND SCIENTIFICALLY INQUISITIVE
AND WANT TO SEE GOOD DATA FOR
BEST PRACTICE IN DIALYSIS AND
WORKED WITH DIETEDITIONS TO BE
ON THE GROUND IMPLEMENTATION OF
THE TRIAL PERSONNEL.
AND REHASHES AND THE RESEARCH
INVOLVED CLINIC RISK.
HOW DO WE GET CONSENT ON 4,000
PATIENTS WITH THE PERSONNEL ON
THE GROUND AND WE HAVE
STREAMLINED SOME OF THOSE LAST
MINE PAGES OF BOILER PLATE
INFORMATION ON TYPICAL INFORMED
CONSENT DOCUMENTS THAT ARE
REALLY CHALLENGES FOR EVERYBODY
INVOLVED IN THE PROCESS.
MOST IMPORTANTLY THE PATIENTS.
WE HAVE THE SERUM PHOSPHATE
THAT'S WHAT PEOPLE ARE BEING
ASKED TO TRITATE TO AND
INTERVENE IF PLACES ARE HAVING
STRUGGLES BY THE DATA BRIDGE
THAT WE HAVE WITH OUR PARTNERS
THAT SENDS US ON A MONTHLY BASIS
THE UPDATED LABORATORY RESULTS.
EVERY MONTH WE CAN SEE SERUM
PHOSPHATE AND CREATED A
DASHBOARD AT THE STUDY WIDE
LEVEL AND AT THE FACILITY LEVEL
WE FEEDBACK TO THE DIETICIANS
SHOWING THEM HOW WE'RE DOING
NATIONALLY AND WHICH PATIENTS
THEY MIGHT NEED TO FOCUS ON A
BIT MORE BECAUSE THEY'RE OUT OF
TARGET.
HERE'S THE OUTCOMES.
THE WAY THIS WORK AND I'LL GIVE
CREDIT TO FRANK AT THE BCRI THE
LEADER OF STATISTICS HERE WHERE
YOU HAVE THE SITUATION WHERE YOU
HAVE THINGS MEASURED ON TWO
DIFFERENT SCALES IN YOUR OUTCOME
YOU CAN'T JUST COMBINE THEM BY
ADDING THEM TOGETHER AND SAY
TIME TO FIRST.
THERE'S A THING CALLED
ESSENTIALLY THE WIN RATIO WHERE
YOU TRANSLATE BOTH SCALES ON TO
A NEW SCALE WHICH IS ONE PATIENT
IN BLUE IN THIS CASE VERSUS ONE
PATIENT IN RED.
WHAT I'M SHOWING HERE TAKE THE
FIRST EXAMPLE, THAT PATIENT IN
BLUE DIES RELATIVELY EARLY IN
FOLLOW-UP WHEREAS THE PATIENT IN
RED MAKES IT PRETTY FAR OUT.
THE EARLIER TIME TO DEATH MEANS
RED HAD A BETTER OUTCOME AND
PLUS ONE GOES IN THE RED COLUMN
AND MINUS ONE GOES IN THE BLUE
COLUMN.
THEN YOU CAN SEE ON THE
COMPARISON 2 IS A NICE EXAMPLE
WHERE THERE WERE TWO
HOSPITALIZATIONS THAT THE RED
COMPARATOR PATIENT IN THIS CASE
HAD BEFORE THE BLUE PATIENT DIED
BUT NEVERTHELESS SINCE WE HAVE
HIERARCHICALLY ASSIGNED THE
BIGGER PROFILE FOR BIGGER
PROFILE TO DEATH, YOU CAN SEE
SINCE THE RED PATIENT SURVIVED
LONGER THAN THE BLUE PATIENT
DID, THAT'S A WIN FOR RED THOUGH
THEY'RE EXPERIENCED MORE
HOSPITALIZATIONS.
YOU CAN TURN IT AROUND.
I WON'T GO THROUGH ALL OF THESE
BUT THE IDEA AND THE WAY THE
METHOD WORKS IS IT TAKES EVERY
PATIENT FROM THE BLUE ARM, THE
LOW ARM AND COMPARES IT TO EACH
POSSIBLE PATIENT IN THE RED ARM
AND RUNS THROUGH EVERY
PERMUTATION FROM THERE AND
GENERATES A SCORE AND YOU CAN
DERIVE A TEST STATISTIC FROM
THAT TO SAY WHICH GROUP HAD
BETTER OUTCOMES, ONE VERSUS THE
OTHER.
THE DOWN SIDE TO THE METHOD IS
THE SCORE IS HARD TO UNDERSTAND.
IT'S NOT LIKE A HAZARD RATIO
WHERE WE CAN QUANTIFY THE
MAGNITUDE OF EFFECT AND THE
SECONDARY ANALYSES IN OUR CASE
ARE THE COMPONENTS OF THE PRIME
PRIORY OUTCOME AND DO AN
ANALYSIS OF ADJUST TO DEATH AND
HOSPITALIZATIONS.
THE OVERALL PRIMARY OUTCOME WILL
BE DEFINED BY THE RATIO.
AND I'M SHOWING YOU A SNIPPET OF
WHAT TABLE 1 LOOKED LIKE BUT WE
HAD SOME IMBALANCES AND OTHER
THINGS THAT WERE BALANCED THAT
LED US TO THINK THERE WAS
SOMETHING FROM A CLINICAL TRIAL
PERSPECTIVE NOT GOING ON.
YOU CAN SEE FOR EXAMPLE THE
SERUM PHOSPHATE WAS ALREADY IN
RANGE GREATER THAN 6.5 AND THE
HIGH AT BASELINE AND CLOSE TO
RANGE IN THE LOW ARM.
AND THE WILLINGNESS TO
PARTICIPATE DELIVERED BETWEEN
THE TWO ARMS.
THE LOW ARM WE WERE ASKING
PEOPLE TO DO NOTHING DIFFERENT
JUST CONTINUE WIN -- WITH THE
STANDARD OF CARE AND IN THE HIGH
ARM GOOD CONSENT RATE BUT LOWER
THAN THE LOW ARM.
WE THINK AND SINCE THEY KNEW
WHAT THE HOUSING UNITS THEY WERE
IN WHAT THEY WERE RANDOMIZED TO
THAT PATIENTS WHO HISTORICALLY
HAD DIFFICULTY GETTING TO THEIR
PHOSPHATE TARGET WERE NOW
OFFERED THE OPPORTUNITY TO STOP
BEING BOTHERED BY EVERYBODY
THEY'RE PHOSPHATE'S TOO HIGH IF
THEY'RE DIALYSIS UNIT GOT
ASSIGNED TO THE HIGHER ARM AND
WERE PREFERENTIALLY AGREEING TO
PARTICIPATE IF THEY WERE ALREADY
HIGH AND VICE VERSA FOR THE LOW
ARM.
WE'RE WORRIED ABOUT BIASSED
ENROLLMENT AT THE OUTSET AND THE
NUMBERS AT THE BOTTOM SUPPORT
THAT.
WE MADE IT TO 500 PLUS PATIENTS
AND MADE THE REAL DRAMATIC
DECISION TO RE-WORK EVERYTHING
AND ESSENTIALLY START OVER
AGAIN.
AND THERE'S EXPERTISE AND
KNOW-HOW FROM HAVING DONE THIS
FIRST PART WITH THE CLUSTER.
I'D SAY FOR THIS GROUP AND FOR
TODAY'S SUBJECT MATTER THE MORAL
OF THE STORY FROM MY PERSPECTIVE
ARE TWO THINGS IF YOU YOU HAVE
DONE IT INTEREST A TRIAL IT
WOULD FROM THIS AND SUNK US IN
THIS CASE AND MORE ZOOMED OUT
FROM THAT 50,000 FOOT VIEW IN
FOCUSSING TRYING TO BE PRAGMATIC
WHEREVER FEASIBLE BUT NOT
NECESSARILY NOT BE A PRAGMATIC
ZEALOT AND THERE'S TIMES TO BE
PRAGMATIC AND SOMETIMES WHERE
BEING PRAGMATIC CAN CAUSE REAL
HARM TO INTERNAL VALIDITY AND
THOSE THINGS YOU SHOULD TRY TO
AVOID.
THANKS VERY MUCH.
>> WOULD YOU CHOOSE A DIFFERENT
DESIGN AND IT'S YES AND THE
SECOND ANSWER IS ALREADY HAVE
CHOSEN.
NOW WE TRANSITION TO PROVEN AND
VINCE MOR.
>> THANK YOU, IT'S FAS IN A
LOTTING.
OUR TRIAL HAS BEEN OVER FOR THE
VIDEO DID NOT MAKE A DIFFERENCE
IN OUR PRIMARY OUTCOME.
AND WORK WITH SUSAN MITCHELL AND
I'D LIKE TO BRIEFLY DISCUSS
CLUSTER RANDOMIZED TRIAL AND
SUMMARIZE THE MAIN FINDINGS AND
SPEND TIME TALKING ABOUT WOULD
DESIGN CHANGES HAVE MADE A
DIFFERENCE AND WHAT THE
IMPLICATIONS MIGHT HAVE BEEN.
