planning for successful engagement in research
TRANSCRIPT
Planning for Successful Engagement in ResearchChinenye Anyanwu, PharmD, MPH Engagement OfficerPatient & Public Engagement
• Betterresearchthroughengagement• Engagementtoolsandresources• ElementsofEngagement• Q&A
Discussion for Today
Better Research Through Engagement
We Fund Research That…
• Patientsarepartnersinresearch,notjust“subjects”
• Activeandmeaningfulengagementbetweenscientists,patients,andotherstakeholders
• Community,patient,andcaregiverinvolvementalreadyinexistenceorawell-thought-outplan
“Patientandstakeholderengagement”
Whatwemeanby…
• Theprojectaimstoanswerquestionsorexamineoutcomesthatmattertopatientswithinthecontextofpatientpreferences
• Researchquestionsandoutcomesshouldreflectwhatisimportanttopatientsandcaregivers
“Patient-centeredness”
Why Engage?
Toestablishtrustandasenseoflegitimacyinresearchfindings
Toencouragesuccessfuluptakeanduseofresearchresults
Toinfluenceresearchtobepatient-centered,relevant,anduseful
• Meaningfulinvolvementofpatients,caregivers,clinicians,andotherhealthcarestakeholdersthroughouttheresearchprocess
• Detailed,well-thought-out,andcreativeengagementplan
• Diversegroupsofstakeholders
• Engagementtakesmanyshapesandsizes,notonesizefitsall!
What We Mean by Engagement…
• Reciprocalrelationships• Co-learning• Partnership• Trust,transparency,honesty
Core Engagement Principles
PCORI projects engage many stakeholders
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PCORIProjectsensureresultsareUSEFUL by
activelyinvolvingthePEOPLEWHO
KNOW
59%ADVOCACYORGS
87%PATIENTS
88%CLINICIANS
50%CAREGIVERS
56%HEALTHSYSTEMS
Top5EngagedStakeholderCommunities:(bypercentofprojects)
Note:Datafromannualawardeereport;93responsesaboutprojectyear1;145responsesaboutprojectyear2
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PCORI projects engage stakeholders throughout the entire research process.
Note:Datafromannualawardeereport;93responsesaboutprojectyear1;145responsesaboutprojectyear2
Decidingwhatthestudyisabout
61%Choosinginterventionsorcomparators
68%
Choosingoutcomes Choosingother
aspectsofstudydesign
Recruitingorretainingstudyparticipants
Collectingdata
75%
66%
63%
39%
ResearchPhasesEngagingStakeholders:(bypercentofprojects)
3outof5PCORIprojectsengagestakeholdersineveryearlyphaseofresearchsothatthestudiesmattertopatients
Providepersonalperspectives(e.g.,priorities,experiences)
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Giveguidancetoimprove researchprojectprocessesandmaterials(e.g.,outcomesstudied,recruitmentstrategies)
Activeparticipationinconductanddissemination(e.g.,recruitingparticipants,collectingdata,presentingresults)
Note:DatafromannualawardeereportandPatientandStakeholderWE-ENACT.258responsesfromawardees,254responsesfrompartners
PCORI research partners change the research
Betterunderstandingofstakeholders’personalperspectives(e.g.,priorities,experiences)
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Refinedstudy thatismorepatient-centered• Researchquestions• Interventionsand/orcomparators• Outcomesandmeasures• Datacollection• Recruitment/retentionstrategies
Enhancedstudyparticipantenrollmentrates
Engagement makes a Difference in PCORI Projects
Note:Keythemesfromprojectyears1and2(N=258awardees,254partners)Themesmentionedin>10%ofresponsesofbothpartnersandawardees.
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Minneci PC,Nacion KM,LodwickDL,CooperJN,DeansKJ.ImprovingSurgicalResearchbyInvolvingStakeholders.JAMASurgery.June2016.
A20-membermultidisciplinarystakeholdergroupwasengagedinallphasesoftherandomizedcontrolledtrial(RCT)investigatingtheeffectsofapatientactivationtoolinuncomplicatedpediatricappendicitis.
Stakeholdersinvolved:• Childrenages7to17andtheir
families• Community-based
pediatricians• Emergencymedicine
physicians,surgeons,nurses• Patienteducators• Payers
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Minneci et al. 2016 JAMA
“Participantenrollmentand30-dayretentionratesintheRCTofpediatricappendicitisimprovedsignificantlyaftertheadoptionof
stakeholderrecommendations.”
