WELCOME, EVERYONE, TO OUR
NINTH ANNUAL WORKSHOP HOSTED BY
NIH AND THE PRAGMATIC TRIALS
COLLABORATORY.
MY NAME IS WENDY WEBER, AND I AM
THE BRANCH CHIEF FOR CLINICAL
RESEARCH IN COMPLEMENTARY AND
INTEGRATIVE HEALTH AT THE
NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH AT NIH.
I HAVE SERVED AS THE PROGRAM
OFFICER FOR THE COORDINATING
CENTER OF THE PRAGMATIC TRIALS
COLLABORATORY SINCE WE LAUNCHED
IN 2012.
AND WE'RE JOINED BY MANY OF OUR
NIH COLLEAGUES AND MANY OF THE
PRINCIPAL INVESTIGATORS, ALL OF
THE DIFFERENT TRIALS THAT WE'VE
HAD OVER THE COURSE OF THE
YEARS, AND I KNOW MANY OF YOU
ARE JOINING US VIA VIDEOCAST
TODAY AS WELL.
WE'RE ALSO JOINED BY ONE OF OUR
CO-CHAIRS, DR. HELENE LANGEVIN.
SHE IS THE DIRECTOR OF THE
NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH, AND WE'LL HEAR MORE FROM
HER TOMORROW.
ABOUT SOME OF THE
EXCITING THINGS THAT ARE
HAPPENING AT NIH RELATED TO
PRAGMATIC RESEARCH.
OUR OTHER CO-CHAIR IS
DR. RICHARD HODES, WHO IS THE
DIRECTOR OF THE NATIONAL
INSTITUTE ON AGING.
HE'LL BE JOINING US, I THINK, AS
WELL.
SO IN THE PAST, I MENTIONED THIS
WAS THE NINTH YEAR WE'VE DONE
THIS WORKSHOP, WE'VE COVERED A
RANGE OF DIFFERENT TOPICS
RELATIVE TO PRAGUE MA TUCK
TRIAPRAGMATIC TRIALSCONDUCTED IE
SETTING, EVERYTHING FROM
BIOETHICS, STUDY DESIGN AND
ANALYSIS OF THESE TYPES OF
PRAGMATIC TRIALS, HOW TO THINK
ABOUT DESIGNING FOR
IMPLEMENTATION AND
SUSTAINABILITY, AS WELL AS THE
INCLUSION OF DIVERSE
PARTICIPANTS.
THIS YEAR, OUR TOPIC IS GOING
FROM ZERO TO 100: GENERATING
EVIDENCE THROUGH PRAGMATC
RESEARCH TO ADDRESS PRESSING
HEALTHCARE ISSUES.
AND TODAY WE'RE GOING TO FOCUS
ON THAT PHASE ZERO IN OUR
SESSIONS, WHICH IS WHAT REALLY
ACTUALLY NEEDS TO HAPPEN BEFORE
THE RESEARCH APPLICATION IS EVEN
SUBMITTED TO YOUR FUNDING
AGENCY.
AND WE'RE GOING TO FOCUS ON
GETTING THE QUESTION RIGHT, AND
ENGAGING FRONT-LINE CLINICIANS,
PATIENTS AND COMMUNITY PARTNERS
TO MAKE SURE THAT THE EVIDENCE
THAT'S GENERATED IS USEFUL AND
CAN POTENTIALLY IMPACT
HEALTHCARE ISSUES AND
POLICYMAKING AS IT RELATES TO
HEALTHCARE DELIVERY.
SO WE'LL BE HERE TODAY FOR ABOUT
FOUR HOURS, AND THEN -- THREE
HOURS, SORRY, TODAY, AND THEN
TOMORROW, WE'RE GOING TO START
AT 11:00 A.M. EASTERN AND WE'LL
BE JOINED BY THE NIH DIRECTOR,
DR. MONICA BERTAGNOLLI, WHO WILL
BE GIVING OUR KEYNOTE ADDRESS
ENTITLED "CONNECTING LAB, CLINIC
AND COMMUNITY: COMMUNITIES
ADVANCING RESEARCH EQUITY," OR
THE CARE FOR HEALTH PROGRAM.
AND TOMORROW, WE'LL HAVE THREE
ADDITIONAL PANEL DISCUSSIONS
FOCUSED MORE ON ONCE YOU GET
THINGS UP AND GOING, USING THAT
DATA FROM DISPARATE DATA
SYSTEMS, REACHING POPULATIONS
THAT ARE MOST AFFECTED BY HEALTH
INEQUITIES, AND OVERCOMING THE
MANY ADMINISTRATIVE BURDENS IN
PRAGMATIC RESEARCH TO REALLY DO
WHAT WE'RE TRAIN TODAY DO, WHICH
IS GENERATE THAT -- TRAINED TO
DO, WHICH IS GENERATE THAT
EVIDENCE AND MOVE FORWARD
QUICKLY.
WE WANT TO THANK, OF COURSE, ALL
OF OUR PRESENTERS FOR BEING
WILLING TO SHARE THEIR
EXPERIENCES IN THESE IMPORTANT
TOPICS.
MANY OF THE INVESTIGATORS YOU'LL
HEAR FROM OVER THE NEXT TWO DAYS
COME FROM THE PRAGMATIC TRIALS
COLLABORATORY PROGRAM.
FOR THOSE OF YOU WHO ARE
UNFAMILIAR WITH THE PROGRAM, WE
LAUNCHED AS I SAID IN 2012, WITH
THE GOAL OF DETERMINING HOW TO
CONDUCT CLINICAL TRIALS IN THE
CLINICAL CARE SETTING WITH
HEALTHCARE SYSTEMS AS PARTNERS
IN THE TRIAL.
OVER THE COURSE OF THE LAST JUST
OVER A DECADE, THE PROGRAM HAS
WORKED WITH 32 DIFFERENT TRIALS
AND LEARNED A GREAT DEAL.
AND THE LESSONS LEARNED ARE
AVAILABLE ON THE PROGRAM'S
WEBSITE, WHICH IS RE-THINK
RE-THINKINGCLINICALTRIALS.ORG.
IT HAS DETAILED LIVING TEXTBOOK
WITH CHAPTERS AND INFORMATION
ABOUT EACH OF THE TRIALS, IT HAS
AN EXTENSIVE SET OF RESOURCES,
INCLUDING ARCHIVING OF THE
WEEKLY GRAND ROUNDS AND TRAINING
MATERIALS FOR THOSE WHO WANT TO
LEARN MORE.
BEFORE I TURN IT OVER TO OUR
FIRST SESSION AND OUR FIRST
MODERATOR, I ALSO WANT TO THANK
THE ORGANIZERS OF THE WORKSHOP.
AS YOU KNOW, THESE WORKSHOPS
DON'T HAPPEN MAGICALLY.
THERE'S A LOT OF HARD WORK THAT
GOES INTO THEM.
SO I WANT TO GIVE A SPECIAL
THANKS TO OUR PLANNING GROUP,
LESLIE CURTIS, TAMMY REESE, GINA
OLENBROCK AND MARIJO MAR MENCI.,
I'M SURE I'VE MISSED A COUPLE OF
INDIVIDUALS BUT THIS IS A HUGE
GROUP EFFORT AND I WANT TO THANK
EVERYBODY FOR JOINING US TODAY.
SO KEVIN, I'M GOING TO TURN IT
OVER TO YOU TO GET US STARTED
WITH OUR VERY FIRST SESSION.
I DO HAVE ONE HOUSEKEEPING NOTE,
WHICH IS IF YOU HAVE QUESTIONS
FOR US, PLEASE EMAIL THEM TO US.
IF YOU HAVE A MOMENT, JUST JOT
THIS EMAIL DOWN.
WE WILL BE TAKING QUESTIONS FROM
EVERYONE VIA THIS EMAIL.
AND WE WOULD LOVE TO HEAR FROM
YOU AND WHAT YOUR QUESTIONS ARE.
WE WILL DO OUR BEST TO
PRIORITIZE THOSE QUESTIONS AND
GET TO AS MANY AS POSSIBLE, AND
WE MAY DO A LITTLE BIT OF
LUMPING THINGS TOGETHER.
BUT KEVIN, I'LL TURN IT OVER TO
YOU TO TALK ABOUT THIS PHASE
ZERO TOPIC ABOUT GETTING THE
QUESTION RIGHT.
>> GREAT.
THANKS SO MUCH, WENDY, AND
WELCOME, EVERYONE.
WE'RE SO EXCITED ABOUT THIS
TOPIC BECAUSE THIS IS REALLY THE
FIRST TIME TO OUR WRECK LITION N
THE FIRST TIME WE ADDRESSED THIS
ISSUE OF HOW YOU DEFINE THE
RESEARCH QUESTION.
WE'RE USUALLY FOCUSED ABOUT
THINGS WE'RE LEARNING ABOUT
DESIGNING THE TRIALS,
IMPLEMENTING THOSE DESIGNS,
INTERPRETING THE RESULTS, ET
CETERA, AND SO WE'RE HAPPY TO
GET A CHANCE TO TALK ABOUT THIS
WITH FOUR PEOPLE WHO HAVE BEEN
THINKING ABOUT THIS A LOT AND
WELCOME YOUR QUESTIONS ABOUT
THIS AS WELL.
SO WE HAVE FOUR PANELISTS
REPRESENTING TWO OF OUR MORE
RECENT TRIALS, AND TWO OF OUR
OLDER TRIALS.
WE'VE GOT ANDREA CHEVILLE, KEVIN
MCLAWSLIN, KUSHANG PATEL AND
GREG SIMON.
WE'RE GOING STOORT OFF WITH
KEVIN TALKING ABOUT EXPERIENCES
WITH THE ARBOR TELEHEALTH
STUDIES SO LET ME TURN IT OVER
TO KEVIN.
EACH PERSON IS GOING TO TAKE
ABOUT 10 MINUTES, AND TALK ABOUT
HOW THEY'VE SORT OF TRIED TO
ALIGN THE RESEARCH QUESTION WITH
THE PATIENT HEALTHCARE SYSTEM
PRIORITIES AND HOW THEY CRAFTED
THAT QUESTION TO HELP
DECISION-MAKERS.
WE ASKED EVERYONE TO TELL THE
REAL STORY, WARTS AND ALL, ABOUT
HOW THEY ARRIVED AT THE QUESTION
THEY DID, WHAT WERE ALL THE
CONSIDERATIONS THAT WENT INTO
THAT.
SO EACH PERSON IS GOING TO TELL
THAT STORY AND SORT OF END UP
WITH THEIR FINAL RESEARCH
QUESTION.
SO IT SHOULD BE A LOT OF FUN,
THEN WE'LL HAVE DISCUSSION
AFTERWARDS.
SO LET ME TURN IT OVER TO KEVIN
TO BEGIN.
>> THANKS VERY MUCH, TODAY I'M
GOING TO BE TALKING ABOUT THE
ARBOR TELEHEALTH STUDY.
I'M GOING TO NOT NECESSARILY
GIVE AWAY ALL THE DETAILS OF OUR
RESEARCH QUESTION RIGHT OFF THE
BAT IN ATTEMPT TO BUILD UP A
LITTLE BIT OF SUSPENSE AS HOW I
TELL YOU THE STORY OF HOW WE
EVENTUALLY GOT TO OUR RESEARCH
QUESTION.
SO TO TELL YOU THAT STORY I
THINK WE NEED TO PROVIDE
HISTORICAL CONTEXT.
TELEHEALTH PHYSICAL THERAPY HAS
ALWAYS BEEN USED AS A MEANS TO
IMPROVING ACCESS TO PT FOR
PEOPLE WHO CAN'T QUITE MAKE TO
IN-CLINIC PT FOR WHATEVER
REASON.
BUT ITS REAL WORLD USE HAS
ALWAYS BEEN REALLY LIMITED BY
POLICY REIMBURSEMENT.
SO MEDICARE HAS TRADITIONALLY
NOT PAID FOR PHYSICAL THERAPY
DELIVERED BY TELEHEALTH,
COMMERCIAL PAYORS KIND OF HAVE
HAD THE SAME STANCE, AND MOST --
OR MANY STATES IN THE U.S. SH
RESTRICTIONS ON THIS IN THEIR
STATE PRACTICE ACTS, BANNING
PHYSICAL THERAPISTS FROM
PROVIDING CARE BY TELEHEALTH.
SO IT REALLY WAS VERY LITTLE
REAL WORLD OPPORTUNITY TO
PROVIDE THESE TYPES OF
INTERVENTIONS.
BUT THAT CHANGED, IT SEEMED LIKE
IN A MATTER OF DAYS DURING THE
EARLY PHASES OF THE PANDEMIC,
WHERE IT FELT LIKE ONE WEEK, WE
COULD NOT PROVIDE CARE BY
TELEHEALTH AND THEN THE NEXT
WEEK, YOU KNOW, PHYSICAL
THERAPISTS LIKE MYSELF WERE ABLE
TO PROVIDE TELEHEALTH
IMMEDIATELY.
SO IT REALLY MOVED QUITE
QUICKLY.
IF WE GO TO THE NEXT SLIDE, I
HAVE A GRAPH, WITHOUT GOING INTO
A LOT OF DETAIL ABOUT THIS
PARTICULAR STUDY, PROVIDES A
LITTLE BIT OF CONTEXT AS TO HOW
QUICKLY THIS ALL HAPPENED.
SO THIS IS A RETROSPECTIVE
ANALYSIS OF COMMERCIAL CLAIMS WE
DID USING THE MARKET SCAN
DATABASE.
YOU CAN SEE IN JANUARY AND
FEBRUARY OF 2020, ALL OF ZERO
VISITS CONDUCTED BY A PHYSICAL
THERAPIST WERE CONDUCTED BY
TELEHEALTH.
IMMEDIATELY BY APRIL OF 2020,
OVER 12,000 PSM T OR
OCCUPATIONAL THERAPY, OT, VISITS
WERE CONDUCTED BY TELEHEALTH.
SO THAT'S WANED DOWN SINCE THIS
INITIAL PEAK BUT GIVES YOU AN
IDEA OF JUST HOW QUICKLY THESE
TYPES OF THINGS CHANGED DURING
THE PANDEMIC.
SO QUICKLY, WE HAD OUR
INTERVENTION, AND YOU CAN SEE
RIGHT AWAY, WE'RE GOING OUT OF
ORDER.
WE HADN'T REALLY IDENTIFIED OUR
POPULATION YET.
WE JUST KNEW BASED ON THE WAY
THINGS WERE HAPPENING IN THE
WORLD, WE NEEDED TO DO, WANTED
TO DO SOMETHING WITH TELEHEALTH
PT WE KNEW THIS WAS PROBABLY
PROVIDING AN OPPORTUNITY TO
BENEFIT SPECIFIC POPULATIONS BUT
ACTUALLY IDENTIFIED THE
INTERVENTION FIRST.
SO WE STARTED WITH THE
INTERVENTION PHASE OF OUR
RESEARCH QUESTION.
SO ON THE NEXT SLIDE, WE'RE
TALKING ABOUT POPULATION.
NOW WE'RE GOING BACKWARDS AND
FIGURING OUT, WELL, WHO WOULD
TELEHEALTH PT MAYBE BE
BENEFICIAL FOR?
SO THE THOUGHT PROCESS WE WENT
WITH HERE INCLUDED SOME
QUESTIONS.
FIRST QUESTION WAS WHAT
POPULATIONS HAVE LIMITED ACCESS
TO PT?
AND AMONG THOSE POPULATIONS,
WHICH CLINICAL GROUPS AMONG
GROUPS THAT HAVE DECREASED
ACCESS TO PT ARE MOST LIKELY TO
BENEFIT FROM INCREASED ACCESS TO
PT?
THEN ON THE FEASIBILITY SIDE OF
THINGS, WE HAD TO THINK ABOUT,
WELL, WHAT POPULATIONS DO WE AS
RESEARCHERS REALLY HAVE ACCESS
TO, AND IN WHAT AREAS DOES OUR
TRACK RECORD REALLY PUT US IN A
GOOD POSITION TO CONTRIBUTE TO
NEW RESEARCH?
SO ON THE NEXT SLIDE, WE HAVE
SORT OF A GRAPHIC THAT JUST PUTS
ALL OF THESE FACTORS INTO ONE
SPOT SO WE CAN KIND OF DESCRIBE
THEM AS A GROUP.
ON THE LEFT SIDE OF THE SLIDE,
WE'VE GOT FACTORS THAT HELPED US
IDENTIFY POPULATIONS WITH A
CLINICAL NEED, AND ON THE RIGHT
SIDE OF THE SLIDE, WE'VE GOT
FACTORS THAT INFLUENCE JUST
FEASIBILITY AND YOU COULD EVEN
SAY A LITTLE BIT OF
GRANTSMANSHIP.
SO WE KNEW THAT CHRONIC LOW BACK
PAIN IS JUST A MAJOR BURDEN ON
SOCIETY.
IT'S THE NUMBER ONE CAUSE OF
DISABILITY IN THE COUNTRY, AND
IT'S THE TOP NON-CANCER REASON
THAT PEOPLE GET OPIOIDS.
WE KNOW ALSO THAT PHYSICAL
THERAPY IS EFFECTIVE FOR LOW
BACK PAIN AND THAT THERE'S
DECREASED ACCESS TO PHYSICAL
THERAPY IN RURAL COMMUNITIES
WITH STUDIES SHOWING THAT
THERE'S ABOUT 40% FEWER PTs
PER CAPITA IN RURAL COMMUNITIES
VERSUS NON-RURAL COMMUNITIES.
AND THEN FROM A FEASIBILITY
STANDPOINT, OUR TEAM HAD
EXPERIENCE CONDUCTING CLINICAL
TRIALS AMONG PATIENTS WITH LOW
BACK PAIN.
WE HAD SOME PRELIMINARY DATA
FROM THE PANDEMIC WHEN WE WERE
DELIVERING CARE VIA TELEHEALTH
TO PATIENTS WITH CHRONIC LOW
BACK PAIN.
WE HAD CLINICAL EXPERTISE IN
THIS AREA, AND THEN MAYBE MOST
IMPORTANTLY, WE HAD A RESEARCH
PARTNER IN TITLE HEALTH.
TITLE HEALTH IS A HEALTHCARE
SYSTEM ON MARYLAND'S EASTERN
SHORE WHICH INCLUDES A FEW
FEDERALLY RECOGNIZED RURAL
COUNTIES THAT IS PART OF THE
JOHNS HOPKINS CLINICAL RESEARCH
NETWORK, WHICH PROVIDED US
ACCESS TO A RURAL HEALTHCARE
SYSTEM AND PATIENTS THAT RECEIVE
CARE THERE.
SO ALL THESE FACTORS COMBINED
LED US TO OUR POPULATION, WHICH
IS PATIENTS WITH CHRONIC LOW
BACK PAIN LIVING IN RURAL
MARYLAND, SPECIFICALLY THOSE
RECEIVING CARE FROM TITLE HEALTH
ON THE EASTERN SHORE.
SO NOW WE HAVE OUR POPULATION
AND THE INTERVENTION COMPONENTS
OF OUR RESEARCH QUESTION, AND
THEN WE'LL MOVE ON TO THE
CONTROL OR COMPARISON ARM.
SO THIS WAS A LITTLE BIT MORE
CHALLENGING.
THERE'S A LOT OF COMPARISONS
THAT WE COULD THINK OF WHEN
YOU'RE THINKING OF TELEHEALTH
PT.
ONE OF THE MOST TEMPTING AND ONE
OF THE ONES THAT COMES UP THAT
PEOPLE ARE MOST INTERESTED IN
WAS ONE OF OUR INITIAL THOUGHTS,
WAS MAYBE WE SHOULD COMPARE
TELEHEALTH PT TO IN-CLINIC PT.
THAT CERTAINLY SEEMS TO BE THE
MOST OBVIOUS COMPARISON, BUT
THEN WHEN WE REALLY THOUGHT
ABOUT IT, OUR PAPILLATION, THE
POPULATION, THEWHOLE REASON WE O
RESEARCH IN THIS AREA IS PEOPLE
IN RURAL COMMUNITIES DON'T HAVE
ACCESS TO IN-CLINIC PT SO IS
THAT REALLY THE MOST USEFUL
INFORMATION FOR US?
WE EVENTUALLY GOT TO THIS
QUESTION, THE QUESTION BEFORE
THE QUESTION, AND THIS FIRST
QUESTION WAS, WELL, WHAT IS
USUAL CARE FOR PATIENTS WITH LOW
BACK PAIN LIVING IN RURAL
COMMUNITIES WHEN PT IS NOT
AVAILABLE?
AND WE WERE GOING TO USE THAT
QUESTION TO REALLY HELP IDENTIFY
OUR COMPARISON ARM.
SO IN THIS NEXT SLIDE, WE HAVE
SOME -- SO WE THOUGHT ABOUT,
WELL, WHAT IS GUIDELINE ADHERENT
CARE, LET'S AT LEAST THINK ABOUT
ALL THE OPTIONS THAT WOULD BE
USEFUL FOR PATIENTS WITH LOW
BACK PAIN AND NARROW IT DOWN
FROM THERE.
THE CLINICAL GUIDELINES FOR
NONSPECIFIC LOW BACK PAIN
INCLUDE ADVICE, NON-OPIOID
MEDICATION AND NON-PHARMACOLOGIC
PAIN INTERVENTIONS LIKE PT.
THEN ON THIS NEXT SLIDE, WE HAVE
SOME OTHER CONSIDERATIONS THAT
WE THOUGHT ABOUT.
THESE ARE THINGS WHEN WE WERE
SELECTING OUR INTERVENTION THAT
WE REALLY WANTED TO DO OR MAYBE
AVOID TIMES.
WE DEFINITELY WANTED TO AVOID
DISRUPTION IN USUAL CARE.
WE, A RESEARCH TEAM AT JOHNS
HOPKINS, WERE COMING INTO THIS
DIFFERENT SEPARATE RURAL
HEALTHCARE SYSTEM THAT WE HAD AN
AFFILIATION WITH BUT CERTAINLY
IS A DIFFERENT HEALTHCARE
SYSTEM.
THE LAST THING WE WANTED TO DO
WAS COMPLETELY DISRUPT THE WAY
THAT THEY'RE ALREADY PROVIDING
CARE.
SO WE WANTED TO BE MINIMALLY
DISRUPTIVE.
AND WE CERTAINLY WANTED TO DO NO
HARM, AND WHEN YOU THINK ABOUT
THE RISK OF TELEHEALTH PT, IT'S
PRETTY MUCH AS LOW RISK AS IT
COMES.
AND SO PICKING A CONTROL ARM
THAT HAD INHERENTLY MORE RISK
SEEMED LIKE JUST NOT A GOOD
IDEA.
SO THINGS LIKE MEDICATION,
INVASIVE PROCEDURES LIKE SPINE
INJECTIONS, WERE PRETTY
IMMEDIATELY OFF THE TABLE FOR US
AS IT FELT LIKE PEOPLE IN THE
CONTROL ARM WOULD ALL OF A
SUDDEN HAVE MORE RISK THAN
PEOPLE IN OUR INTERVENTION ARM,
WHICH DIDN'T MAKE SENSE AND
DIDN'T SEEM ETHICAL.
WE REALLY WANTED TO MAXIMIZE THE
GENERALIZABILITY TO THE RURAL
SETTING.
AFTER THINKING ABOUT ALL OF
THESE DIFFERENT OPTIONS, WE FELT
THAT IN LOWER RESOURCE RURAL
COMMUNITIES, ADVICE WAS PROBABLY
THE INTERVENTION MOST COMMONLY
BEING DELIVERED BY PRIMARY CARE
PROVIDERS TO THEIR PATIENTS WITH
CHRONIC LOW BACK PAIN.
SO ADVICE SEEMED TO MAKE THE
MOST SENSE GENERALLY SPEAKING.
AND THEN WE HAD TO REALLY THINK
ABOUT WHEN OUR KIND OF IN THE
BIGGER PICTURE, OUR
INTERVENTIONS WOULD BE
DELIVERED, AND BASED ON OUR
EXPERIENCE ON OTHER STUDIES, WE
TYPICALLY USE A RECRUITMENT
STRATEGY THAT LEVERAGES THE
ELECTRONIC HEALTH RECORD TO
IDENTIFY PEOPLE WHO HAD RECENTLY
BEEN TREATED BY THEIR PRIMARY
CARE PROVIDER FOR CHRONIC LOW
BACK PAIN, WHICH MEANS THAT THAT
PRIMARY CARE INTERACTION HAS
ALREADY OCCURRED AND YOU CAN'T
GO BACK IN TIME AND CHANGE IT,
AND TRYING TO IMPLEMENT A
STANDARD PRACTICE IN PRIMARY
CARE CLINICS THAT HAPPENS BEFORE
ENROLLMENT IS JUST INCREDIBLY
CHALLENGING.
SO WE NEEDED SOMETHING THAT CAN
BE DELIVERED POST-INITIAL
INTERACTION WITH A PROVIDER.
SO ON THIS NEXT SLIDE, YOU CAN
SEE OUR CONTROL OR COMPARISON,
STANDARDIZED EDUCATION WE'RE
DELIVERING THROUGH A STUDY
WEBSITE.
OUR PROCESS HERE IS THAT THIS
WILL ESSENTIALLY RAISE THE FLOOR
FOR EVERYBODY IN THE CONTROL
GROUP, THOSE WHO FOR WHATEVER
REASON DON'T RECEIVE BEST
PRACTICE ADVICE FROM THEIR
PHYSICIAN WILL RECEIVE IT
THROUGH THE STUDY, AND THOSE WHO
RECEIVE IT FROM THEIR PHYSICIAN,
WHICH WE THINK IS PROBABLY A
HIGH PERCENTAGE OF PATIENT, WILL
GET REPETITION, WHICH CERTAINLY
CAN'T HURT AND IS LIKELY TO
PROVIDE SOME ADDITIONAL BENEFIT.
SO WE HAVE POPULATION
INTERVENTION AND CONTROL
COMPONENTS OF OUR RESEARCH
QUESTION, AND ON THIS NEXT
SLIDE, WE START TO TALK ABOUT
OUTCOMES.
THIS IS A BIT MORE
STRAIGHTFORWARD WHEN IT COMES TO
CHRONIC LOW BACK PAIN.
WE WANT TO BE REFLECTIVE OF THE
REAL WORLD BURDEN OF CHRONIC LOW
BACK PAIN IN THAT THE MAIN
PROBLEMS SURROUNDING BACK PAIN
ARE THE DISABILITY IT CREATES,
THE PAIN ITSELF, AND THE OPIOID
USE.
SO WE WANTED TO MAKE SURE WE
WERE MEASURING THOSE THREE.
WE WANTED TO MAKE SURE THAT WE
COULD MAKE COMPARISONS TO
PREVIOUS AND FUTURE STUDIES IN
THIS AREA, AND WE WANTED TO
INCORPORATE ALL OF THE GREAT
GUIDANCE THAT WAS AVAILABLE
THROUGH THE BAC PAC MINIMUM
DATASET, AND THEN THE HEAL
COMMON DATA ELEMENTS DATASET,
WHICH IS ALWAYS USEFUL AND WE
WERE ALSO APPLYING FOR A HEAL
FUNDING MECHANISM, SO IT WAS
IMPORTANT WE INCLUDED THAT.
AND THEN MOVE ON TO THE NEXT
SLIDE.
SO OUR OUTCOMES -- OUR PRIMARY
OUT COME IS LOW BACK
PAIN-RELATED DISABILITY,
MEASURED BY THE OSWESTRY
DISABILITY INDEX, PAIN IN WHICH
WE MEASURE IN MULTIPLE WAYS,
THEN OPIOID USE, WHICH WE
MEASURE BY SELF-REPORT AND
THROUGH EHR DATA EXTRACTION.
THEN MOVING ON TO THE NEXT SLY,
WE'VE GOT THE LAST COMPONENT OF
OUR RESEARCH QUESTION WHICH IS
TIME.
THE CONSIDERATIONS WE HAD HERE
WERE FIRST THE LENGTH OF
INTERVENTION.
WE WANTED OUR PRIMARY END POINT
TO OCCUR SHORTLY AFTER THE
INTERVENTION WAS DELIVERED, BUT
BEING A BEHAVIORAL INTERVENTION
LIKE P.T., IT TAKES EIGHT WEEKS
TO DELIVER THE INTERVENTION.
IT'S NOT SORT OF A ONE-TIME
INTERVENTION.
AND WE WANTED TO PROVIDE A
LITTLE BIT OF FLEX IBILITY IN
THE EVENT THAT SHOULD SOMEONE
NEED TO RESCHEDULE ONE OF THESE
EIGHT VISITS, IT COULD TAKE NINE
OR 10 WEEKS TO GET ALL EIGHT
WEEKLY VISITS, SO WE WANTED TO
PROVIDE SOME FLEXIBILITY THERE.
WE ALSO WANTED TO MAKE SURE WE
WERE MEASURING CARRYOVER OF
TREATMENT EFFECTS AFTER THE
IMMEDIATE POST INTERVENTION
PHASE, AND THEN AGAIN WANTED TO
MAKE SURE THAT WE COULD MAKE
COMPARISONS TO PAST AND FUTURE
STUDIES, ONE OF THEM, FOR
EXAMPLE, THE OPTIMIZE TRIAL,
WHICH IS A PCORI FUNDED STUDY
THAT JOHNS HOPKINS IS
PARTICIPATING IN, WHICH INCLUDES
PHYSICAL THERAPIES AND ACTIVE
TREATMENT INTERVENTION FOR
PATIENTS WITH CHRONIC LOW BACK
PAIN, MAKING SURE WE HAD SIMILAR
TIME POINTS TO THAT STUDY WOULD
ALLOW US TO MAKE SOME IMPORTANT
COMPARISONS DOWN THE ROAD.