YOU CAN GET VIDEO ASSISTED
ADVANCE CARE PLANNING AND DID IT
WITHIN TWO LARGE NURSING HOME
CHAINS.
AND THE RATIONALE IS THERE'S 1.5
MILLION PEOPLE AT THE TIME
LIVING IN NURSING HOMES OR
MOVING THROUGH NURSING HOMES
ABOUT 3 MILLION AND OFTEN
THEY'RE VERY SICK WITH ADVANCED
ILLNESS AND SUBJECTED TO
BURDENSOME INTERVENTIONS
PARTICULARLY HOSPITAL TRANSFERS
INCONSISTENT WITH PREFERENCES
AND OF LITTLE CLINICAL BENEFIT
IN TERMS OF EXTENDED LIFE.
IT'S PLANNING MAN DATES AND
OBSERVESAL STUDIES SUGGEST
PEOPLE WITH AN ADVANCED CARE
PLAN HAVE LESS LIKELY TO HAVE
HOSPITALIZATION AND TUBE FEEDING
OR GO TO AN ICU.
THOSE ARE OBSERVATIONAL.
THERE'S BEEN SOME SMALL PHASE 3
TRIALS TO SUGGEST ADVANCE CLAIR
PLANNING CAN LEAD TO PEOPLE
INCREASINGLY LIKELIHOOD ADVANCED
CARE PLAN AND HAVING LESS
INTENSIVE INTERVEGS --
INTERVENTIONS THEY'RE HARD TO
SCALE UP WHERE THE AVERAGE SKILL
LEVEL OF THE STAFF IN THE
NURSING HOME WILL NOT BE AS
INTENSE IN HOSPITALS BUT EVEN IN
HOSPITALS THEY'RE DIFFICULT TO
SCALE UP.
THE VIDEO ASSISTED SUPPORT TOOL
WOULD STIMULATE THE CONVERSATION
AND THAT WAS THE IDEA BEHIND
THIS.
SO THE VIDEOS ARE FOCUSED ON
GOALS OF CARE AND PROLONGATIONS
AND SPECIFIC CONDITIONS AND AS
AN ADJUNCT TO OR LEAD-IN TO
COUNSELLING AND EACH OF THE
VIDEOS IS MAYBE FIVE TO EIGHT
MINUTES AT MAX.
WE DID A CLUSTER RANDOMIZED
TRIAL AND WORKED WITH TWO
SYSTEMS AND STARTED WITH 260
NURSING FACILITIES IN THE TWO
SYSTEMS AND SO WE FIRST
STRATIFIED BY HEALTH CARE SYSTEM
BECAUSE THEY'RE QUITE DIFFERENT,
DIFFERENT LOCATIONS IN THE
COUNTRY AND RANDOMLY ASSIGNED
THEM TO RANDOM CONTROL ARMS
WITHIN THAT.
THE PATIENT PARTICIPANT IS
IMPORTANT.
THEY'RE OF THEY'RE ALL
INDIVIDUALS IN THE NURSING
HOMES.
THIS WAS WAIVER OF CONSENT YOU,
CLUSTER RANDOM ASSIGNMENT, NO
CONSENT WHATSOEVER AND
FACILITIES IN THE INTERVENTION
GROUP THAT ADOPTED SOMETHING NEW
AND ACTUALLY WAS APPLIED TO ALL
NURSING HOME RESIDENTS DURING
THAT ENROLLMENT PERIOD.
HOWEVER, WE USED THE EMR IN THE
NURSING HOMES TO IDENTIFY THOSE
PEOPLE WHO ADVANCED ILLNESS WHO
WE THOUGHT HAD THE GREATEST
OPPORTUNITY TO BENEFIT FROM
ADVANCE D CARE PLANNING FOR
MEDICARE BENEFICIARIES 65 OR
OLDER WHO HAVE BEEN RESIDENTS
OVER 100 DAYS AND HAD EITHER
ADVANCED DEMENTIA OR COPD WITH
SIGNIFICANT COGNITIVE OR
PHYSICAL IMPAIRMENT AND BASED ON
HISTORICAL DATA THIS POPULATION
HAD A 50% PROBABILITY OF A
SIX-MONTH MORTALITY WITHIN SIX
MONTHS OF A GIVEN DATE AND THAT
WAS BASED ON MOLD -- MODEL AND
DATA AND THE POPULATION MORE
APPROPRIATE FOR.
WHILE EVERYONE WAS EXPOSED THIS
SUB GROUP OF THE POPULATION IS
WHERE IT TESTED THE PRIMARY
OUTCOME.
ING ON THE INTERVENTION SIDE
THERE WERE CHAMPIONS WHO TRIED
TO GET TWO PEOPLE TWO DO
TRAINING.
THERE WERE OFFERS OF VIDEOS AT
THE TIME OF ADMISSION AND IT WAS
INCORPORATED IN FOR NEW PATIENTS
INTO THE STANDARD ORIENTATIONS
IN THE FIRST 48-72 HOURS OF THE
ADMISSION TO THAT PATIENT
BECAUSE THERE'S LOTS OF DOWN
TIME IN THE NURSING HOME SETTING
AS THEY'RE SETTING YOU UP FOR
THE BEGINNING OF REHAB AND OTHER
POPULATIONS FOR THE LONG STAY
WAS EVERY SIX MONTHS OR AT THE
QUARTERLY CARE PLAN ADJUSTMENTS.
YOU CAN CHOOSE IN VIDEO OR
SPANISH.
WE HAD THEM EMBEDDED FOR THAT
AND THERE WERE PARTS OF THE
COUNTRY WHERE THERE WERE LOTS OF
SPANISH PATIENTS.
AND THIS MADE IT TOUGH TO CREATE
REPORTS ABOUT FIDELITY LARGELY
BASED ON THE PROPORTION OF
PEOPLE ENTERING TRYING TO GET A
HANDLE ON WHEN THESE WERE DONE
SO THERE WOULD BE SOME
REPORTING.
AND PEOPLE WERE OFFERED VIDEO.
EVERY TIME THERE WAS AN OFFERING
OF THE VIDEO AND THERE'S A VIDEO
IF THEY DID WANT IT THEY WERE
SHOWN.
THE PRIMARY OUTCOME I WAS
CHUCKLING WHEN MYLES WAS TALKING
ABOUT HIS COMPLEX AND COMPOSITE
OUTCOME WHICH WAS COMPLICATED
BECAUSE WE OF COURSE MORTALITY
IS MORTALITY AND MORTALITY WOULD
BE A SENSORING EVENT WHICH IS
COMPLICATED AND WE WERE
CONSCIOUS OF THAT GOING FORWARD.
WE HAD THE NUMBER OF HOSPITAL
TRANSFERS PER 1,000 PER 1,000
STAYS AMONG THE GROUP CALIBRATED
ON MEDICARE CLAIMS AND HAD
ACCESS TO THE DATA CENTER AT CMS
FOR THE DATA AND THEY'RE TWO OR
THREE MONTHS BEHIND.
WE WERE ABLE TO DO OUR FINAL
ANALYSES WITHIN THREE OR FOUR
MONTHS OF WHEN OUR LAST PATIENT
SORT OF MET THE 12-MONTH
FOLLOW-UP PERIOD.
HERE'S CHARACTERISTICS.
WITH RANDOM CLUSTER ASSIGNMENT
AT THE FACILITY LEVEL WE GOT
GOOD BALANCE ON MOST THINGS A
SLIGHT DIFFERENCE ON RESIDENTS
BECAUSE OF THE DISTRIBUTION OF
WHERE THE FACILITIES WERE ACROSS
THE COUNTRY.
WE DODGE THE BULLET.
THE MORTALITY RATE WAS SIMILAR
BETWEEN THE CONTROLS AND DAYS OF
FOLLOW-UP IN TERMS OF TOTAL
SURVIVAL TIME WERE LITERALLY
RIGHT ON THE MONEY.
DESPITE ALL THAT BALANCE WE
ACHIEVED NO DIFFERENCE IN THE
NUMBER OF HOSPITAL TRANSFERS PER
1,000 PERSON DAYS ALIVE, 3.7
VERSUS 3.9 AS WE LOOKED AT EACH
INDIVIDUAL ONES AND NONE OF
THOSE.
THERE WERE NO EFFECT IN THE
PRIMARY OUTCOME OR EVEN SOME OF
THE OTHER SUBANALYSIS SECONDARY
OUTCOMES WE LOOKED AT.
THERE'S DISTRIBUTION OF PERCENT
OF FACILITIES WHICH HAD WHAT
PERCENT OF RESIDENTS WITH
ILLNESS SHOWN ONE OF THE VIDEOS.
YOU CAN SEE THERE'S LOTS OF
VARIATION ACROSS THE
PARTICIPATING FACILITIES OR A
WHOLE BUNCH OF DIFFERENT REASONS
FROM TURNOVER IN THE STAFF TO
THIS IS ALL PRE-COVID SO WE
AGAIN DODGED THAT BULLET AS
WELL.
THERE WAS LOTS OF VARIATION FOR
MANY REASONS.
