Collaborating with the OEF/OIF/OND Community for Research Success

1. Collaborating with the OEF/OIF/OND Community for Research Success Drew A. Helmer, MD, MS Neurorehabilitation: Neurons to Networks Rehabilitation Research & Development Center of Excellence Michael E. DeBakey VA Medical Center Baylor College of Medicine August 10, 2011

2. Objectives • At 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.

3. Research • The systematic collection of information for the purpose of discovering new, universal truths • Generalize findings from the sample to the population • Expensive • Requires extensive education/training • Invasive/intrusive • Time consuming

4. Ethical Principles of Research • Ethics guided by three Belmont Principles • Autonomy/Respect for Persons • Beneficence/Non-maleficence • Justice/Equity

5. 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: • Locus • Sharing • Joint action • Social ties • Diversity • Examples • Family • Neighborhood/city • Civic or social organizations • Business

6. Research Case Examples- An intentionally provocative comparison AIDS Persian Gulf War ‘Syndrome’ Identified ca. 1980 Identified etiology Effective, evidence-based treatments widely available Improved prevention Continues to be prominent research priority Scientific benefits beyond the original focus Identified ca. 1992 Etiology(ies) unclear No specific evidence-based treatment Persistent post-concussive symptoms in OEF/OIF Veterans Low research priority Impact of results?

7. 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”

8. Post-Deployment Health Research • Examples • Funding • Funding Sources • Foci • Post-traumatic stress disorder • Traumatic brain injury • Pain • Care Delivery • Prosthetics • Reintegration/Social Factors

9. Challenges of PDH Research • Recruitment • Retention • Concerns about secondary gain/symptom exaggeration • Complex comorbidities/condition overlap • VA stigma • Mental health stigma • Regulatory/Policy restrictions • Channels of communication • Participant reimbursement • Engaging clinicians in the effort

10. A Culture of Curiosity-VHA Research Stakeholders • Engage patients and families at enrollment • Consent to care includes language about research uses of clinical data • Engage employees • Highlight Veteran employee participation • Educate about ongoing projects • Provide talking points • Provide buttons/information cards • Engage clinicians • VHA physician-researchers more satisfied than non-researchers • Include in study design, recruitment, assessment, analysis and dissemination

11. Community Engaged Research • A framework • A continuum • Community 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)

12. Benefits of Community Engaged Research • Promote 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.

13. Ethical Considerations & Processes for Managing Issues • Considerations • Risks to individual • Risks to community (group) • Risks to individual vis a vis group membership • Solutions • Train Investigator and Research team • Institutional Review Board • Data Safety and Monitoring Plan • Conflict of Interest Review • Research Ethics Consultation program • Research Subject Advocacy program • Community Advisory Board

14. Neurorehabilitation:Neurons to Networks RR&D Research COE • Recruit for the main protocol • Genetics • Community Reintegration of Servicemembers instrument • Temporal perception test • Behavioral Assessment Core I • Behavioral Assessment Core II • fMRI- working memory processing • fMRI- social interaction

15. Participant Flow BAC1 BAC2 fMRI

16. Who • Inclusion Criteria • OEF/OIF veterans • mTBI or controls • Injured after 2003 • Exclusion Criteria • Pre or Post deployment hospitalization for head injury • Baseline cerebral palsy, mental disability, epilepsy, bipolar disorder, schizophrenia • Any history of brain surgery

17. Targets for Recruitment • Core pilots of the protocol had a wide range of recruitment targets, without specific time frames • Current expectation • 60 cases & 40 controls per year • Recruitment weekly goals • Referrals- 10 • Screened- 8 • Eligible- 3 • These targets will result in 144 subjects a year

18. Resources for Recruitment • Director of Recruitment and Retention Core • Clinical Champion for Post-deployment health at facility and VISN • Full time research assistant • Administrative assistance from administrative officer and other research assistants • Center investigators