SO ON OUR LAST SLIDE HERE, WE'VE
GOT ALL COMPONENTS OF OUR
RESEARCH QUESTION, SO FOR TIME,
WE LANDED ON OUR PRIMARY END
POINT BEING 10 WEEKS, WHICH
PROVIDES A LITTLE BIT OF
FLEXIBILITY AFTER THAT 8-WEEK
INTERVENTION.
FOUR MONTH IS WHEN WE WILL
MEASURE OUR INTERMEDIATE CARRY
CARRYOVER AND 12 MONTHS IS OUR
LONG TERM FOLLOW YU. FOLLOW-UP.
THANK YOU VERY MUCH, THIS IS OUR
RESEARCH QUESTION AND LOOKING
FORWARD TO THE PANEL DISCUSSION.
>> THANK YOU VERY MUCH, KEVIN.
THAT WAS GREAT.
LET'S GO TO KUSHANG PATEL FOR
THE PE PERSPECTIVE FROM THE AIMP
TRIAL.
KUSHANG, ARE YOU ALL SET?
>> THANKS, I'M A RESEARCH
PROFESSOR, UNIVERSITY OF
WASHINGTON.
I HAVE A STRONG INTEREST IN --
TREATMENTS FOR PAIN MANAGEMENT.
ON THIS PROJECT, AIM-CP,
FORTUNATE TO TEAM UP WITH
DR. SBA C SEBASTIAN TONG.
SO WE ARE MOTIVATED BY THE DATA
SHOWN IN THESE FIGURES.
CLEARLY THESE DATA SHOW THAT THE
BURDEN OF PAIN IS HIGHER AMONG
ADULTS IN MORE RURAL AREAS THAN
IN URBAN AREAS.
THERE ARE APPROXIMATELY
9 MILLION ADULTS IN RURAL AREAS
WHO HAVE CHRONIC PAIN, AND 3 1/2
MILLION OF THEM HAVE HIGH IMPACT
OR ACTIVITY-LIMITING PAIN.
SIMILAR TO WHAT KEVIN HAD TALKED
ABOUT, MANY OF THESE INDIVIDUALS
DO NOT HAVE ACCESS TO MULTIMODAL
PAIN MANAGEMENT AND WE KNOW FOR
MANY CHRONIC PAIN CONDITIONS
THAT EXERCISE IS A FIRST-LINE
TREATMENT, BUT ACCESS TO
EVIDENCE-BASED PROGRAMS IS
SEVERELY LIMITED IN RURAL AREAS,
AND THERE ARE SEVERAL BARRIERS
TO PARTICIPATING IN PHYSICAL
ACTIVITY.
SO BASED ON STUDIES -- PREVIOUS
STUDIES IN OUR OWN INTERVIEWS
WITH RURAL PATIENTS WHO HAVE
CHRONIC PAIN, WE KNOW THAT THERE
ARE SEVERAL BARRIERS INCLUDING
FEW IF ANY OPTIONS FOR
STRUCTURED EXERCISE PROGRAMS OR
FACILITIES IN RURAL AREAS.
IF CLASSES DO EXIST, THEY ARE
OFTEN INCONSISTENTLY OFFERED
BECAUSE OF LIMITATIONS IN
STAFFING OR COST.
IF THEY ARE OFFERED, THEY ARE
OFTEN FAR AWAY FROM A PATIENT'S
HOME, WHICH IS PARTICULARLY
CHALLENGING FOR OLDER PATIENTS
WHO DO NOT DRIVE OR DON'T HAVE
ACCESS TO TRANSPORTATION.
AND LONG DISTANCES ARE
PARTICULARLY CHALLENGING FOR
THOSE WHO ARE CAREGIVERS WHO
NEED TO STAY CLOSE TO LOVED ONES
THAT THEY'RE CARING FOR.
THERE ARE ALSO BARRIERS TO
WALKING FOR EXERCISE IN RURAL
AREAS.
INCLUDING A LACK OF SIDEWALKS
AND STREETLIGHTS, UNEVEN
SURFACES, HILLY AREAS WHICH CAN
BE PARTICULARLY CHALLENGING FOR
THOSE WITH LOW BACK PAIN OR PAIN
IN THE LOWER EXTREMITIES.
SO -- AND LASTLY, DESTINATIONS
ARE OFTEN MORE SPREAD OUT AND
LESS CONDUCIVE TO WALKING IN
RURAL AREAS.
THERE ARE ALSO ADDITIONAL SAFETY
CONCERNS THAT HAVE BEEN
EXPRESSED BY PATIENTS IN RURAL
AREAS, INDIGENOUS WOMEN CITE
FEAR OF VIOLENCE OR BEING
ABDUCTED WHEN WALKING, AS WELL
AS DANGERS FROM WILDLIFE.
AND CERTAINLY EXTREME WEATHER
CAN ALSO LIMIT OUTDOOR PHYSICAL
ACTIVITY.
SO MANY OF THESE BARRIERS CAN BE
ADDRESSED THROUGH TELEEXERCISE,
AND AS WE HAVE ALL EXPERIENCED,
COVID-19 WAS A GREAT ACCELERATOR
OF TELEHEALTH, SO DURING THE
EARLY PHASE OF THE PANDEMIC, WE
NEED A DELIBERATE PARTICIPATORY
APPROACH TO ADAPTING AN
EVIDENCE-BASED EXERCISE PROGRAM
CALLED ENHANCE FITNESS.
THIS IS AN INSTRUCTOR-LED
GROUP-BASED MULTICOMPONENT
EXERCISE PROGRAM INVOLVING
STRENGTH, ENDURANCE AND BALANCE
TRAINING TA IS HELD FOR AN HOUR
THREE DAYS A WEEK IN COMMUNITY
CENTERS LIKE YMCAs.
THIS PROGRAM IS NOW WIDELY
DISSEMINATED, AVAILABLE IN OVER
800 SITES IN 44 STATES, AND
RANDOMIZED CLINICAL TRIALS HAVE
SHOWN IT SHOWS ENHANCEMENT OF
PHYSICAL FUNCTIONS IN OLDER
ADULTS.
SO PRIOR TO THE PANDEMIC,
ENHANCE FITNESS WAS NOT ABLE
TO -- OR NOT ACCESSIBLE TO
PEOPLE IN RURAL AREAS.
SO TO ADAPT IT FOR REMOTE
DELIVERY, WE ENGAGED ENHANCE
FITNESS USERS, INSTRUCTORRED AND
THE NATIONAL LEADERSHIP ABOUT
WHAT THEY WOULD LIKE TO HAVE IN
TERMS OF SAFETY, EFFECTIVENESS,
AND CONCERNS ABOUT TECHNOLOGY
FOR REMOTELY DELIVERED VERSION
OF ENHANCED FITNESS, SO WE USED
AN ITERATIVE PROCESS TO DEVELOP
AND THEN PREPILOT THE REMOTE
DELIVERY PROTOCOL AND THEN WE
PARTNERED WITH A RURAL SERVING
HEALTH SYSTEM CALLED ARBOR
HEALTH IN WASHINGTON STATE.
THIS HEALTH SYSTEM WAS TRULY
AMAZING.
ARBOR HEALTH HAD PROMOTED OUR
PILOT STUDY THROUGH MULTIPLE
CHANNELS, INCLUDING SOCIAL MEDIA
IN PRINTS, AND THEN THEY EMAILED
THEIR PATIENTS WITH KNEE
OSTEOARTHRITIS, WHICH WAS OUR
TARGET POPULATION FOR THIS PILOT
STUDY, AND IN THE END, THE PILOT
HAD DEMONSTRATED THAT REMOTELY
DELIVERED ENHANCED FITNESS IS
FEASIBLE AND ACCEPTABLE TO RURAL
PATIENTS WHO HAVE CHRONIC PAIN.
THERE WERE HIGH RATES OF
TREATMENT SATISFACTION.
87% HAD COMPLETED THE THREE
MONTH EXERCISE PROGRAM, AND
MEDIAN CLASS ATTENDANCE RATES
WERE 91%.
SO REALLY POSITIVE RESULTS.
SO BASED ON THIS PILOT, ARBOR
HEALTH HAS ACTUALLY, IN FACT,
SUSTAINED THE TELE-EF PROGRAM
FOR THE PAST 2 1/2 YEARS, SO
THEY'VE ADOPTED IT, AND THE
REMOTE DELIVERY PROGRAM THAT WE
DEVELOPED IS NOW NATIONALLY
DISSEMINATED TO ALL ENHANCE
FITNESS SAITS THROUGHOUT THE
COUNTRY.
ONE OF THE LEARNINGS THAT WE
TOOK AWAY FROM THE PILOT WAS
THAT THROUGH EXIT INTERVIEWS
WITH PARTICIPANTS, THE
IMPORTANCE OF ENGAGING WITH
HEALTH SYSTEMS WAS REALLY KEY TO
OUR SUCCESS FOR, ONE, ACCESSING
RURAL PATIENTS, AND FOR GAINING
THEIR TRUST.
IN FACT SOME OF THE PARTICIPANTS
HAD EXPRESSED TO US THAT THEY
HAD CONTACTED THEIR PRIMARY CARE
PROVIDERS BEFORE DECIDING TO
PARTICIPATE IN THE STUDY.
SO DESPITE A LOT OF PROMOTION
THROUGH THE HEALTH SYSTEM THAT
MANY PATIENTS REALLY WANTED TO
STILL TALK TO THEIR PCPs ABOUT
ABOUT THIS PROGRAM AND WHETHER
IT WOULD BE A GOOD FIT FOR THEM,
SO WE SOUGHT TO ENGAGE A RURAL
SERVING PRIMARY CARE PHYSICIANS
AND PRACTICES BY CONDUCTING
INTERVIEWS WITH THEM ABOUT
EXERCISE COUNSELING AND
PRESCRIBING AND REFERRING
PATIENTS TO TELE-ENHANCED
FITNESS BASED ON THOSE RESULTS,
WE DESIGNED AN EXERCISE PATHWAY
AND IMPLEMENTED IT THROUGH
PRIMARY CARE CLINIC IN WYOMING.
THIS INVOLVES SCREENING OF
PHYSICAL ACTIVITY AND PROVIDER
COUNSELING PATIENTS ON PHYSICAL
ACTIVITY AND REFERRING PATIENTS
TO TELE-ENHANCED FITNESS.
HOWEVER, THIS PILOT FACED A
NUMBER OF CHALLENGES DURING THE
COVID-19 PANDEMIC.
AND WE WERE ONLY ABLE TO SCREEN
SIX PATIENTS FOR THE STUDY OVER
A 4 1/2 MONTH PERIOD.
AND ONLY FOUR PATIENTS WERE
REFERRED -- FOUR OF THE SIX WERE
REFERRED TO TELEHEALTH ENHANCED
FITNESS.
THERE WERE MANY LESSONS WE
LEARNED FROM THIS PILOT,
INCLUDING THAT PRIMARY CARE
PHYSICIANS HAVE LITTLE TIME TO
SPARE AND HAVE MANY CO-MORBID
CONDITIONS TO MANAGE, SO
EXERCISE WAS OFTEN NOT A
PRIORITY DURING VISITS AND OFTEN
GOT PUSHED BACK TO THE BACK
BURNER.
PCPs ALSO WANTED TO REFER ANY
OF THEIR PATIENTS TO EXERCISE,
VERSUS WE FOCUSED ON
OSTEOARTHRITIS IN THIS
PARTICULAR STUDY, SO THAT WAS
ANOTHER LIMITATION OF THE
PROJECT.
KEY FOR US WAS ROOMING STAFF WHO
ORIGINALLY -- WHO WERE SUPPOSED
TO ORIGINALLY SCREEN FOR
PHYSICAL ACTIVITY WERE BURNED
OUT BECAUSE OF STAFFING
SHORTAGES DURING THE COVID-19
PANDEMIC, SO ADDING THIS
SCREENING TO THEIR PLATE WAS NOT
FEASIBLE.
SO ALL OF THESE LEARNINGS FED
INTO OUR M ACATION FOR FUNDING
AND IN RESPONSE TO THE HEAL
INITIATIVE, THE NOSY FOR RURAL
PATIENTS.
WE DECIDED TO ADAPT A NURSE CARE
MANAGEMENT MODEL TO IMPROVE PAIN
OUTCOMES AMONG RURAL PRIMARY
CARE PATIENTS.
THERE ARE A NUMBER OF ADVANTAGES
FOR THIS MODEL, KR INCLUDING ONE
HAVING FOCUS, A NURSE CARE
MANAGER WOULD HAVE FOCUS TIME TO
DIG INTO PAIN, PHYSICAL ACTIVITY
AND COUNSEL THEM AROUND PAIN
MANAGEMENT AS WELL AS PHYSICAL
ACTIVITY.
AND SO THIS ELIMINA EE -- NURSEE
MANAGEMENT MODEL WOULD REDUCE
COMPETING ATTENTION FROM OTHER
COMORBIDITIES AND REALLY FOCUS
ON PAIN AND THEN PROVIDED FOR A
VERY SIMPLIFIED REFERRAL
MECHANISM TO TELEENHANCED
FITNESS, AND SO FOR THIS
PROJECT, OUR NURSE CARE MANAGER
MEETS WITH PATIENTS SIX TIMES TO
COORDINATE THEIR CARE, AND
POTENTIALLY DELIVER COGNITIVE
BEHAVIORAL THERAPY FOR 6 TO 10
SESSIONS, DEPENDING ON THE
PATIENT'S NEEDS, AND THEN REFER
THEM TO ENHANCE FITNESS IF THE
PATIENT IS READY.
SO WE HAD A LOT OF -- CONDUCT A
LOT OF PILOT STUDIES IN ADVANCE
OF OUR CURRENT PROJECT, AND SO
BASED ON THE LEARNINGS OF THOSE
PILOTS AS WELL AS THE EXPERIENCE
OF OUR COLLABORATORS, OUR PICOT
FOR OUR PROJECT IS HERE, OUR
POPULATION RURAL DWELLING
PATIENT WHO HAVE CHRONIC PAIN.
THE INTERVENTION INVOLVES NURSE
CARE COORDINATION OF PAIN
MANAGEMENT AS WELL AS COGNITIVE
BEHAVIORAL THERAPY FOR MANAGING
NOT ONLY PAIN BUT ALSO OTHER
ACTIVITY LIVING SYMPTOMS SUCH AS
DEPRESSED MOOD, ANXIETY, FEAR OF
MOVEMENT, AND THE CBT IS
INTENDED TO HELP BEHAVIORALLY
ACTIVATE OUR PATIENTS AND
DEPENDING ON WHERE THE PATIENT
IS AT, THE NURSE CARE MANAGER
WILL MAKE A REFERRAL TO
TELEENHANCE FITNESS.
FOR OUR COMPARISON GROUP, WE
DECIDED ON USUAL CARE TO REFLECT
THE REALITY THAT MANY OF THESE
PATIENTS DO NOT HAVE ACCESS TO
PHARMACOLOGIC TREATMENTS AND
COMING UP WITH A ACTIVE
COMPARISON GROUP WOULD HAVE
BEEN -- IS CHALLENGING AND
RESOURCE-INTENSIVE FOR -- GIVEN
THE AMOUNT OF MONEY THAT WE
HAVE -- FUNDING WE HAVE
AVAILABLE FOR THE PROJECT.
OUR PRIMARY OUTCOME IS PAIN
INTERFERENCE AS MEASURED BY THE
PEG.
IN TERMS OF TIMING, SIMILAR TO
THE PREVIOUS SPEAKER, WE DECIDED
ON A 6-MONTH INTERVENTION PERIOD
TO ALLOW FOR TIME FOR ASSESSMENT
OF THE PATIENT AS WELL AS
DELIVERY OF PAIN CARE SERVICES
AS WELL AS TIME FOR THE CBT AND
ENGAGEMENT WITH THE ENHANCE
FITNESS PROGRAM.
SO IN TERMS OF OUR OUTCOMES,
WE'LL BE ASSESSING THEM AT
BASELINE, 6 MONTHS AND 12 MONTHS
AND OUR PRIMARY END POINT IS AT
6 MONTHS.
THANK YOU ALL.
APPRECIATE THIS OPPORTUNITY.
>> THANKS, KUSHANG.
THAT WAS TERRIFIC.
OKAY, LET'S HEAR FROM TWO OF THE
TRIALS THAT ARE FURTHER ALONG OR
COMPLETED.
ANDREA, ARE YOU READY TO GO?
>> YEAH, I AM.
CAN YOU HEAR ME OKAY?
>> WE CAN HEAR YOU JUST FINE.
YEAH.
>> EXCELLENT.
WELL, THANK YOU VERY MUCH FOR
ALLOWING ME TO SHARE THE THOUGHT
AND EVENTS THAT LED TO THE
KNOW-HARM PRAGMATIC TRIAL.
NO HARM STANDS FOR
NON-PHARMACOLOGIC OPTIONS IN
POST HOSPITAL AND REHABL PAIN
MANAGEMENT.
VERY MUCH INFLUENCED BY CONTEXT.
IT WAS EARLY 2019.
AND OUR TEAM WAS IN THE MIDST OF
GOING LIVE WITH THE INTERVENTION
FOR THE E2C2 TRIAL, ALSO
PRAGMATIC TRIAL.
E2C2 STANDS FOR ENHANCED EHR
FACILITATED CANCER SYMPTOM
CONTROL.
THE INTERVENTION SYSTEMATIZED
ELECTRONIC REPORTED SCREENING AT
THE POPULATION LEVEL AMONG
CANCER PATIENTS IN MIDWEST
PRACTICES.
IT ATTEMPTED TO AUTOMATE EHR
RESPONSES FOR CLINICALLY
ACTIONABLE SCORES WHICH THE
LITERATURE IS QUITE ROBUST IN
DEMONSTRATING THAT ARE
INCONSISTENT.
SO WE WANTED TO OUGHT MADE
PREFERENCE-CONCORDANT,
EVIDENCE-BASED AND ACTIONABLE
SCORES TO PROBLEMATIC LEVELS OF
SYMPTOMS.
THROUGH EHR PARAMETERIZATION.
WE ACHIEVED A VERY HIGH REACH BY
VIRTUE OF TWO FACTORS, THE EHR
ENROLLMENT, AS WELL AS THE FACT
THAT OUR INSTITUTIONAL IRB
AWARDED A WAY FOR INFORMED
CONSENT, THIS BEING CONSIDERED A
STANDARD OF CARE TRIAL.
BUT WE GRAPPLED WITH LIMITED
PROVIDER ENGAGEMENT AS WELL AS
THE FACT THAT PATIENTS JUST
DON'T LOVE PROMs OFTEN AND
THEY REALLY -- IN QUALITATIVE
INTERVIEWS, THEY REQUESTED
GREATER PERSONALIZATION.
SO AT THIS TIME, AN RFA APPEARED
ENTITLED PRAGMATIC AND
IMPLEMENTATION STUDIES FOR THE
MANAGEMENT OF PAIN TO REDUCE
OPIOID PRESCRIBING, OR PRISM,
AND IT GALVANIZED OUR TEAM TO
CAREFULLY CONSIDER NEXT
PROGRAMMATIC STEPS.
WAS THIS RELEVANT TO OUR PROGRAM
AND THE DIRECTION WE WANTED TO
GO, AND WE DECIDED VERY MUCH SO.
AND THAT WE WERE TRYING TO FIND
EFFECTIVE WAYS TO LEVERAGE
DIGITAL TOOLS TO ADVANCE
EFFECTIVE AND EQUITABLE
SUPPORTIVE CARE DELIVERY IN
VULNERABLE POPULATIONS.
WE HAD LIMITED BANDWIDTH.
WE THOUGHT THIS WOULD BE
INTERESTING AND ENJOYABLE.
VERY IMPORTANTLY.
BUT GRAPPLED WITH WHETHER WE
COULD COME UP WITH FUNDABLE
OPPORTUNITY TO LEGITIMATELY
ADVANCE THE STATE OF THE
SCIENCE.
AND NOT MUCH HEADWAY WAS MADE
FOR QUITE A WHILE, UNTIL IN VERY
CASUAL SETTINGS AN IDEA CAME UP
THAT WAS GROUNDED IN OUR
UNDERSTANDING OF THE CURRENT
STATE.
IN EPROM-BASED SYMPTOM
SCREENING.
AND THAT WAS THAT PATIENT WOULD
ENGAGE WITH FAIRLY STERILE,
HIGHLY STRUCTURED PROM
INTERFACES, THE SCORES WOULD
THEN POPULATE EHR CHARTS,
TABLES, THEY MIGHT BE DELIVERED
TO CLINICIANS WHO MAY OR MAY NOT
INCLUDE THEM IN THEIR CLINICAL
NOTES.
BUT AT THAT POINT, OFTEN THE
DATA DID NOT GO ANY FURTHER, AND
WERE NOT LEVERAGED TO IMPROVE
PATIENTS' EXPERIENCE OR
OUTCOMES.
AND WE CONCEPTUALIZED AN
ENHANCED FUTURE STATE, WHEREBY
PATIENTS WOULD ENGAGE WITH A
MUCH MORE ESTHETICALLY APPEALING
INDIVIDUALIZED INTERFACE THAT
DIDN'T JUST -- WASN'T
UNIDIRECTIONAL, DIDN'T JUST
SERVE TO COLLECT THEIR
INFORMATION, BUT ALSO TO DELIVER
EDUCATION TO BUILD THERAPEUTIC
ALLIANCE, AND WE THOUGHT THAT
PERHAPS THE INFORMATION
COLLECTED FROM SUCH AN INTERFACE
COULD THEN DRIVE CLINICAL
DECISION SUPPORT TOOLS IN THE
EHR TO SEND DIRECT TO PATIENT
CONTENT, TO PROMPT PROVIDERS,
FOR TIMELY CARE INTEGRATION, TO
RESPOND TO CONTEXTUAL TRIGGERS,
AND TO INFORM DEFAULT SETTINGS.
AND AS OTHERS HAVE MENTIONED, WE
TOOK STOCK.
WE WERE EXCITED ABOUT THIS IDEA
BUT RECOGNIZED THAT IT HAD TO BE
TRANSLATED INTO A TETHERRABLE TE
HYPOTHESIS.
CONSIDERING OUR ASSET, WE WERE
AT A HIGH DESTINATION MEDICAL
CENTER WITH EXCELLENT RURAL
REPRESENTATION AND BROAD
GEOGRAPHIC COVERAGE.
WE ALSO IDENTIFIED SOME
OPPORTUNITIES FROM THE
E2C2 TRIAL, NAMELY POPULATION
ENROLLMENT THROUGH THE EHR, AS
WELL AS WAYS THAT EHR,
SPECIFICALLY EPIC CLINICAL
DECISION SUPPORT COULD BE
PARAMETERIZED TO INFLUENCE
PATIENT EXPERIENCE.
BUT WE RECOGNIZED LIMITATIONS.
WE HAD A FAIRLY CONSTRAINED
PRIMARY CARE PRACTICE AT MAYO
WITH LIMITED OPTIONS FOR
LONGITUDAL FOLLOW-UP.
RACIAL AND ETHNIC DIVERSITY WAS
ALSO A LIMITATION.
WE WERE ALREADY GRAPPLEING WITH
CLINICIAN ENGAGEMENT ISSUES AND
HAD RECENTLY GONE THROUGH THE
PAINS OF ADVANCING FAIRLY
CUSTOMIZED BESPOKE EHR BUILD
THAT SPANNED MULTIPLE EPIC
FUNCTIONALITIES.
BUT WE WANTED TO GO FORWARD.
WE WERE UNDETERRED, AND THAT
LEFT A NUMBER OF QUESTIONS, AND
WE THOUGHT PRINCIPAL AMONG THESE
WERE WHO WOULD THE TEAM BE AND
WHAT WOULD THE INTERVENTION BE?
IT WOULD ENABLE US TO ADVANCE AN
IDEA WITH STRONG EMPIRICAL
SUPPORT THAT WAS INNOVATIVE, AND
FOR WHICH WE COULD MARSHAL
ADEQUATE RESOURCES AND AN
INVESTIGATIVE TEAM.
AND SO WE TACKLED THE TEAM FIRST
AND RECOGNIZED THAT AMONG A
GROUP OF FAIRLY SEASONED
TRIALISTS AND NIH-FUNDED
INVESTIGATORS, WE HAD WHAT WE
THOUGHT WERE A UNIQUE SKILLSET,
A COLLECTION OF SKILLSETS IN EHR
BUILD BESPOKE EHR BUILD SHARED
DECISION-MAKING WITH DECISION
AIDS, INTEGRATIVE MEDICINE, USER
CENTERED E DESIGN, PARTICULARLY
PATIENT DIRECTED E DESIGN, AS
WELL AS REHABILITATIVE AND
TELEREHABILITATIVE APPROACHES TO
PAIN CONTROL.
SO WE FURTHER MATURED THE IDEA
AT THIS POINT AND DECIDED
INSTEAD OF -- WE KNEW WE WANTED
TO ADVANCE NON-PHARMACOLOGIC
PAIN CARE.
AND WE DECIDED THAT IF WE POOLED
REHABILITATIVE APPROACHES AND
INTEGRATIVE APPRO APPROACHES THT
PERHAPS INSTEAD OF ADVANCING A
FEW MORE MODALITY, WE COULD
OFFER PATIENT A BROADER ARRAY
AND PROVIDE THEM AGENCY TO
SELECT THOSE THAT WERE APPEALING
AND IDEALLY EFFECTIVE FOR THEM.
YOU SO THE IDEA WAS BORN TO
ESSENTIALLY CREATE -- EMBED A
PROMPT, A GUIDE THAT WOULD TEACH
PATIENTS ABOUT NON-PHARMACOLOGIC
PAIN CARE OPTIONS, AND THE DOWN
SIDES OF OPIOIDS, WHILE
COLLECTING THEIR NPPC
PREFERENCES AND THEIR MOTIVATION
AND CONFIDENCE FOR USE.
BUT THIS LEFT US WITH THE
QUESTION OF WHO WOULD THE
POPULATION BE AND HOW WOULD WE
CREATE CLINICAL DECISION SUPPORT
TO CREATE UNIFIED SUPPORT FOR AN
INDIVIDUALIZED PAIN MANAGEMENT
PLAN.
SO WE THOUGHT AT THAT POINT
PERHAPS THE NEXT MOST IMPORTANT
DECISION WAS POPULATION.
WE WERE VERY MUCH CONSIDERING
AND HOPING TO ACHIEVE A WAIVER
OF INFORMED CONSENT AND RECRUIT
AT THE POPULATION LEVEL.
SO THAT INFLUENCED OUR CHOICE OF
POPULATIONS.
WE CONSIDERED CANCER PATIENTS,
VARIOUS TYPES OF MUSCULOSKELETAL
PAIN, CHRONIC PAIN, BUT WE
ULTIMATELY DECIDE ON SURGICAL
PATIENTS FOR THREE REASONS.
THIS WAS IMPACTFUL AS OPIOIDS
PRESCRIBED FOR PERIOPERATIVE
CARE CONTINUED TO FUEL THE
OPIOID CRISIS, IMPROVE
PERIOPERATIVE PAIN CONTROL, AND
GUIDELINE CONCORDANT PAIN
CONTROL WAS VERY APPEALING TO
INSTITUTIONAL LEADERSHIP, AND
ALSO WE FOUND THAT THERE WAS
STRONG EMPIRICAL SUPPORT FOR
MULTIPLE NPPC APPROACHES FOR
MANAGING PERIOPERATIVE CARE.
SO THIS WAS ENCOURAGING.
WE ALSO THOUGHT ABOUT CONTEXT
AND CONSIDERED EXPANDING BEYOND
OUR SETTING TO ENGAGE OTHER
HEALTHCARE SYSTEMS, BUT GIVEN
ONE OF OUR SALIENT STRENGTHS WAS
A UNIFIED EHR ACROSS DIVERSE AND
GEOGRAPHICALLY DISBURSED CENTERS
AND THE FACT THAT WE HAD
EXPERIENCED A DIFFICULTY
ADVANCING EHR BUILD, WE GAVE UP
THAT OPTION AND EVENTUALLY
DECIDED TO TARGET AND ENGAGE THE
ENTIRE MAYO CLINIC EN ENTERPRIS,
WHICH SPANNED SIX STATES WITH
VERY, VERY LARGE CATCHMENT
AREAS.
SO AT THIS TIME OUR CONCEPT HAD
MATURED TO WE WOULD DELIVER THE
CONVERSATION TO SURGICAL
PATIENTS, IT WOULD STAY WITH
THEM THROUGHOUT THE ENTIRE
PERIOPERATIVE TRAJECTORY.
WE WOULD COLLECT THEIR NPPC OR
CAM PREFERENCES AND THEN CREATE
VERY DISCRETE ALIQUOTS OF
INFORMATION THAT WE WOULD
STRATEGICALLY DELIVER ACROSS
MULTIPLE CLINICAL STAKEHOLDERS,
SPANNING THE FULL PERIOPERATIVE
TRAJECTORY.
TO ADVANCE THIS
AGENDA OF NPPC INTEGRATION, AND
THAT INCLUDED ALLIED HEALTH,
SURGICAL TEAM MEMBERS, BEDSIDE
NURSES, PREOPERATIVE CLINICS,
AND POSTOPERATIVE FOLLOW-UP
CLINICS.
AND THE IDEA WAS TO DELIVER JUST
THE RIGHT INFORMATION TO THE
RIGHT PERSON AT THE RIGHT TIME
SO THEY COULD DO A REASONABLE --
HAVE A REASONABLE EVENT ON
PATIENTS' USE OF NPPC.