Changetheenrollmentscript
EnrollmentinRCTincreasedfrom65%to95%
Offeranonlineoptiontocompletefollow-upquestionnaires
StakeholderRecommendation:
Rateofcompletionfor30-dayfollow-upincreasedfrom58%to85%
Impact:
• Establishednewrelationships• Improvedpersonalhealthmanagement• Madeadifferenceinthelivesofothers• Personalgrowthorself-improvement• Gainednewknowledgeandinsightsaboutresearch• Newprofessionalopportunities• Beliefinpatient/stakeholderrepresentationinresearch
MostCommonEffectsofEngagementonPartners
Effects of Engagement on Partners
Understandingthevarioushealthdisparitiesleadingtodiabetes,kidneydiseasehasmademeassessmypersonallife,mylevelofphysicalactivityandmyfoodintake.Ihavemadechangesinmylifestyle whichincludeexercising3xperweekandencouragingmyfamilytotakepartinphysicalactivitiessuchashiking,basketballandsoforth…Thiswasaneyeopener.
–OthertypeofStakeholder
PatientsI'vebeenworkingwithhavetaughtmetobeabetterpatient,toselfadvocate.– Caregiver/FamilyMember
Asan‘older’citizen,withmobilitylimitations,thisinvolvementhasallowedmeto…contribute"tothebettergood".AlthoughIhavepersonalmedicalissuesandchallenges,…doingwhatIcaninmyverylimitedcapacitytoimprovingopportunitiesforbroaderpatientinvolvementinhealthcaredecisionmakingandtheshapingofhealthcaretoreflectpatientneeds.– Patient/Consumer
Engagement Tools and Resources
• Relationshipbuilding,maintainingthroughoutandbetweenprojects
• Budgetingforengagementexpenses
• Feasibilityofincorporatingfeedback
• Trainingandskilldevelopmentneeds(forpartnersandresearchers)
• Compensation
• Determininglevelanddepthofengagementofstakeholders
• Engaginghardtoreachandvulnerablepopulations
“Engagement is hard…”
Engagement Rubric
Providespracticalguidancetoapplicants,meritreviewers,awardees,andengagement/programofficersoneffectiveengagementinresearch
• PlanningtheStudy:Howpatientandstakeholderpartnerswillparticipateinstudyplanninganddesign
• ConductingtheStudy:Howpatientandstakeholderpartnerswillparticipateintheconductofthestudy
• DisseminatingtheStudyResults:Howpatientandstakeholderpartnerswillbeinvolvedinplanstodisseminatestudyfindingsandensurethatfindingsarecommunicatedinunderstandable,usableways
• PCOREngagementPrinciples:Reciprocalrelationships,co-learning,partnership,trust,transparency,honesty
InitialreviewofEngagementPlansinportfolio,postedexemplarplanstoPCORIwebsite PartnerBiosketches,
templatecreatedtocaptureexpertiseofpatient/caregiverpartners
CreationofEngagementOfficer,stafftaskedwithensuringandsupportingengagementinfundedawards
EngagementBudgetingDocument,aresourcethatprovidesguidanceonhowtoappropriatelybudgetforengagementactivities
EngagementToolkit(underdevelopment),acomprehensivepackageofmaterialsonpatient-engagedresearch
EngagementWebinarSeries,highlightingemergingpromisingpracticesofpatientandstakeholderengagementfromPCORI-fundedprojects
PCORICompensationFramework,atoolforevaluatingtheeffortandappropriatefinancialcompensationforpatient/caregiverpartners
Patient-CenteredMethodologyStandardsandMeritReviewCriteriaestablished
2013 2014 2015 2016
Additional Tools to Support Engaged Research
Elements of Engagement
• Structure• Budget• Levelofinvolvement• “Representativeness”• Training• Maintainingengagementthroughstudyconduct• Evaluation• Dissemination
Elements of Engagement to Consider
• AdvisoryBodyCategories– singleadvisorygroupwithpatientsandstakeholders– stakeholders/patientsblendedwithcorestudyteam– stakeholder-onlyadvisorygroup– patient-onlyadvisorygroup– Other….
• Frequencyofconvenings• Locationofconvenings (neutral? virtual?)• Leadership
– Designatedengagementlead/pointofcontact• Representationofleadonkeydecision-makingcommittee?