19. Overall Numbers for TBI CoE • Referrals= 420 • Screened= 302 • Initial visits= 118

20. 2011 summary

21. Participant Volume

22. Reasons for Exclusion/Drop Off • From referral to screening • Not interested • No contact info • Not 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 testing • Positive alcohol abuse screen • Positive substance abuse screen

23. Referrals by source to date • Post deployment clinic 36 – 9% • Traumatic Brain Injury clinic 167 – 40% • Mental Health 42 – 9% • Other- ** 178 – 42% • **(PrimeCare, Vet Centers, CBOC’s, community events)**

24. Putting things in perspective In the greater Houston area: • 19,000 deployed OIF/OEF veterans • 10,000 have used VHA • 5,000 used VHA in past year • 2132 out of 9082 (23%) screened positive for TBI • 1471 out of 2132 (69%) completed TBI 2nd level clinical evaluation • 989 of 1471 (68%) were determined to have experienced a concussion/mTBI

25. Recruitment Sources

26. Recruitment Strategies • Direct • Indirect • Community Engaged Research • Marketing/Public Relations • Social Media

27. Direct Recruitment • Face to face- in facility • Ellington Field Joint Reserve Base • OEF/OIF program outreach • Welcome home events • Yellow Ribbons • Veteran Service Organization Meetings/Activities • Lonestar Veterans Association • Iraq and Afghanistan Veterans Association • Student Veteran Associations

28. Indirect Recruitment • VHA providers • PrimeCare • TBI clinic • Post Deployment Clinic • Mental Health (Trauma Recovery Program) • Community Based Outpatient Clinics • School Veteran Counselors • Veteran Service Organizations • Vet Centers • Other community-based healthcare providers

29. Community Engagement • Community Council for TBI COE • Speakers bureau • Attendance/sponsorship at community events • Engage OIF/OEF/OND Veteran volunteers • Clinical placements for OEF/OIF/OND Veterans

30. Social Media/Other Technology • Facebook • VHA national • VHA local • Non-VHA • Invited group facebook page • Twitter • Text messaging

31. Marketing/Public Relations • Press releases • Media relations • Brochures • Advertisements

32. Criteria for Recruitment Activities • Audience size • Audience type: military, researchers, students • Type of activity: direct, indirect, community engagement, PR • Cost • Other potential benefits to N:N2N COE • Education • Name recognition • Goodwill

33. Current/Future direction for recruitment • Maintain/Build/Enhance current clinical referral base • Schools • Working with counselors for new enrollment year • Strengthen relationships with VSO’s • Advertisements • Social media • Plan to use local Facebook page starting October 1, 2011 • Mail recruitment letters from providers • “Refer a friend” rewards program

34. Retention • Ongoing contact with VSO’s • Mailed thank you cards at end of calendar year 2010 • Newsletter planned for end of 2011 • Recontact participants for new research opportunities

35. Observed Challenges • Recruiting controls • Scheduling appointments (no-shows) • Comorbidities (e.g., PTSD, mTBI, alcohol abuse) • Failure rate on effort testing • Paucity of visible, effective OEF/OIF VSO’s • Volunteer fatigue in VSO community leaders • Delay in development of ‘veteran’ identity • Stigma of combat experience in the school/workplace • Handling disappointed ineligible Veterans

36. Next Steps • Enhance retention through a longitudinal study • Need more resources • Promote more ‘give backs’ to participants and community • Newsletter • Presentations of results to lay audiences • Summary of some findings from assessments • Enlarge pool of OEF/OIF/OND Veteran volunteers engaged in COE activities • Formalize/enhance Veteran Community Council involvement

37. Conclusions • Recruiting OEF/OIF/OND Veterans for research is challenging. • Community engaged research activities may help. • Other benefits to community • Cost/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.

38. Contact Information • Drew A. Helmer, MD, MS • Michael E. DeBakey VA Medical Center • Houston, TX 77030 • Drew.helmer@va.gov • 713-791-1414 x 7010 or 713-794-8157