AND AT THIS POINT, WE THOUGHT
WE'D CHECKED ALL OUR BOXES WITH
RESPECT TO EMPIRICAL SUPPORT,
INNOVATION, RESOURCES AND TEAM.
AND SO THE CONCEPT WAS A
CLINICALLY INTEGRATED EHR SYSTEM
TO INCREASE THE USE OF SAFE,
VALIDATED AND EVIDENCE-BASED
PREFERENCE-CONCORDANT
NON-PHARMACOLOGIC PAIN CARE
OPTIONS.
SUCH THAT ACROSS THE FULL
PERIOPERATIVE TRAJECTORY, WE
WOULD ENCOMPASS DIVERSE
CLINICIAN, SETTING AND WORKFLOWS
TO ADVANCE THIS AGENDA OF NPPC
INTEGRATION.
OUR OUTCOMES WERE ACTUALLY
FAIRLY SIMPLE BECAUSE THE HEAL
INITIATED MANDATED THESE, AND
THEY ALIGNED OUR COPRIMARY
OUTCOMES FOR PAIN MANAGEMENT AND
FUNCTION.
WE CHOSE A STEPPED WEDGE CLUSTER
RANDOMIZED DESIGN FOR TWO
PRINCIPAL REASONS.
ONE, WE WERE WORRIED ABOUT
TEMPORAL TRENDS WITH RESPECT TO
OPIOID AVAILABILITY AND
LEGISLATION, AND ALSO, BECAUSE
WE HAD LIVED THROUGH THE
CHALLENGES OF COMPLEX
INFORMATICS IMPLEMENTATION OF
EHR CLINICAL DECISION SUPPORT
WITH THE E2C2 TRIAL.
AND APPRECIATED THE HIGH HUMAN
RESOURCE REQUIREMENTS AND
REALIZED WE COULD NOT DO ALL OR
HALF OF THE CLUSTERS AT ONE TI
TIME.
SURGICAL TYPE -- PRACTICE AND
DEPARTMENT.
SO WE WENT WITH A CLUSTER
RANDOMIZED APPROACH.
AND OUR USUAL CARE, WE REALLY
COULDN'T, IT WAS A BIG LIFT TO
IMPLEMENT AS WE WERE, BUT IT WAS
USUAL CARE.
AND WITH THAT, I'LL THANK YOU
FOR YOUR ATTENTION, AND PASS THE
MIC BACK TO KEVIN.
>> THANK YOU SO MUCH, ANDREA.
LET'S GO TO OUR FINAL TRIAL
DISCUSSING THE SPOT TRIALS, GREG
SIMON.
GREG, YOU ARE ALL SET?
>> I DIDN'T.
CAN YOU HEAR ME OKAY?
>> YEP.
>> OKAY, THANKS VERY MUCH.
SO I'LL BE TALKING TO YOU ABOUT
ONE OF THE VERY FIRST IN THE
FIRST COHORT OF PRAGMATIC TRI
TRIALS.
WE'RE GOING TO HAVE TO PUT
OURSELVES IN A TIME MACHINE AND
TAKE OURSELVES BACK TO JANUARY
OF 2012 IN TERMS OF WHERE WE
WERE AND WHAT WE KNEW.
SO OUR SITUATION THEN IN TERMS
OF SUICIDE PREVENTION, WE WERE
MOTIVATED BY THIS SORT OF
CONVERGENCE OF PRIORITIES.
THERE HAD BEEN A STEADY INCREASE
IN U.S. SUICIDE MORTALITY RATES
FOR AT THAT .15, 20 YEARS.
THE SURGEON GENERAL'S CALL TO
ACTION TO PREVENT SUICIDE
PUBLISHED IN 1999, THE STRATEGIC
PLAN AT NIMH IN PLACE AT THE
TIME IDENTIFIED SUICIDE
PREVENTION AS ONE OF THREE TOP
PRIORITIES FOR NIMH RESEARCH,
AND VERY IMPORTANT THE HEALTH
SYSTEMS PART OF OUR MENTAL
HEALTH RESEARCH NETWORK, MANY OF
THEM HAD STARTED TO FOCUS ON
SUICIDE PREVENTION AS ONE OF
THEIR TOP QUALITY AND SAFETY
PRIORITIES.
THE NATIONAL ACTION ALLIANCE FOR
SUICIDE PREVENTION WHICH IS A
NATIONAL SORT OF COORDINATING OR
CONVENING ORGANIZATION INCLUDING
INSURERS, HEALTH SYSTEMS, LARGE
EMPLOYERS, RESEARCH FUNDERS AND
RESEARCHERS, HAD PUT OUT THIS
IDEA ABOUT ZERO SUICIDE AS A
SCHEME FOR REDUCING OR
ADDRESSING THE RISK OF SUICIDE
IN HEALTHCARE.
SO THERE WAS DEFINITELY THIS
SORT OF CONVERGENCE OF
PRIORITIES FROM DIFFERENT
DIRECTIONS.
ALSO AT THAT TIME WHEN WE LOOKED
AT THE STATE OF THE EVIDENCE,
WHAT WE SAW WAS, ACCUMULATING
EVIDENCE THAT WE COULD ACTUALLY
ACCURATELY IDENTIFY PEOPLE WHO
WERE AT RISK.
WE FEW PEOPLE WHO ATTEMPTED OR
DIED BY SUICIDE THAT MORE THAN
70% OF THEM HAD AN OUTPATIENT
HEALTHCARE CONTACT IN THE PRIOR
YEAR, AS THE HEALTHCARE SYSTEMS,
WE WORKED AND STARTED TO USE
THESE STANDARD DEPRESSION
QUESTIONNAIRES LIKE THE PHQ9.
WE FOUND THAT HOW PEOPLE
RESPONDED TO THAT NINTH QUESTION
ON THE PHQ9 REGARDING THOUGHTS
OF SUICIDE OR SELF-HARM ACTUALLY
DID IDENTIFY PEOPLE WHO WERE AT
SIGNIFICANT RISK, PEOPLE WHO
REPORTED THOUGHTS OF DEATH OR
SELF-HARM MORE THAN HALF THE
DAYS OR NEARLY EVERY DAY HAD
ABOUT A 4% RISK OF A SUICIDE
RISK OR SELF-HARM EVENT IN THE
FOLLOWING YEAR.
WE ALSO WERE AWARE OF EVIDENCE
FOR THE EFFECTIVENESS OF VARIOUS
INTERVENTIONS THAT ADDRESSED
VARIOUS PARTS OF THE RISK
SPECTRUM.
THERE WERE SEVERAL STUDIES
ROARED BUT WHAT WE WOULD CALL AT
THE TIME CARING LETTERS BUT NOW
WHAT WE WOULD CALL CARING
CONTACTS WHICH WERE SORT OF LOW
INTENSITY SUPPORTIVE CONTACTS
OFTEN FOR PEOPLE WHO HAD BEEN IN
AN EMERGENCY DEPARTMENT FOR A
SELF-HARM EVENT OR HOSPITALIZED
SHOWING THAT EVEN THIS LOW
INTENSITY CONTACT MIGHT DECREASE
RISK.
THERE WERE PRETTY GOOD
RANDOMIZED TRIAL EVIDENCE THAT
SIGNIFICANT PSYCHOTHERAPIES,
COGNITIVE BEHAVIOR THERAPIES CAN
REDUCE RISK, ESPECIALLY FOR
PEOPLE WHO RECENTLY EXPERIENCED
A SELF-HARM EVENT OR HAD
RECENTLY BEEN HOSPITALIZED OR
SEEN IN THE EMERGENCY DEPARTMENT
FOR SUICIDE RISK.
AND THERE WAS SOME EVIDENCE THAT
IN THESE PSYCHOTHERAPY PROGRAMS,
THERE WERE SPECIFIC SKILLS OR
SKILLS TRAINING THAT WERE THE
KEY ACTIVE INGREDIENTS.
WE ALSO WERE AWARE AND MANY OF
US HAD BEEN INVOLVED IN SOME OF
THE WORK ON OUTREACH TO IMPROVE
CARE OF COMMON MENTAL HEALTH
CONDITIONS.
THESE CARE MANAGEMENT OR
COLLABORATIVE CARE INTERVENTIONS
WHERE THE MOTUS OPERANDI WAS
SORT OF ACTIVE OUTREACH, CARE
NAVIGATION TO KEEP PEOPLE
ENGAGED IN CARE.
AND HEN REA FOR HENRY FORD RECEY
PUBLISHED THEIR EXPERIENCE WITH
SOMETHING THEY CALLED THE
PERFECT DEPRESSION CARE PROGRAM,
WHICH WAS VERY MUCH FOCUSED ON
SYSTEMATICALLY IDENTIFYING
PEOPLE WHO WERE AT HIGH RISK,
WHO HAD DROPPED OUT OF
TREATMENT, MAKING SURE THEY
STAYED ENGAGED IN CARE, AND THEY
HAD REPORTED IN SORT OF A REALLY
BEFORE/AFTER OBSERVATIONAL
DESIGN SIGNIFICANT REDUCTION IN
SUICIDE RATES IN PEOPLE WHO THEY
WERE SEEING IN THEIR MENTAL
HEALTH SPECIALTY CLINIC.
SO FIRST WE CAN IDENTIFY PEOPLE
WHO WERE AT HIGH RISK FOR
SELF-HARM.
WE HAVE INTERVENTIONS THAT
APPEAR TO BE EFFECTIVE IN PEOPLE
WHO ARE AT THE REALLY HIGH END
OF THE RISK SPECTRUM.
PEOPLE WHO TO PUT A NUMBER ON IT
SAY MIGHT HAVE A 40 OR EVEN 50%
CHANCE OF A SELF-HARM EVENT.
WHAT WE WERE VERY INTERESTED IN
IS, ARE THERE POPULATION-BASED
APPROACHES THAT COULD BE HELPFUL
FOR PEOPLE WHO WERE A ONE STEP
DOWN ON THE RISK SCALE.
IF YOU THINK ABOUT THE PARADOX
FOR CARDIOVASCULAR DISEASE OR
OTHER HEALTH CONDITIONS, THE
PARADOX IS THAT ALTHOUGH THERE
ARE PEOPLE NE VERY TOP TIER OF
RISK MAY HAVE A HIGH RISK, MANY
OF THE EVENTS OCCUR IN THOSE WHO
ARE AT MODERATE RISK, AND THAT
WAS WHAT WE HAD HOPED TO BE ABLE
TO ADDRESS.
ALSO IMPORTANT TO THINK ABOUT
THE CONSTRAINTS AT THE TIME,
BECAUSE THIS WAS 2012.
IF WE WERE THINKING ABOUT USING
SORT OF NEW TECHNOLOGY TOOLS TO
DELIVER LOW INTENSITY
INTERVENTIONS AT A POPULATION
LEVEL, THE NEW TECHNOLOGY THEN
WAS NOT THAT NEW.
THE I PHONE WAS 4 YEARS OLD AT
THAT TIME.
SO WE REALLY WERE FOCUSED ON
THINGS THAT COULD BE DELIVERED
THROUGH WEBSITES RATHER THAN
THINGS THAT COULD BE DELIVERED
THROUGH MOBILE APPS.
BACK THEN IT ALMOST HARD TO
BELIEVE, THERE WAS MESSAGING
CAPABILITIES IN THE ELECTRONIC
HEALTH RECORD THROUGH THE
PATIENT PORTAL, BUT THEY WERE
REALLY LIMITED TO PLAIN TEXT.
AT THE TIME WE STARTED THIS
PROJECT, IT WAS NOT EVEN
POSSIBLE TO SEND A LINK TO A
QUESTIONNAIRE THAT SOMEONE COULD
COMPLETE.
WE HAD TO SORT OF SET UP AN
OUTSIDE WORKAROUND FOR THAT.
AND ALTHOUGH WE DEVELOPED A SORT
OF INTERACTIVE SKILLS TRAINING
PROGRAM, I THINK IT WOULD NOT
NECESSARILY BE THOUGHT OF AS
THAT INTERACTIVE BY TODAY'S
STANDARD.
I'LL BE HONEST, IT WAS SOMEWHAT
CLUNKY, BUT IT WAS THE
TECHNOLOGY AVAILABLE TO US IN
2012.
ONE OTHER IMPORTANT CONSTRAINT
FOR US WAS ABOUT AFFORDABILITY.
SOME OF THIS MAY HAVE BEEN
INFLUENCED BY MY OWN PERSONAL
EXPERIENCE IN MANY OF THESE
COLLABORATIVE CARE TRIALS, OF
DEMONSTRATING THE EFFECTIVENESS
OF POPULATION BASED CARE
IMPROVEMENT PROGRAMS THAT WERE
NOT IMPLEMENTED BECAUSE THEY
WERE CONSIDERED TO BE TOO
EXPENSIVE.
SO WE ACTUALLY DID A FAIRLY
EXPLICIT AND I HOPE THIS DOESN'T
SOUND TOO MERCENARY CALCULATION
TO SAY, IF WE'RE FOCUSED ON A
POPULATION THAT HAS AN ABSOLUTE
RISK OF A SELF-HARM EVENT OF 4%
AND WE WOULD HOPE TO REDUCE THAT
TO 3%, THAT'S AN ABSOLUTE RISK
REDUCTION OF 1% OR NUMBER NEEDED
TO TREAT 100, AND WE KNEW BASED
ON DATA FROM OUR HEALTH SYSTEM
AND OTHERS THAT THE DIRECT
HEALTHCARE COSTS OF SOMEONE WHO
WAS SEEN IN EMERGENCY DEPARTMENT
OR HOSPITALIZED FOR SELF-HARM
EVENT WAS AT THAT TIME ABOUT
$9,000.
IF YOU DO THE ARITHMETIC, YOU'D
SAY A NUMBER NEEDED TO TREAT OF
100, AND A PER-EVENT COST OF
$9,000, MEANS THE BREAK-EVEN
COST FOR A HEALTHCARE SYSTEM TO
SAY IF WE CAN REDUCE RISK, THE
ABSOLUTE RISK BY 1%, WHERE WOULD
THE BREAK-EVEN POINT BE, IT
WOULD BE AN INTERVENTION THAT
KOCOST $90 PER PERSON.
SO RATHER THAN THOSE PROGRAMS
LIKE THE SORT OF FULL BORE
DIALECTICAL BEHAVIOR THERAPY
WHICH WOULD BE ON THE ORDER OF
AT LEAST A THOUSAND DOLLARS PER
PERSON.
I WOULDN'T NECESSARILY SAY THIS
WAS A CONSTRAINT BUT IT WAS
RECOGNITION OF WHAT I WOULD CALL
THE ROOM FOR EXPERIMENTATION OR
THE WINDOW FOR EXPERIMENTATION.
AT THE TIME WE WERE STARTING
THIS WORK, HEALTHCARE SYSTEMS
HAD BEGUN TO IMPLEMENT THESE
ROUTINE SCREENING PROCESSES
WHICH BEGAN REALLY AS SCREENING
FOR DEPRESSION BUT I THINK THEY
RECOGNIZED THAT THAT NINTH ITEM
OF THE PHQ9 IDENTIFIED PEOPLE
WITH SELF-HARM AND HEALTHCARE
SYSTEMS WE WORKED WITH TO USING
THESE IN MENTAL HEALTH SPECIALTY
CARE AND EVEN IN PRIMARY CARE
WHEN PEOPLE WERE IDENTIFIED AS
HAVING DEPRESSION OR SOME OTHER
MENTAL HEALTH CONDITION.
TO US THAT WAS REALLY GOOD NEWS,
BUT IT WAS NOT A RESEARCH
QUESTION.
THIS WAS A DONE DEAL.
THE HEALTHCARE SYSTEMS ALSO HAD
BEGUN FOLLOWING THIS ZERO
SUICIDE MODEL TO IMPLEMENT
SYSTEMATIC PROCESSES FOR
ADDRESSING RISK AT THE TIME OF A
HEALTHCARE VISIT.
AS WHAT WE WOULD CALL STANDARD
WORK THAT PEOPLE WHO IN RESPONSE
TO THAT NINTH ITEM OF THE PHQ9,
STRUCTURED PROCESSES FOR RISK
ASSESSMENT USING SOMETHING
CALLED THE COLUMBIA SUICIDE
SEVERITY RATING SCALE,
DEVELOPING COLLABORATIVE SAFETY
PLANS, THIS WAS ALSO NOT A
RESEARCH QUESTION.
TO US THIS WAS REALLY GOOD NEWS,
BUT THIS WAS NOT THE PLACE FOR
EXPERIMENTATION.
THIS WAS DECIDED.
THE SPACE FOR EXPERIMENTATION
WAS THE HEALTHCARE SYSTEM
SAYING, WHAT ABOUT OUTREACH AND
THESE OTHER PROGRAMS FOR PEOPLE
WHO SEEM TO HAVE LEFT CARE, BEEN
DISCONNECTED FROM CARE, SHOULD
WE GO OUT AND MAKE ACTIVE
EFFORTS TO RE-ENGAGE PEOPLE AND
TO DELIVER THESE LOW INTENSITY
PROGRAMS AND THAT WAS THE SPACE
FOR EXPERIMENTATION THAT WE
FOCUSED ON.
ALSO IMPORTANT TO ACKNOWLEDGE
WHAT WE DID NOT KNOW AT THE
TIME.
WHAT WE WERE HOPING TO DO WAS TO
PUT IN PLACE A CARE MANAGEMENT
PROGRAM FOR PEOPLE AT HIGH RISK
OF SELF-HARM OR SUICIDE ATTEMPT
WOULD RECEIVE OUTREACH FROM A
STRANGER REALLY, SOMEONE WHO WAS
PART OF THEIR HEALTHCARE CYST
TESTIMONY BUT SOMEONE THEY'D NOT
EVER MET, AND WE DID NOT KNOW
HOW ACCEPTABLE THAT WOULD BE.
WE WERE HOPING TO PUT IN PLACE
THESE LOW INTENSITY ONLINE
INTERVENTIONS AND SUPPORT THEM
WITH A COACHING PROGRAM, BUT
COACHING WAS BY ASYNCHRONOUS
MESSAGING, NOT LIVE TELEPHONE
CONTACT OR ANYTHING THAT WOULD
BE RESOURCE-INTENSIVE.
WE HAD EVIDENCE FOR THE
EFFECTIVENESS OF THESE
DIALECTICAL -- IN PEOPLE SEEKING
TREATMENT OR WHO VOLUNTEERED TO
PARTICIPATE IN RESEARCH BUT WE
DID NOT KNOW ABOUT THEIR
ACCEPTABILITY OR EFFECTIVENESS
IN PEOPLE NOT SEEKING TREATMENT.
AND WE CERTAINLY HOPED AND
BELIEVED THAT KEEPING PEOPLE
ENGAGED IN TRADITIONAL MENTAL
HEALTHCARE, CARE FOR THEIR
PRIMARY MENTAL HEALTH DIAGNOSIS,
WHATEVER THAT WAS, WOULD REDUCE
RISK OF SELF-HARM BUT WE DID NOT
HAVE STRONG EVIDENCE FOR THAT.
SO I'M AM KNOWLEDGING WE MADE A
RELATIVELY SIGNIFICANT LEAP.
THE SORT OF -- YOU COULD SAY
LOGIC MODEL WE HAD WAS THAT
PEOPLE WHO WERE AT HIGH RISK FOR
SUICIDE OR SELF-HARM.
IF WE COULD GET THEM AND KEEP
THEM ENGAGED IN THIS
INTERVENTION, THAT WOULD LEAD TO
REDUCTION IN THEIR SUICIDAL
IDEATION OR SUICIDAL EVENT,
EVENTUALLY REDUCTION IN SUICIDAL
BEHAVIOR.
IN OUR TRIAL WE KNEW WE COULD
NOT VERY ACCURATELY MEASURE
SUICIDAL IDEATION OIRN TENT BUT
WE COULD MEASURE SUICIDAL
BEHAVIOR BECAUSE THAT APPEARS IN
HEALTHCARE RECORD OR INSURANCE
CLAIMS.
SO THAT WAS WHERE WE ENDED UP,
ACKNOWLEDGING THIS WAS A LEAP,
AND EVEN AT THE TIME, GOING BACK
AND READING THE APPLICATION THAT
WE WROTE FOR FUNDING AT THE
TIME, WE ACKNOWLEDGED THIS WAS A
SIGNIFICANT LEAP AND ACTUAL LU
QUOTED THE RFA WE WERE
RESPONDING FOR THAT CALLED FOR
BOLD, INNOVATIVE AND OFTEN RISKY
APPROACHES TO ADDRESS PROBLEMS
THAT MAY SEEM INTRACTABLE.
SO THIS IS WHERE WE ENDED UP.
WE FOCUSED ON THE POPULATION OF
PEOPLE WHO REPORTED FREQUENT
THOUGHTS OF SUICIDE OR SELF-HARM
AT AN OUTPATIENT VISIT WHEN THEY
FILLED OUT ONE OF THESE STANDARD
QUESTIONNAIRES, REGARDLESS OF
WHETHER THEY WANT OED OR SEEKING
TREATMENT OR WERE ENGAGED IN
TREATMENT.
WE TESTED TWO LOW INTENSITY
OUTREACH INTERVENTIONS, ONE MORE
FOCUSED ON THE DIALECTICAL
BEHAVIOR THERAPY SKILLS, THE
OTHER ON CARE NAVIGATION, TO
MAINTAIN ENGAGEMENT IN
OUTPATIENT TREATMENT.
THESE WERE DELIVERED PRIMARILY
BY ASYNCHRONOUS ONLINE MESSAGES
THROUGH THE EHR PATIENT PORTAL,
THE INTERVENTIONS LASTING UP TO
12 MONTHS.
THE COMPARISON WAS USUAL CARE.
PEOPLE MIGHT GET MENTAL
HEALTHCARE, BUT THERE WAS NO
ADDED INTERVENTION OR CONTACT.
THE OUTCOME WAS CODED AS
SELF-HARM OR SOME CODED AN
UNDETERMINED INTENT, AND THE
TIME FRAME WAS UP TO -- SORRY,
THAT SHOULD BE A YEAR PLUS 180
DAYS FOLLOWING RANDOM ASSIGNMENT
OR 540 DAYS.
AND THAT'S WHERE WE ENDED.
I THINK I'LL TURN IT BACK TO
KEVIN TO MODERATE THE
DISCUSSION.
>> THANK YOU VERY MUCH, GREG.
AND MARIJO, CAN WE STOP THE
SCREEN SHARE SO WE CAN SEE THE
FACES?
AND I'D INVITE OUR PANELISTS TO
COME ON CAMERA IF YOU CAN.
THAT WAS A TERRIFIC VERY
EFFICIENT OVERVIEW.
EVERYONE
PROVIDED THERE.
ONE OF THE THINGS I THINK IS
INTERESTING IS TO LA LOOK AT HOW
THAT RESEARCH QUESTION CAME
TOGETHER AND WHEN WE PRESENT
THESE THINGS TO PEOPLE IN THE
CONTEXT OF SCIENTIFIC
PRESENTATIONS, WE USUALLY ADAPT
A FAIRLY LINEAR PRESENTATION
BECAUSE THAT'S AN EFFECTIVE WAY
TO PRESENT THAT, BUT SOME OF YOU
MENTIONED SOME THINGS THAT
SUGGESTED THAT THERE WERE SOME
NON-LINEAR ASPECTS TO THE
DEVELOPMENT PROCESS, MAYBE A
LITTLE BIT OF SERENDIPITY, MAYBE
SOME FALSE STARTS.
I WONDER IF YOU COULD COMMENT A
LITTLE BIT ABOUT THAT AND MAYBE
FOR SOMEONE WHO'S NOT GONE
THROUGH THIS PROCESS, WHAT ARE
REALISTIC EXPECTATIONS ABOUT
WHAT THIS PHASE ZERO LOOKS AND
FEELS LIKE FROM YOUR
PERSPECTIVE?
>> I CAN SHARE THAT IT'S QUITE
UNCOMFORTABLE.
IT WAS NOT PLEASANT.
IN RETROSPECT, IT'S EASY TO MAKE
A LINEAR -- AS YOU'RE
HIGHLIGHTING, A LINEAR STORY,
BUT IT WAS NOT.
AND EVERY DECISION HAD
RAMIFICATIONS FOR PRIOR
DECISIONS.
AND SO FOR US, THERE WAS A LOT
OF ITERATIVE AND CYCLICAL
REFINEMENT OF THE IDEA.
I THINK WE WERE VERY EXCITED
ABOUT THE IDEA, AND THAT'S --
AND THAT WAS KIND OF A TRUE
NORTH FOR US.
ONCE WE WANTED THAT TO BE
PRAGMATIC AND GREG HIGHLIGHTS
CRITICAL -- THE CRITICAL
IMPORTANCE OF AFFORDABILITY AND
SCALABILITY.
WE WANTED TO REALIZE THIS
CONCEPT IN AN IMPACTFUL WAY AND
ONE -- I EARLIER ELIMINATED A
SLIDE THAT TALKED ABOUT CHECKING
IN WITH MYRIAD STAKEHOLDERS
ACROSS THE INSTITUTION TO ENSURE
APPETITE AND SUPPORT.
>> GREAT, THANKS, ANDREA.
WHAT ABOUT OTHERS?
ANY COMMENTS ON THAT IN THE
NON-PRETTY, NON-LINEAR ASPECT OF
THAT DEVELOPMENT WORK?
>> I CAN COMMENT ON THAT.
I REALLY TRIED TO HIGHLIGHT IN
THE INTRODUCTION TO THE ARBOR
TELEHEALTH STUDY, WE CERTAINLY
DIDN'T START WITH THE P IN PICOT
AND JUMPED RIGHT TO THE
INTERVENTION BECAUSE OF CURRENT
WORLD EVENT AND THEN SORT OF
BUILT IN PIECES AROUND IT AND
EVEN THEN, IT WAS PROBABLY NOT
AS CLEAN AS THE STORIES I TOLD.
I MEAN, WE'RE STILL IN OUR
UG3 PHASE, AND WE'VE EVEN --
SINCE WE GOT FUNDED ABOUT A YEAR
AGO, WE'VE CHANGED PARTS OF OUR
INTERVENTION AND DELIVERY
STRATEGY SINCE WE STARTED
PLANNING, WHICH IS THE NATURE OF
A PLANNING YEAR, THAT'S WHAT
IT'S FOR.
BUT YOU KNOW, WE HAD ORIGINALLY
DESIGNED THIS WORK COMPLEX
INTERVENTION STRATEGY THAT WAS
GOING TO INCLUDE A
PSYCHOSOCIALLY RISK STRATIFIED
CARE DELIVERY MECHANISM AND
YOU'D USE AN APP VERSUS, YOU
KNOW, SYNCHRONOUS TELEHEALTH AND
THEN WE GOT FEEDBACK FROM
STAKEHOLDERS THAT SAID MAYBE
THAT'S REALLY COMPLICATED FOR A
RURAL HEALTHCARE SYSTEM, SO EVEN
SOMETIMES AFTER YOU THINK THE
RESEARCH QUESTION IS FINALIZED
AND IT'S EVEN BEEN FUNDED, IT'S
NOT FINALIZED, AND YOU'VE GOT TO
GO BACK AND PULL IN MORE INPUT
AND SO YEAH, IT CAN BE VERY
CIRCULAR IN WAYS.
BUT I THINK IN THE END, IT'S
ABOUT A RESEARCH QUESTION FOR
ALL THE WORK THAT'S GONE INTO
IT.
>> THANKS, KEVIN.
ANYONE ELSE ON THAT QUESTION?
KUSHANG?
>> I WOULD JUST ADD THAT WE HAD
SIMILAR EXPERIENCES, LIKE REALLY
HAD SERENDIPITY -- SERENDIPITOUS
OPPORTUNITIES TO CONDUCT A
VARIETY OF DIFFERENT PILOT
STUDIES AND THEN JUST THE RFA
CAME OUT AFTER BEING AWARDED,
WORKING WITH A VARIETY OF
DIFFERENT HEALTHCARE SYSTEMS,
WE'RE REALLY HAVING TO ADJUST TO
MEET LOCAL CONTEXT AND TO BE
FLEXIBLE IN IMPLEMENTING OUR
INTERVENTION TO -- IN ONE
HEALTHCARE SYSTEM, IT WILL BE A
NURSE AND POTENTIALLY ANOTHER
HEALTHCARE SYSTEM MIGHT BE A
DIFFERENT HEALTHCARE PROVIDER
THAT'S DOING THE CARE
COORDINATION.
SO WE'RE STILL LEARNING, AND
SIMILAR TO WHAT KEVIN JUST SAID,
WE'RE IN THE EG3 PHASE AND
PILOTING, AND SO WE HAVEN'T
FULLY LANDED ON OUR INTERVENTION
YET, AND SO TAKE ADVANTAGE OF
PILOTING OPPORTUNITIES FOR SURE.
>> GREAT.
AND FOR FOLKS WHO ARE LISTENING
OR LESS FAMILIAR WITH
COLLABORATORY LINGO, THE
UG3 PHASE IS THAT FIRST YEAR OF
PLANNING, THE UH3 PHASE FOR MOST
OF THE TRIALS WOULD BE THE
ACTUAL IMPLEMENTATION OF THE
TRIAL.
SO KEVIN, KUSHANG, REFERRING TO
ACTIVITIES DURING THAT FIRST
YEAR.
AFTER YOU GET THE FUNDING, YOU
GET A YEAR OF PLANNING.
GREG, DO YOU HAVE ANYTHING TO
NOTE ON IT?
>> THE ONLY THING I'D ADD, AND I
REFER TO THAT IN ONE OF THE
SLIDES I SHOWED IS SORT OF, YOU
KNOW, THINKING ABOUT WHAT IS THE
SPACE FOR EXPERIMENTATION.