AFTER A WHILE SOME OF THE
ADMINISTRATORS FORGOT THEY WERE
EVEN INVOLVED BECAUSE OF CHANGES
IN ADMINISTRATION OR OTHERWISE.
SO WHAT COULD WE HAVE DONE
DIFFERENTLY?
WE THOUGHT WE COULD HAVE
STRATIFIED ON SOME MEASURE OF
FACILITY IMPLEMENTATION
CAPACITY.
NOW I COULD DO THAT AND COULD
COME UP WITH A SET OF RULES FOR
THAT BECAUSE YOU COULD ESTIMATE
THE EFFECT IN THE FACILITIES
THAT IMPLEMENTED.
WE CAN DO THAT PROSPECTIVELY
WITHOUT DOING POST HOC MASK YOU
COULD HAVE PEERS THAT WERE
ENGAGED A SHARING OF HOW THEY
SOLVED THE PROBLEM WHICH IS AN
IMPORTANT THING WHEN YOU DO
THESE EMBEDDED TRIALS.
YOU WANT TO GET ENGAGEMENT
ACROSS THE UNITS WHICH WERE
BEING DONE.
THE POST HOC ANALYSIS HAD MATCH
AND FACILITIES THAT WERE EXPOSED
WE DID SEE A DIFFERENCE BUT
THAT'S ONE OF THE REASONS WHY WE
THOUGHT IT WAS ABOUT
IMPLEMENTATION.
ON THE OTHER HAND WE COULD HAVE
BEEN UNDER POWERED BECAUSE WE
WOULD HAVE HAD FEWER FACILITIES
TO PICK.
THERE WAS A HIGHER ICC IN THE
OBSERVED INTERCLASS CORRELATION
IN THE DATA WE SAW RELATIVE TO
WHAT WE HAD PREDICTED AND
RELATIVE TO WHAT THE HISTORICAL
DATA SUGGESTS.
WE MAY NOT HAVE BEEN ABLE TO
PREDICT IMPLEMENTATION ALL THAT
WELL.
IT'S NOT ALL THAT GREAT AND HOW
PRAGMATIC IS IT YOU ONLY DEAL
WITH A QUARTER OF THE FACILITIES
AND COMPLICATES THE ANALYSIS AND
RESULTS.
PERHAPS WE CAN LOOK AT THIS
AMONGST THE SICK POSTACUTE
PATIENTS.
NOT THAT WE SAW AN EFFECT IN
THAT SUBGROUP BUT AGAIN WE WERE
UNDERPOWERED BECAUSE THERE
WEREN'T AS MANY OF THOSE PEOPLE.
THERE WERE HIGHER
HOSPITALIZATION RATES AND THE
VIDEO COULD HAVE BEEN INTRODUCED
AS PART OF THAT ADMISSION
ORIENTATION PROCESS AND THIS
WOULD HAVE BEEN SOMEBODY THAT
WAS SALIENT TO THE SKILLED
NURSING AND TO THE HOSPITAL THAT
WAS TRANSFERRING PEOPLE AND
COULD HAVE BEEN INVOLVED IN SOME
FORM OF INTERVENTION.
THE DISADVANTAGE IS A SMALLER
NUMBER OF PATIENTS AND VARIABLE
NUMBER OF POST-ACUTE PATIENTS
PER FACILITY BECAUSE WHEN YOU DO
FACILITY ANALYSIS AND PERHAPS WE
MIGHT HAVE DONE SOME
PATIENT-LEVEL RANDOM ASSIGNMENT
BUT THAT WOULD BE MORE DIFFICULT
TO DO BECAUSE OF THE BUILDING
OVER TIME AND OTHERWISE WE COULD
HAVE HAD THE PROBLEM MYLES HAD
WITH RECRUITMENT OF CLUSTER
RANDOM ASSIGNMENT.
IN THE END I THINK THERE WERE NO
WOULD HAVE BEEN NO CLEAR
ADVANTAGES DOING A DIFFERENT
KIND OF DESIGN IN THE OVERALL
STUDY.
AND YOU CAN GET DEMONSTRATION
PROJECTS IN NURSING SETTINGS IN
OLDER PEOPLE WITH DEMENTIA SO
THIS IS A VIBRANT ISSUE TO ME.
THANK YOU AND I LOOK FORWARD TO
QUESTIONS.
>> AND I THINK WE HAVE SUSAN
SHORTREED AS THE PRESENTER.
>> THANK YOU.
AS A BIO STATISTICIAN FOR THE
SUICIDE PREVENTION I'LL TRY NOT
TO DOUBLE UP ON INFORMATION.
I WANT TO ACKNOWLEDGE THIS IS
ANOTHER ONE OF THOSE HUGE TRIALS
IN THINKING ABOUT HEALTH SYSTEM
TRIALS AND PRAGMATIC TRIALS.
THERE'S A LOT OF NAMES THAT RNT
EVEN ON THIS INVOLVED IN
IMPLEMENTING THE TRIAL.
I WANT TO ACKNOWLEDGE ALL OF
THAT WORK.
AND THE GOAL OF THIS SUICIDE
PREVENTION OUTREACH TRIAL WAS TO
STUDY TWO LOW INTENSITY OUTREACH
INTERVENTIONS WHICH IS DIFFERENT
THAN SUICIDE PREVENTION RESEARCH
THAT HAS BEEN DONE WHICH FOCUSES
ON INDIVIDUALS WHO HAVE ALREADY
AGREED TO PARTICIPATE IN AN
INTERVENTION AND THE OUTCOME
WITH SELF-HARM OR SUICIDE
ATTEMPT INCLUDING FATAL SUICIDE
ATTEMPTS RESULTING IN SUICIDE.
NEITHER OF THE INTERVENTIONS
REDUCE RISK AND FOUND ONE OF THE
INTERVENTIONS MIGHT HAVE
INCREASED RISK.
IN LIGHT OF THIS DISAPPOINTING
RESULT IN THE EXTRA YEARS OF
EXPERIENCE I DON'T THINK THE
STUDY TEAM WOULD CHANGE THE
STUDY DESIGN.
WE WOULD OF COURSE HAVE
APPRECIATED AND HOPED THAT THESE
INTERVENTIONS WOULD PROVIDE US
SOME MORE PREVENTION STRATEGIES
IN OUR TOOLBOX BUT WE WEREN'T
CHANGE THINGS GOING BACK.
I WANTED TO PUT UP THE RESULTS.
AND THERE'S SKILLED TRAINING
WHICH I CAN TALK ABOUT LATER AND
THE TWO OVERLAPPING LINES THAT
ARE BLUE AND RED ARE CARE
MANAGER ANOTHER INTERVENTION AND
UNUSUAL CARE.
OUR STUDY QUESTION WAS AROUND
HEALTH QUESTIONS AND
IMPLEMENTING OUTREACH PROGRAMS
AND THE TWO INTERVENTIONS WERE
COACH WITH REDUCING SUICIDAL
BEHAVIOR WITH PATIENTS WHO
REPORTED SUICIDE IDEATION.
IN THINKING ABOUT THE POPULATION
IS SO WHO IS ENROLLED IN OUR
STUDY?
ALL INDIVIDUALS WERE ENROLLED IN
THE PARTICIPATING HEALTH
SYSTEMS, FOUR, WHO PRESIDENT
TRUMP OF RESPONDS WITH A PATIENT
QUESTIONNAIRE AND SUICIDE
IDEATION IS THE POPULATION WE
SAY ENDORSED SUICIDAL IDEATION.
THEY ALSO HAD TO USE MY CHART TO
BE RANDOMIZED BECAUSE IT WENT
THROUGH THE PATIENT PORTAL AND
SO THAT WAS IMPORTANT.
AND WE SEE AN INDIVIDUAL LEVEL
RANDOMIZATION IN THE
INTERVENTION IS DELIVERED
SEPARATELY FROM THE CLINICAL
STAFF AND CLINICAL CARE
CENTRALIZED LOCATION.
INDIVIDUAL LEVEL RANDOMIZATION
MADE THE MOST SENSE.
AND THERE'S A RESPONSE WITH
PARALLEL RANDOMIZATION EARLIER I
SAID ALL PARTICIPANTS IN FOUR
SITES.
ONE OF THE CHANGES WE BROUGHT ON
A SITE AND STARTED WITH THREE
SITES BUT WHEN YOU'RE ENROLLING
ALL INDIVIDUALS IF YOU'RE NOT
HITTING ENROLLMENT NUMBERS
THERE'S NOT A LOT YOU CAN DO
OTHER THAN WAIT LONGER OR BRING
ON ANOTHER SITE.
SO WE WERE ABLE TO BRING ON
ANOTHER SITE.
BECAUSE RANDOMIZATION WAS
PARALLEL, INDIVIDUAL LEVEL AND
STRATIFIED BY SITE IT WAS NOT
TOO MUCH OF A LIFT TO BRING IN
ANOTHER SITE.
WE CAN TALK ABOUT THE
OPERATIONAL CHALLENGES.
I DON'T WANT TO MINIMIZE THOSE.
