Drew A. Helmer, MD, MSNeurorehabilitation: Neurons to

Networks Rehabilitation Research & Development Center of Excellence

Michael E. DeBakey VA Medical Center

Baylor College of MedicineAugust 10, 2011

Collaborating with the OEF/OIF/OND Community

for Research Success

ObjectivesAt the end of this session, participants will

be able to:Articulate challenges in recruiting

OEF/OIF/OND Veterans for research activities.Discuss the pros and cons of engaging the

OEF/OIF/OND Veteran community as an active partner in research.

Apply examples from the case presented to their personal research endeavors.

ResearchThe systematic collection of information for

the purpose of discovering new, universal truthsGeneralize findings from the sample to the

populationExpensiveRequires extensive education/trainingInvasive/intrusiveTime consuming

Ethical Principles of ResearchEthics guided by three Belmont Principles

Autonomy/Respect for PersonsBeneficence/Non-maleficenceJustice/Equity

Community A group of people with diverse characteristics who are linked

by social ties, share common perspectives, and engage in joint action in geographical locations or settings.

Common elements:LocusSharingJoint actionSocial tiesDiversity

ExamplesFamilyNeighborhood/cityCivic or social organizationsBusiness

Research Case Examples- An intentionally provocative comparisonAIDS Persian Gulf War ‘Syndrome’Identified ca. 1980Identified etiologyEffective, evidence-

based treatments widely available

Improved preventionContinues to be

prominent research priority

Scientific benefits beyond the original focus

Identified ca. 1992Etiology(ies) unclearNo specific evidence-

based treatmentPersistent post-

concussive symptoms in OEF/OIF Veterans

Low research priorityImpact of results?

OEF/OIF/OND Veterans Demographics-

70% <40 years old 88% men

Geography- Rural vs. urban Regional distribution Mobility

Education/Training- not researchers Life Experience-

High school, some college Military

Personal Priorities- Education/training Employment Family

Identity- many don’t self-identify as a “Veteran”

Post-Deployment Health ResearchExamplesFundingFunding SourcesFoci

Post-traumatic stress disorderTraumatic brain injuryPainCare DeliveryProstheticsReintegration/Social Factors

Challenges of PDH ResearchRecruitmentRetentionConcerns about secondary gain/symptom

exaggerationComplex comorbidities/condition overlapVA stigmaMental health stigmaRegulatory/Policy restrictions

Channels of communicationParticipant reimbursement

Engaging clinicians in the effort

A Culture of Curiosity-VHA Research StakeholdersEngage patients and families at enrollment

Consent to care includes language about research uses of clinical data

Engage employeesHighlight Veteran employee participationEducate about ongoing projects

Provide talking pointsProvide buttons/information cards

Engage cliniciansVHA physician-researchers more satisfied than

non-researchersInclude in study design, recruitment, assessment,

analysis and dissemination

Community Engaged ResearchA frameworkA continuumCommunity Based Participatory Research

A collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities. (WK Kellogg Foundation)

Benefits of Community Engaged ResearchPromote understanding between researchers

and target groups (e.g., promote trust).Enhance participation in research activities.Provide a more detailed understanding of the

environmental and social aspects of a problem that may impact implementation.

Promote adoption of effective solutions.Provide continuity for sustained impact.Educate targeted group members.Prepare target community and members for

findings of study.

Ethical Considerations & Processes for Managing IssuesConsiderations

Risks to individualRisks to community (group)Risks to individual vis a vis group membership

SolutionsTrain Investigator and Research teamInstitutional Review BoardData Safety and Monitoring PlanConflict of Interest ReviewResearch Ethics Consultation programResearch Subject Advocacy programCommunity Advisory Board

Neurorehabilitation:Neurons to Networks RR&D Research COERecruit for the main protocol

GeneticsCommunity Reintegration of Servicemembers

instrumentTemporal perception testBehavioral Assessment Core IBehavioral Assessment Core IIfMRI- working memory processingfMRI- social interaction