WHAT THINGS ARE ALREADY DECIDED
OR ARE GOING TO HAPPEN REGA
REGARDLESS.
WHAT THINGS ARE PROBABLY NEVER
GOING TO HAPPEN REGARD
LEUKOENCEPHALOPATHY, AND WHAT
SORT OF IN BETWEEN IS THIS WOULD
HAPPEN WITH EVIDENCE BUT WON'T
HAPPEN WITHOUT.
BUT THAT WINDOW IS NOT STATIC
OVER TIME, THE WORLD CHANGES.
BUT UNDERSTANDING WHERE IS THAT
SORT OF SPACE IF YOU COULD THINK
OF IT AS ORGANIZATIONAL
EQUIPOISE, YOU KNOW, WE'RE NOT
READY TO DO THIS RIGHT NOW, WE
WOULD BE READY TO DO IF WE HAD
EVIDENCE THAT IT WORKED, WHICH
IS SORT OF BETWEEN -- THAT
DOESN'T SOUND LIKE ANYTHING WE'D
EVER DO.
WE'RE DOING THAT NEXT WEEK,
WE'RE NOT WAITING.
>> RIGHT.
YOU KNOW, ONE OF THE ASPECTS OF
THE RESEARCH QUESTION, IT SEEMS
LIKE WE DISCUSS LESS FREQUENTLY
IS THAT COMPARISON GROUP.
KEVIN RVETIO, I THOUGHT, HAD SOT
CONSIDERATIONS OF HOW THEY
ARRIVED AIN'T PRE TAITION OF ATF
USUAL CARE THERE, KEVIN I THINK
YOU SAID RAISING THE FLOOR FOR
EVERYONE WITH WEB-BASED
EDUCATION TO REFLECT ADVICE.
I'M JUST WONDERING IF ANYONE
COULD TALK THROUGH A LITTLE BIT
ABOUT SOME OF THE CHALLENGES AND
THINKING THROUGH WHAT THAT RIGHT
COMPARISON GROUP OUGHT TO BE.
>> THE SHORT ANSWER IS USUAL
CARE, BUT I THINK A LONGER
ANSWER IS, USUAL CARE AT THE
TIME AND PLACE WHERE THESE
RESULTS MIGHT BE APPLIED.
WHICH IS SOMETIMES COMPLICATED.
BECAUSE YOU MAY BE STUDYING
THESE INTERVENTIONS IN SETTINGS
THAT ACTUALLY MAY BE FARTHER
ALONG IN TERMS OF CARE,
IMPROVEMENT IN THIS AREA OR MAY
HAVE RESOURCES THAT OTHER
SETTINGS DON'T HAVE, AND THEN OF
COURSE THE RESULTS ARE GOING TO
BE APPLIED OFTEN FOUR, FIVE-PLUS
YEARS FROM NOW AND SO YOU'RE
SORT OF ANTICIPATING -- YOU HOPE
ANTICIPATING WHERE THINGS ARE
GOING AND THINKING THIS IS WHERE
WE THINK THE WORLD MIGHT BE SOME
YEARS FROM NOW.
AND THEN QUALIFIED AS I THINK WE
HEARD EARLIER, YOU MAY HAVE SOME
ETHICAL OBLIGATION, YOU KNOW, IF
THE RESEARCH IS DISCOVERING SOME
NEED THAT CANNOT BE IGNORED, YOU
MIGHT SAY PROBABLY WE NEED TO
PUT IN PLACE SOME SAFETY VALVE
TO MAKE SURE WE'RE NOT IGNORING
SOMETHING THAT WOULD BE
UNETHICAL TO IGNORE.
SO I THINK THAT I THINK USUAL
CARE IS USUALLY THE RIGHT
COMPARISON, BUT IT'S USUAL CARE
WHEN AND WHERE THE RESULTS OF
THIS RESEARCH WOULD BE APPLIED.
>> I THINK FOR US I'LL JUST NOTE
THAT WE DECIDE ON USUAL CARE AS
GREG SAID, TYPICALLY FOR PAIN
PRAGMATIC TRIALS, USUAL CARE IS
THE TYPICAL COMPARATOR.
WE'RE WORKING WITH MULTIPLE
HEALTHCARE SYSTEMS, SO HAVING A
HEALTHCARE SYSTEM, IN ADDITION
TO IMPLEMENTING THE NURSE CARE
MANAGEMENT MODEL IMPLEMENT
ANOTHER ACTIVE CONTROL OR SOME
OTHER COMPARATOR MIGHT BE A
HEAVY LIFT.
FOR US, WHAT WE PLAN TO DO IS
BECAUSE WE HAVE DIFFERENT
HEALTHCARE SYSTEMS IS TO REALLY
CHARACTERIZE WHAT CARE PEOPLE
GET IN USUAL -- IN THE USUAL
CARE ARM, SO WE MAKE GREAT
EFFORTS TO MONITOR WHAT TYPES OF
MEDICATIONS PEOPLE ARE GETTING,
WHAT KIND OF REFERRALS FOLKS ARE
GETTING TO SPECIALTY SERVICES,
AND SO YEAH, WE JUST DEFAULTED
TO USUAL CARE, BUT WE'LL DO A
GOOD JOB OF CHARACTERIZING IT
ACROSS SYSTEMS.
>> I CAN SAY THE TWO IMPORTANT
CONSIDERATIONS FOR US WERE POOR
RESOURCES, IMPLEMENTING TWO
INTERVENTIONS ACROSS A VERY
LARGE NATIONAL HEALTH SYSTEM.
WOULD HAVE BEEN CHALLENGING.
WE POTENTIALLY COULD HAVE
CONSIDERED AN EHR-BASED
ALTERATION OF USUAL CARE.
BUT THAT'S NOT A TRIVIAL
RESOURCE INVESTMENT AT ALL.
AND ALSO, PREVENTING
CONTAMINATION.
WE WERE TRYING TO MAKE A VERY
CLEAN DISTINCTION BETWEEN THE
INTERVENTION AND USUAL CARE.
SO WE THOUGHT ABOUT IT, THERE
DIDN'T SEEM TO BE A CLEAR WAY OF
DOING THIS.
AND THE POTENTIAL FOR
MAINTAINING FIDELITY WITHIN THE
INTERVENTION AS WE HAD IT WAS A
CHALLENGE.
MAINTAINING FIDELITY OF A USUAL
CARE STATE THAT WE KR CREATED WD
PROBABLY HAVE BEEN BEYOND OUR
RESOURCE, RESOURCES.
>> THANKS, ANDREA.
OKAY.
WENDY WEBER'S POSTED A QUESTION
HERE, AND THIS IS FOR ANDREA AND
GREG.
LOOKING BACK NOW THAT YOU'VE
COMPLETED OR ALMOST COMPLETED
THE TRIAL, IS THERE ANYTHING YOU
WISHED YOU HAD PILOTED BETTER
THAT WOULD HAVE HELPED YOU
ADDRESS CHALLENGES THAT AROSE
DURING THE TRIAL?
>> YEAH, IT'S A GOOD QUESTION.
I MEAN, I THINK AS PEOPLE KNOW,
ALTHOUGH I DIDN'T SAY, AT THE
END OF THE DAY, THE
INTERVENTIONS WE TESTED WERE NOT
EFFECTIVE.
YOU KNOW, THEY DID NOT REDUCE
RISK OF SELF-HARM OR SUICIDE
ATTEMPT.
AND THE LEVEL OF ENGAGEMENT IN
THE INTERVENTIONS WAS ACTUALLY
RELATIVELY LOW.
NOT THAT MUCH LOWER THAN WE
EXPECTED BASED ON OUR PILOT
WORK, BUT THE ENGAGEMENT WAS
RELATIVELY LOW.
LOOKING BACK ON IT, THE
QUESTION -- THE INTERESTING
THING AND MAYBE SORT OF
RELATIVELY SORT OF UNIQUE TO OUR
TRIAL, AND THIS IS THAT SLIDE I
SHOWED WHERE WE TALKED ABOUT
SORT OF MAKING A LEAP.
MUCH OF THE RESEARCH ON THE
EFFECTIVENESS OF INTERVENTIONS
TO REDUCE SELF-HARM OR SUICIDE
ATTEMPT HAD BEEN PEOPLE WHO
PARTICIPATE IN RESEARCH TO
PREVENT SUICIDE.
SO YOU MIGHT SAY WELL WHAT ABOUT
THOSE PEOPLE WHO DIDN'T
VOLUNTEER TO PARTICIPATE IN
RESEARCH ABOUT SUICIDE, THOSE
MIGHT BE THE PEOPLE YOU WOULD
CARE ABOUT THE MOST, THAT'S WHAT
I WOULD SAY AT LEAST.
IT'S HARD TO KNOW HOW YOU MIGHT
HAVE UNDERSTOOD MORE ABOUT THAT
GROUP OF PEOPLE WITHOUT TAKING A
LEAP.
YOU WOULD LIKE YOUR LEAPS TO BE
MAYBE SMALLER.
WHEN I LOOK BACK ON IT, I SAY,
WELL, MAYBE WE SHOULD HAVE DONE
SOMETHING SMALLER IN SCOPE, YOU
KNOW, A SMALLER NUMBER OF PEOPLE
AND FOCUS ON SORT OF MORE KIND
OF APPROXIMATE OR IPT IMMEDIATE
OUTCOMES RATHER THAN TAKING A
BIG LEAP, BUT THEN AT THAT
POINT, YOU'D SAY WELL, YOU KNOW,
NOW I KNOW THAT MIGHT HAVE BEEN
THE RIGHT THING TO DO.
BUT THAT WOULD HAVE BEEN
ANOTHER -- THAT WOULD NOT BE, TO
USE OUR JARGON, THAT WOULD NOT
BE THE SORT OF PILOT YEAR.
THAT WOULD BE ITSELF A THREE- TO
FIVE-YEAR PROJECT.
SO WOULD YOU SAY WE SHOULD DO A
THREE- TO FIVE-YEAR PROJECT FOR
THAT INTERMEDIATE STEP.
AND PROBABLY, YOU KNOW, FOR WHAT
I THINK FUNDERS SHOULD THINK
ABOUT IS WHAT DOES A PORTFOLIO
LOOK LIKE?
YOU KNOW, A PORTFOLIO SHOULD
PROBABLY LOOK LIKE SOME BIG
STEPS AND SOME SMALL STEPS.
AND THINKING ABOUT THE
APPROPRIATE BALANCE OF BIG STEPS
AND SMALL STEPS, YOU PROBABLY
DON'T WANT TO HAVE ONLY BIG
LEAPS AND YOU DON'T WANT TO HAVE
ONLY SMALL STEPS, YOU WANT TO
HAVE SOME MIX OF THOSE.
>> THANKS, GREG.
ANDREA, ANY THOUGHTS ABOUT THAT?
>> YEAH, TWO.
I IN RETROSPECT WISH WE HAD DONE
MORE DUE DILIGENCE IN DEVELOPING
SAFETY CHECKS FOR OUR EHR
PROCESSES.
I THINK WE ASSUMED EPIC WAS
GOING TO DO WHAT WE TOLD TO DO,
AND THAT WAS INCORRECT SO I WISH
WE HAD CONSIDERED THAT EARLIER
ON AND BEEN MUCH MORE SYSTEMATIC
IN STEP WISE VALIDATION.
I ALSO WISH THAT WE HAD SPENT
MORE TIME ON INFORMATICS
IMPLEMENTATION.
WE REALIZED THIS WAS CRITICAL
WITH E2C2 AND ADVANCED IT
FURTHER, BUT IF WE'RE GOING TO
USE DIGITAL TOOLS AND TRY AND
ENGAGE VERY BUSY CLINICIANS WHO
MAY NOT SHARE YOUR PRIORITIES
USING THESE DOLLS,
IMPLEMENTATION BECOMES
ABSOLUTELY CRITICAL.
SO I WISH WE HAD HAD THE
LATITUDE TO BUY LOT SOME
ADDITIONAL STRATEGIES.
WE DID THIS ON THE FLY OF
NECESSITY, BUT IT WOULD HAVE
BEEN NICE TO HAVE THE LUXURY TO
DO THAT IN A MORE FOCUSED WAY.
>> YOU KNOW, I'D LIKE TO GO BACK
TO SOME OF THE COMMENTS THAT
WERE JUST MADE AND MADE EARLIER
TOO ABOUT THE ROLE OF THE CALL
FOR FUNDING.
IN SHAPING THE
APPROACH THAT YOUR TEAMS TOOK,
AND THIS IS THE NIH WORKSHOP,
PART OF THE REASON WHY WE HAVE
THIS WORKSHOP IS TO TRY TO
ENGAGE WITH OUR NIH COLLEAGUES,
AND I WONDER IF WE THOUGHT FOR A
MINUTE ABOUT THOSE NIH CALLS FOR
APPLICATIONS, FOR THESE
PARTICULAR TRIALS BUT FOR OTHER
ONES YOU MIGHT HAVE CONSIDERED
TOO, ARE THERE THINGS THAT CAN
BE INCLUDED IN THOSE CALLS THAT
FACILITATE YOU HONING IN ON AN
IMPACTFUL RESEARCH QUESTION, ARE
THERE ANY ELEMENTS THAT
SOMETIMES CONTRIBUTE TO SOME
UNCERTAINTY OR CONFUSION WHEN
TRYING TO CRAFT A RESEARCH
QUESTION?
HOPEFULLY THAT'S NOT TOO BROAD,
BUT I KNOW GREG PULLED OUT THAT
QUOTE FROM THE ORIGINAL
COLLABORATORY ENCOURAGING BOLD,
RISKY PROJECTS, AND THAT
DIRECTLY INFORMED HOW BIG OF A
LEAP OVER THOSE VARIOUS UNKNOWNS
YOU LISTED YOU WERE WILLING TO
TAKE.
SO JUST WONDERED WHETHER PEOPLE
HAD THOUGHTS ABOUT WAYS THAT THE
CALL FOR FUNDING ITSELF IS
SOMETIMES HELPFUL OR PERHAPS
INTRODUCES SOME UNCERTAINTY IN
THE THINGS IT SAYS.
GLL I PERSON
>> I PERSONALLY REALLY LEAN ON
THE EXAMPLES.
I LIKE WHEN EVERYTHING IS
EXPLAINED BUT THERE'S A LOT OF
JARGON IN THERE AND IT'S VERY
CAREFULLY WORDED.
THEY'RE WRITTEN WELL, BUT
OFTENTIMES I THINK THINGS ARE
GOING IN ONE DIRECTION AND THEN
I GET DOWN TO THE EXAMPLES OF
PROJECTS THAT WILL BE RESPONSIVE
TO THIS AND I GO, OH, THIS IS
WHAT HE TH THEY MEAN.
SO I THINK THOSE HYPOTHETICAL
STUDIES THAT WOULD BE RESPONSIVE
AND WOULD NOT BE RESPONSIVE ARE
ALWAYS REALLY HELPFUL FOR ME AND
OFTEN GIVE ME AN IDEA THAT MAYBE
I HADN'T ALREADY HAD BUT IS
SIMILAR TO ONE OF THE
HYPOTHETICAL STUDIES THEY
MENTIONED.
>> OKAY.
OTHER THOUGHTS ON THAT?
>> GOING BACK TO WHAT I SET
ABOUT SORT OF YOU WANT THE SORT
OF DIVERSITY IN AN OVERALL
PORTFOLIO, I THINK IT'S
CERTAINLY POSSIBLE FOR FUNDING
OPPORTUNITIES, ESPECIALLY HAVING
MULTIPLE FUNDING OPPORTUNITIES,
ITHAT REALLY PINPOINT DIFFERENT
SORT OF -- WHERE IS THIS
OPPORTUNITY FOCUSED AND WHERE
ARE YOU GOING.
ONE THAT I'M JUST VERY
INTERESTED IN PAYING ATTENTION
TO, YOU KNOW, I'LL JUST USE AS
AN EXAMPLE, NIMH HAS JUST PUT
OUT SOME FUNDING ANNOUNCEMENTS
ABOUT PERSO PERSONALIZING MENTAL
HEALTH TREATMENTS.
INTERESTINGLY THERE'S ONE
ANNOUNCEMENT MORE ABOUT WE NEED
TO DEVELOP TOOLS OR DEVELOP
TOOLS THAT WOULD ALLOW FUTURE
PERSONALIZATION AND THE OTHER IS
WE NEED TO TEST THE TOOLS WE
HAVE RIGHT NOW.
NOW THOSE ARE TWO REALLY
DIFFERENT THINGS, AND I THOUGHT
IT WAS ACTUALLY WISE TO SAY WE
WANT BOTH.
YOU KNOW?
WE WANT TO KNOW WHAT'S THE BEST
WE CAN DO WITH WHAT WE HAVE NOW,
BUT KNOWING WHAT WE HAVE NOW IS
ACTUALLY NOT VERY GOOD, WOULD
LIKE SOMETHING THAT WE CAN USE
IN THE FUTURE THAT WILL BE
BETTER, BUT WE WANT BOTH.
>> AIL JUST ADD TO ADREE WITH
WHAT GREG AND KEVIN, THE RFA
THAT WE RESPONDED TO WAS VERY --
HAD VERY SPECIFIC CALLS AND FOR
AN EXAMPLE, WHAT IS RURAL AND
THAT REALLY HELPED, I THINK, TO
DEFINE -- HELPED ALL THE
APPLICANTS IDENTIFY HEALTHCARE
PARTNERS THAT HAD REASONABLE
NUMBERS OF PEOPLE THAT WOULD
MEET -- PATIENTS THAT WOULD MEET
THE DEFINITION OF RURALITY OR
RURAL.
SO HAVING SPECIFIC CRITERION AND
THEN ALSO HAVING, LIKE KEVIN WAS
SAYING, THIS WAS A RANGE OF
EXAMPLES TO DESCRIBE THE TYPES
OF INTERVENTIONS WAS SUPER
HELPFUL.
JUST IN TERMS OF THE POPULATION,
I REALLY APPRECIATED HAVING VERY
SPECIFIC CRITERIA BEING LISTED
IN THE RFA.
>> I WOULD JUST FOLLOW UP WITH
THAT IN THAT WE ALL KNOW
LANGUAGE IS POWERFUL AND
SOMETIMES AMBIGUOUS LANGUAGE IN
THE RFA, IN OUR SITUATION, WE
WERE VERY MUCH ON THE FENCE.
WE WERE WORRIED ABOUT BANDWIDTH,
AND HAVING THE SPECIFICITY OF
LANGUAGE, I THINK HELPS EMPOWER
A TEAM TO FEEL LIKE WE HAVE A
FIGHTING SHOT.
THE OPPORTUNITY COST OF
DEVELOPING A MISFIRE, MISAIMED
POPULATION ARE NOT TRIVIAL.
SO I THINK IT'S IMPORTANT TO USE
OPEN-ENDED LANGUAGE WH, CREATIVE
THOUGHT, PUSHING THE ENVELOPE,
DISRUPTION IS DESIRED.
THE FLIP SIDE OF THAT IS THAT IN
THAT AMBIGUOUS LANGUAGE CAN BE
VERY DISCOURAGING AND
OFFPUTTING, BECAUSE OF THE
POTENTIAL, AGAIN, TO COMPLETELY
MISSPECIFY AN APPLICATION THAT
DOES NOT HIT THE MARK.
>> ALL RIGHT.
WELL, GOOD.
THAT'S HELPFUL.
SO HE HELENE, YOU'VE COME ON
CAMERA.
DO YOU FIND THAT --
>> I FIND THIS WHOLE DISCUSSION
REALLY INTERESTING.
THIS IS SOMETHING THAT I WORRY A
LOT ABOUT.
IN TERMS OF WELL-INTENTIONED
LANGUAGE, RIGHT, IN RFAs THAT
ARE MEANT TO GUIDE AND ENCOURAGE
HOW OFTEN DOES THAT END UP
MISFIRING, MISLEADING, WITHOUT,
YOU KNOW, SENDING PEOPLE IN A
DIRECTION THAT MAY NOT BE
NECESSARILY THE BEST.
WHAT I WORRY ABOUT IS THAT, I
MEAN, I'VE BEEN AN INVESTIGATOR
FOR 25 YEARS, I KNOW WHAT IT
LIKE, YOU KNOW, READING THESE
RFAs AND TRYING TO -- YOU'RE
CONFLICTED, RIGHT?
ON ONE HAND, YOU WANT YOUR
APPLICATION TO GET FUNDED.
ON THE OTHER HAND, YOU MAY HAVE
YOUR OWN IDEAS ABOUT WHAT'S THE
BEST THING TO DO.
AND HOW DO YOU RECONCILE THAT?
AND SO I THINK THIS IS WHERE
DISCUSSIONS LIKE THEEZ THAT ARE,
YOU KNOW, REALLY CANDID AND OPEN
WHERE YOU ALL CAN REALLY GIVE US
THE FEEDBACK IS SO IMPORTANT.
WE NEED TO UNDERSTAND THE EXTENT
TO WHICH THE DETAIL AND THE
EFFORTS THAT WE PUT IN IN
CREATING THESE RFAs ARE
HITTING THE MARK, YOU KNOW, AND
SO -- AND IF IT ENDS UP CREATING
EITHER CONFUSION OR SENDING YOU
ALL IN DIRECTIONS THAT YOU
PERSONALLY IN THE BACK OF YOUR
HEADS ARE WONDERING MAYBE THAT'S
NOT THE RIGHT THING BUT I'LL DO
IT THIS WAY BECAUSE THAT'S WHAT
THE RFA SAYS.
YOU KNOW?
I'M JUST CURIOUS WHAT YOU ALL
THINK ABOUT THAT.
IS THERE -- YOU KNOW, I THINK
THIS IS PARTLY WHAT THIS
DISCUSSION IS ABOUT, IS YOU'RE
ALL VERY POLITE AND TELLING US
THAT WE SHOULD THINK ABOUT
CAREFULLY HOW THESE RFAs ARE
WRITTEN.
>> WELL, I MEAN, I'D GO BACK TO
THAT EXAMPLE I CITED WHICH I
THOUGHT WAS QUITE WISE.
NIMH SAYING WE NEED BOTH OF
THESE.
SO WE'RE GOING TO HAVE ONE RFA
FOR THIS AND ONE RFA FOR THAT
AND THEY'RE GOING TO BE VERY
CLEAR, AS OPPOSED TO BEING
RELATIVELY VAGUE AND ENDING UP
WITH ALL ONE OR ALL THE OTHER
SAYING WE NEED BOTH.
I ACTUALLY AGREE WITH THAT.
>> SO IN SOME CASES IT'S GOOD TO
BE SPECIFIC.
>> YEAH, WELL --
>> WHAT IF IT'S WRONG?
>> BUT SPECIFIC IN TERMS OF
PORTFOLIO BALANCE, YOU KNOW?
>> RIGHT.
>> IN TERMS OF, OKAY, I THINK
TO SAY FIRST OF ALL, THIS
PROBLEM IS A PRIORITY, A AND
THEN TO SAY WHAT DOES A BALANCED
PORTFOLIO LOOK LIKE TO ADDRESS
THIS PROBLEM, AND THAT BALANCED
PORTFOLIO OFTEN NEEDS TO INCLUDE
SOME -- TO USE THE FOOTBALL
ANALOGY, IT NEEDS TO INCLUDE A
FEW SHOTS DOWN THE FIELD AND A
FEW 6-YARD PASSES AND THINGS
LIKE THAT, AND YOU'RE GOING TO
NEED A MIX OF THOSE THINGS.
AND I THINK IT'S FINE FOR RFAs
TO BE PRETTY CLEAR ABOUT THIS IS
THE RFA FOR THIS AND THIS IS THE
RFA FOR THAT.
NOW THAT IS MORE WORK FOR
PROGRAM STAFF TO PUT OUT
MULTIPLE RFAs BUT I ACTUALLY
THINK THAT'S HELPFUL.
THE ONE THING THAT I'VE
SOMETIMES FOUND SORT OF
CHALLENGING IS, IT SEEMS THAT
EVERYONE HAS THEIR OWN
DEFINITION OF INNOVATIVE.
AND IT ACTUALLY MIGHT BE HELPFUL
IF RFAs WERE A LITTLE MORE
SPECIFIC ABOUT IN THIS RFA, WHAT
KIND OF INNOVATION ARE WE
LACKING FOR?
DON'T MEAN TO WHINE TOO MUCH
BUT HAVING HAD THE EXPERIENCE OF
A PROPOSAL BEING REVIEWED WHERE
ONE REVIEWER SAYS, YOU KNOW,
THIS IS COMPLETELY IMPOSSIBLE,
THIS COULD NEVER BE DONE, WHICH
ACTUALLY I WOULD SAY IS A PRETTY
GOOD MARKER OF INNOVATION IF
SOMEBODY SAYS NOT EVEN POSSIBLE.
AND ANOTHER REVIEWER SAYS NOT
INNOVATIVE AT ALL.
THE CHALLENGE IS THAT PEOPLE ARE
FOCUSED ON VERY DIFFERENT
THINGS.
SOMEBODY SAYS, YOU KNOW, THIS IS
A HUGE STRETCH, TRYING TO APPLY
SOMETHING THAT'S NEVER BEEN DONE
IN THIS FIELD BEFORE, AND THEN
ANOTHER REVIEWER SAYS OH, BUT
YOUR STATISTICAL METHODS ARE
TOTALLY ESTABLISHED.
SO IT WOULD BE HELPFUL IF AN RFA
SAID IN THIS RFA, THIS IS THE
KIND OF INNOVATION WE'RE LOOKING
FOR.
BECAUSE I THINK SOMETIMES YOU
ARE LOOKING FOR INNOVATION IN
SPECIFIC AREAS.
YOU'RE SAYING HERE WE'RE LOOKING
FOR INNOVATION FOR REALLY NEW
METHODS.
HERE WE'RE LOOKING FOR
INNOVATION IN A REALLY DIFFERENT
SETTING OR A NEW POPULATION.
HERE WE'RE LOOKING FOR
INNOVATION IN THIS AREA.
>> THAT'S ASSUMING WE'RE LOOKING
FOR THE RIGHT THING.
>> YEAH.
WELL, YOU KNOW, I HAVE TO SAY,
MY OWN EXPERIENCE, BELIEVE ME,
I'M NOT JUST SUCKING UP HERE,
THAT THE NIMH, OUR SCIENTIFIC
COLLEAGUES AT NIH ARE OFTEN MUCH
MORE INTERESTED IN AND TO BE
HONEST WITH YOU ATTUNED TO WHAT
INNOVATION IS NECESSARY THAN
SOME OF US RESEARCHERS.
>> WELL, MAYBE -- THAT'S MAYBE
FROM WHERE WE SIT, WE HAVE A
BIGGER IDEA ON BIG PICTURE, BUT
I ALSO DO BELIEVE THAT SOMETIMES
INVESTIGATORS CAN HAVE INSIGHTS
THAT ARE QUITE IMPORTANT AND IF
THERE'S -- DON'T FIT THE RFA
THEN THEY WON'T GET FUNDED AND
THEN THAT IDEA WILL BE WASTED.
>> AND THERE, I THINK ONCE
AGAIN, I THINK ABOUT PORTFOLIO
BALANCE, YOU KNOW, IT IS, I
THINK, YOU KNOW, TO SAY, YOU
KNOW, WE'RE GOING TO HAVE SOME
FUNDING OPPORTUNITIES THAT
REALLY ARE FOCUSED IN TERMS OF
THIS IS ABOUT THIS PROBLEM AND
THIS IS REALLY ABOUT THIS LEVEL
OF LEAP FOR THIS PROBLEM.
BUT IT'S GOOD TO HAVE SOME
THINGS THAT ARE JUST LIKE ALLOW
ANY TOTALLY UNHEARD OF IDEA THAT
SOMEBODY THOUGHT OF, I THINK YOU
HAVE TO HAVE ALL OF THOSE, BUT
NOT ALL ONE OR NOT ALL THE
OTHER.
>> ABSOLUTELY.
COULD NOT AGREE MORE.
I SEE YOU PUT YOUR FINGER RIGHT
ON IT.
>> I ALSO THINK IT'S VERY
IMPORTANT TO USE LANGUAGE TO
CALIBRATE INVESTIGATORS AND TO
CAL GREAT REVIEWERS.
BECAUSE SOMETIMES IF YOU WANT
INNOVATION YOU KIND OF GET
LET -- OR GREG'S EXPERIENCE,
THAT THIS IS -- YOU SHOOT FOR
THE STARS AND IT ABSOLUTELY
FALLS FLAT.
ONCE REVIEWER JUST KILLS IT.
AND I DO THINK THE SROs CAN BE
VERY, VERY EFFECTIVE IN
EMPHASIZING, JUST PUTTING IT AT
THE TOP OF THE REVIEW FORM IS
NOT ENOUGH.
BUT TO REALLY EMPHASIZE REPEA
REPEATEDLY THAT THIS IS THE
LEVEL, AS GREG WAS HIGHLIGHTING,
THE TYPE, MAYBE THE LEVEL OF
INNOVATION THAT WE'RE LOOKING
FOR, BECAUSE THAT'S, I THINK,
REASSURING AND EMPOWERING TO AN
INVESTIGATIVE TEAM.
IT TELLS US WHERE TO AIM.
>> I DON'T WANT TO MONOPOLIZE
THE WHOLE CONVERSATION, BUT I
REALLY THINK THIS HAS BEEN VERY
INTERESTING, SO THANK YOU.
>> MAYBE I'LL JUST ADD ON TOP OF
THIS TOO, IT SOUNDED LIKE ONE OF
THE THINGS THAT WAS REALLY
USEFUL FOR PARTICULAR RFAs IS
WHEN THEY'RE COMMUNICATING THE
EXTENT TO WHICH THERE'S INTEREST
IN LOOKING AT OUTCOMES WITHOUT
HAVING PRIOR EVIDENCE OF A
MECHANISTIC OUT COME EFFECT.