AND I'LL SAY SPECIFICALLY
THINKING ABOUT SETTING AND
POPULATION IN SUICIDE PREVENTION
TRIALS AND RESEARCH, THIS
POPULATION IS ONE THAT HAS A
WIDER RANGE OF BASELINE RISK
THAN PREVIOUSLY STUDIED AND A
LOT OF SUICIDE PREVENTION
TRIALS.
SO THIS IS INCLUDING INDIVIDUALS
WHO HAVE NOT SOUGHT EMERGENCY
DEPARTMENT CARE FOR SELF HARM OR
PSYCHIATRIC CONDITIONS.
PEOPLE COULD BE SEEING THEIR
PRIMARY CARE PROVIDER, TALKING
ABOUT DEPRESSION AND WOULD BE
RANDOMIZED INTO THE TRIAL.
>> THERE'S TWO INTERVENTIONS
CALLED DBT SKILLS BY AN ONLINE
CARE AND RISK CARE MANAGEMENT.
I WANT TO HIGHLIGHT IN TERMS OF
THE RESULTS THAT BOTH
INTERVENTIONS ARE MUCH LOWER IN
INTENSITY THAN PREVIOUSLY
STUDIED.
THERE WAS NO COMPONENT WHICH CAN
OFTEN BE PART OF DBT SKILLS
THERAPY.
SO I WANTED TO CALL THAT OUT.
THE INVITATION PROCESS WAS
DELIVERED THROUGH THE ELECTRONIC
HEALTH RECORD.
IT DID NOT HAVE THE SAME
PERSONAL NOTE ATTACHED WE OFTEN
WOULD LIKE TO ATTACH TO MENTAL
HEALTH CARE.
I WOULD SAY THE INVITATION
PROCESS DID INVOLVE EXPRESSIONS
OF COMPARING AND CONCERN WHICH
THERE HAS BEEN SOME EVIDENCE
THAT IS EXPRESSING CARE, CARING
MESSAGES CAN BE A PREVENTION
STRATEGY FOR SUICIDE PREVENTION
MIXED RESULTS IN THAT AREA.
ONE THING THAT IS DIFFERENT
ABOUT OUR INVITATION PROCESS IS
WE'LL EXPRESS CONCERN THERE IS
ALSO AN ASK ABOUT WOULD YOU LIKE
TO PARTICIPATE IN THIS STUDY.
THE RESEARCH IS VOLUNTARY AND
YOU'RE FREE TO DECLINE.
THAT'S A VERY DIFFERENT
COMPONENT NOT IN TRADITIONAL
CARING MESSAGES AND THERE WAS A
REMINDER PROCESS AS WELL AS IS
STANDARD IN RESEARCH TO TRY TO
INCREASE INVOLVEMENT.
NOT ALL DBT SKILLS WERE COVERED
THIS WAS A COLLABORATION WITH
INDIVIDUALS WITH LIVED
EXPERIENCE AND INDIVIDUALS WHO
WORK WITH INDIVID INDIVIDUALS W
SUICIDAL THOUGHTS AND THE SKILLS
WERE USED.
THERE'S AN ONLINE COMPONENT AND
THE COACH SUPPORT HAD WITH
TAILORED REINFORCEMENT PERIODS
UP TO A 12-MONTH PERIOD.
CARE MANAGEMENT SIMILAR TO CARE
MANAGEMENT FOR DEPRESSION, SAME
OUTREACH.
IT WAS RISK-BASED AND IT COULD
OCCUR FOR UP TO 12 MONTHS AFTER
RANDOMIZATION.
LONG PERIODS OF POTENTIAL
INTERVENTION.
SO WITH EACH INTERVENTION IS
COMPARED TO USUAL CARE.
IN THE FIRST SLIDE I SAID ALL
INDIVIDUALS WERE RANDOMIZED AND
PEOPLE WERE BROUGHT FORTH AND
RANDOMIZED AND INTERVENTIONS
SENT AND EVERYONE WAS INCLUDED
IN THE COMPARISON WHETHER OR NOT
THEY TOOK UP THE INTERVENTION
AND THE LAST SPEAKER SHOWED A
VIDEO OF CARE PLANNING.
AND WE HAD OTHER INDIVIDUAL
WHO'S CRENGAGED IN THE
INTERVENTION AND OUTREACH WAS
WHO WOULD PARTICIPATE AND WHO
WOULDN'T AND WOULD THAT STILL BE
ABLE TO IMPACT SUICIDE ATTEMPT
RATES.
AND THE HYPOTHESIS ABOUT THE
POTENTIAL FOR INCREASED HARM IS
AROUND PERHAPS REPEATEDLY
REACHING OUT TO INDIVIDUALS WITH
SERVICES NOT INTERESTED.
THAT MAY NOT BE HELPFUL AND MAY
BE HARMFUL.
IT'S A POST HOC ANALYSIS AFTER
RANDOMIZATION AND A HYPOTHESES
FOR THE FUTURE BUT SOMETHING WE
WONDER ABOUT.
OUR OUTCOME WAS ALSO A COMPOSITE
OUTCOME BUT ABOUT 90% OF THE
OUTCOMES WERE NON-FATAL SUICIDE
ATTEMPTS AND 10% WERE SUICIDES.
AND WE HAD A CHART ADJUDICATION
SYSTEM DWREG --
GREG TALKED ABOUT AND I
APPRECIATE THIS AS A
STATISTICIAN.
THERE WAS A LOT OF THOUGHT THAT
WENT INTO THIS TO HAVE A
RIGOROUS OUTCOME THAT WAS
COLLECTED ACROSS EVERYONE
UNIVERSALLY IN THE USUAL CARE AS
WELL AS THE INTERVENTION ARMS
AND ADDED TO THE RIGOR OF THE
STUDY.
SO WE DID LOOK AT 18 MONTHS
FOLLOWING RANDOMIZATION.
THE INTERVENTIONS COULD BE FOR
12 MONTHS OR SIX MONTHS
MAINTENANCE PERIOD BUT THINKING
ABOUT POTENTIAL CONTAMINATION
AND OTHER PROVIDERS WERE NOW
EXTENDING THAT TIME FOR WHICH
PEOPLE CAN DO THAT.
AND PERSONALLY IMPORTANT IN
OUTREACH TRIALS FOR SOME WHO
CONTINUE TO BE AT RISK FOR
SUICIDAL BEHAVIOR AND IS THAT
INTERVENTION -- IS THAT
SOMETHING WE NEED TO BE ONGOING
OR IS THAT MAINTAINED AT ANY
LEVEL?
I WANTED TO THROW OUT WE DID
HAVE TO CENSOR PEOPLE BECAUSE OF
AVAILABILITY OF INFORMATION
ABOUT SUICIDE ATTEMPTS.
THOSE NOT ENROLLED IN THE HEALTH
SYSTEM WE WERE NOT GUARANTEED TO
ASCERTAIN THAT OUTCOME.
I DO BELIEVE THIS WAS THE RIGHT
SETTING AND IS THIS SOMETHING
HEALTH SYSTEMS SHOULD WANT TO DO
TO REACH OUT TO PEOPLE WHO MAY
NOT SPECIFICALLY BE SEEKING CARE
FOR SUICIDAL IDEATION BUT MAY
HAVE INCREASED RISK AND DELIVER
ONE OF THE INTERVENTIONS?
I BELIEVE THAT WAS MY LAST
SLIDE -- NO, THIS IS AN
IMPORTANT SLIDE NOT RELATED
WHICH I FORGOT ABOUT.
I WANTED TO BRING IT UP IN A
GROUP OF INDIVIDUALS WHO ARE
PROBABLY DESIGNING OTHER STUDIES
IN THIS REALM.
IN THIS STUDY WE DIDN'T EXPECT
DO SEE AN INCREASED RISK OF
HARM.
THIS COULD EVEN HAPPEN IN
STUDIES WHERE WE DON'T THINK IT
CAN.
DATA SAFETY MONITORING BOARDS
ARE IMPORTANT EVEN FOR THOSE IN
PRAGMATIC TRIALS.
FOR THOSE STAFFING TRIALS WITH
SERIOUS OUTCOMES HAVING MORE
THAN ONE PERSON RESPONSIBLE FOR
THOSE REPORTS I JUST WANT TO
THROW THAT OUT THERE AS THERE'S
PEOPLE PLANNING STUDIES OR IN
THE FIELD IT'S IMPORTANT TO HAVE
MULTIPLE PEOPLE ON THE REPORT.
IN ANOTHER PIECE THAT'S BEEN
TOUCHED ON BY A FEW DIFFERENT
PEOPLE IS QUALITY ASSURANCE OF
THE DATA IS COMPLICATED IN
STUDIES THAT USE ADMINISTRATIVE
DATA AND ELECTRONIC HEALTH
RECORDS AND MANY STUDIES ARE
GOING OVER YEARS, THINGS CHANGE
OVER TIME AND BREAK OVER TIME.
I HEARD MULTIPLE STUDIES TALK
ABOUT THAT.
I PERSONALLY THINK THAT
SOMETHING THAT WOULD BE REALLY
IMPORTANT FOR DSMBs TO START
DOING IS TO INVOLVE THE REGULAR
QUALITY ASSURANCE AS PART OF THE
MONITORING OF THE TRIAL LIKE WE
MONITOR ENROLLMENT.