– Engagementoutsourcedorsubcontractedtoaseparateinstitute/institution/organization
Structure of Engagement
• OngoingCommunication– Mechanisminplacetoensuretransparencyandequalaccesstoinformation
forallmembersoftheresearchteamincludingpatient/stakeholderpartners
• RolesandResponsibilities– Sharedunderstandinganddocumentationofpatient/stakeholderpartners’
rolesandresponsibilities
Structure of Engagement
StudyAdvisoryCommittee(SAC)Co-leads:MattMichaels&ElizaSingletonSpecificmembersTBDFacilitatedby:SamanthaMooreMeetstwiceperyear
ALPHAOrgMattMichaelsLeeRogersBethMcAdamsJimSandersJohnLevingston
XYZHealthSystem AcmeResearch
University
CoreResearchTeam
EstablishedPanels&Workgroups
Facilitatedby:SamanthaMooreMeetseverytwoweeks;participantsvarybasedonagendaitems
StudyPatientPanelLead:BethMcAdams
Facilitatedby:NormanBates
Meetsquarterly
BobJacobsMeredithMiller
StudyCaregiverPanelLead:JimSandersFacilitatedby:NormanBates
Meetsquarterly
ElizaSingleton(PI)AndrewFisherSteveMillerAlbertoSing
StudyClinicalStakeholderPanelLead:JohnLevingstonFacilitatedby:SamanthaMoore
Meetsquarterly
StudyStateStakeholderPanelLead:LeeRogersFacilitatedby:SamanthaMoore
Meetsquarterly
ALPHAPatientEngagementPanel(PEP) ALPHAPractice-BasedResearchNetwork(PBRN)
NormanBates(Co-Chair)JimSanders(Member)BethMcAdams(Member)
Meetsmonthly
MattMichaels(Co-Chair)JohnLevingston(Member)
Meetsmonthly
MedicaidEvidence-basedDecisionsProject(MED)
JessicaMcDonald(Member)Meetsmonthly
TheinvestigatorswillupdatePEPquarterly,solicitfeedbackandreportbacktoResearchTeam
TheinvestigatorswillupdatethePBRNquarterly,solicitfeedbackandreportbacktoResearchTeam
TheinvestigatorswillupdatetheMEDquarterly,solicitfeedbackandreportbacktoResearchTeam
University(U)MichaelStewart,PhDDean,SchoolofHealthProfessions
BrookshireFoundation(BF)DwightHowardPresident,BF
EmilyStriverBusinessManager
FrankGoldstein,PhDPrincipalInvestigatorBFEndowedChair&ResearchDirector
BrookshireFoundation
LisaMingProjectCoordinator
MarkWhiteU/BFResearchCollaborativeManager
ToddManlyVideographer
PamO'HaraGraduateResearchAssistant
RonaldCenterforAlzheimer’s(clinicalfacility)
University
Dissemination&RecruitmentStakeholderTheConsortiumofAlzheimerCenters– SouthAmericanResearchConsortiumonAlzheimer– NationalAlzheimerSociety– AlzheimerFoundation– AlzheimerAssociationofAmerica
Patient&EngagementCoreTeriRider,MDCo-PrincipalinvestigatorBrittanyDonahueClinicalStudyCoordinator
Alzheimer’sPatientand
StakeholderPanel
ParticipatingClinicalCenters
AnalyticsCore
BehavioralCore
Information&CommunicationTechnologyCore
ConsultantsJessLochte,PhD JimHubert,PhD
TomArnold,PhD
SusanBoshLeadBiostatistician
DonAndrewsDataAnalyst
KarenFosterBehaviorInterventionist
Soon- LeeHuPostDoc
BenThompsonDirectorofInformationTech.
SteveFreeholdJohnSmithApp.Developers
RobinJeffries,PhD– StakeholderPanelChairTiaBurns– BethanyLonghorn– ChrisStewart– MollyMoore– SandyHigh– RachelVaughn– SamWestfield
Brownstone– Strayer– Fulhorn–SouthCoastMethodist– SilverWest– TherapyPartners
• Adequatebudgetingforengagementactivities(e.g.,compensationofpartners,meetingsupport,etc.)
• Equityinpartnercompensation• Supportallaspectsofpartners’roles(e.g.,meetingpreparationsupport,stipend,
childcare,travel,presentations,etc.)
Budget
Level of Involvement
Adapted from Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic. See also Arnstein SR. A ladder of citizen participation. Journal of the American Planning Association. 1969;35:216–24
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• Information:Researcher(s)describedecisionstopatientsafterdecisionsaremade.