AND THAT'S HOW GREG INTERPRETED
THE BOLD PART IN SOME WAYS, THE
RISKY PART, THERE WASN'T --
THERE WEREN'T THOSE STUDIES IN
THAT POPULATION OF PEOPLE WHO
DON'T VOLUNTEER FOR RESEARCH ON
WHETHER IT MIGHT REDUCE
IDEATION, THAT SORT OF THING.
SO SIGNALING SOMEHOW WHAT LEVEL
OF PRIOR EVIDENCE IS REQUIRED
NOT ONLY ABOUT THE FEASIBILITY
BUT ALSO ABOUT SORT OF THE
CAUSAL CHAIN INVOLVED IN THIS,
SEEMS LIKE THAT'S HELPFUL WHEN
THOSE THINGS COME OUT, AND I
REALLY SECOND ANDREA'S REMARK
THAT FOR STUDY SECTIONS, MAKING
SURE TO REMIND THE REVIEWERS
ESPECIALLY WHEN YOU'RE SITTING
FOR REVIEWING MULTIPLE
MECHANISMS THAT DIFFER IN THOSE
PARAMETERS, IT'S REALLY HELPFUL
TO GET THE REMINDERS, AND I WAS
JUST -- AND THEN NCCIH REVIEW
THAT WAS -- THEY DID JUST THAT
REALLY, REALLY WELL, I THOUGHT.
SO VERY HELPFUL.
WE'VE GOT ONE QUESTION FROM
WENDY HERE.
WHEN PLANNING A PCT AND CREATING
A RESEARCH QUESTION, DO YOU
WORRY ABOUT OR TAKE INTO
CONSIDERATION OTHER TRIALS THAT
THE POPULATION MAY BE OR
DEFINITELY ARE PARTICIPATING IN,
AND IF OR HOW IT COULD AFFECT
OUTCOMES?
BY THE WAY, WHEN I SAY QUESTION
FROM WENDY, WE WENDY IS CHANNELG
THE VIDEO WEBCAST AUDIENCE FOR
US.
ANY TAKERS ON THIS QUESTION?
WORRYING ABOUT OTHER TRIALS THAT
THE POPULATIONS MAY BE
PARTICIPATING IN.
WE'VE GOT A COUPLE MINUTES LEFT
HERE.
GREG, WERE YOU GOING TO SAY
SOMETHING?
>> I'M NOT SURE IF SHE'S ASKING
ABOUT THE BROADER SORT OF
ECOSYSTEM OF ARE THERE OTHER
TRIALS GOING ON, WHAT WILL THEY
LEARN OR HOW MIGHT THAT CHANGE,
OR IF SHE'S TALKING ABOUT WITHIN
THE CERTAIN PATIENT POPULATION,
THERE MIGHT BE OTHER TRIALS
GOING ON WITHIN THIS SYSTEM OR
WITHIN THIS CLINIC.
I'M NOT SURE WHAT -- YEAH.
>> I THINK IT'S WITHIN THE
POPULATION.
SO IT WITHIN THE SAME
POPULATION.
SO FOLKS MIGHT BE PARTICIPATING
IN OTHER TRIALS.
>> YEAH.
>> I CAN SHARE, THIS WAS A
PRETTY SIGNIFICANT ISSUE FOR US
IN NOHARM.
IT ACTUALLY WORKED IN OUR FAVOR,
IN THAT THE ORTHOPEDIC SURGERY
WAS ONE OF THE CLUSTERS AT ALL
OF THE SITES THAT WERE
PARTICIPATING.
THEY WERE ALREADY COLLECTING
OUTCOMES.
SOME FOR JUST SURVEILLANCE,
BUT -- OUTCOME LONGITUDAL -- BUT
SOME WERE OTHER TRIALS.
WE RECEIVED QUITE A BIT OF
PUSHBACK OF THE RETURN BECAUSE
WE WOULD CANNIBALIZE THEIR
RESPONSES, IF WE ADDED MORE
EPROMS TO THE POOL, WE WOULD
CANNIBALIZE.
ACTUALLY WE WERE ABLE TO WORK
WITH THEM AND IT WORKED OUT VERY
WELL BECAUSE WE LEVERAGED THEIR
RESPONSES AS WELL.
WE RECOGNIZED THAT WE WERE
COLLECTING INFORMATION ON
SIMILAR OUTCOMES, AND IT WAS A
WIN-WIN.
BUT I THINK IT HIGHLIGHTED
PARTICULARLY IN A CLINICAL GROUP
THAT YOU'RE TRYING TO ENGAGE
WITH AND IMPLEM T IMPLEMENT INN,
IT DOESN'T GO REALLY WELL WHEN
THEY PERCEIVE YOU AS A THREAT TO
THEIR ONGOING RESEARCH, SO
THERE'S DEFINITELY A TENSION.
>> THANKS, ANDREA.
WE ARE ACTUALLY AT TIME, AND I
WANT TO BE RESPECTFUL OF THE
REST OF OUR AGENDA HERE, SO I
WANT TO THANK KEVIN, KUSHANG,
ANDREA AND GREG FOR SHARING
THEIR EXPERIENCES AND CANDOR
WITH US.
THIS WAS A REALLY INTERESTING
DISCUSSION, AND I THINK WE COULD
HAVE GONE ON EVEN LONGER, BUT WE
JUST THANK YOU ALL, AND I THINK
I'LL TURN IT BACK TO YOU, WENDY,
FOR NEXT STEPS?
>> I THINK WE'RE GOING TO TAKE
JUST MAYBE A 5-MINUTE BIOBREAK
AND COME BACK, GREG, WITH YOUR
PANEL AT 2:35.
SO WE'LL GIVE EVERYONE JUST A
SO GOOD MORNING OR GOOD
AFTERNOON, EVERYBODY.
I'M GREG SIMON, INVESTIGATOR,
KAISER PERMANENTE RESEARCH
INSTITUTE.
I'LL BE YOUR SORT OF HOST AND
MOD KAY TORMODERATOR, FOR THIS T
SESSION.
WHAT WE'LL BE TALKING ABOUT HERE
IS ENGAGEMENT AS SORT OF THE
CORNERSTONE OF PRAGMATIC
RESEARCH AND ESPECIALLY
ENGAGEMENT THROUGHOUT THE
LIFECYCLE OF A PROJECT.
IN SOME WAYS, IT'S A
CONTINUATION OF A DISCUSSION
THAT WE HAD AT OUR INVESTIGATOR
MEETING A MONTH OR SO AGO.
AND YOU KNOW, THERE, WE STARTED
TALKING ABOUT INFRASTRUCTURE AND
MY RECOLLECTION WOULD BE WE
ENDED UP SAYING INFRASTRUCTURE
IS REALLY ABOUT RELATIONSHIPS.
SO ENGAGEMENT IS ABOUT
RELATIONSHIPS AS WELL, THAT'S
WHAT WE'LL BE TALKING ABOUT
HERE.
WE'RE GOING TO HEAR FROM FOUR OF
OUR INVESTIGATORS AND THEY'LL BE
SOMEWHAT DIFFERENT.
WE'LL HEAR FIRST FROM NATALIA
FROM THE OPTIMUM TRIAL, WHO WILL
BE TALKING ABOUT SORT OF A
PARTICULAR SORT OF ENGAGEMENT
STRATEGY OR ENGAGEMENT PROCESS.
AND THEN WE'LL HEAR FROM JULIE
FRITZ REGARDING BEATPAIN UTAH,
ANNA KRUPP REGARDING BEST-ICU
AND SEBASTIAN TONG ABOUT AIM-CP
TALKING ABOUT THEIR EXPERIENCE
WITH ENGAGEMENT ESPECIALLY
ENGAGEMENT THROUGHOUT THE
LIFECYCLE OF THE PROJECT, HOW IT
STARTS, WHAT THE RELATIONSHIPS
ARE AND HOW THAT CHANGES OVER
TIME.
AND THEN WE'LL COME BACK FOR
SOME QUESTIONS AT THE END.
SO I'LL TURN IT OVER TO NATALIA
TO START US OFF.
>> THANK YOU SO MUCH, GREG.
IT'S REALLY WONDERFUL TO BE
HERE.
I'M ASSUMING YOU CAN HEAR ME,
BECAUSE I HAVEN'T HEARD
OTHERWISE.
>> YES, WE CAN HEAR YOU FINE.
>> SO WONDERFUL.
SO YES, I'M NATALIA MORONE, I'M
AT BOSTON UNIVERSITY AND BOSTON
MEDICAL CENTER, AND I'M REALLY
HAPPY TO GET US STARTED ON THI
THIS -- ON THIS SERIES OF TALKS.
JUST REAL QUICK, OPTIMIZING PAIN
TREATMENT IN MEDICAL SETTINGS
USING MINDFULNESS IS OBVIOUSLY A
PRAGMATIC CLINICAL TRIAL AS THEY
ARE TODAY.
IT INTEGRATING A TELEHEALTH
GROUP-BASED STRESS REDUCTION
PROGRAM INTO PRIMARY CARE
SETTINGS FOR PEOPLE WHO HAVE
CHRONIC LOW BACK PAIN.
WE'RE FOLLOWING PEOPLE UP FOR A
YEAR.
WE'VE ACTUALLY COMPLETED --
WE'RE ALMOST COMPLETE WITH
12-MONTH FOLLOW-UP NOW, WE'LL BE
DONE SOON.
WE'VE RANDOMIZED 451 PEOPLE IN
THREE HEALTHCARE SYSTEMS, BOSTON
MEDICAL CENTER, THE UNIVERSITY
OF PITTSBURGH AND UNIVERSITY OF
NORTH CAROLINA CHAPEL HILL.
THE CONTROL GROUP IS USUAL CARE.
AND THE PRIMARY OUTCOME IS THE
PEG, AS WAS MANY PAIN STUDIES,
SO WE ARE ALSO LOOKING AT OTHER
MEASURES THAT IMPACT PAIN LIKE
PSYCHOLOGICAL FUNCTION, PHYSICAL
FUNCTION, QUALITY OF LIFE, THEIR
HEALTHCARE UTILIZATION AS WELL
AS THEIR MEDICATION AND OPIOID
USE.
SO PRIMARY ENGAGEMENT HAS BEEN
AN IMPORTANT PART OF THE OPTIMUM
STUDY.
AND I'M GOING TO JUST TELL YOU A
LITTLE BIT ABOUT HOW WE'VE BEEN
DOING THAT AND HOW REALLY
CRITICAL IT BEEN FOR US.
SO PARTNERS ARE PEOPLE WHO COME
FROM GROUPS OR ORGANIZATIONS
SUCH AS HEALTHCARE
ADMINISTRATORS, INSURERS,
PATIENTS, ADVOCATES, COMMUNITY
MEMBERS, POLICY MAKERS, ALL OF
THESE TYPES OF PEOPLE CAN BE A
PARTNER AND THEY HAVE BEEN A
PARTNER FOR OPTIMUM.
AND THEY CAN SERVE MULTIPLE
ROLES AND BRING SEVERAL
PERSPECTIVES TO A PROJECT.
AND ALSO YOU HAVE INDIVIDUALS
THAT CAN BE INVOLVED BUT YOU CAN
ALSO HAVE A COMMUNITY ADVISORY
BOARD AND WE SET UP OUR
COMMUNITY ADVISORY BOARD AND
THEY REALLY DO PARTNER WITH
OPTIMUM AND HAVE BEEN REALLY
IMPORTANT TO THE STUDY
THROUGHOUT BECAUSE OF THE UNIT
PERSPECTIVES AND EXPERTISE THAT
THEY BRING AND OFFER.
SO SOME OF THE COMMUNITY
ADVISORY BOARD CONTRIBUTIONS
THAT THEY'VE GIVEN US, FOR
EXAMPLE, IS THEY REALLY PROVIDE
FEEDBACK ON THE NEEDS PERSONS
WHO ARE LIVING WITH CHRONIC LOW
BACK PAIN.
THEY ADVISE ON THE BEST WAYS TO
ENGAGE WITH THE PROVIDERS AND
SERVE POTENTIAL OF PARTICIPANTS
AS WELL AS INTEGRATING INTO THE
HEALTHCARE CY SYSTEM.
BECAUSE THIS IS A MINDFULNESS
STUDY, THEY HAVE ADVISED ON WAYS
TO PROVIDE MINDFULNESS IN
PRIMARY CARE AND THAT
INTEGRATION.
THEY'VE ALSO PROVIDED ADVICE
WHEN PATIENTS ARE RESISTANT TO
MINDFULNESS AND HOW WE CAN POE
TEXT TENSIPOTENTIALLY YOU A DRE.
THEY'VE ALSO BEEN VERY HELPFUL
IN THE NUTS AND BOLTS OF RUNNING
THE STUDY, SUCH AS TAILORING THE
STUT DI AND RECRUITMENT METHODS.
AND CURRENTLY THEY'RE PLAYING AN
IMPORTANT ROLE ON NEXT STEPS AS
OUR STUDY IS COMING TO
COMPLETION.
NOW WE HAVE DONE ONE-TIME
INTERVIEWS ALSO, ACTUALLY QUITE
A FEW OF THEM.
I THINK WE'RE GOING ON 25
ONE-TIME INTERVIEWS, THESE HAVE
BEEN EXTREMELY EYE OPENING FOR
US TO UNDERSTAND SOME OF THE
REAL BARRIERS THAT EXIST FOR
INTEGRATING GROUP-BASED
MINDFULNESS INTO PRIMARY CARE.
SO FOR EXAMPLE, WE'VE
INTERVIEWED MEDICAL DIRECTORS OF
INTERNAL MEDICINE CLINIC.
I DIDN'T MENTION IT BUT I'M A
GENERAL INTERNIST.
THAT'S WHERE MY STRONG INTEREST
IN BRINGING PAIN TREATMENT AND
CHRONIC PAIN TREATMENT INTO
PRIMARY CARE IS REALLY GROUNDED
IN.
BUT WE'VE ALSO INTERVIEWED
PEOPLE WHO AN EXECUTIVE DIRECTOR
OF A BUSINESS FOR GROUP MEDICAL
VISITS, AND GROUP MEDICAL VISITS
IS THE MODEL THAT WE USE IN
OPTIMUM TO DELIVER GROUP-BASED
MINDFULNESS IN PRIMARY CARE, BUT
WE'VE ALSO LOOKED AT PEOPLE WHO
ARE INVOLVED WITH BUSINESS
DEVELOPMENT AND POLICY LEADS TO
UNDERSTAND THAT, ADVOCACY, PAIN
ADVOCACY GROUP LEADERS HAVE BEEN
VERY HELPFUL.
LOOKING AT FOLKS WHO ARE
ACTUALLY LEAD MEDICAL GROUP
VISITS LIKE A FAMILY PHYSICIAN
AND GETTING THEIR FEEDBACK.
WE'VE TALKED TO MINDFULNESS
INSTRUCTORS, WE'VE LOOKED AT --
WE'VE SPOKEN WITH A DIRECTOR OF
A FAMILY MEDICINE DIRECTOR OF
COMMUNITY HEALTH INITIATIVE, AS
WELL AS ENSURE REPRESENTATIVES.
SO ALL OF THESE HAVE BEEN REALLY
GIVING US A MUCH MORE FULL
PICTURE OF WHAT IT ACTUALLY
MEANS TO MOVE TO THE NEXT PHASE
OF IMPLEMENTING IN PRIMARY CARE
GROUP-BASED MINDFULNESS.
AND OF COURSE THIS IS ALL
FOLLOWING THE QUALITATIVE
ETHNOGRAPHIC INTERVIEW GUIDES.
SO IN OUR COMMUNITY ADVISORY
BOARD, AGAIN REFLECTS A BROAD
ARRAY OF PEOPLE, SO PATIENTS WHO
HAVE LIVED EXPERIENCE OF LOW
BACK PAIN BUT HAVE ALSO
UNDERGONE THE MINDFULNESS-BASED
STRESS REDUCTION PROGRAM.
WE HAVE MINDFULNESS INSTRUCTORS
AND HEALTHCARE PROFESSIONAL THE,
PAIN ADVOCACY GROUP LEADERS AND
ADMINISTRATORS, AND ALL 10
MEMBERS MEET MONTHLY FOR AN HOUR
AND THEY GET REIMBURSED.
JUST QUICKLY, THERE ARE SOME
WONDERFUL RESOURCES OUT THERE
FOR STARTING A COMMUNITY
ADVISORY BOARD, AND THIS
PARTICULAR ONE BY TRACY BATAGLIA
IS CONNECTING COMMUNITY TO
RESEARCH AND IT REALLY IS A STEP
BY STEP GUIDE.
JUST SO YOU GET A SENSE THAT WE
REALLY HAVE BEEN INTEGRATING THE
CAB RECOMMENDATIONS INTO WHAT WE
DO, THE CAB WILL MEET AND THEY
MIGHT, FOR EXAMPLE, REVIEW
MATERIALS THAT WE PROVIDE FOR
THEM OR CURRENTLY BECAUSE WE'RE
IN THE WRITING PHASE, THEY'VE
BEEN GIVING US COMMENTS BACK ON
SOME OF OUR PAPERS THAT WE'RE
WRITING.
SO ANYWAY, THEY MEET AND WE
CREATE A QUICK LIGHTNING REPORT
OF THE KEY POINTS OF WHAT
THEY'VE SAID.
WE BRING THAT BACK TO THE TEAM
SO THE TEAM CAN IMPLEMENT WHAT
WE RECOMMEND.
WE BRING THAT BACK TO THE
ADVISORY BOARD, SO THERE'S THIS
CYCLE AND WE'RE CLOSING THE LOOP
WITH THE ADVISORY BOARD SO THEY
CAN SEE WHAT WE'RE DOING.
SO THERE'S THIS CYCLE OF THE CAB
MEETING, GIVING US
RECOMMENDATIONS, INTEGRATING
THAT INTO WHAT WE'RE DOING AND
THEN SHOWING THEM THE RESULT OF
THAT.
AND TOPICS CAN VARY.
AT THE BEGINNING OF THE STUDY,
AS YOU CAN IMAGINE, IT WAS ABOUT
FEEDBACK ON OUR FLYERS AND
LANGUAGE IN THE MATERIALS,
REALLY BRAINSTORMING IDEAS FOR
PARTICIPANT ENGAGEMENT IN
STUDIES, IN THE STUDY, AND THEN
ALSO JUST UPDATES BECAUSE
THEY'RE CURIOUS ON THE UPDATES
OF HOW THINGS ARE GOING.
OF COURSE THE MONTHLY TOPICS
CHAIKED OVER TIME.
CHANGED OVER TIME, IT CAN'T BE
STATIC.
SO CURRENTLY THEY GIVE US --
INTO THE MANUSCRIPTS WE'RE
WRITING, THE PARTNER INTERVIEWS
WE TALKED ABOUT, WE DISCUSSED
THAT WITH FOLKS, BRAINSTORMING
DISSEMINATION WITH THEM AS WELL
AS NEXT STEPS.
SO SOME OF THE CHALLENGES WHEN
YOU'RE WORKING WITH PARTNERS
LIKE WE ARE, THERE'S A LOT OF
BENEFITS, I JUST MENTIONED THEM
TO YOU, WI BUT YOU KNOW, WE DO T
INCONSISTENT FACTS.
FOR EXAMPLE, WE'VE
INTERVIEWED -- AND THIS WAS TRUE
FOR ONE OF THE REPRESENTATIVES
FROM AN INSURANCE COMPANY, THEY
WERE LIKE MEDICAL GROUP VIS RITZ
NOT POSSIBLE IN PRIMARY CARE.
SO PEOPLE ARE CURRENTLY DOING IT
BUT WE WILL GET INCONSISTENT
FACTS OR OPINIONS FROM PEOPLE.
WE ALSO GET CHALLENGES LIKE THE
PROVIDERS AREN'T INTERESTED IN
GROUP MEDICAL VISITS, OR THAT
MINDFULNESS FOR CHRONIC LOW BACK
PAIN IS NOT EVIDENCE-BASED.
THIS IS ALL FEEDBACK WHEN WE DO
THE INTERVIEWS.
SO IT IS A CHALLENGE WHEN WE
START GETTING, YOU KNOW,
FEEDBACK THAT IS ILLUSTRATED
THAT PEOPLE AREN'T COMPLETELY
AWARE OF EITHER THE EVIDENCE OR
WHAT CURRENT PRACTICE MIGHT BE
IN ANOTHER STATE.
FOR EXAMPLE.
SO IN CONCLUSION, SO THE
ENGAGEMENT -- WE FOUND
ENGAGEMENT REALLY TO BE CRITICAL
IN OUR PRAGMATIC TRIAL, IT
REALLY PROVIDED REALLY IMPORTANT
PERSPECTIVES THAT HELP TO
ACTUALLY MOVE OUR RESEARCH
FORWARD.
WE FOUND THAT INVESTIGATORS AND
STAFF FAMILIAR WITH ENGAGEMENT
ARENESS SARE NECESSARY TO CARRYN
ENGAGEMENT SO WE HAD A TEAM VERY
WELL VERSED AND HOW TO WORK WITH
PARTNERS SUCCESSFULLY.
ENGAGEMENT REALLY SHOULD BEGIN
BEFORE A TRIAL STARTS BUT
THERE'S NO REALLY -- NOT A LOT
OF CURRENT FUNDING OR MECHANISM
FOR THAT, SO THAT KIND OF HAS TO
COME -- IT KIND OF HAS TO HAPPEN
WITHOUT THAT KIND OF FUNDING.
BUT PARTNERS REALLY DO PROVIDE
PERSPECTIVES AND RECOMMENDATIONS
THAT ASSIST IN IDENTIFYING
BARRIERS AND THEY CAN PROVIDE
POSSIBLE SOLUTIONS.
SO SOME OF THE INCONSISTENCIES
OF THE FEEDBACK WE'RE GETTING,
FOR EXAMPLE, WE CAN BRING BACK
TO OUR CAB AND DISCUSS.
THE CAB TOPICS HAVE TO, OFTEN,
CHANGE WHEN YOU'RE DEALING WITH
YOUR PARTNERS.
THEY HAVE TO CHANGE OVER TIME
DEPENDING ON THE STAGE OF THE
STUDY.
AS I MENTIONED, THEIR
PERSPECTIVES MAY BE CONSISTENT,
YOUR PARTNER PERSPECTIVE,
UNCOVERING OPPORTUNITIES FOR
INTERVENTION AND DISSEMINATION
TO ADDRESS SOME OF THE INCON
INCONSISTENCY.
SO I JUST WANT TO THANK MY TEAM.
NONE OF THIS COULD HAPPEN
WITHOUT THEM.
SO I THINK THAT'S IT.
IS THE LAST SLIDE A THANK YOU
SLIDE?
YES.
>> THANKS, NATALIA.
NOW WE'LL HEAR FROM JULIE.
>> GREAT, THANK YOU.
AND FIRST OFF, THANKS FOR THE
INVITATION TO TALK ABOUT OUR
WORK HERE, AND IT'S NICE TO
FOLLOW NATALIA, BECAUSE WE'RE
WORKING WITH SIMILAR QUESTIONS,
SIMILAR PATIENT POPULATION.
SO I LEAD THIS PROJECT THAT
WE'VE LABELED BEATPAIN UTAH, AND
WE'RE WORKING WITH A SIMILAR
POPULATION OF INDIVIDUALS WITH
CHRONIC LOW BACK PAIN,
SPECIFICALLY, AND PARTNERING
WITH FEDERALLY QUALIFIED HEALTH
CENTERS AROUND THE STATE OF UT
UTAH.
SIMILAR TO WHAT NATALIA WAS
TALKING ABOUT, PAIN MANAGEMENT
WAS PARTICULARLY -- DETERMINANTS
IN PATIENTS THAT SEEK CARE IN
COMMUNITY HEALTH CENTERS LIKE
WE'RE PARTNERING WITH.
SO UNLIKE MY PRIMARY EXPERIENCE
WHICH IS IN ACADEMIC MEDICAL
CENTERS, REALLY WORKING WITH
PATIENTS WHERE LIVING IN RURAL
COMMUNITIES AND HAVING LOWER
EDUCATIONAL ATTAINMENT, LOWER
INCOME LEVELS, ARE REALLY
PREVALENT WITH PATIENT
POPULATION THAT WE'RE WORKING
WITH.
SO JUST TO BE A LITTLE BIT MORE
SPECIFIC ABOUT THE PATIENT
POPULATION, THIS IS DATA FROM
HRSA BOTH IN MY STATE IN UTAH
AND THEN NATIONALLY ABOUT WHO
RECEIVES CARE IN COMMUNITY
HEALTH CENTERS.
AGAIN, YOU CAN SEE THE
REPRESENTATION OF INDIVIDUALS
WHO LIVE IN RURAL COMMUNITIES
ESPECIALLY IN THE STATE OF UTAH,
PEOPLE AT THE FEDERAL POVERTY
LEVEL, AND THEN IN UTAH, THE
ETHNIC AND RACIAL DIVERSITY
THAT'S REPRESENTED IN THESE
CLINICS IS INDIVIDUALS OF
HISPANIC AND LATINO ETHNICITY,
MANY OF WHOM COMMUNICATE
PRIMARILY IN SPANISH.
SO IN THINKING ABOUT ENGAGEMENT
WITH THE PATIENT POPULATION AS
WELL AS CLINICS SERVING THE
PATIENTS, THESE WERE FACTORS WE
HAD TO BE VERY COGNIZANT OF
GOING INTO OUR PARTNERSHIP.
SO THIS IS THE STUDY THAT WE'RE
DOING.
OUR PROJECT IS ABOUT TWO THIRDS
OF THE WAY THROUGH RECRUITING
PATIENTS, SO WE'RE NOT AS FAR
ALONG AS NATALIA IS IN HER
STUDY.
YOU CAN SEE THE TRIAL DESIGN
HERE, AND THERE'S A COUPLE
REALLY KEY THINGS THAT I'LL
POINT OUT HERE TO UNDERSTAND HOW
ENGAGEMENT LOOKS IN OUR PROJECT.
ONE IS IN THE RECRUITMENT SIDE,
AND ENGAGING WITH THE CLINICS
AND THE PROVIDERS WHO WORK IN
THE SETTINGS THAT WE'RE
PARTNERING WITH.
WE NEEDED TO UNDERSTAND HOW TO
ENGAGE THESE CLINICS WHO DON'T
HAVE A LONG HISTORY OR A LOT OF
EXPERIENCE PARTICIPATING IN
CLINICAL RESEARCH, AND WE HAD TO
DO IT IN A WAY THAT WAS
DECENTRALIZED BECAUSE THESE
CLINICS ARE LOCATED THROUGHOUT
THE STATE OF UTAH.
SO THAT PIECE OF ENGAGEMENT WAS
REALLY CRITICAL TO THE SUCCESS
OF THE PROJECT.
THEN THERE'S THE PATIENT
ENGAGEMENT THAT PLAYS OUT AS WE
SEEK TO ENROLL PATIENTS IN THE
PROJECT, AND THEN PROVIDE
DIFFERENT TYPES OF TELEHEALTH
PHYSICAL THERAPY SERVICES FOR
PAIN MANAGEMENT, WHICH IS THE
CORE INTERVENTION THAT WE'RE
STUDYING IN OUR PATIENT
POPULATION.
SO THERE'S A COUPLE DIFFERENT
WAYS THAT WE'RE DELIVERING THAT
TREATMENT, BUT WE HAD TO THINK
VERY CAREFULLY ABOUT HOW TO
ENGAGE PATIENTS WHO HAVE THE
TYPE OF CHARACTERISTICS THAT I
SHOWED YOU EARLIER IN A
TELEHEALTH INTERVENTION THAT
COULD BE UNFAMILIAR TO THEM IN A
NUMBER OF DIFFERENT WAYS.
AND ONE OF THE THINGS THAT I WAS
REALLY FORTUNATE AT THE
UNIVERSITY OF UTAH WAS TO BE
ABLE TO REALLY BRING OUR PROJECT
INTO AN EXISTING PARTNERSHIP
MODEL THAT WAS BASED AT A GROUP
CALLED THE CENTER FOR HOPE,
WHICH IS ACTUALLY IN OUR CANCER
INSTITUTE AT THE UNIVERSITY, WHO
WAS ALREADY WORKING WITH THE
COMMUNITY HEALTH CENTERS THAT
ARE PARTNERS IN OUR STUDY.
SO THEY HAD REALLY DEVELOPED
THIS PARTNERSHIP AND ENGAGEMENT
MODEL THAT I'VE JUST FOUND
REALLY INVALUABLE IN TERMS OF
COMING INTO PARTNERSHIP WITH
GROUPS THAT I WAS UNFAMILIAR
WITH AND WHO ARE UNFAMILIAR WITH
ME AND THE WORK THAT OUR TEAM
DOES.
SO A COUPLE THINGS THAT I'LL
POINT OUT HERE THAT I THINK ARE
REALLY IMPORTANT TO THE TOPIC AT
HAND ARE THE ENGAGEMENT
ACTIVITIES.
SO WE REALLY HAVE VERY MUCH A
SHARED MUTUAL RESPECT KIND OF
COLLABORATIVE AGREEMENT AMONGST
OUR PARTNERS, AND THAT REALLY
FEEDS INTO A COUPLE OF REALLY
KEY ENGAGEMENT ACTIVITIES.
ONE IS NATALIA REALLY EMPHASIZED
NICELY, HAVING PATIENTS IN STUDY
ADVISORY COMMITTEES WHO ARE NOT
ONLY SPECIFIC TO ONE PROJECT,
BUT WHO CAN THINK ABOUT HOW
CLINICS AND PATIENTS MIGHT BE
PARTICIPATING IN SEVERAL
DIFFERENT STUDIES AND MAKING
SURE THAT WE'RE NOT
OVERBURDENING EITHER CLINICS OR
PARTICIPANTS WITH RESEARCH
ACTIVITIES.