ARE WE GETTING THE DATA WE
EXPECT TO GET?
ARE WE GETTING IT EQUALLY ACROSS
THE GROUPS.
THESE ARE THINGS WE CAN PROBABLY
DO IN A BLINDED FASHION.
MAYBE NOT EVERYTHING BUT I THINK
IT'S ACTUALLY REALLY IMPORTANT
TO THE FIDELITY OF OUR RESEARCH
AND MAKING SURE WE'RE GETTING
THE ANSWER THAT WE SHOULD BE
GETTING.
AND I'M PRETTY SURE THAT'S MY
LAST SLIDE.
>> TERRIFIC.
MANY THANKS.
I WANT TO MAKE A QUICK SUMMARY
COMMENT AND THEN WE'LL OPEN IT
UP.
IT WOULD BE GREAT IF OUR
PANELI
PANELISTS AND REALLY, REALLY
INTERESTING.
THANK YOU FOR LAYING OUT THIS
POPULATION INTERVENTION
COMPARISON OUTCOMES, TIMING AND
SETTING AND I HAVE A QUESTION ON
EACH OF THOSE THAT I'D LOVE TO
ASK IF THERE'S TIME BUT I WANT
TO SAY YOU GUYS NICELY REMINDED
ME IT'S SOMETHING THAT WAS
TOUCHED ON AND THE CONSENT WAS
ALSO A FUNDAMENTAL PART OF THE
DESIGN OR EXECUTION OF THE
DESIGN AND THEN INTERVENTION
FIDELITY WAS REALLY IT SEEMED
LIKE A CRITICAL PART OF AT LEAST
THREE OF THE PRESENTATIONS.
SO MAYBE I'LL START THERE AND
INVITE OTHERS TO ASK QUESTIONS.
IN FACT, I DON'T WANT TO START
THERE.
I WANT TO SAY ARE THERE ANY
QUESTIONS FROM YOU PANELISTS OR
COMMENTS YOU WANT TO MAKE BASED
ON WHAT YOU HEARD FROM THE OTHER
PANELISTS.
>> THIS IS VINCE MOR.
MYLES I LOVED YOUR DESCRIPTION
OF THE DIAL -- DIALYSIS CENTER
IS THE PERFECT WAY AND I THINK
OF NURSING HOMES AND WAS VERY
AWARE OF THE WORK ON THE TIME AS
WELL.
IT'S GREAT STRUCTURE.
I THINK YOUR EXPERIENCE OF
BASICALLY FINDING YOU NEEDED TO
SWITCH TO PERSONAL RECRUITMENT
BECAUSE OF THE NATURE OF THE
OFFER UNDER THE CONSENT
CIRCUMSTANCE IS SUCH AN
INTERESTING AND COMPLICATED
CIRCUMSTANCE BECAUSE FOR MANY OF
THE CLUS FOR RANDOMIZED TRIALS
YOU'RE TRIAL IS THERE'S REALLY
NOT -- THEY SHOULD BE DOING WHAT
WE ARE PROPOSING FOR THEM TO DO
A LOT MORE OF ANYWAY.
SO WE'RE JUST TRYING TO GOOSE
THEM IN A QUALITY IMPROVEMENT
WAY BUT IN A RIGOROUS WAY.
TO DO A SHIFT IN WHAT THE
INTERVENTION IS ON THE CLINICAL
SIDE WITHOUT ASKING CONSENT IS A
COMPLICATED THING.
IT INTRODUCES A MORE COMPLICATED
WAY OF THINKING ABOUT WHAT'S THE
RIGHT UNIT OF RANDOM ASSIGNMENT.
>> I WOULD RESPOND SOME SMART
PEOPLE INVOLVED IN HEARING OUR
STUDY ALONG THE WAY AND I DON'T
THINK WE SHOULD TAKE CREDIT FOR
ANY GREAT CONTRIBUTION HERE TO
FIGURING THIS.
AT SOME LEVEL THE
POST-RANDOMIZATION CONSENT IS A
PREDICTABLE THING AND WE SAID
LET'S TRY TO OVERCOME IT.
WE WEREN'T SURE WHICH DIRECTION
IT WOULD GO.
WE THOUGHT FOR INSTANCE THERE
MIGHT BE ENOUGH PATIENTS WHO
WOULD SAY, GREAT, THIS MAKES MY
LIFE EASIER AND THAT THE HIGH
ARM WOULD HAVE HAD HIGHER
RECRUITMENT THAN ULTIMATE IT
PROVED TO BE.
I THINK WE PROVED SOMETHING
PEOPLE ALREADY KNEW.
>> I DIDN'T KNOW.
I'VE BEEN OFF THE COLLABORATORY
CALL FOR A WHILE BUT IT CAME UP
WITH THE COMMENT SUSAN WAS
SAYING ABOUT DSMBs.
YOU CAN SPEND SO MUCH TIME WITH
YOUR DSMB ON THINGS THAT ARE NOT
IMPORTANT AND YET THERE MAY BE
THINGS THAT ARE REALLY IMPORTANT
AND I THINK THE SOLUTION TO THAT
IS TAILORING DSMBs TO PRAGMATIC
TRIALS.
WE TALK ABOUT IT CAN'T HAVE IT'S
OWN PRAGMATIC TRIALS ACROSS
INSTITUTES BUT SAY WHAT YOU'VE
DONE TO TAILOR DSMBs TO TRIALS.
>> UNDER IMPACT WE'RE FUNDING
PILOTS AND DEMOS.
WE'VE NOW FUNDED LIKE 18 OF
THEM.
MOST THE PILOTS END UP WITH JUST
A SAFETY OFFICER AND WE HAVE A
SINGLE ONE WHO HAS A BROAD
PERSPECTIVE ON THIS.
SOMEBODY NOT INVOLVED IN TRIALS
BUT CLINICAL WORK AND KNOWS
GERIATRICS AND DEMENTIA BUT IT'S
APPLIED TO THREE OR FOUR OF THE
PILOTS IN THE DEMOS.
IT'S A STANDING DSMB OF SIX
PEOPLE.
THERE'S LARGE-SCALE TRIALS AND
THE STATISTICIANS PARTICULARLY
ARE.
IT'S NOT LIKE THE NIMH STANDING
DSMB MORE FAMILIAR WITH
INDIVIDUAL RANDOM ASSIGNMENT
DRUG TRIALS.
THESE PEOPLE KNOW ABOUT THE
VARIETIES HERE.
AS IT ALL ABOUT DEMENTIA AND
OLDER PEOPLE IN LOTS OF
SETTINGS.
THERE'S A COHERENCE TO THE
UNDERSTANDING OF THE POPULATION.
>> OTHER COMMENTS OR QUESTIONS
FROM OUR PANELISTS FIRST?
>> IT'S TANGENTIALLY RELATED TO
THE DSMBs KNOWLEDGE IN THIS
SPACE
>> WHAT SUNK US IN THE ATTEMPT
AT THE CLUSTER RANDOMIZATION WAS
A BIT OF A KNOWLEDGE GAP OR MORE
OF A BIT IN CLINICAL TRIALS AND
HOW THEY'RE DONE OF WHAT THEY'RE
TRYING TO EMBED THIS IN.
WE HAVE PEOPLE WILLING PARTNERS
WHICH IS AN ENORMOUS OBSTACLE TO
SURMOUNT.
THEY SOMETIMES HAVE SEE A
CLINICAL TRIAL THROUGH THE LENS
OF THEIR CLINICAL EXPERIENCE AND
THEIR BIASES OF WHAT THEY THINK
IS THE RIGHT ANSWER AND WHAT
THEY THINK WE WANT THEM TO DO
AND I THINK THAT HAD A BIG
INFLUENCE ON PEOPLE BEING COAXED
INTO A STUDY.
ONE OF THE BIG HURDLES TO THINK
ABOUT AND MAYBE OVER TIME AS THE
BUSINESS EXPANDS AND THERE'S
MORE AND MORE OF THE STUDIES IT
WILL START TO SEEP INTO MORE
PEOPLE'S CONSCIOUSNESS BUT
THERE'S A HUGE EDUCATIONAL GAP
FOR THE PEOPLE TO IMPLEMENT
STUDIES ON THE GROUND THAT NEEDS
TO BE THOUGHT ABOUT IN THE
DESIGN PHASE.
>> I AGREE.
HERE'S ONE FROM THE AUDIENCE.
ANY OTHER COMMENTS FROM
PANELISTS WHO WANT TO WEIGH IN?
LET'S HEAR FROM THE AUDIENCE.
WENDY, WHY DON'T YOU OPEN THE
MIC AND OFFER YOUR QUESTION.
>> GREAT PRESENTATIONS,
EVERYONE.
THE FIRST COMMENT FROM THE
AUDIENCE, FANTASTIC DISCUSSIONS
AND PRESENTATIONS.