• Consultation:Patientsprovideinputtoresearchersthatmayinformdecision-makingbuthavenorepresentationwithinstudyleadership(steering,executive,orinvestigatorcommittee)
• Collaboration:Patientsworkdirectlywiththeresearcher,maybeinvitedtoparticipateinleadershipmeetings(e.g.,steering,executive,investigatorcommittees)inactivepartnership,toensurethattheirperspectivesareincorporatedindecision-making.
• Patient/stakeholderdirection:Alsoknownas“usercontrol,”patientshavecontrolovertheresearchprocessandthefinaldecision-making.Co-IorCo-PI
Level of involvement: Patient
• Information:Researcher(s)describedecisionstostakeholdersafterdecisionsaremade.
• Consultation:Stakeholdersareconsultedfortheirinputbuthavenorepresentationwithinstudyleadership
• Collaboration:Stakeholdersworkdirectlywiththeresearcher,maybeinvitedtoparticipateinleadershipmeetings(e.g.,steering,executive,investigatorcommittees)inactivepartnership,toensurethattheirperspectivesareincorporatedindecision-making.
• Patient/stakeholderdirection:Stakeholderlevelofinvolvementexceedsservinginanadvisorycapacityandincludesanyofthefollowing;coveringinterventioncosts,supportingstudysites,overseeingdatacoordinatingcenters,servingonstudyleadershipcommittees,isaCo-Investigator/Co-PrincipalInvestigator,
Level of involvement: Stakeholder
• Theextenttowhichmembersservingonadvisorycommitteesorinanypartnershipcapacityarerepresentativeofthestudypopulationorrangeofendusers
• Challengingissueinengagedresearch
Also...thinkaboutadequatebalanceofinterests
“Representativeness”
WhichStakeholder?Whatisatstake? (1)Patients (2)ED
Clinicians(3)Primarycarephysicians
(4)Heathpolicydecisionmakers/Payers
(5)Cardiologists
Access tooutpatientcare X X X X
Quality &safetyofcare X X X
EDoperations(flow,utilization)
X X
Cardiologyproceduralservices(e.g.,stresstesting,catheterization)
X X
Healthcareutilization/costs
X X
Inthisstudy,whataretheanticipatedcentralissuesatstakeforeachofthestakeholders?
Giventheseanticipatedissuesandthepotentiallyaffectedparties,whichindividualswillcomprisethepatientandstakeholderadvisorygroup?
• Patient/Stakeholdertrainingonresearch,humansubjectsprotectionand/orethics
• Studyteammemberskill-basedtrainingonengagement(e.g.meetingfacilitation,developingconsensusetc.)
• Combinedtrainingofpartnersandresearchersonteamscience,basicsofengagedresearch
Training
• InvolvementinRecruitment– developingandreviewingrecruitmentmaterials– developingrecruitmentstrategies– collectingdatafromstudyparticipants– trainingstaffonrecruitmentprocess
• DataAnalysis– Training/preparing– Interpretation
Maintaining Engagement
• Mechanisminplacetoassesspatient/stakeholderpartnerinvolvementthroughoutthecourseofthestudy
Consider…- periodicsurveyofpatient/stakeholderpartnerstogatherfeedback/satisfaction- assessmentofpatient/stakeholderengagementviavalidatedsurveyinstrument
orsemi-structuredinterviewstocontinuouslyimproveengagement
Evaluation
• Patientandstakeholderpartnershaveadefinedroleindisseminatingstudyfindings(e.g.beyondprofessionalsocietymemberships,socialmediapostings,websitepostings)
Dissemination
• PCORI’sMethodologyStandardsPC-1toPC-4
• PCORIhasdevelopedotherresourcestohelpguideyourengagementactivities,housedonthe“WhatWeMeanbyEngagement”pageonthePCORIwebsite
• EngagementResourcesinclude:– FrameworkforFinancialCompensationofPatient,CaregiverandPatientOrganizationStakeholders
– EngagementRubric– SampleEngagementPlans– PCORIStakeholderGroups– ShortVideosonEngagementinResearch
Additional Engagement Resources
• CommunicationisKEY!• Alwayskeeptheenduserinmind(clinicians,patients,caregivers,
stakeholders,etc.)• Mistrusttakessecondstoformandyearstodeconstruct• Training,training,training!• Engagementisrelational,nottransactional• Createequity—environmentthatsupportspartnerships,bi-directional
learning,etc.• Mentorship• Cultureshift—Researchersareafraidofpatients,patientsareafraidof
researchers
Engagement is hard….but not Impossible!