TO REALLY THINK ABOUT
IMPLEMENTING PROJECTS WITH AN
EYE TOWARDS CLINIC WORKFLOWS AND
HOW WE ANALYZE AND EXAMINE AND
FIT NEW PROJECTS INTO THE
WORKFLOW TO BE AS MINIMALLY
DISRUPTIVE AS IS POSSIBLE.
AND TO UNDERSTAND THAT WORKING
WITH CLINICS THAT ARE VERY
DIFFERENT IN TERMS OF THEIR
PHYSICAL INFRASTRUCTURE, WHERE
THEY'RE SITUATED IN EITHER URBAN
OR RURAL SETTINGS, THE NATURE OF
THE PATIENT POPULATION THEY
SERVE, THAT ADAPTATIONS TO
IMPLEMENTATION STRATEGIES HAD TO
BE REALLY BUILT INTO HOW WE
PLANNED TO PARTNER AND CONDUCT
CLINICAL RESEARCH.
SO I WANT TO JUST KIND OF
EMPHASIZE A COUPLE OF POINTS IN
THOSE ENGAGEMENT ACTIVITIES A
LITTLE BIT FURTHER.
SO FIRST OFF, I THINK FOR US
IT'S BEEN VERY IMPORTANT TO HAVE
A PARTNERSHIP MODEL THAT HELPS
KEEP ALL OF US GROUNDED TO THE
PRINCIPLES THAT WE'VE AGREED ON
ABOUT HOW TO PARTNER.
SO FOR US ON THE RESEARCH SIDE,
FOR OUR CLINICAL PARTNERS, TO
REALLY UNDERSTAND WHAT OUR
SHARED VALUES ARE AND TO
RECOGNIZE THAT ANY RESEARCH
TOPIC HAS TO REFLECT THE
PRIORITY DOMAINS FOR COMMUNITY
HEALTH CENTERS.
THAT BRINGING IN NEW PROCEDURES,
IMPLEMENTING ANYTHING THAT'S
GOING TO BE POTENTIALLY
DISRUPTIVE TO THE CLINICAL
WORKFLOW REALLY TAKES AN
INFORMED AND INTENTIONAL EFFORT,
AND WE FOUND IMPLEMENTATION
MAPPING A PROCESS THAT'S BEEN
REALLY HELPFUL FOR THINKING
ABOUT THAT, AND BEING VERY
SPECIFIC ABOUT HOW WE IMPLEMENT
NEW PROCESSES.
WHAT WE REALLY DESIRED TO DO, IT
GOT A LITTLE BIT CHANGED WITH
THE TIMING WITH RESPECT TO
COVID, IS TO EXAMINE THE
CLINICAL WORKFLOW FROM AN ON THE
GROUND SOCIAL TECHNICAL
PERSPECTIVE.
SO NOT ONLY UNDERSTANDING THE
TECHNICAL OPERATIONS OF HOW
CLINIC STAFF INTERACT WITH THEIR
I.T., BUT TO REALLY UNDERSTAND
SORT OF HOW IT FITS INTO THE
FLOW AND THE WORKDAY FOR
INDIVIDUAL STAFF MEMBERS AND HOW
OUR PROJECT COULD FIT INTO THAT
WITH CAUSING AS LITTLE
DISRUPTION AS POSSIBLE.
THEN FINALLY RECOGNIZING THAT
BECAUSE OF THE GEOGRAPHIC
DISTRIBUTION OF CLINICS, THAT WE
HAD TO REALLY THINK ABOUT HOW TO
PARTNER IN A WAY THAT'S VERY
DECENTRALIZED FOR BOTH RESEARCH
AND CLINICAL PROCEDURES.
SO THAT TOOK SOME UNIQUE
CONSIDERATIONS FROM RESEARCH AT
LEAST THAT I WAS FAMILIAR WITH
FROM PRIOR STUDIES.
SO I WANT TO JUST AGAIN SAY
ANOTHER LITTLE WORD ABOUT
IMPLEMENTATION MAPPING BECAUSE I
REALLY THINK THIS WAS THE KEY TO
US IN OUR UG3 PHASE, AND HAVING
THE TIME TO KIND OF WORK THROUGH
THIS WAS REALLY IMPORTANT FOR US
IMPLEMENTING SOMETHING NEW.
SO I WON'T GO INTO THE DETAILS
OF THIS PROCESS, BUT IT REALLY
BEGINS WITH THINKING ABOUT WHO
ARE WE ASKING TO DO SOMETHING
THAT THEY'RE NOT USED TO DOING,
IN OUR CASE THAT INCLUDED
CLINIC, STAFF MEMBERS AND
PATIENTS SO WE THOUGHT OF THEM
BOTH AS IMPLEMENTERS.
AND THEN REALLY UNDERSTANDING
WHAT ARE WE ASKING THEM TO DO,
AND HOW CAN WE DO IT.
AND THEN OBVIOUSLY AS THE
RESEARCH CONTEXT EVALUATING
WHETHER WE WERE SUCCESSFUL OR
NOT.
AND THINKING THIS THROUGH REALLY
REVEALED SOME THINGS THAT
MODIFIED SOME OF OUR PROCESSES
IN THE UG3 PHASE, AND I THINK
GENERALLY FOR THE BETTER.
SO FROM A PATIENT STANDPOINT,
THESE WERE SOME OF THE KEY
THINGS THAT WE PULLED OUT OF
THIS PROCESS.
AGAIN, THERE'S A LOT THAT WE
LEARNED FROM THE PROCESS, BUT WE
RECOGNIZE THAT PATIENTS HAD
UNIQUE ACCESS CONCERNS, BOTH
WITH RESPECT TO TECHNOLOGY AND
THE HOURS THEY WERE AVAILABLE,
AND ISSUES AROUND HOW WE WOULD
DELIVER CARE.
WE HAD TO ADAPT OUR PT
INTERVENTIONS TO UNDERSTAND THE
COMMUNITIES WHERE PATIENTS LIVED
AND THE PARTICULAR STRESSORS
THAT WERE MORE PREVALENT IN THE
PATIENT POPULATION.
WE HAD TO THINK QUITE A BIT
ABOUT HOW TO DEVELOP STRONG
RELATIONSHIPS WITH PATIENTS WHEN
EVERYTHING WAS BEING DONE
REMOTE.
AND TO THINK ABOUT THE UNIQUE
CULTURAL ASPECTS OF THE PATIENTS
IN THE COMMUNITIES THAT RECEIVED
CARE IN THESE CLINICS.
SO THIS INCLUDED THE ETHNIC
DIVERSITY AS WELL AS THINKING
ABOUT THE UNIQUE CONSIDERATIONS
OF PERSONS WHO LIVE IN VERY
RURAL AREAS OF THE STATE.
HE THEN FROM A CLINIC OR
PROVIDER STANDPOINT, SEVERAL
DIFFERENT THINGS THAT WERE VERY
IMPORTANT THAT CAME OUT OF THIS
PROCESS REALLY AROUND TECHNOLOGY
AND TRUST ARE THE PRIMARY THINGS
I WOULD HIGHLIGHT HERE.
HAVING SUFFICIENT SUPPORT AND
EXPERTISE TO HELP WITH EHR
SYSTEMS WAS CRITICAL.
AND THEN REALLY BUILDING TRUST
THROUGH VERY DIFFICULT TIMES,
PARTICULARLY WHERE CLINICS WERE
QUITE OVERWHELMED WITH COVID
CONCERNS, WAS AT TIMES VERY --
IT TOOK A LONG TIME SOMETIMES TO
WORK THROUGH SOME OF THE ISSUES
AND HAVE WHAT WE WERE WORKING ON
RISE TO THE TOP OF THE PRIORITY
LIST WHEN A LOT ELSE WAS GOING
ON, AND THAT TOOK A GOOD BIT OF
PATIENCE ON OUR PART AS
RESEARCHERS AND A REAL
COMMITMENT TO WORKING WITH AND
PARTNERING WITH CLINICS THAT
WERE GOING THROUGH LOTS OF
REALLY CHALLENGING TIMES.
SO THIS IS REALLY WHAT IT ENDED
UP LOOKING LIKE WITH MORE DETAIL
AFTER WE WENT THROUGH THIS
PROCESS.
JUST A COUPLE THINGS THAT I'LL
POINT OUT.
WE KNEW WE NEEDED TO HAVE A WAY
FOR PROVIDERS TO REFER PATIENTS
ON A ONE TO ONE BASIS IN THE
MIDST OF A CLINICAL ENCOUNTER,
AND THAT WE NEEDED TO USE VERY
STANDARDS-BASED WAYS OF DOING
THAT, BECAUSE OF THE DIVERSITY
OF THE EHRs.
SO WE SET UP A PROCESS THAT
COULD BE FLEXIBLE AND ADAPT TO
THE DIFFERENT EHRs, BUT WOULD
ALSO PROVIDE THE OPPORTUNITY FOR
A PROVIDER TO REFER A PATIENT TO
US.
AND IMPORTANTLY FOR US TO
PROVIDE FEEDBACK ABOUT THE
STATUS OF THAT PATIENT.
BUT WE ALSO KNOW THAT WE WOULD
MISS THE OPPORTUNITY TO OFFER
WHAT WE WERE DOING TO PATIENTS
WITH THIS PROCESS BEING OUR ONLY
WAY TO IDENTIFY PARTICIPANTS.
SO WE ALSO HAVE IMPLEMENTED,
WITH THE CLINIC'S PERMISSION, A
TEXT MESSAGING-BASED OUTREACH TO
ALLOW US TO REALLY DO A MORE
POPULATION-BASED EFFORT TO LET
PATIENTS KNOW THAT THIS SERVICE
IS AVAILABLE TO THEM.
AND WE FOUND BOTH OF THESE
STRATEGIES TO BE VERY IMPORTANT
IN TERMS OF RECRUITING PATIENTS
AND MAKING SURE THAT THEY'RE
AWARE THAT THEY MAY WANT TO
PARTICIPATE IN WHAT WE'RE DOING.
SO JUST A COUPLE OF LESSONS
LEARNED THAT MIGHT BE HELPFUL
FOR OUR CONVERSATION HERE TODAY.
AGAIN I THINK FOR ME IN
PARTICULAR, HAVING A MODEL TO
UNDERSTAND HOW TO PARTNER WITH
GROUPS THAT I WASN'T USED TO
PARTNERING WITH, THAT WAS REALLY
KEY.
THE COMMUNITY HEALTH CENTERS IN
THE STATE OF UTAH HAVE A PRIMARY
CARE ASSOCIATION THAT THE
UNIVERSITY AND COLLEAGUES OF
MINE HAVE BUILT A STRONG
TRUSTING RELATIONSHIP, AND
THAT'S REALLY BENEFITED US IN
THIS PARTICULAR PROJECT, AND
THAT TOOK A LOT OF TIME TO
DEVELOP AS NATALIA MENTIONED
WELL BEFORE THIS STUDY WAS EVER
FUNDED.
I THINK THE UG3/UH3 MECHANISM
HAS BEEN CRITICAL IN PARTNERING
WITH CLINICS THAT AREN'T USED TO
PARTICIPATING IN CLINICAL
RESEARCH THAT HAVE FEWER
RESOURCES, THAT THAT UG3 YEAR
AND THE ABILITY TO REALLY THINK
INTENTIONALLY ABOUT HOW WE WERE
GOING TO PARTNER AND IMPLEMENT
WHAT WE WERE DOING WAS REALLY
CRUCIAL TO BUILDING TRUST AND TO
BEING SUCCESSFUL.
AND THEN THE FINAL POINT HERE
AGAIN, THE IT CAPACITY HAS JUST
BEEN CRITICAL, AND THAT LEVEL OF
EXPERTISE HAS BEEN ALSO REALLY
KEY TO OUR SUCCESS AND HAS
BROUGHT SOMETHING VALUABLE, I
THINK, TO THE CLINICS AND THE
STAFF THAT WERE ABLE TO HELP
TROUBLESHOOT IT-RELATED
PROBLEMS.
I THINK THAT'S BEEN A
VALUE-ADDED FOR THE CLINICS OF
THEIR PARTICIPATION WITH US IN
THIS RESEARCH PROJECT.
SO THANK YOU VERY MUCH.
THIS IS THE TEAM THAT I'VE BEEN
WORKING WITH ON THIS PROJECT,
AND ALL OUR PARTNERS.
AND I'LL HAND IT OVER TO THE
NEXT SPEAKER.
>> THANKS VERY MUCH, JULIE.
AND I THINK ANNA IS UP NEXT, IS
THAT RIGHT?
>> GOOD AFTERNOON.
MY NAME IS ANNA KRUPP.
I AM A SITE P.I. ON THE BESTICU
TRIAL AND ALSO AN ASSISTANT
PROFESSOR AT THE UNIVERSITY OF
IOWA COLLEGE OF NURSING.
BEST-ICU IS LED BY MPIs
DR. MICHELLE BALAS AT THE
UNIVERSITY OF NEBRASKA AND THE
UNIVERSITY OF WISCONSIN.
AND OUR STUDY BEST-ICU DESCRIBES
BEHAVIORAL, ECONOMIC AND
STAFFING STRATEGIES TO INCREASE
ADOPTION OF THE ABCDEF BUNDLE IN
THE ICU.
ON THE NEXT SLIDE YOU'LL SEE
THAT WHAT WE'RE REALLY
INTERESTED IN IS IMPROVING ICU
SURVIVORSHIP.
WE KNOW THAT AN INCREASING
NUMBER OF PATIENTS ARE SURVIVING
THEIR INITIAL CRITICAL ILLNESS,
BUT BEING DISCHARGED WITH
WORSENING OR NEW IMPAIRMENTS
INCLUDING CHANGES IN MENTAL
HEALTH, NEW COGNITIVE AND/OR
PHYSICAL IMPAIRMENTS, AND THESE
ALSO IMPACT PATIENTS AND
FAMILIES' FINANCES AND LARGER
FAMILY IMPACT.
THIS IS BROADLY CALLED POST
INTENSIVE CARE SYNDROME.
ON THE NEXT SLIDE, WE KNOW THAT
THIS MORBIDITY IS POTENTIALLY
PREVENTABLE THROUGH THE
APPLICATION OF EVIDENCE-BASED
GUIDELINES FROM THE SOCIETY OF
CRITICAL CARE MEDICINE.
SO THESE GUIDELINES REALLY
PROVIDE INTERDISCIPLINARY
APPROACH TO MANAGE AND TREAT
COMMON ICU INTERVENTIONS AND
SYMPTOMS, IN AN
INTERDISCIPLINARY FASHION.
ONE WAY THAT THESE GUIDELINES
HAVE BEEN PROMOTED TO BE
IMPLEMENTED INTO PRACTICE IS
THROUGH THE ABCDEF BUNDLE, AND
YOU CAN SEE ON THE RIGHT-HAND
SIDE OF THE SLIDE SORT OF WHAT
THE BUNDLE INCLUDES, AND REALLY
HOW IT IS A MULTIDISCIPLINARY
TEAM-BASED APPROACH THAT
INCLUDES NURSES, PHYSICIANS,
RESPIRATORY THEIR PACIFIC
ISLANDERS, PHYSICAL AND
OCCUPATIONAL THERAPISTS, AS WELL
AS THE WHOLE TEAM REALLY WORKING
TOGETHER EACH DAY TO IMPLEMENT
THE BUNDLE.
BUT THE CHALLENGE IS, EVEN
THOUGH THE BUNDLE IS HIGHLY
EFFICACIOUS, IT'S NOT ALWAYS
HAPPENING ROUTINELY IN CARE.
SO THERE'S MULTIPLE BARRIERS TO
THE DELIVER REE REST OF THE BUNE
BUT WHAT BEST-ICU DOES IS TO
TEST THE IMPLEMENTATION
STRATEGIES.
SO OUR TRIAL IS BEING CONDUCTED
IN THREE GEOGRAPHICALLY AND
ORGANIZATIONALLY SEPARATE SAFETY
NET HOSPITALS IN THE MIDWEST,
AND WE'LL BE TESTING TWO
IMPLEMENTATION STRATEGIES.
THESE ARE UNIT-BASED STRATEGIES.
THE FIRST ONE IS AN ELECTRONIC
UNIT DASHBOARD THAT PROVIDES
REALTIME AUDIT AND FEEDBACK TO
ALL CLINICIANS ON THE UNIT,
USING A DEDICATED DISPLAY ON THE
MONITOR.
IT REALLY SHOWS COMPLETION
STATUS OF EACH BUNDLE ELEMENT IN
REALTIME.
THE SECOND IMPLEMENTATION
STRATEGY IS A NURSE FACILITATOR,
WHICH IS A DEDICATED ICU NURSE
OUT OF STAFFING WHO HELPS THE
ICU TEAM TASKED WITH THE BUNDLE
DONE, ALSO SERVING AS A COACH OR
CHAMPION ON THE UNIT.
UNITS WILL BE RANDOMIZED TO
THESE STRATEGIES IN A STEPPED
WEDGE FASHION WITH THE FIRST TWO
ICUs GETTING READY TO
IMPLEMENT IN OCTOBER OF 2024.
WITH THE LAST TWO UNITS BEING
RANDOMIZED IN JANUARY OF 2026.
THIS IS A HYBRID TYPE THREE
TRIAL.
OUR PRIMARY OUT COME IS BUNDLE
ADOPTION.
ALSO EVALUATING CLINICAL
OUTCOMES AND THEN CLINICIAN WORK
INTENSITY ACCEPTABILITY BARRIERS
AND FACILITATORS.
I'M GOING TO TALK A BIT ON HOW
WE'VE STARTED TO ENGAGE THE
HEALTH SYSTEM.
ONE OF OUR MILESTONES IN THE
PLANNING PHASE WAS WORKING WITH
STAKEHOLDERS AT EACH SITE TO
TAILOR OUR IMPLEMENTATION
STRATEGIES.
SO WE CONDUCTED STAKEHOLDER
FOCUS GROUPS ACROSS ALL SITES,
REALLY TALKING ABOUT THE
IMPLEMENTATION STRATEGIES THAT
WE WERE PLANNING TO TEST AND GET
IN THEIR FEEDBACK ABOUT WHAT
MIGHT BE NEEDED IN THEIR UNIT TO
ADOPT ONE OF THESE STRATEGIES.
SO YOU CAN SEE FROM THE SECOND
COLUMN THAT WE GOT REALLY
HELPFUL INFORMATION FROM
STAKEHOLDERS THAT THEN HELP US
FURTHER SPECIFY OUR
IMPLEMENTATION STRATEGIES.
SO FOR EXAMPLE, WITH THE NURSE
FACILITATOR, WE'VE ADJUSTED OUR
TRAINING AND ONGOING CONNECTION
WITH FACILITATORS TO ENSURE THAT
THEY HAVE THE SKILLS THEY NEED
TO COMPLETE THE ROLE.
ON THE NEXT SLIDE, WE DESCRIBE
ADDITIONAL ENGAGEMENT THAT WE'VE
CONDUCTED AT THE HEALTH SYSTEM,
BOTH ACROSS LEVELS IN THE HEALTH
SYSTEM AND ALSO OVER TIME.
SO THINKING ABOUT WHO WE ENGAGED
IN THE PLANNING PHASE OF THE
GRANT, OUR ENGAGEMENT FOCUSED
MORE ON EXECUTIVE LEADERSHIP AND
ICU LEADERSHIP IN GETTING
INTEREST AND BUY-IN, POTENTIALLY
PARTICIPATING IN THE STUDY.
NOW THAT WE ARE IN THE PLANNING
PHASE STARTING THE CLINICAL
TRIAL, WE'VE ENGAGED MUCH MORE
WITH ICU LEADERS AND UNIT
LEADERS, INCLUDING NURSE
MANAGERS AND MEDICAL DIRECTORS,
BECAUSE WE REALLY WANT TO ENSURE
THAT THE INTERVENTIONS ARE
TAILORED TO THEIR UNIT.
ANOTHER KEY MEMBERS,
MULTI-DI DISCIPLINARY, ALL
CLINICIANS ARE FAMILIAR WITH THE
STUDY.
PATIENT AND FAMILY ENGAGEMENT
REALLY HAS HAPPENED FROM THE
BEGINNING.
THE SOCIETY OF CRITICAL CARE
MEDICINE'S GUIDELINES INCLUDE
PATIENTS, FAMILIES AND THEIR
DEVELOPMENT, SO YOU KNOW THEIR
VOICES HAVE BEEN INCLUDED EARLY
IN THIS WORK.
AND THEN FINALLY, IT HAS BEEN
REALLY EARLY ON IN ENGAGEMENT
BECAUSE AS I MENTIONED, ONE OF
OUR IMPLEMENTATION STRATEGIES IS
AN EHR DASHBOARD, SO ENSURING
THAT THAT WAS BUILT AT EACH SITE
TOOK A LOT OF ENGAGEMENT.
AND THEN OVER TIME AS FAR AS
WHEN WE INVOLVED HEALTH SYSTEM
PARTNERS, DURING THE PLANNING
PHASE OF THE GRANT, WE SPENT
TIME, EACH OF THE SITE PIs
REVIEWED LOCAL POLICIES AND EH
RDOC EUM TAITION TO ENSURE THAT
THE EVIDENCE-BASED PRACTICES
WERE PRESENT, AND WE ALSO
IDENTIFIED WHEN THERE WERE
ORGANIZATION-SPECIFIC
CHARACTERISTICS THAT MAY DIFFER
BUT DIDN'T NEED TO CHANGE.
THEN LIKE I MENTIONED, WE ALSO
INVOLVED THE SITES AND TAILORING
IMPLEMENTATION STRATEGIES.
NOW THAT WE'RE CONDUCTING STUT
DI, WE'RE WORKING ON ENGAGE OUR
UNIT CHAMPIONS MORE FULLY BY
PROVIDING RESOURCES BOTH
WEB-BASED AND UPDATES AS THE
STUDY CONTINUES.
ON THE NEXT SLIDE, I WANTED TO
MENTION A BIT ABOUT OUR TEAM
COMPOSITION FOR THE STUDY,
BECAUSE I THINK THAT IT'S BEEN
REALLY HELPFUL THAT TEAM MEMBERS
AT EACH SITE HAVE RESEARCH
CRITICAL CARE QUALITY
IMPROVEMENT AND HEALTH SYSTEMS
EXPERTISE, AND WE'VE REALLY
BUILT OUR RELATIONSHIPS WITH
BEST ICU ON PREVIOUS
COLLABORATIONS.
SO WE'VE HAD PREVIOUS WORK WITH
UNIT COMMITTEES SUCH AS QUALITY
IMPROVEMENT AND THAT SORT OF
EXISTING TRUST HAS BEEN REALLY
HELPFUL ENGAGING THEM WITH THIS
RESEARCH.
AND THEN FINALLY FROM A SITE
P.I. PERSPECTIVE, WHAT'S BEEN
REALLY HELPFUL FOR ME IS THE
FREQUENCY OF MEETINGS.
OUR RESEARCH TEAM MEETS BYE
WEEKLYBIWEEKLY, SERVING AS THE
INTERFACE BETWEEN THE BROADER
RESEARCH TEAM AND THE HEALTH
SYSTEM, BECAUSE I CAN TAKE
INFORMATION FROM THE TEAM TO THE
HEALTH SYSTEM, BUT I CAN ALSO
QUICKLY -- LOCAL SITES THAT NEED
TO BE PROVIDED TO THE RESEARCH
TEAMS, SO IT REALLY HELPS
PROMOTE THAT COMMUNICATION.
FREQUENCY OF MEETINGS, YOU CAN
SEE OUR INTERVENTIONS ARE PRETTY
COMPLEX SO WE NEEDED TO BREAK
OUT ADDITIONAL MEETINGS TO GET
THOSE UP AND RUNNING DURING THE
PLANNING PHASE.
AND THEN FINALLY, IT'S BEEN
REALLY HELPFUL FOR OUR TEAM TO
BE ENGAGED WITH THE PRAGMATIC
TRIALS COLLABORATORY AND
REFINING OUR RESEARCH PROJECT.
ARE JUST THINKING ABOUT SOME
CONSIDERATIONS THAT WE'VE
LEARNED JUST IN THE LAST YEAR
AND A HALF WITH THIS WORK, BUN
OF THE THINGS WE CONTINUED TO
NAVIGATE IS SO SOME OF THOSE
HEALTH SYSTEM STRUCTURES, LIKE
FOR EXAMPLE, HOW WE COMPENSATE
THE NURSE FACILITATOR THAT IS
ONE OF OUR IMPLEMENTATION
STRATEGIES BUT REALLY ENSURING
HOW THE UNIT GETS REIMBURSED FOR
THAT HOURLY RATE TAKES
NAVIGATING THROUGH VARIOUS HR
AND NURSING APPROVAL COMMITTEES,
AND IT DIFFERS AT EACH SITE.
BLENDING RESEARCH AND CLINICAL
TIMELINES HAS BEEN A LEARNING
CURVE, RECOGNIZING THAT WE'VE
HAD DASHBOARD BUILD AT EACH SITE
AND THAT CLINICAL I.T. SUPPORT
WILL HAVE HAD A FULL LIST OF
CLINICAL RESPONSIBILITIES.
SO HOW WE FIT IN OUR RESEARCH
REQUEST AND THE TIMELINE
NAVIGATING THAT AT EACH SITE WAS
DOABLE BUT IT TOOK SOME TIME.
THEN FINALLY HIRING THE NURSE
FACILITATOR INTERVENTION CAN
FEEL LIKE A BIG ASK, GIVI GIVENT
THERE IS A NATIONWIDE NURSING
SHORTAGE AND HIGH BURNOUT, BUT
ENGAGING WITH THE NURSE MANAGERS
EARLY AND REALLY HAVING THEM
UNDERSTAND THE INTERVENTION HAS
BEEN HELPFUL IN THIS PROCESS.
SO I THINK BOTH OF THOSE POINTS
JUST DESCRIBE THE LAYERS OF
APPROVAL AND REALLY NAVIGATING A
LARGE ACADEMIC HEALTH SYSTEM, IT
JUST TAKES SOME TIME.
FINALLY ONE THING THAT WE'VE
BEEN THINKING ABOUT IS THE
FREQUENCY OF ENGAGEMENT,
PARTICULARLY AS IT RELATES TO
SITES THAT MIGHT NOT BE
RANDOMIZED TO AN INTERVENTION
UNTIL A YEAR AND A HALF LATER,
SO WE'RE REALLY THINKING ABOUT
HOW WE CAN KEEP THOSE UNITS
ENGAGED BUT NOT OVERBURDEN THEM.
SO I THINK MY LAST COMMENTS JUST
RELATE TO OUR CONCLUSIONS.
WHAT WE'VE FOUND IS THAT OUR
RESEARCH TOPIC, IT'S BEEN
HELPFUL, THAT IT'S MEANINGFUL
AND TIMELY FOR HEALTHCARE
SYSTEMS.
EACH OF THE SITES HAS BEEN
WORKING ALREADY ON INCREASING
THEIR ADOPTION OF THE A BSM CDEF
BUNDLE SO THEY'RE VERY
INTERESTED IN THIS STUDY.
IT WAS ALSO HELPFUL FOR US TO
BUILD ON PREVIOUS COLLABORATIONS
AND PARTNERSHIPS AT EACH SIDE R.
SITE THAT WE'VE ESTABLISHED
THAT'S HELPED THIS WORK MOVE
FORWARD, AND THEN FINALLY WOULD
SAY THAT THIS MECHANISM HAS BEEN
REALLY HELPFUL TO BUILD
INFRASTRUCTURE FOR COMPLEX
INTERVENTIONS THAT WE'RE TESTING
IN REAL WORLD SETTINGS.
SO I JUST WANTED TO THANK THE
BROADER BEST-ICU TEAM,
RECOGNIZING DRS. MICHELLE BALAS
FOR LEADING THIS TEAM.
>> THANKS VERY MUCH.
WE'LL HEAR NEXT FROM SEBASTIAN.
>> HI.
MY NAME IS SEBASTIAN TONG.
I'M A FAMILY PHYSICIAN AND
ASSISTANT PROFESSOR AT THE
UNIVERSITY OF WASHINGTON AND I'M
ONE OF THE CO-PIs WITH CUE
SHK -- HOWWE ENGAGE WITH OUR PRN
COMPLEMENTING KIND OF ENGAGEMENT
IN SPECIFIC STUDIES, AND I WANT
TO TALK MORE TODAY ABOUT A
LARGER ENGAGEMENT INFRASTRUCTURE
KIND OF PRE AND POST STUDY AND
ALSO LONGITUDALLY.
SO I'M GOING TO BRIEFLY REVIEW
OUR STUDY AGAIN, I THINK YOU
HEARD IT FROM DR. PATEL EARLIER.
WE'RE USING A NURSE CARE
MANAGEMENT MODEL TO PROVIDE
NON-PHARMACOLOGICAL TREATMENTS
TO CHRONIC PAIN ESPECIALLY IF
RURAL AREAS.
AND OUR PROJECT HAS A NURSE CARE
MANAGER PROVIDE THREE DIFFERENT
COMPONENTS OF CARE, DOING SOME
CARE COORDINATION FOR CHRONIC
PAIN MANAGEMENT, THEY'LL BE
TRAINED TO PROVIDE COGNITIVE
BEHAVIORAL THERAPY AND HAVE
ONGOING CASE-BASED SESSIONS WITH
ONE OF OUR CLINICAL
PSYCHOLOGISTS AT UW, AND THEN
THERE WILL ALSO BE PREPARING
PATIENTS AND REFERRING PATIENTS
TO PARTICIPATE IN A REMOTELY
DELIVERED ENHANCED FITNESS
EXERCISE PROGRAM, WITH THE
ULTIMATE GOAL WITH THESE
ELEMENTS OF REDUCING PAIN
INTERFERENCE IN PEOPLE'S DAILY
LIVES.