THEY'D LOVE TO HEAR THE PROS AND
CONS OF INDIVIDUAL VERSUS THE
PROVIDER CLINIC LEVEL AND YOU
ALLUDED TO THIS IN A COMMENT AND
CURIOUS WHAT PEOPLE THINK ONE
VERSUS THE OTHER.
>> IT'S FUN AND IT'S A PRIVILEGE
TO BE ABLE TO SEE ACROSS SUCH A
WIDE RANGE OF TRIALS AS THEY
DEVELOP THROUGH THIS NETWORK AND
OTHERS.
WE HAVE LEARNED INDIVIDUALLY
RANDOMIZED IS PREFERRED TO
PARALLEL GROUP RANDOMIZED
PREFERRED TO STEP WEDGE.
IT'S HARD TO GENERALIZE BUT
THAT'S THE CASCADE OF THINKING
AND WHAT DOUG OR SUSAN COMMENTED
ON WHEN IT'S RANDOMIZED YOU CAN
BALANCE THINGS THAT CHANGE OVER
TIME.
STEP WEDGE PUTS LATER THINGS IN
THE INTERVENTION GROUP AND
DOESN'T BALANCE ON TIME.
PARALYZED RANDOMIZED TRIAL MAY
BUT THERE'S OTHER BALANCE OF
DRIFT TO CONSIDER IN THAT DESIGN
AS WELL.
THERE'S A 50,000 FOOT
GENERALIZIZATION AND MAYBE IT'S
THE ROBUSTNESS ISSUE THAT
CREATES THE HIERARCHY BUT HAS TO
MATCH THE QUESTION.
IF THE QUESTION'S ABOUT CHANGING
THE CLINIC STRUCTURE, YOU CHANGE
THE CLINIC STRUCTURE AND
RANDOMIZE CLINICS.
THE DESIGN HAS FIDELITY TO THE
QUESTION.
MAYBE WHAT WE'RE TALKING ABOUT
TODAY ARE ELEMENTS OF ROBUSTNESS
OF THAT DESIGN TO THE
INTERCURRENT FORCES IN THE WORLD
AS WE LISTED IN THE ONE SUMMARY
SLIDE.
OTHER COMMENTS?
>> I WOULD ADD TO THAT MAYBE
25,000 VIEW BASED ON WHAT YOU
SAID INDIVIDUAL RANDOMIZATION
WOULD ALWAYS BE THE WINNER.
IF YOU HAVE AN INTERVENTION THAT
DOES NOT NEED INFORMED CONSENT
AND YOU COULD GET HUGE SWATHS OF
NUMBERS IN ONE FELL SWOOP WITH
CLUSTER RANDOMIZATION THAT'S
PERHAPS AN OPPORTUNITY WHERE
OPERATIONALLY IT'S EASIER AND
YOU CAN OVERCOME THE STATISTICAL
HEAD WITH NUMBERS.
IF CONSENT'S INVOLVED YOU HAVE
TO DO INDIVIDUAL LEVEL
RANDOMIZATION.
IF YOU DON'T HAVE CONSENT, THEN
IT BECOMES MUCH MORE NUANCED AND
THE ADVANTAGES START TO PILE UP
A LITTLE BIT MORE IN THE CLUSTER
SIDE.
>> THE OTHER INTERCURRENT
EVENTS.
WE ALL SURVIVED COVID AND MANY
ARE INVOLVED IN HEAL, PAIN,
OPIOID TRIALS.
A COUPLE YEARS AGO THERE WAS A
METH EPIDEMIC LIKE PATRICK
CALLED -- WE'RE INVOLVED IN AN
OPIOID TRIAL.
COVID IS ITS OWN EPIDEMIC THEN
THERE'S METH NOW THERE'S
FENTANYL.
THINK OF THE NATIONAL
VARIABILITY IN THE DIFFERENT
DRUGS AND MYLES IF YOU HAVE ALL
THESE SITES AND THE EAST COAST
HAS SEEN THE FENTANYL WAVE AND
NOW IT'S ROCK FENTANYL IN THE
MIDWEST.
THANK GOD FOR INDIVIDUAL
RANDOMIZATION.
THAT'S JUST MY BIAS.
>> MYLES, IF YOU DON'T NEED TO
CONSENT AND THE INTERVENTION IS
DELIVERED AT THE CLINIC OR
FACILITY LEVEL BECAUSE THERE'S
TOO MUCH BLEEDING WITHIN PLACE
YOU NEED TO DO CLUSTER DESIGN.
YOU REALLY GOT TO KNOW WHAT ELSE
IS GOING ON TO DO THE PROPER
STRATIFICATION IN ADVANCE.
I'VE DONE A LARGE TRIAL OF
VACCINE HIGH DOSE VERSUS
STANDARD DOSE INFLUENZA
VACCINATION IN NURSING HOMES.
WE HAD 400 IN THE CONTROL AND I
STILL GOT SCREWED BECAUSE WE
DIDN'T STRATIFY ON THE
PROPORTION OF AFRICAN AMERICAN
AND DIFFERENTIAL RESPONSES AND
YOU THINK HOW COULD I NOT HAVE
DONE THAT WHEN YOU THINK THE LAW
OF LARGE NUMBERS IS GOING TO
WORK BUT SOMETIMES DOESN'T.
>> I LIKE THAT COROLLARY.
I WAS GOING TO ADD THAT TO YOUR
COMMENT, MYLES, YES, NUMBERS IN
INDIVIDUAL PATIENTS BUT WHAT
ABOUT REPLICATION OF CLIN IBZ TO
CONTROL THAT VARIATION THROUGH
AVERAGING.
WE'RE CONTROL BY AVERAGING BUT
HOW TO THINK OF ADDRESSING
CONTROL OF THE CLINIC-LEVEL
VARIATION AND WHAT WE HEARD IN
POPULATION AND HOW THEY DELIVER
THE INTERVENTION AND HOW THEY
MAY OR MAY NOT CAPTURE THE
OUTCOME FOR YOU AND WHAT ARE THE
SETTING CHARACTERISTICS, VINCE,
YOU CANNOT CAPTURE AND SAY THOSE
ARE IMPORTANT.
I'M GOING TO CONTROL THAT
VARIATION UP FRONT.
>> WE DID A TRIAL IN THE MIDST
OF COVID ON VACCINATION RATES.
IN SOME PLACES THERE WEREN'T
MUCH COVID SO THEY DIDN'T WANT
TO GET VACCINATED.
IT'S YOU HAVE TO HAVE THE
STRATIFICATION IN PLACE.
>> I WANT TO BRING SOMETHING UP
BECAUSE I THINK THERE'S A
MISNOMER THAT CLUSTER
RANDOMIZATION CAN PREVENT
CONTAMINATION AND I WANT TO
TOUCH ON IT AND IT'S ACROSS THE
BOARD AND ACROSS FIELD.
THAT'S NOT OFTEN THE CASE.
I PERSONALLY THINK.
I THINK WHAT THE INTERVENTION IS
AND HOW IT WOULD BE DELIVERED IS
THE MOST IMPORTANT THING IN
DECIDING WHO SHOULD BE CLUSTERED
AND AT WHAT LEVEL AND HEALTH
CARE IS MORE COMPLICATED THAN
WHO YOUR PRIMARY DOCTOR IS OR
CARDIOLOGIST.
I WANT TO BRING THAT UP AS A
COMPLEXITY OF CONTAMINATION GOES
BOTH WAYS AND IT'S THINKING
THROUGH THAT WHOLE PROCESS.
>> I WANT TO ASK ONE QUESTION.
I HEARD FROM YOU, DOUG, VINCE
AND SUSAN THERE WAS A LOT OF
VARIABILITY IN THE UPTAKE OF THE
INTERVENTION OR THE FIDELITY TO
THE INTERVENTION.
YOU CALLED THAT OUT.
ANY LESSON LEARNED ON HOW --
VINCE, YOU OFFERED ONE LESSON.
CAN YOU PREDICT IT AND CONTROL
IT BUT ANY ADVICE ON SOMEONE
THINKING OF A TRIAL AND THE
PRAGMATIC EMBEDDED CONTEXT ON
HOW TO DEAL WITH OR MITIGATE
MAYBE VARIABILITY OF THE
INTERVENTION UPTAKE?
ANY THOUGHTS?
>> THIS IS BASICALLY WHAT OUR
HEALTH CARE SYSTEM IS ALL ABOUT.
MASSIVE AMOUNTS OF VARIABILITY.
AT THE DOCTOR LEVEL AND HOSPITAL
SYSTEM LEVEL.
THERE'S A LOT OF VARIABILITY.
TO THINK WE CAN ACTUALLY GET A
HEALTH CARE PROVIDER OR GROUP TO
SAY OH, YEAH WE'LL ALL DO THIS
ONE THING WITHOUT ACTUALLY
ENGINEERING IT WITH THE WORK
FLOW IN A DIFFERENT WAY FROM ONE
PLACE TO THE OTHER BECAUSE THE
WORK FLOW IS NOT NECESSARILY
ACROSS THE SAME ACROSS THE
DIFFERENT UNITS, IT'S VERY
DISHEARTENING BUT BASICALLY SEEN
AS A MAJOR ISSUE ABOUT
IMPLEMENTATION.