Participant Flow

BAC1

BAC2

fMRI

WhoInclusion Criteria

OEF/OIF veteransmTBI or controlsInjured after 2003

Exclusion CriteriaPre or Post deployment hospitalization for

head injuryBaseline cerebral palsy, mental disability,

epilepsy, bipolar disorder, schizophreniaAny history of brain surgery

Targets for RecruitmentCore pilots of the protocol had a wide range

of recruitment targets, without specific time frames

Current expectation60 cases & 40 controls per yearRecruitment weekly goals

Referrals- 10Screened- 8Eligible- 3

These targets will result in 144 subjects a year

Resources for RecruitmentDirector of Recruitment and Retention Core

Clinical Champion for Post-deployment health at facility and VISN

Full time research assistantAdministrative assistance from

administrative officer and other research assistants

Center investigators

Overall Numbers for TBI CoEReferrals= 420Screened= 302Initial visits= 118

2011 summary

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35

40

ScreenedInitial visits

Participant Volume

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10

20

30

40

50

60

70

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20

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90

1/20/10-1/1/11 1/1/11-6/26/11 6/27/11-Present

Volume

Reasons for Exclusion/Drop OffFrom referral to screening

Not interestedNo contact infoNot qualified; not OIF/OEF veteran

From screening to initial visit (BAC1)No show (3 chances)

From initial visit (BAC1) to neuropsychologic testing (BAC2)Failed effort testingPositive alcohol abuse screenPositive substance abuse screen

Referrals by source to datePost deployment clinic 36 – 9%Traumatic Brain Injury clinic 167 – 40%Mental Health 42 – 9%Other- ** 178 – 42%

**(PrimeCare, Vet Centers, CBOC’s, community events)**

Putting things in perspectiveIn the greater Houston area:19,000 deployed OIF/OEF veterans10,000 have used VHA5,000 used VHA in past year2132 out of 9082 (23%) screened positive

for TBI1471 out of 2132 (69%) completed TBI 2nd

level clinical evaluation989 of 1471 (68%) were determined to

have experienced a concussion/mTBI

Recruitment Sources

Recruitment StrategiesDirectIndirectCommunity Engaged ResearchMarketing/Public RelationsSocial Media

Direct RecruitmentFace to face- in facilityEllington Field Joint Reserve BaseOEF/OIF program outreach

Welcome home eventsYellow Ribbons

Veteran Service Organization Meetings/ActivitiesLonestar Veterans AssociationIraq and Afghanistan Veterans AssociationStudent Veteran Associations

Indirect RecruitmentVHA providers

PrimeCareTBI clinicPost Deployment ClinicMental Health (Trauma Recovery Program)Community Based Outpatient Clinics

School Veteran CounselorsVeteran Service OrganizationsVet CentersOther community-based healthcare providers

Community EngagementCommunity Council for TBI COESpeakers bureauAttendance/sponsorship at community

eventsEngage OIF/OEF/OND Veteran volunteersClinical placements for OEF/OIF/OND

Veterans

Social Media/Other TechnologyFacebook

VHA nationalVHA localNon-VHAInvited group facebook page

TwitterText messaging

Marketing/Public RelationsPress releasesMedia relationsBrochuresAdvertisements

Criteria for Recruitment ActivitiesAudience sizeAudience type: military, researchers,

studentsType of activity: direct, indirect, community

engagement, PRCostOther potential benefits to N:N2N COE

EducationName recognitionGoodwill

Current/Future direction for recruitmentMaintain/Build/Enhance current clinical referral

baseSchools

Working with counselors for new enrollment yearStrengthen relationships with VSO’sAdvertisementsSocial media

Plan to use local Facebook page starting October 1, 2011

Mail recruitment letters from providers“Refer a friend” rewards program

RetentionOngoing contact with VSO’sMailed thank you cards at end of calendar

year 2010Newsletter planned for end of 2011Recontact participants for new research

opportunities

Observed ChallengesRecruiting controlsScheduling appointments (no-shows)Comorbidities (e.g., PTSD, mTBI, alcohol abuse)Failure rate on effort testingPaucity of visible, effective OEF/OIF VSO’sVolunteer fatigue in VSO community leadersDelay in development of ‘veteran’ identityStigma of combat experience in the

school/workplaceHandling disappointed ineligible Veterans

Next StepsEnhance retention through a longitudinal study

Need more resourcesPromote more ‘give backs’ to participants and

communityNewsletterPresentations of results to lay audiencesSummary of some findings from assessments

Enlarge pool of OEF/OIF/OND Veteran volunteers engaged in COE activities

Formalize/enhance Veteran Community Council involvement

ConclusionsRecruiting OEF/OIF/OND Veterans for research is

challenging.Community engaged research activities may help.

Other benefits to communityCost/benefit assessment is critical

Veterans must participate in research if they want answers to their concerns about deployment-related health issues.

Researchers must consider the priorities of the Veteran community regarding deployment-related health issues, demonstrate appreciation for their participation, and educate the community to succeed.

Contact InformationDrew A. Helmer, MD, MSMichael E. DeBakey VA Medical CenterHouston, TX 77030Drew.helmer@va.gov713-791-1414 x 7010 or 713-794-8157