SO OUR STUDY IS TAKING PLACE IN
TWO REALLY DIVERSE SETTINGS.
WE'RE DOING THIS WITHIN OUR
EXISTING PRACTICE-BASED RESEARCH
NETWORK INFRASTRUCTURES IN WHAT
WE CALL THE WASHINGTON WYOMING
ALASKA WYOMING WIE ONLY ACROSSE
COUNTRY, IN THE MECKLENBURG AREA
PARTNERSHIP FOR PRIMARY CARE
RESEARCH.
SO THESE ARE TWO WELL
ESTABLISHED PRIMARY CARE
PRACTICE-BASED RESEARCH NETWORKS
THAT DO ONGOING STUDIES WITH
THEIR PRIMARY CARE PRACTICES AT
A NUMBER OF PRACTICES.
SO I'LL TALK NEXT ABOUT SOME OF
THE PRACTICE ENGAGEMENT
STRATEGIES THAT ARE ONGOING,
ESPECIALLY WITHIN THE WAMY
REGION BUT APPLY TO DIFFERENT
ELEMENTS AS WELL.
SO THREE OF THE WAYS WE HAVE
ONGOING ENGAGEMENT IS THROUGH
OUR STEERING COMMITTEE, THREUR
OUR ANNUAL CONFERENCE THAT WE
HOST EACH YEAR WITHIN OUR
NETWORK, AND ALSO THROUGH A
SURVEY AND INTERVIEW RESEARCH
PANEL THAT WE HAVE.
SO FIRST TO TALK A BIT ABOUT OUR
STEERING COMMITTEE, SO WE HAVE
MONTHLY CALLS ABOUT WHAT WE CALL
OUR STEERING COMMITTEE FOR OUR
PRACTICE BASED RESEARCH NETWORK,
AND THIS IS A GROUP OF
CLINICIANS THAT IS ACROSS OUR
FIVE-STATE PACIFIC NORTHWEST
INTERMOUNTAIN WEST REGION, AND
THEY INCLUDE BEHAVIORAL HEALTH
PROVIDERS, PHARMACISTS, PRIMARY
CARE CLINICIANS, RESIDENCY
LEADERSHIP FOR FAMILY MEDICINE
PROGRAMS, AND ALSO SOME HEALTH
SYSTEM LEADERSHIP FOR RURAL
HEALTH SYSTEMS AS WELL.
AND THEY DO BASICALLY STUDY
AGNOSTIC DISEASE AGNOSTIC
FEEDBACK AND APPROVAL FOR ALL
THE STUDIES THAT HAPPEN IN OUR
NETWORK.
SO THEY MEET MONTHLY TO PROVIDE
FEEDBACK ON ANY STUDY THAT COMES
TO OUR NETWORK.
AND THEY ALSO HELP SET RESEARCH
PRIORITIES FOR NETWORK AND SAY
THESE ARE THE THINGS THAT ARE
IMPORTANT, THESE ARE THE WAYS
AND METHODS THAT COULD BE REALLY
IMPORTANT, AND THEN HELP GUIDE
THE PRAGMATISM IN THAT WAY.
SO REALLY THEY SERVE AS A
CONDUIT BETWEEN THE RESEARCH
INVESTIGATORS AT KIND OF WHAT I
CALL THE IVY TOWER IN SEATTLE
AND OTHER ACADEMIC INSTITUTIONS
AND THE STEERING COMMITTEE
SERVES AS A CONDUIT TO THE
PRACTICES OF WHAT WE HAVE ABOUT
140 AT THIS POINT AND KIND OF
REPRESENT THEIR VIEWPOINTS AND
BRING THEIR VIEWPOINTS TO THE
FOREFRONT.
ANOTHER WAY WE GET DIRECT MEMBER
FEEDBACK, NOT THROUGH THE
STEERING COMMITTEE, IS THROUGH
OUR ANNUAL MEETING.
WE ARE FORTUNATE TO BE
PARTNERING WITH THE UNIVERSITY
OF WASHINGTON CTSA TO GET
FUNDING TO BRING TOGETHER ANYONE
WHO IS A PRACTICE CHAMPION OR
REPRESENTING A PRACTICE THAT IS
INTERESTED IN RESEARCH, ENPHAGED
IN RESEARCH, TOGETHER FOR AN SL
ANNUAL MEETING IN SEATTLE.
THIS IS A PHOTO AT THIS YEAR'S
ANNUAL MEETING.
WE WERE FORTUNATE TO HAVE SUN IN
SEATTLE FOR THE DAY.
AND THE PRACTICE CHAMPIONS COME
TOGETHER WITH INVESTIGATORS TO
REALLY THINK ABOUT RESEARCH
TOPICS AND WAYS THAT RESEARCH
STUDIES CAN BE ACTUALIZED AND
PRAGMATIC FOR PRIMARY CARE
SETTINGS.
SO SOME OF THE THINGS WE DO, WE
HAVE WHAT WOULD BE THE USUAL
POSTER SESSION, FOR CHAMPIONS,
SO THAT'S BOTH ACTUALLY
CHAMPIONS SHOWCASING QI DONE IN
THEIR PRACTICES SO INVESTIGATORS
CLERN AND MAYBE BROADEN THAT
INTO A BROADER CONTRACT OR FOR
INVESTIGATORS TO PRESENT POSTERS
AND SHOWCASE AND GET FEEDBACK
FROM CLINICAL SITES.
ANOTHER THING WE DO IS HAVE WHAT
WE CALL NEW COLLABORATORS
DISCUSSION.
SO EACH INVESTIGATOR COMES IN
AND GIVES A FIVE-MINUTE
PRESENTATION AND THEN BREAK OUT
INTO SMALL GROUPS WHERE
CLINICIANS WHO SPEND MOST OF
THEIR TIME IN PRACTICE SIT DOWN
IN SMALL GROUP SETTINGS AND FOR
20 MINUTES GIVE FEEDBACK TO
INVESTIGATORS ABOUT THEIR STUDY
DESIGN, THEIR STUDY TOPIC,
WHAT'S ACTUALLY PRAGMATIC,
WHAT'S NOT, AND THEY USUALLY ARE
IN A PROCESS OF GETTING READY TO
SUBMIT A GRANT APPLICATION AT
THAT POINT.
WE HAVE DISCUSSION OF SPECIFIC
TOM IX AS WELL.
AND THE FINAL ENGAGEMENT WAY I
WANT TO HIGHLIGHT IS OUR PARTNER
PANEL FOR RESEARCH, SO THIS IS A
GROUP OF CLINICIANS FROM WITHIN
OUR PRACTICES WHO AGREE TO
RECEIVE REQUESTS FOR UP TO FIVE
SURVEYS OF QUALITATIVE
INTERVIEWS A YEAR.
THEY DON'T COMMIT TO -- BUT WE
ACTUALLY HAVE A PRETTY GOOD
RESPONSE RATE FOR RECRUITING FOR
INTERVIEWS AND SURVEYS.
THESE CAN BE CLINICIANS WHO ARE
IN PRACTICES WHERE THE PRACTICE
IS PART OF A MEMBER -- OF THE
WPRN AND HAS PARTICIPATED OR IS
ONGOINGLY PARTICIPATING IN
RESEARCH, OR THE OPPOSITE WOULD
BE CLINICIANS INTERESTED IN
RESEARCH BUT THEIR PRACTICE
LEADERSHIP INFRASTRUCTURE
DOESN'T ALLOW THEM TO REALLY
ENGAGE IN RESEARCH, SO THAT
HELPING OUT IN THE WAY THAT --
SOME WAY THAT THEY CAN.
AND IT'S DESIGNED TO HELP
INVESTIGATORS GET PERSPECTIVES
OF INDIVIDUALS WORKING IN
PRIMARY CARE PRACTICES.
WE'VE HAD REALLY GOOD SUCCESS
WITH GETTING INVESTIGATORS WHO
LAUNCH THESE SURVEYS OR
INTERVIEWS ACTUALLY GET FUNDED
OR USE IT AS A PART OF
ENGAGEMENT STRATEGY EARLY ON IN
THEIR STUDY TO REFINE OR ADAPT
THEIR STUDIES TO PRIMARY CARE
PRACTICES.
SO SPEAKING SPECIFICALLY ABOUT
AIM-CP, WE USED A COMBINATION OF
ALL THESE STRATEGIES TO ENGAGE
PRACTICES WITHIN A BROADER
INFRASTRUCTURE.
WE DID HAVE A SURVEY LAUNCHED
SPECIFICALLY ABOUT OUR ENHANCED
FITNESS COMPONENT AND HOW TO
ADAPT THAT.
WE ALSO DID A QUALITATIVE STUDY
WHERE WE REALLY LEARNED ABOUT
THE PARTNER PANEL -- PARTNER
PANEL FOR RESEARCH AND WE
LEARNED ABOUT HOW ARE PRACTICES
IMPLEMENTING NON-PHARMACOLOGICAL
TREATMENT MODALITIES, AND THEN
AS WE WERE FINISHING UP, CHRONIC
PAIN MANAGEMENT CAME OUT SO IT
WAS A REALLY TIMELY RFA FOR US.
WE'VE HAD DISCUSSIONS WITH OUR
WPRN STEERING COMMITTEE TO SEE
THE RELEVANCE, HELP ADAPT OUR
STUDY AND WE'VE BEEN PRESENTING
POSTERS AT THE ANNUAL
CONFERENCE, AND HEARING ABOUT
NETWORK RESEARCH PRIORITY AND
HOW OUR STUDY FITS TOGETHER WITH
THAT.
AND I'LL SAY WHAT'S CORE TO KIND
OF OUR ENGAGEMENT IS REALLY
LONGITUDAL RELATIONSHIPS WITH
THE PRACTICES, AND LONGITUDAL
CONNECTIONS GOING TO SITES, AND
HEARING -- AND GOING TO
COMMUNITIES AND FULLY ENGAGING
AND BEING OPEN AND RECEPTIVE TO
A BIDIRECTIONAL WAY OF DOING
RESEARCH.
AND SECOND, I WOULD SAY HAVING
ONGOING INFRASTRUCTURAL SUPPORT,
SO WE ARE FORTUNATE ENOUGH TO
HAVE ONGOING SUPPORT FROM OUR
CTSA THAT'S FUNDED THROUGH NCATS
TO DO A LOT OF THIS WORK,
BECAUSE NONE OF THIS WORK
HAPPENS WITHOUT DOLLARS
UNFORTUNATELY.
AND THE OTHER THING WE'VE DONE
ON AN ONGOING BASIS IS WE'VE
ASKED FUNDED STUDIES THAT WORK
THROUGH OUR NETWORK TO PROVIDE A
SMALL AMOUNT THAT KIND OF FEEDS
BACK INTO THE NETWORK AND
SUPPORTS THE INFRASTRUCTURE.
SO THAT'S KIND OF WHAT I HAVE.
I THINK WE'LL BE HAPPY TO ANSWER
ANY QUESTIONS ABOUT WHAT I
TALKED ABOUT OR KIND OF THE
LARGER PICTURE AS WELL.
THANK YOU.
>> THANKS, SEBASTIAN, AND THANKS
TO ALL OF YOU.
SO I'LL ASK ALL OF OUR PANELISTS
TO COME BACK ON CAMERA IF YOU
CAN, AND FOR A MINUTE, BEFORE WE
UNDUE THE SLIDE SHARING, WE'LL
LEAVE THIS SLIDE UP THERE
BECAUSE YOU CAN SEE THAT EMAIL
ADDRESS FOR PEOPLE TO EMAIL IN
QUESTIONS.
SO WE'LL AT LEAST LEAVE THAT UP
THERE FOR A FEW MINUTES WHILE WE
GET STARTED ON THE DISCUSSION.
THEN I HAVE TO SWITCH BACK AND
SEE, WE'VE GOT OUR FOLKS BACK ON
CAMERA AGAIN.
THANKS.
BUT I'LL START WHILE WE'RE
WAITING FOR QUESTIONS TO COME
IN, I'LL START WITH ONE.
THIS WAS INSPIRED BY SOMETHING
NATALIA SAID BUT I'D BE
INTERESTED IN WHAT ALL OF YOU
THINK ABOUT THIS.
NATALIA TALKED ABOUT SORT OF
GETTING INPUT FROM DIVERSE
STAKEHOLDERS AND GETTING PRETTY
DIVERSE -- YEAH, PEOPLE HAD
DIFFERENT FACTS.
SOUNDS LIKE THIS IS A DIFFERENT
DEFINITION OF ECK POISE, WHERE
DIFFERENT PEOPLE ARE UNSURE
ABOUT DIFFERENT THINGS AND THEY
CONFLICT WITH EACH OTHER.
SO WHAT DO YOU DO ABOUT THAT?
HOW DO YOU HEAR THAT, WHAT'S
YOUR ROLE IN RESOLVING OR NOT
RESOLVING ANY OF THAT, HOW DO
YOU LEARN FROM THAT WHEN YOU
HEAR VERY DIFFERENT THINGS FROM
DIFFERENT PEOPLE.
NATALIA, MAYBE I'LL START WITH
YOU SINCE YOU BROUGHT THE
QUESTION UP, AND I'M SURE THE
REST OF YOU MAY HAVE HAD THAT
EXPERIENCE AS WELL, ABOUT
HEARING DIFFERENT THINGS FROM
DIFFERENT PEOPLE.
>> THANKS, GREG, FOR BRINGING
THAT UP.
YOU CAN IMAGINE HOW KIND OF
FRUSTRATING IT IS IN SOME WAYS.
I THINK WHAT WAS EYE OPENING,
THOUGH, IS SOME OF THE PEOPLE
WHO HAD DIFFERING IDEAS, FOR
EXAMPLE, ABOUT GROUP MEDICAL
VISITS OR THE EVIDENCE BASE
IN -- FOR BACK PAIN, THEY SAID
PEOPLE HAD VERY HIGH LEVELS
WITHIN INSURANCE COMPANIES.
SO CERTAINLY ONE OF THE WAYS
THAT WE'RE APPROACHING IT IS
SOMETIMES NOW WE'RE TALKING
ABOUT ISSUES THAT AREN'T JUST AT
OUR LOCAL LEVEL BUT POTENTIALLY
AT A STATE OR EVEN NATIONAL
LEVEL WHERE YOU HAVE THESE
DIFFERENT VIEWPOINTS, AND SO
PART OF IT FOR US NEEDS TO BE
HOW TO MORE EVENTUALLY
DISSEMINATE THE EVIDENCE.
WE ALWAYS -- I KNOW WE TALK
ABOUT THAT ALL THE TIME, BUT
IT'S MORE DIFFICULT THAN IT
SOUNDS BECAUSE WE HAVE -- YOU
KNOW, WE HAVE OUR STUDIES THAT
ARE -- WE DON'T WANT THEM
SITTING IN, YOU KNOW, IN THE WEB
VIRTUALLY SOMEWHERE.
SO PART OF IT IS WE'RE REALLY
THINKING ABOUT DIFFERENT WAYS TO
STRATEGIZE AROUND IMPLEMENT
IMPLEMENTATION.
AND DISSEMINATION.
>> THANKS.
ANYONE ELSE WITH THOUGHT ABOUT
THAT, ABOUT WHEN YOU'RE ENGAGING
WITH SORT OF DIFFERENT PARTNERS
AND DIFFERENT COMMUNITIES AND
HEARING DIFFERENT THINGS, HOW
YOU DEAL WITH THAT?
>> I CAN JUMP IN AND SAY WE
DEFINITELY FELT THAT FROM
DIFFERENT HEALTH SYSTEMS AND
COMMUNITIES THAT WE'VE ENGAGED
WITH.
AND I THINK ONE OF THE THINGS
THEY WERE STRUGGLING WITH, WITH
A PRAGMATIC TRIAL, IS FIGURING
OUT WHAT ARE THE KIND OF CORE
EVIDENCE-BASED COMPONENTS THAT
CONSTITUTE AN INTERVENTION?
WE CAN'T BE TESTING DIFFERENT
THINGS AT DIFFERENT SITES.
BUT ARE THERE WAYS WE CAN DO
SLIGHTLY ADAPTED RECRUITMENT,
SLIGHTLY DIFFERENT ENGAGEMENT
STRATEGIES THAT WOULD STILL HAVE
THE CORE COMPONENT OF OUR
INTERVENTION STAY THE SAME, AND
THAT CAN BE COMPARABLE ACROSS
SITES.
>> LOOKING TO SEE IF IB ELSE HAD
THOUGHTS ABOUT THAT.
MAYBE A SPECIFIC ONE, I'LL START
WITH NATALIA AND SEE WHAT THE
REST OF YOU SAY.
SOUNDS LIKE, NATALIA, YOU DID
BOTH SORT OF INDIVIDUAL
INTERVAWS WITH DIFFERENT
INTERESTED PARTIES, AND THEN YOU
ALSO HAD A BOARD WHERE PEOPLE
CAME TOGETHER.
CAN YOU TALK ABOUT THE PROS AND
CONS OF THOSE IN TERMS OF
EVERYBODY BEING IN THE SAME ROOM
WHEN THEY MIGHT HAVE VERY
DIFFERENT VIEWS, OR BEING ABLE
TO SPEAK TO PEOPLE SEPARATELY
AND MAYBE YOU'D HEAR MORE ABOUT
THE VERY DIFFERENT VIEWS?
>> FOR SURE THE PROS OF THE
GROUP IS KIND OF WHAT I'M ALMOST
HEARING WHEN JULIE SAID THAT AND
SEBASTIAN SPOKE ABOUT WHERE
THERE WAS AN ALREADY ESTABLISHED
GROUP, SO THEY'RE FAMILIAR.
THERE'S A FAMILIARITY NOW THAT
THEY CAN HAVE WITH THE PROCESS,
WHICH IS ABSOLUTELY CRITICAL,
BECAUSE IT TAKES EDUCATION TO
GET PEOPLE TO THAT POINT.
SO ONE -- SO THAT IS A HUGE --
YOU KNOW, IS A HUGE ADVANTAGE,
BUT IN SOME WAYS, YOU WANT
TURNOVER, NEW PEOPLE, SO YOU CAN
GET NEW VOICES, NEW
PERSPECTIVES, AND THIS IS WHERE
THE INDIVIDUAL INTERVIEWS ARE SO
HELPFUL.
BECAUSE THIS ALLOWS YOU FOR
ADDITIONAL PERSPECTIVES.
SO THEY BOTH HAVE THEIR PART,
THEIR PROS, AND I THINK IN
GENERAL, THEY OUTWEIGH THE CONS
JUST SOME QUICK THOUGHTS.
>> I'D SECOND WHAT NATALIA SAID
IN TERMS OF THINKING ABOUT THE
PURPOSE OF THE ENGAGEMENT AND
ARE YOU THINKING NOW OF ENGAGING
PROVIDERS AND CLINICIANS, ARE
YOU SOLVING A SPECIFIC
IMPLEMENTATION PROBLEM THAT'S
VERY SPECIFIC TO THE CONTEXT OF
A CLINIC OR A PROVIDER OR REALLY
TRYING TO BUILD MORE OF A MODEL
OF SHARED VALUES AND
COMMUNICATION AT THE
ORGANIZATIONAL LEVEL WHERE
GROUPS REALLY HELPFUL.
THE ONE OTHER THING I'D JUST ADD
IN IS BEING COGNIZANT ALSO OF
SORT OF THE OVERALL BURDEN AND
THAT THESE DIFFERENT ENGAGEMENTS
TAKE ON.
I THINK SOMETIMES ON THE
RESEARCH SIDE WE THINK MORE IS
ALWAYS BETTER FROM OUR
PERSPECTIVE IN TERMS OF
ENGAGEMENT, BUT THERE HAS TO BE
A LOT OF ATTENTIVENESS TO WHAT
THE ASK IS ON THE PART OF THE
PARTNERS, AND REALLY TRYING TO
BE EFFICIENT WITH THEIR TIME AND
HOW MUCH BURDEN IS PLACED THERE.
>> I SHOULD ASK ON THE PART OF
THE PARTNERS, SOMETHING
SEBASTIAN SAID WHEN YOU TALKED
ABOUT THIS PANEL OF PEOPLE WHO
HAVE AGREED TO RECEIVE SURVEYS,
MADE ME WONDER ABOUT HOW YOU
THINK ABOUT THE DIVERSITY AMONG
THE PEOPLE YOU'D WANT TO HEAR
FROM IN TERMS OF I DON'T KNOW
WHAT TO CALL IT SEPTEMBER THEIR
EXCEPT THEIRLEVEL OF ENGAGEMENT.
YOU MAY BE HEARING FROM THE
ALREADY ENTHUSIASTIC AND NOT
HEARING FROM THOSE WHO ARE
UNENTHUSIASTIC OR EVEN ACTIVELY
OPPOSED.
HOW DOES ONE ENGAGE WITH THE
DISENGAGED OR HOW DOES ONE
ENGAGE WITH THE DIFFICULTY TO
ENGAGE AND HOW DO YOU MAKE SURE
YOU'RE HEARING FROM THAT
DIVERSITY, OR MAYBE YOU DON'T
NEED TO HEAR FROM THAT
DIVERSITY.
BUT HOW YOU THINK ABOUT THE
VARIETY OF THE VIEWS OUT THERE,
EVEN SAY WITHIN A PARTICULAR
GROUP, THE VARIETY OF CLINICIAN
VIEWS ABOUT THIS, THE VARIETY OF
PATIENT OR FAMILY MEMBERS' VIEWS
ABOUT THIS.
ESPECIALLY THOSE PEOPLE WHO WILL
NOT BE THE PEOPLE WHO ARE GOING
TO SIGN UP FOR A COMMUNITY
ADVISORY BOARD OR SOMETHING LIKE
THAT.
>> I THINK THAT'S AN ONGOING
CHALLENGE NOT JUST FOR
ENGAGEMENT BUT FOR ALL RESEARCH,
FOR THOSE WHO SIGN UP FOR A
RESEARCH STUDY ARE MORE LIKELY
TO BE ENGAGED IN GENERAL.
I THINK IN SEVERAL WAYS WE'RE
MORE ATTENTIVE TO THAT.
AS NATALIA SAID, KIND OF
ONE-ON-ONE, ONE-OFF INTERVIEWS
CAN AB BETTER WAY TO ENGAGE
SOMETIMES THAN LIKE A MONTHLY OR
QUARTERLY OR ONGOING KIND OF
COMMITTEE ADVISORY GROUP MEET
MEETING.
I THINK ANOTHER WAY WE GET
OPINIONS IS KIND OF SECONDHAND
WE ASK PEOPLE WHO DO SIGN UP FOR
THE INTERVIEWS OR SURVEYS, WHAT
HAVE YOU HEARD FROM YOUR
COLLEAGUES?
SO IT'S A BIT OF KIND OF
SECONDARY FEEDBACK, BUT IT DOES
GET TO THAT ISSUE SOMEWHAT.
AND I THINK INTENTIONALLY WE TRY
TO GO INTO COMMUNITIES THAT ARE
UNDERREPRESENTED IN RESEARCH AND
TRY TO RECRUIT PEOPLE IN THOSE
COMMUNITIES BUT THERE ARE
LIMITATIONS EVEN WITHIN THAT
WITH WHO WILL SIGN UP.
GLB OTHER PEOPLE IN TERMS OF
THAT DIVERSITY AND HOW YOU HEAR
FROM THOSE WHO MIGHT NOT
NECESSARILY BE THAT EXCITED
ABOUT THE IDEA YOU'RE PURSUING?
>> I'LL JUST SECOND ONE THING
THAT SEBASTIAN SAID ABOUT IF YOU
HAVE SORT OF AN INTERMEDIARY, SO
FOR US, WE HAVE INDIVIDUAL FQHC
CLINICS, THEN WE HAVE THIS
ASSOCIATION THAT REPRESENTS THEM
AND SORT OF SERVES AS A LIAISON
BETWEEN THE UNIVERSITY AND THE
RESEARCH TEAMS AND THE CLINICS
AND THE STAFF, AND THEY HAVE
THEIR EAR TO THE GROUND AND WHEN
SOME PROVIDER OR CLINIC OR GROUP
IS JUST NOT THAT INTO WHAT WE'RE
DOING OR WE'VE DONE SOMETHING
THAT HASN'T BEEN A REALLY GOOD
EFFORT AT PARTNERSHIP, WE HAVE
THAT WAY TO GET THE FEEDBACK
THROUGH THEM OF WHAT'S HAPPENED,
WHICH HAS BEEN REALLY
INVALUABLE, AND AT TIMES THE
PROVIDER RS, INDIVIDUAL
PROVIDERS CAN KIND OF PLAY A
SIMILAR ROLE WITH PATIENTS.
PATIENT WHO THEY'VE OFFERED THE
OPPORTUNITY TO PARTICIPATE AND
PATIENTS AREN'T INTERESTED AND
SOMETIMES WE GET SOME FEEDBACK
ABOUT WHAT THEY HEAR FROM
PATIENTS THAT WAY, SO SORT OF
THAT THIRD PARTY CAN BE REALLY
VALUABLE IF THAT EXISTS TO GET
FEEDBACK FROM PEOPLE THAT YOU'RE
NOT ABLE TO CONNECT WITH.
>> ANOTHER PIECE I WOULD ADD
FROM OUR TRIAL IS THAT IN
ADDITION TO ONE-ON-ONE MEETINGS,
FITTING INTO EXISTING MEETINGS
HAS BEEN HELPFUL AS WELL, SO
MAYBE IT'S SORT OF A QUICK
ANNOUNCEMENT ABOUT OUR STUDY,
BUT IT ALSO HELPS US SEE SORT OF
THE OTHER TOPICS THAT THE TEAM
IS WORKING ON, WHETHER IT BE THE
CRITICAL CARE COMMITTEE OR THE
NURSE LEADERSHIP MEETING OR UNIT
COUNCIL, I THINK THAT HELPS WITH
A LOT OF INFORMATION AS WELL.
>> SO WHAT THEY'RE COMPLAINING
ABOUT WHEN THEY'RE NOT TALKING
ABOUT YOUR STUDY BUT THEY'RE
TALKING ABOUT THEIR LIFE IN
GENERAL.
YOU'D LIKE TO KNOW WHAT
BOTHERS -- THE PEOPLE YOU'RE
TRYING TO HELP, YOU'D LIKE TO
KNOW WHAT BOTHERS THEM THE MOST,
EVEN IF IT'S NOT DIRECTLY
RELEVANT TO YOUR PROJECT.
RELATED TO -- THERE WAS A
QUESTION ABOUT COMPENSATING
PEOPLE, AND HOW THAT'S WORKED,
AND ESPECIALLY WHEN YOU THINK
ABOUT PEOPLE WHO ARE ENGAGED --
SOMEONE WHO MIGHT BE AN ONGOING
MEMBER OF A COMMUNITY ADVISORY
BOARD, SOMEBODY WHO MIGHT BE A
MEMBER OF THE SURVEY PANEL,
SOMEBODY WHO MIGHT BE
PARTICIPATING IN ONE OF THESE
ONE-OFF INTERVIEWS, SOME OF YOU
MENTIONED, I'M ASSUMING YOU'RE
SAYING THAT THESE ARE PEOPLE WHO
ARE -- THEY'RE CONTRIBUTING
EXPERTISE, THEY'RE NOT SUBJECT
TO RESEARCH, THEY'RE PARTNERS,
AND YOU WOULD PROBABLY, I
SUSPECT, PAY THEM FOR THEIR
TIME, BUT WHO WANTS TO TELL ME
HOW YOU'VE DONE THAT?
>> SO I CAN SAY WE COMPENSATE
PEOPLE FOR EACH MEETING THEY
ATTEND OR FOR EACH SURVEY
INTERVIEW THEY COMPLETE.
AND WHAT WE'VE DONE IN OUR U
UG3 PHASE, UG3/UH3 EMBED THAT
COST WITHIN THE GRANT AND WE
ALSO HAVE FUNDS IN THE -- TO
COMPENSATE ONGOING
INFRASTRUCTURE.
>> AGREE WITH THE SAME WITH
SEBASTIAN.
ACTUALLY I THINK IT'S REALLY
IMPORTANT TO VALUE PEOPLE'S TIME
BY COMPENSATING THEM.
YOU KNOW, IN SOME WAY.
I WAS A LITTLE BIT WORRIED WITH
SOME OF THE HIGHER PAID
PARTNERS, BUT THEY WANTED THE
COMPENSATION TOO, SO THEY
APPRECIATED THE COMPENSATION.
SO I THINK IT'S -- THE VALUE OF
PEOPLE'S TIME AND THAT COMES
BACK TO -- I'M REALLY GLAD THAT
THERE'S STARTING TO BE GREATER
APPRECIATION OF HOW IMPORTANT
INVOLVING PARTNERS IS, BECAUSE
THEY REALLY ARE TRYING TO MOVE
OUR WORK INTO HEALTHCARE, AND IT
TURNS OUT THAT THIS IS A REALLY
VALUABLE PIECE OF GETTING IT IN
INSTEAD OF NOT BEING ABLE TO GET
IT IN.
SO THAT'S WHAT WE DO.
>> OTHER THOUGHTS ABOUT THAT?
ONE OF THE OTHER QUESTIONS THAT
CAME IN, A LOT OF YOU TALKED
ABOUT HAVING THESE SORT OF
ONGOING RELATIONSHIPS OR EVEN A
SORT OF SOMETIMES FORMAL
INFRASTRUCTURE TO SUPPORT THESE
ONGOING RELATIONSHIPS AND THE
IMPORTANCE OF THAT ESPECIALLY
NOT TALKING TO PEOPLE WHEN IT'S
TOO LATE.