I KEEP ASKING PEOPLE WHO RUN
HEALTH CARE SYSTEMS HOW DO YOU
GET ANYTHING DONE AT ALL?
I KNOW THEY DO.
>> ONE ANSWER IS ACCEPTANCE.
IT'S A LOT OF VARIABILITY.
DEAL WITH IT, YOU CAN'T CHANGE
IT BUT YOU HINTED AT POTENTIAL
PATHS TO INFLUENCE CARE
PROCESSES.
IT WOULD BE GOOD.
HE SAID IT'S IMPORTANT TO BE
PRAGMATIC BUT SOMETIMES YOU HAVE
TO GO IN ON THE WHEEL.
WHETHER IT'S THE 5:00 ARM OR
7:00 ON, YOU GUYS TELL ME.
THE TRACKING EVEN IF YOU'RE NOT
GOING TO CONTROL THE
INTERVENTION AND WE WERE ABLE TO
PICK UP AND RATE THE VARIABILITY
IN THE SITE IMPLEMENTATION
PROCESSES.
TSOS LOOKS LIKE A FLAT TIRE AND
DAVID CHAMBERS HAS APROVIDER WH
FOLKS AT NCI.
IT'S A DIMPLE AND FLAT TOOIR BUT
IT'S REALLY IMPORTANT BECAUSE
FOR TSOS WE HAVE THIS NEBULOUS
EFFECT.
WE HAD A SIX-MONTH REDUCTION IN
PTSD SYMPTOMS BUT ONCE YOU LOOK
MORE CAREFULLY, SOME OF OUR
IMPLEMENTATION WAS CUT AND
DRIVE.
LIKE HOW MUCH PATIENTS DID YOU
RECRUIT.
THE FIDELITY OF THE INTERVENTION
IS WE SPENT TIME ON AND CREATED
INDEX AND THE GOOD IMPLEMENTERS
DID A MUCH BETTER JOB IN
REDUCING PTSD SYMPTOMS.
>> WE HAD AN OUTREACH
INTERVENTION WHICH MAY BE
DIFFERENT BUT THE FIRST QUESTION
IS IS FIDELITY PART OF YOUR
QUESTION.
FROM A PATIENT-CENTERED
APPROACH.
IF WE'RE OFFERING PEOPLE THINGS
THEY DON'T WANT IN A WAY OR IN A
WAY THEY DON'T WANT I DON'T KNOW
IF FORCING OUR POPULATION INTO A
GROUP OF PEOPLE WILLING TO DO
WHAT WE ASK THEM TO DO IS GOING
GIVE US THE QUESTIONS WE NEED IN
THE HEALTH CARE SETTING.
SO THAT'S MY FIRST THING AS A
STATISTICIAN, IS THE FIDELITY
PART IT?
WE'RE MAKING GENERALIZATION IT'S
WE WENT TO A DIFFERENT
POPULATION IT'D BE 30% BUT IT'S
AN IMPORTANT QUESTION WE SWEEP
UNDER THE RUG IN RESEARCH IN THE
NAME OF RIGOR AND IS PART OF THE
QUESTION.
>> EXCELLENT POINT.
I APPRECIATE THAT.
>> I GOT THREE MINUTES.
LET ME ASK ABOUT VARIABILITY AND
CONTROL AND CHARACTERIZE IT.
I THINK FOR THE POPULATIONS WE
HEARD SOME COMMENTS ABOUT
SPECIFIC RESTRICTION OF THE
POPULATION OR CLARIFICATION.
PRAGMATIC TRIALS AND MANY
CLUSTERS POTENTIAL STUDY WOULD
INCLUDE VARIABILITY IN THE
PARTICIPANTS.
DID YOUR STUDIES REALLY HAVE AN
INTEREST IN DOING THOSE SUBGROUP
ANALYSES?
WAS THAT IMPORTANT AND IS THAT
VARIABILITY YOU SHOULD TRY TO
LEARN FROM OR WOULD YOU SAY IT'S
REALLY CHALLENGING TO LEARN FROM
THAT VARIABILITY?
ANY THOUGHTS ON THAT?
WHAT ABOUT PARTICIPANT
VARIATION?
>> I'LL JUMP IN.
I DON'T THINK THIS IS DIFFERENT
BETWEEN A TYPICAL CLINICAL TRIAL
OR PRAGMATIC TRIAL.
YOU'RE GOING TO GO AND PUT IN
THE KIND OF WORK THAT ALL THE
PEOPLE WHO ARE PANELISTS, DOUG
SAID WE SURVIVED COVID BUT WE
MAY OR MAY NOT SURVIVE THE
TRIALS WE'RE DOING.
TO NOT EXTRACT ALL THE VALUE OUT
OF THE DATA AT THE END OF ALL
THAT JUST SEEMS SILLY TO ME.
OF COURSE YOU'VE GOT TO HAVE A
GRAIN OF SALT WITH THE ANALYSIS
YOU'RE DOING TO UNDERSTAND THAT
WHEN YOU DO A STRATIFIED
ANALYSIS MAY NOT HAVE RANDOMIZED
ASSIGNMENT ANYMORE BECAUSE YOU
CAN RANDOMIZE ON THAT FACTOR OR
WITHIN THAT SUBGROUP.
I THINK YOU HAVE TO BE CAUTIOUS.
I THINK YOU HAVE TO UNDERSTAND
HOW INTERPRET THOSE RESULTS AND
WHAT YOU'LL DO WITH THEM
AFTERWARDS BUT TO TAKE THIS HARD
LINE VIEW IT'S THE PRIMARY END
POINT AND EVERYTHING ELSE YOU
LOOK AT, I DON'T SEE HOW THAT
HELPS ANYONE.
>> YOU HAVE SO MUCH RICH DATA.
THE PRIMARY OUTCOME I KEEP
THINKING WITH THE RESULTS OF OUR
STUDY FROM THE PERSPECTIVE OF
THE HEALTH CARE SYSTEM.
IF YOU WENT TO THE CHIEF MEDICAL
OFFICER AND SAID LISTEN, WE
DIDN'T REALLY ACHIEVE OUR
PRIMARY OUTCOME BUT 30% OF YOUR
BUILDING SEEMED TO DO A GOOD JOB
AND THE OTHER 30% ACHIEVED A
GOOD RESULT AND NOBODY WAS
UNHAPPY.
IT'S NOT THAT DIFFERENT FROM
WHAT SUSAN WAS SAYING IS
OFFERING TRIAL.
WE WERE OFFERING TO THE
ADMINISTRATORS EACH OF THESE
CLINICS OR BUILDINGS, ETCETERA,
SOMETHING NEW.
SOME DID AND THE SOME DIDN'T AND
THE ONES THAT DIT THEIR PATIENTS
SEEMED TO HAVE IF THERE WAS
BENEFIT THAT'S WHERE IT WAS.
>> LET ME CLOSE BY SAYING THIS
IS A FUN SESSION FOR ME.
I KEPT TRACK OF VERY INTERESTING
THINGS.
DIFFERENCES IN POSITIONS, ACUTE
INJURY AND ESRD, ADVANCED
ILLNESS, NURSING HOME RESIDENTS,
FOLKS WITH SUICIDE IDEATION.
HUGE VARIATION.
THE SETTINGS AND EMERGENCY
DEPARTMENT DIALYSIS, NURSING
FACILITIES OR HEALTH SYSTEMS.
REALLY RICH AND INTERESTING
VARIATION IN EACH OF THESE
TRIALS THAT I THINK HELPS US
LEARN ABOUT HOW TO APPROACH
DESIGNING TRIALS, THINKING ABOUT
EACH OF THESE THINGS.
THANK YOU VERY MUCH.
I KNOW WENDY, HAVE YOU A
QUESTION BUT YOU CONTROL THE
TIME FROM NOW FORWARD.
I'LL JUST TURN IT OVER TO YOU
BUT I WANT TO SAY MANY THANKS
FOR THE PANELISTS FOR PUTTING
THIS TOGETHER AND SPENDING TIME
WITH US TODAY.
>> REALLY WONDERFUL DISCUSSION
AND WE HAVE QUESTIONS SO WE MAY
FOLLOW-UP VIA E-MAIL TO RESPOND
TO PEOPLE.
PEOPLE HAD QUESTIONS ABOUT THE
SPECIFIC ANALYSIS THAT YOU'RE
USING AND ANALYTIC APPROACHES
YOU'RE USING.
WE'LL KEEP THE QUESTIONS AND GO
AHEAD AND MOVE ON AND SO.
I'D ASK PATRICK AND LESLIE AND
KEITH, IF KEITH IS STILL ON TO
JOIN US FOR A CLOSING PANEL AND
OTHERS CAN TURN OFF YOUR CAMERA
ON ONE OF THE FEATURES OF
VIDEOCAST IS IF YOU'RE CAMERA IS
ON YOU'RE LIVE ON SCREEN AND
ARCHIVED FOREVER.
WE LIKE TO LET PEOPLE KNOW THAT
ON ZOOM.