TALKING TO PEOPLE EARLY ON IN
THE PROCESS.
THERE'S A TENSION THERE, THOUGH,
ABOUT DOES THAT MEAN THAT THIS
RESEARCH CAN ONLY BE DONE OR
SHOULD ONLY BE DONE IN PLACES
THAT HAVE THIS INFRASTRUCTURE,
WHAT DOES THAT MEAN ABOUT
REACHING COMMUNITIES THAT HAVE
TRADITIONALLY BEEN
UNDERREPRESENTED ABOUT
INSTITUTIONS THAT HAVE SERVED
PEOPLE WHO HAVE BEEN
UNDERREPRESENTED IN RESEARCH,
AND SORT OF SPREADING THE
RESEARCH ENTERPRISE.
MANY OF THE PEOPLE INVOLVED IN
THE COLLABORATORY IN TERMS OF
THESE SORT OF -- ARE THE HAVES
OR THE HAVE-NOTS OR
TRADITIONALLY BETTER RESOURCED,
THAT'S GOOD, BUT WHAT ABOUT
THOSE -- HOW WOULD THAT WORK FOR
PEOPLE WHO NODE TO NEED TO GETD
AND HAVEN'T DONE THIS BEFORE,
WHERE WOULD THE RESOURCES COME
FROM?
HARD QUESTION, BUT WOULD ANYBODY
HAVE ADVICE ABOUT THAT?
>> WELL, I GUESS TO BE
PRESUMPTIVE, I WOULD SAY FROM A
FUNDING STANDPOINT, FUNDING THE
INFRASTRUCTURE BUILDING IS
REALLY CRITICAL, AND WHETHER
THAT'S IN KIND OF A PHASED
MECHANISM WHERE THERE'S ADEQUATE
TIME FOR THAT AS MILESTONES OF
PROGRESSION WHERE YOU ARE
BUILDING OR SEPARATE STANDALONE
OPPORTUNITIES FOR FUNDING FOR
THE ECK PRESS PURPOSE OF
BUILDING THE PARTNERSHIP, IT
JUST CAN'T BE DONE ON THE QUICK,
AND IN IF IT DOESN'T EXIST, JUG
INTO A COMPLEX IMPLEMENTATION
PRAGMATIC TRIAL IS PROBABLY
GOING TO FAIL.
>> OTHER THOUGHTS ABOUT THAT,
HOW WOULD NEWCOMERS TO THIS
WORLD GET STARTED?
>> I THINK NEWCOMERS, WE
GENERALLY WELCOME
COLLABORATIONS, SO FINDING AN
EXISTING GROUP WITH THAT KIND OF
INFRASTRUCTURE, AND THEN I THINK
WHAT I SEE EMERGING IN THE
ENVIRONMENT IS ALSO MORE
RECOGNITION THAT THERE NEEDS TO
BE FUNDING FOR INFRASTRUCTURE
ACTUAL SUPPORT.
SO WHETHER THAT'S WITHIN PCORI,
I KNOW THE NIH COMMON FUND HAS
AN INITIATIVE NOW FOR PRIMARY
CARE RESEARCH NETWORKS, SO
WITHIN THOSE STUCK HAVE STRUCTU,
DEVELOPING A NEW STRUCTURE I
THINK IS AN OPPORTUNITY AT IT
POINT.
>> YEAH.
I DON'T THINK INTASES CHAN WAS T
UP TO IT BUT THAT WAS SORT OF AN
ANNOUNCEMENT WE WANT EVERYONE TO
COME BACK TOMORROW TO LISTEN TO
THE NIH DIRECTOR TALK ABOUT THIS
PROGRAM BECAUSE THAT'S ONE
EXAMPLE OF WHERE THAT MIGHT COME
FROM.
SO THE FACT THAT IN OUR LAST
SESSION, WE HAD THE DISCUSSION
SORT OF WENT ON TO SORT OF THE
NIH SORT OF STRATEGY, WHAT SORT
OF FUNDING STRATEGIES ARE, WHAT
A RESEARCH PORTFOLIO LOOKED LIKE
GOT ME THINKING, THE QUESTION I
WROTE DOWN IN MY LITTLE PAD AS
YOU WERE TALKING WAS, WELL,
SHOULD EACH RFA HAVE A COMMUNITY
ADVISORY BOARD?
YOU KNOW, IS IT -- WHEN NIH
DECIDES WE WANT TO FUND RESEARCH
IN THIS AREA, HOW DO THE
INTERESTED PARTIES OR THE PEOPLE
AFFECTED, HOW DO THEY HAVE INPUT
INTO THAT PROCESS?
I'M CURIOUS IF ANY OF YOU HAVE
THOUGHTS ABOUT THAT, OR WE COULD
EVEN INVITE ANY OF OUR NIH
COLLEAGUES WHOO ARE JO WHO ARE O
THEY HAVE INPUT AT THE NIH
LEVEL?
THIS IS YOUR OPPORTUNITY TO TELL
NIH WHAT THEY SHOULD DO.
BEFORE WE ASK THEM TO TALK.
SOMEBODY'S GOT TO BITE ON THAT.
>> I THINK ONE OF THE KEY THINGS
IS -- WHAT I THINK MANY OF US
DID IS PUT SOME FEEDBACK FROM
COMMUNITY GROUPS INTO OUR
PROPOSALS, SO LIKE SEEING THAT
AS A NECESSARY COMPONENT OF A
GRANT APPLICATION OR LIKE A MUCH
DESIRED COMPONENT OF A GRANT
APPLICATION IS A WAY THAT NIH
COULD HEAR THAT.
I THINK HISTORICALLY STUDY
REVIEW SECTIONS HAVE BEEN MADE
UP OF PEOPLE WHO ARE ACADEMIC
RESEARCHERS.
SO A POTENTIAL OPPORTUNITY IS
HAVING COMMUNITY MEMBERS OR
VOICES BE IN SECTIONS TO PROVIDE
THAT PERSPECTIVE.
>> ANY OTHER THOUGHTS ABOUT
THAT?
OKAY.
I GOT WENDY TO TURN HER CAMERA
ON.
>> SURE, GREG.
I'LL NOT SPEAK ON BEHALF OF NIH
BUT I'LL GIVE YOU SOME IDEAS OF
HOW WE DO TRY TO ENGAGE MORE
SORT OF COMMUNITY VOICES AND I
THINK SEBASTIAN, AS YOU
MENTIONED, YOU'RE SEEING MORE OF
THIS ACROSS NEW NIH INITIATIVES
AND THINKING ABOUT THIS.
AND SO THERE ARE TIMES WHEN WE
CAN GET COMMUNITY INPUT AND
THOSE OPPORTUNITIES ARE -- YOU
KNOW, WATCH FOR REQUESTS FOR
INFORMATION.
THAT IS HOW WE SEEK INFORMATION
FROM THE COMMUNITY.
HOW DO WE GET THE COMMUNITY TO
UNDERSTAND THAT IS ANOTHER
QUESTION IN TERMS OF HOW DO WE
ENGAGE THEM IN THAT PROCESS AND
GET THEM TO PROVIDE US INPUT,
BECAUSE THAT'S THE FORMAL WAY
THE GOVERNMENT CAN ASK FOR BROAD
INPUT ON THINGS.
OTHER PLACES WHERE WE COLLECT
INFORMATION THAT SORT OF GUIDE
US AS WE'RE DEVELOPING NEW
INITIATIVES, CERTAINLY ARE WHEN
WE HOST WORKSHOPS, WE'RE OFTEN
TRYING TO UNDERSTAND A GIVEN
AREA AND WHAT'S HAPPENING IN
DIFFERENT PLACES, AND SO THOSE
ARE OPPORTUNITIES TO GIVE US
FEEDBACK AND LET US KNOW WHAT'S
HAPPENING IN A FIELD.
AND THEN THE OTHER ONE THAT I
WAS THINKING OF IS, YOU KNOW,
OCCASIONALLY WE WILL HAVE OTHER
SORT OF PLATFORMS LIKE THESE
WORKSHOPS, ROUND TABLES OR STATE
OF THE SCIENCE TYPE
OPPORTUNITIES FOR PEOPLE TO GIVE
US INFORMATION.
WE HAVE VERY STRONG GUIDELINES
ABOUT WHEN PEOPLE CAN PROVIDE
INPUT AND AT WHAT STAGE IT HAS
TO BE SORT OF INCUBATED
INTERNALLY AT NIH, AND PART OF
THAT IS NOT TO GIVE ANYONE AN
UNFAIR ADVANTAGE IN TERMS OF
APPLYING FOR POTENTIAL FUNDING
ANNOUNCEMENTS.
BUT I DO THINK THAT WE CERTAINLY
HAVE SEEN OTHER FUNDING AGENCIES
ENGAGE MORE NOT NECESSARILY
APPLICANTS LIKE RESEARCHERS, BUT
MAYBE COMMUNITY MEMBERS IN OTHER
WAYS, AND PATIENTS WITH LIVED
EXPERIENCE AND OTHER THINGS LIKE
THAT INTO DIFFERENT ACTIVITIES,
WE'RE STARTING TO SEE THAT MORE
IN OUR WORKSHOPS EVEN WHERE IT'S
NOT JUST SCIENCE THAT'S
PRESENTED BUT WE ALSO BRING
INDIVIDUALS WITH LIVED
EXPERIENCE TO TALK TO
RESEARCHERS THAT ARE AT THOSE
WORKSHOPS AND SO THAT NIH CAN
ALSO HEAR THAT PERSPECTIVE.
BUT I DO SEE SOME OTHER
COLLEAGUES ON THE CALL, I DON'T
KNOW IF ANYONE ELSE WANTS TO
VOLUNTEER TO RESPOND TO THAT
SORT OF GENERAL INQUIRY, BUT
THOSE ARE SOME OF THE AVENUES
WHEN WE ARE TYPICALLY AND ARE
ABLE TO SEEK MORE BROADER
COMMUNITY INPUT ON DIFFERENT
ELEMENTS.
DR. LANGEVIN.
>> I HAVE TO JUMP OFF IN A
MINUTE FOR ANOTHER MEETING BUT I
JUST WANT TO SAY COMPLETELY 100%
AGREE WITH EVERYTHING WENDY
EXPLAINED IT REALLY NICELY.
I MEAN, WE HAVE TO BALANCE
THINGS, RIGHT?
AND THERE ARE STRICT RULES,
RIGHT, ABOUT WHO CAN BE ON THE
STUDY SECTION, WHAT KIND OF
INFORMATION WE CAN COMMUNICATE
ABOUT A SPECIFIC PROJECT, SAY A
PROGRAM ANNOUNCEMENT, WHEN WE
CAN COMMUNICATE THAT
INFORMATION.
THAT'S ALL VERY, VERY STRICTLY
REGULATED, AND THE ULTIMATE GOAL
IS TO PROVIDE A FAIR PROCESS
THAT IS COMPLETELY -- AS
UNBIASED AS POSSIBLE, AND WHERE
PEOPLE DO NOT HAVE UNDUE
ADVANTAGE OVER OTHERS IN
APPLYING.
BUT HAVING SAID THAT, WE ARE
VERY, VERY COGNIZANT OF THE FACT
THAT SOMETIMES NIH CAN BE KIND
OF A LITTLE BIT OF ITS OWN
ISLAND, AND WE WANT TO MAKE SURE
THAT BY DEVELOPING THESE FUNDING
OPPORTUNITIES, WE GET -- WE
DEVELOP IT IN A CONTEXT THAT'S
AS APPROPRIATE AS POSSIBLE, AND
WE DON'T WANT TO BE KIND OF, YOU
KNOW, TONE DEAF TO SOME OF THE
PROBLEMS THAT ARE IN THE REAL
WORLD, AND I THINK THAT THIS
WHOLE THING ABOUT I REALLY LOVE
THE EMPHASIS OF THE PRAGMATIC
TRIALS COLLABORATORY ON THE REAL
WORLD.
BECAUSE YOU DON'T WANT SCIENCE
TO BE IRRELEVANT TO THE REAL
WORLD.
AND I THINK THAT THIS IS WHAT
THE COLLABORATORY HAS REALLY
DONE, IS CREATING THIS BRIDGE TO
REALITY THAT WE CAN KEEP
WORKING, AND MAKING THIS AS --
THESE FUNDING OPPORTUNITIES THAT
ARE ISSUED THROUGH THE
COLLABORATORY AS REAL AS
POSSIBLE.
AND IT'S A PROCESS TO GET THERE.
SO THE INPUT THAT WE'RE GETTING
FROM YOU ALL IS SO VALUABLE.
IN
HELPING US TO DO THIS AS
QUICKLY -- AS WELL AS POSSIBLE
AND AS QUICKLY AS POSSIBLE.
SO ANYWAY, I'M SORRY, I HAVE TO
JUMP OFF, BUT GREAT DISCUSSION.
THANK YOU SO MUCH, ALL OF YOU,
FOR SUCH THOUGHTFUL INPUT.
WE'LL SEE YOU TOMORROW.
>> I THINK WE HAVE A COUPLE MORE
MINUTES, MAYBE TIME FOR ONE MORE
QUESTION, AND SOMETHING I WANTED
TO GET BACK TO.
SEVERAL OF YOU TALKED ABOUT SORT
OF THE DIFFERENT PHASES OF THIS
WORK AND THE QUESTIONS THAT COME
UP AND THE THINGS THAT YOU NEED
ADVICE ABOUT AT DIFFERENT
PHASES, RANGING FROM SORT OF THE
OVERALL STUDY DESIGN AND HOW YOU
WOULD STRUCTURE SOME NEW PROGRAM
OR SERVICE, WHAT OUTCOMES THERE
ARE AS YOU'RE TRYING TO ENROLL
OR ENGAGE PEOPLE, AS YOU'RE SORT
OF TRYING TO MAINTAIN
ENTHUSIASM.
I'M CURIOUS, THOUGH, THAT TRUE
ENGAGEMENT MEANS -- AS YOU'RE
LISTENING TO PEOPLE ALONG THE
WAY, YOU MIGHT HEAR THINGS LATER
ON THAT REALLY -- ABOUT THINGS
YOU CAN'T CHANGE ANYMORE.
SOMEONE SAYS, YOU REALLY SHOULD
BE STUDYING SOMETHING DIFFERENT,
YOU REALLY SHOULD BE ASSESSING
DIFFERENT OUTCOMES.
THE PERSON GIVING YOU THAT
ADVICE ACTUALLY MAY BE RIGHT,
BUT WHAT DO YOU DO WITH THAT?
YOU KNOW, HOW DO YOU HEAR AND
REALLY LISTEN TO FEAD BACK THAT
IN SOME WAYS IS TRUE,
INVALUABLE, BUT YOU CAN'T DO
ANYTHING ABOUT IT RIGHT NOW?
NEVER HAPPENED TO ANY OF YOU?
>> I GUESS WHAT RESONATES WITH
ME WITH THAT QUESTION, GREG, IS
MAYBE THE LARGER CONTEXT OF
ESPECIALLY WORKING WITH SITES
AND WITH PATIENTS WHO MAY BE
LESS FAMILIAR WITH CLINICAL
RESEARCH AND SORT OF ITS RULES
AND SOMETIMES THAT CREATES SOME
CHALLENGES OR SOME NEED TO HELP
FOLKS UNDERSTAND WHY CERTAIN
THINGS CAN OR CAN'T BE DONE.
FOR INSTANCE, THE EXAMPLE THAT
COMES TO MY MIND IS JUST THE
TIMELINE OF HAVING AN IDEA AND
SUBMITTING A GRANT AND GETTING
FUNDING AND IT IS AND IT SEEMS
PARTICULARLY TO AN OUTSIDER LONG
AND DELAYED AND THIS IDEA OF
LIKE I'M ASKING YOU TO COMMIT
WITH A LETTER OF SUPPORT FOR
THIS THING THAT MAY OR MAY NOT
EVER HAPPEN, AND IF IT DOES
HAPPEN, IT'S GOING TO HAPPEN
MAYBE A YEAR FROM NOW AND YOUR
PRIORITIES MAY HAVE MOVED ON, IT
IMPORTANT AT MINIMUM OR AT LEAST
IN MY -- MY THOUGHT ON THAT IS
JUST TO NOT ASSUME PEOPLE KIND
OF UNDERSTAND THAT, LIKE AN
ACADEMIC COLLEAGUE WOULD, AND TO
EXPLAIN WHAT IT MEANS, WHAT
STAGE WE'RE AT, WHAT THE NEXT
STAGE IS AND WHAT THAT TIMELINE
MAY LOOK LIKE.
>> ANYBODY ELSE WITH THOUGHTS
ABOUT THAT?
>> I AGREE WITH JULIE, THAT'S
WHY I SEE THAT PROBABLY THE MOST
FREQUENT, BUT AT THE SAME TIME,
IT COULD BE THE MOST VALUABLE.
SO SOMEONE IN THE COMMUNITY WHO
DOESN'T KNOW THE WHOLE SCIENCE
BEHIND HOW TO CARRY OUT A
CLINICAL TRIAL, AND WHY ALL OF A
SUDDEN YOU'RE NOT ASKING THESE
QUESTIONS BECAUSE I MIG THAT MIE
THEIR PARTICULAR INTEREST.
SO I THINK ADDRESSING THOSE HAS
TO DO AAGAIN -- WHY IT TAKES
TIME TO BUILD YOUR PARTNERS WHO
UNDERSTAND THE RESEARCH DOESN'T
HAPPEN OVERNIGHT, YOU KNOW?
BUT ON THE OTHER HAND, I
ACTUALLY -- I ACTUALLY LIKE
BEING CHALLENGED, I LIKE IT WHEN
I SEE PEOPLE DON'T UNDERSTAND
BECAUSE I KIND OF PUT THAT IN MY
MIND TO WHAT'S THE POSITIVE, HOW
CAN WE ADDRESS THIS LACK OF
UNDERSTANDING, HOW CAN WE MAKE
THIS BETTER UNDERSTOOD, OR MAYBE
THEY'RE BRINGING UP A CHALLENGE
THAT I HADN'T THOUGHT ABOUT.
>> SO IN THE MIDDLE OF YOUR
VACATION AT THE BEACH WHEN THE
KIDS SAY WE SHOULD HAVE GONE TO
THE MOUNTAINS, YOU CAN'T EXACTLY
PACK UP AND GO TO THE MOUNTAINS
BUT YOU CAN SAY WE'LL GO ON
VACATION NEXT YEAR.
I'LL REMEMBER THAT NEXT YEAR.
OKAY.
SO WE'VE GOT TO ASK KEVIN AND
OTHERS TO COME BACK ON FOR THE
SORT OF WRAPPING UP OF TODAY.
>> GREAT.
THANK YOU SO MUCH TO ALL OF OUR
SPEAKERS, AND I SEE LESLIE, DO
YOU WANT TO START US OFF ON OUR
WRAP-UP?
>> WELL, FIRST OF ALL, THANKS TO
GREG AND TO KEVIN FOR MODERATING
SUCH EXCELLENT SESSIONS TODAY.
WHAT A GREAT WAY TO START.
YOU KNOW, I WOULD SAY A KEY
TAKEAWAY FOR ME FROM THESE PANEL
DISCUSSIONS IS JUST THE
CREATIVITY THAT IS REQUIRED.
VERY EARLY ON.
LONG BEFORE THE IDEA TAKES ITS
FINAL SHAPE, THE CREATIVITY
THAT'S REQUIRED IN THINKING
CAREFULLY ABOUT THE QUESTION AND
THEN BRINGING TOGETHER ALL OF
THE DIFFERENT -- ALL OF THE
DIFFERENT PERSPECTIVES.
SO IT NO SURPRISE THAT THE PIs
AND THE TEAMS THAT ARE PART OF
THE COLLABORATORY, THEY'RE A
CREATIVE BUNCH OF FOLKS BECAUSE
IT'S INTEGRAL TO GETTING THE
QUESTION RIGHT, AND TO TRULY
ENGAGING THE COMMUNITIES IN
WHICH THIS RESEARCH IS CONDUC
CONDUCTED.
>> KEVIN AND GREG, I'M REALLY
CURIOUS TO HEAR FROM YOU.
WHAT SURPRISED YOU?
WHAT DID YOU LEARN FROM YOUR
PANELISTS TODAY THAT MAYBE
SURPRISED YOU A LITTLE BIT?
KEVIN, DO YOU WANT TO GO FIRST?
>> SURE.
YOU KNOW, I GUESS ONE OF THE BIG
THINGS THAT CAME OUT, I'M NOT SO
SURE IT WAS A SURPRISE BUT
HEARING THE STORIES IN BOTH
PANELS, ACTUALLY, REALLY PUT
SOME MORE FLESH AND FLOOD ON
THESE IDEAS, AND THAT WAS THE
IMPORTANCE OF ALREADY HAVING A
NETWORK OF CLINICAL COLLEAGUES,
PATIENT REPRESENTATIVES, HEALTH
SYSTEMS LEADERSHIP.
PEOPLE TALKED ABOUT THE EXISTING
CONTEXT AND THE ASSETS THEY HAD
WHEN A CALL FOR APPLICATIONS
CAME OUT.
YOU KNOW, AND HAVING THOSE
PARTNERS ALREADY IN PLACE AT
LEAST AT SOME MINIMUM KIND OF
RELATIONSHIP.
IT SEEM LIKE THAT WAS A CONSTANT
INCREED YENT ACROSS -- THESE ARE
ALL VERY SUCCESSFUL PROJECTS
TOO, THESE ARE THE ONES WHO WERE
SELECTED TO BE FUNDED.
THEY ALL HAD THAT TO SOME EXTENT
AND IT REALLY -- I THINK THAT
STRUCK ME MORE IN THESE STORIES
THIS TIME AROUND AND HOW
CRITICAL THAT IS IF YOU WANT TO
BE MAKING MOVES IN THIS SPACE,
TO NOT WAIT UNTIL THE CALL COMES
OUT, START GENERATING THOSE
RELATIONSHIPS AND INVESTING IN
THEM NOW SO THAT YOU CAN TAKE
ADVANTAGE WHEN SOMETHING POPS
UP.
>> RIGHT.
AND ALONG THOSE LINES, WE HEARD
ABOUT THE IMPORTANCE AND
CHALLENGES OF KEEPING ALL OF
THAT WARM.
WHILE YOU WAIT FOR, UNTIL THAT
OPPORTUNITY COMES ALONG.
GREG, WHAT ABOUT YOUR KEY
TAKEAWAYS, SURPRISES?
>> WELL, GOING BACK TO THE OTHER
QUESTION I ASKED AND WHAT
NATALIA SAID, I LIKED THE WAY
SHE PUT IT ABOUT HEARING FROM
PEOPLE AND THEY' THEY'RE HAVING
STRONGLY HELD OPINIONS THAT ARE
DISPARATE OR DIVERGENT AND HOW
YOU DEAL WITH THAT.
WELL, THE GOOD NEWS IS THAT
PEOPLE CARE ABOUT THIS, WHICH IS
GOOD.
YOU WOULDN'T WANT TO BE
INVESTING SIGNIFICANT RESOURCES
AND FOR AN INVESTIGATOR A
SIGNIFICANT CHUNK OF YOUR LIFE
IN SOMETHING THAT NOBODY CARES
ABOUT.
SO PEOPLE HAVE OPINIONS IT'S --
CREATES A CHALLENGE I THINK IN
TERMS OF BEING ABLE TO TAKE ALL
THAT IN, TO LISTEN TO ALL THAT,
TO REALIZE THAT THE GOAL IS NOT
IN, SAY, A MEETING WHERE YOU'RE
ENGAGING WITH VARIOUS INTERESTED
PARTIES.
THE GOAL OF SUCH A MEETING IS
NOT TO SETTLE THE QUESTION, AT
LEAST THAT'S NOT THE GOAL OF THE
INVESTIGATOR BECAUSE DATASET EL
THE QUESTION, WE HOPE, NOT
OPINIONS SETTLE THE QUESTION.
BUT WE NEED TO KNOW ABOUT ALL
THOSE OPINIONS AND WE NEED TO
THINK ABOUT THIS IS THE WORLD I
AM OPERATING IN, AND EVENTUALLY
AS NATALIA POINTED OUT, THESE
ARE THE PEOPLE WHO WILL NEED TO
TRUST ME IF THE DATA I PRODUCE
ARE ACTUALLY TO LEAD TO CHANGE.
SO THAT IS AN INTERESTING DANCE,
I THINK.
BEING ABLE TO HEAR THAT, TO
ACKNOWLEDGE THE IMPORTANCE OF
ALL THOSE DIFFERENT VIEWS, TO
KNOW THAT PROBABLY NO SINGLE ONE
OF THEM IS EVER GOING TO BE
COMPLETELY RIGHT, THAT IDEALLY I
NEED TO PRODUCE -- ULTIMATELY I
WANT TO CREATE INFORMATION OR
PRODUCE EVIDENCE THAT ADDRESSES
ALL OF THOSE CONCERNS AND IS
STILL CREDIBLE TO THOSE PEOPLE.
>> WENDY, WHAT ARE YOUR THOUGHTS
AFTER TODAY?
>> SO I THINK IT WAS REALLY
INTERESTING TO HEAR THE VERY
DIFFERENT WAYS PEOPLE GOT TO THE
SAME -- GOT TO THEIR RESEARCH
QUESTION.
LIKE THERE'S NOT A COOKBOOK FOR
THIS, RIGHT, YOU KNOW, WE HEARD
IT'S ITERATIVE, YOU MAKE ONE
DECISION AND THEN YOU MAKE
ANOTHER DECISION THAT CHANGES
THE FIRST DECISION A LITTLE BIT
AND YOU NEED TIME TO SORT OF
WORK THROUGH THOSE THINGS AND
PLAN ALL OF THOSE DIFFERENT
ELEMENTS OUT.
SO I THINK THAT WAS REALLY
INTERESTING, AND THEN WHAT I
HEARD ALSO WAS NEEDING TO BRING
THE RIGHT PEOPLE INTO THE
CONVERSATION, EVEN JUST TO
DESIGN THE STUDY, AND THINK
ABOUT WHO YOU NEED TO ENGAGE AND
FOR THE ENGAGEMENT ELEMENT BUT
ALSO FOR THE DESIGN ELEMENTS
TOO.
A LOT OF THE STUDIES HAD
IMPLEMENTATION SCIENCE EXPERTISE
OR THEY HAD ENGAGEMENT EXPERTISE
THAT THEY BROUGHT ON TO THEIR
TEAM, WHICH IF YOU'VE DONE
TRIALS BEFORE IS SORT OF MORE A
CLASSIC EFFICACY STUDY, THOSE
USUALLY AREN'T PEOPLE YOU'RE
PARTNERING WITH SO BEING ABLE TO
FIND THOSE FOLKS I THINK IS
REALLY IMPORTANT AND BEING ABLE
TO FIND THAT EXPERTISE.
SO AS ALWAYS, LOTS OF LESSONS
LEARNED FROM ALL OF OUR
INVESTIGATE SORES, AND MORE --
INVESTIGATORS AND MORE TO THINK
ABOUT.
>> GREAT.
WELL, IT WAS A TERRIFIC START,
DAY ONE OF A TWO-DAY WORKSHOP,
AND YOU KNOW, WENDY, I'M LOOKING
AT THE CLOCK AND I SEE THAT WE
REALLY ONLY HAVE A COUPLE OF
MINUTES, SO PERHAPS WE SHOULD
JUST POINT FOLKS TO WHAT'S UP
FOR TOMORROW.
DOES THAT SOUND GOOD?
>> THAT SOUND GREAT.
>> GREAT.
SO WE HOPE YOU'LL ALL JOIN US
TOMORROW.
WE'LL BEGIN WITH A KEYNOTE
PRESENTATION FROM DR. MONICA
BERTAGNOLLI, AND REALLY LOOKING
FORWARD TO THAT, FOCUSING ON
REALLY IDENTIFYING THOSE HIGH
PRIORITY HEALTHCARE ISSUES THAT
REALLY REQUIRE WHAT WE'VE BEEN
TALKING ABOUT HERE, THE EFFORT,
TIME AND FUNDING OF A TRIAL.
WE'LL GO FROM THERE TO HEAR FROM
OUR PIs ABOUT HOW THEY'VE USED
DATA FROM DISPARATE DATA
SYSTEMS, A CHALLENGE THAT'S
COMMON TO ALL PRAGMATIC TRIALS.
WE'LL HEAR FROM ANOTHER PANEL
ABOUT HOW TO REACH THE
POPULATIONS THAT ARE MOST
AFFECTED BY HEALTH INEQUITIES,
AND THEN WE'LL REALLY ROUND IT
OUT BY TALKING ABOUT HOW TO
OVERCOME SOME OF THE
ADMINISTRATIVE BURDENS THAT
THREATEN PRAGMATIC RESEARCH.
SO IT WILL BE A FANTASTIC DAY,
MORE INSIGHTS TO COME, AND MAYBE
WITH THAT, WENDY, I'LL TURN IT
OVER TO YOU FOR THE THANK YOU
AND FAREWELL.
>> YEAH.
SO AGAIN, THANKS TO ALL OF OUR
ORGANIZERS, ALL OF OUR SPEAKERS,
OUR MODERATORS, AND EVERYONE FOR
JOINING US.
WE WILL LOOK FORWARD TO SEEING
YOU TOMORROW.
WE'RE STARTING AT 11:00 A.M.
EASTERN, WHICH IS 8:00 A.M.
PACIFIC.
AND WE'LL SEE YOU ALL TOMORROW.
BYE-BYE, EVERYONE.
>> GOODBYE.