LESLEY, YOUR THOUGHTS AND WE'D
LOVE TO HEAR KEITH AND PATRICK'S
THOUGHTS ABOUT FIRST-DAY WRAP-UP
THOUGHTS AND WHERE WE'RE HEADED.
>> THANK YOU, WENDY.
FIRST OF ALL, WHAT A RICH
AFTERNOON.
MY THANKS TO THE MODERATORS,
KEITH AND PATRICK AND TO ALL THE
PANELISTS REALLY FOR PROVIDING
SUCH INSIGHT ABOUT WHAT THEY
LEARNED, WHAT THEY ENCOUNTERED
AND WHAT THEY MIGHT DO AGAIN
DIFFERENTLY OR NOT DO AGAIN,
PERIOD.
I ALWAYS APPRECIATE THE CANDOR
FOLKS BRING TO THESE
DISCUSSIONS.
I WOULD LOVE TO ASK KEITH AND
THEN PATRICK -- I KNOW WE DON'T
HAVE A LOT OF TIME.
AS YOU LISTENED TO ALL THE PANEL
HAD TO SAY, WHAT WERE SOME KEY
TAKEAWAYS FOR YOU AND MAYBE
WE'LL START WITH YOU, KEITH,
SOME KEY TAKEAWAYS THAT REALLY
COULD INFORM HOW WE DO EMBEDDED
PRAGMATIC TRIALS DIFFERENTLY
GOING FORWARD OR BETTER.
>> IT WAS FASCINATING TO LISTEN
TO THE PANELISTS AND WHAT WORKED
WELL AND WHAT DIDN'T AND
LESSONED LEARNED.
TAKING NOTES AS THEY WERE
SPEAKING AND IE'LL IN NO WAY BE
ABLE TO DO JUSTICE TO WHAT THEY
TALKED ABOUT.
THERE WERE THINGS THAT STOOD
OUT.
PART WAS E.H.R.s CAN PROVIDE A
LOT OF AUTOMATION IN A LOT CASES
BUT MANUAL REVIEW MAY STILL BE
REQUIRED AND YOU'RE IDENTIFYING
PATIENTS AND CAN USE THE LAB
VALUES AND NEED TO MANUALLY
REVIEW TO SCREEN PEOPLE
PROPERLY.
AND A KEY POINT I WROTE DOWN
MANY TIMES IS THE PROCESS IN
MONITORING VARIOUS ASPECTS OF
THE SYSTEM TO LET YOU KNOW THAT
THINGS ARE HAPPENING AS YOU
EXPECT AND THINGS ARE NOT
CHANGING UNDERNEATH YOU.
AND MONITORING TO DELIVERY AND
MONITORING IT AND CHECKING
OUTCOMES.
THERE'S DIFFERENT PROCESSES THEY
HAD BUILT INTO THEIR SYSTEMS TO
LET THEM MONITOR THINGS.
I THINK ONE OF THE LESSONS
LEARNED WAS TO DO AS FREQUENT AS
POSSIBLE SO YOU DON'T MISS
THINGS.
AND IN SOME CASES HAVING BACKUPS
TO SOME OF YOUR OTHER PROCESSES
BECAUSE YOU MAY BE MONITORING
SOMETHING BUT THEN IT'S NOT
ACTUALLY MEASURING THE
UNDERLYING DATA.
SPOT CHECKING.
SO THOSE WERE A FEW THINGS I
STOOD OUT TO ME.
THE OTHER IS THERE ISN'T A ONE
SIZE FITS ALL APPROACH IN
DELIVERING INTERVENTIONS.
WE HEARD FROM A TRIAL HAVING
SOME REPORTS AND SOME PEOPLE
WANTED AN ALERT OPPOSED TO
EMBEDDED.
BEING NIMBLE AND BEING ABLE TO
TAILOR THE INTERVENTIONS TO BEST
SUIT THE CARE SETTINGS IN THE
E.H.R.s.
THOSE WERE SOME OF THE HIGH
POINTS I HAD WRITTEN DOWN.
>> AND THERE'S THE NEED FOR
AGILITY AND CONTINUAL MONITORING
OF THE PROCESSES.
WE ACTUALLY HEARD ABOUT THAT ON
THE PANEL FROM THE PANEL THAT
PATRICK MODERATED AS WELL IN
THIS CONCEPT OF YOU CAN'T WAIT
UNTIL THE END OF A PRAGMATIC
TRIAL TO LOOK AT YOUR DATA AND
DATA QUALITY WHICH IS AN ISSUE I
KNOW IS NEAR AND DEAR TO YOUR
HEART.
PATRICK, I'D LOVE YOUR
REFLECTIONS TOO AND WHAT YOU
WOULD ADD TO THAT SUMMARY.
>> PART OF WHAT SEE IS SOME OF
WHAT WE PUT IN UP FRONT AND
STRUCTURE AND MOTIVATE IT.
AND WHAT WE'RE LEARNING BY BEING
ENGAGED IN DIFFERENT TRIALS IS
WHAT ARE THE THINGS WE NEED TO
THINK ABOUT OVER AND OVER AGAIN.
WHAT ARE THE PATTERNS WE NEED TO
THINK ABOUT IN RESEARCH DESIGN
AND WE TRIED TO PUT SOME OF THAT
TOGETHER TODAY.
YOU SAW IT WASN'T JUST ABOUT
WHAT'S YOUR RANDOMIZATION
ORGANIZATION AND THE INFLUENCE
OF THE INTERVENTION.
IT'S ISSUES AROUND POPULATION
AND POPULATION HETEROGENEITY AND
THE QUESTIONS WE DIDN'T GET TO
TALK ABOUT IMPLEMENTATION
IMPLEMENTATION EFFECTIVENESS
DESIGN.
ONE THING IS RESEARCH DESIGN FOR
THE EMBEDDED PRAGMATIC TRIALS IS
PRETTY BROAD.
THERE'S A LOT PUT ON THE TABLE.
IT TAKES A BIGGER TEAM TO DO IT
AND WE HEARD TODAY THERE'S
ETHICS AND INFORMATICS IS
IMPORTANT TO INCLUDE FOR
OUTCOMES.
THE DELIVERY SYSTEM AND WHAT
HAPPENS THERE IS AN IMPORTANT
TEAM MEMBER.
I THINK WE'VE LEARNED THAT
THROUGH THE COLLABORATCOLLABOCO.
ARE THERE OTHERS THAT MAY COME
OUT TODAY AND THERE'S A TEAM
SPORT AND WHO NEEDS TO BE ON THE
TEAM.
>> LET ME TURN IT BACK TO YOU
FOR CLOSING REMARKS AND ANY
INFORMATION ABOUT TOMORROW.
>> WHAT A GREAT KICKOFF FOR OUR
FIRST DAY.
EXCELLENT PANELS AND SUCH
NUANCED COMMENTS.
I FEEL LIKE I'VE GOTTEN TO KNOW
THE TRIALS SO MUCH OVER THE LT
DECADE AND THERE'S ALWAYS NEW
THINGS AS WE TALK ABOUT EACH OF
THE STUDIES AND ONE OF THE
QUESTIONS WE DIDN'T GET TO I
DIDN'T HAVE A CHANCE TO PUT IN
THE CHAT IS WHAT ARE WE DOING TO
BUILD RESOURCES AND TO EDUCATE
THE BROADER COMMUNITY ABOUT HOW
TO DO THESE TRIALS AND ALSO
WITHIN NIH TO BETTER EDUCATE OR
MAKE INFORMATION AND RESOURCES
AVAILABLE TO OTHER PROGRAM
OFFICERS OR OTHER PARTS OF NIH
AS WELL AS REVIEWERS AND THE
DSMB MEMBERS AND WE EVEN TALKED
ABOUT PEER REVIEWERS OF
MANUSCRIPTS AND SO MAYBE
TOMORROW WE CAN HIGHLIGHT
RESOURCES AVAILABLE AND HAVE
RESOURCES AVAILABLE FOR PEOPLE
BUT CERTAINLY THE WEBSITE IS A
GREAT RESOURCE TO START FOR
PEOPLE AND FIND INFORMATION AND
SO STATE TUNED FOR TOMORROW.
WE HAVE ANOTHER ACTION-FILLED
DAY PLANNED WITH TWO DIFFERENT
PANELS AGAIN OF SPEAKERS.
I'M GOING TO KICK US OFF WITH
THE FIRST ONE TALKING ABOUT HOW
BEST TO USE THAT PLANNING OR
START-UP PERIOD.
WHAT CAN WE DO TO SET YOURSELF
UP FOR SUCCESS IN DOING THE
TRIALS.
YOU HEARD ABOUT THE DIFFICULTIES
AND TRIBULATIONS AND UNEXPECTED
THINGS THAT PEOPLE RAN INTO AND
WE'RE GOING TO HEAR FROM FOUR
GREAT INVESTIGATORS ABOUT MAYBE
WHAT THEY WISHED THEY'D DONE AND
TOMORROW IS THE IMPLEMENTATION
QUESTION AROUND HOW TO WE
IMPLEMENT THE INTERVENTIONS IN
THE COMPLEX HEALTH CARE SYSTEMS.
WE MAY BE ABLE TO FOLLOW ON THAT
QUESTION