1. Conceptual, Methodological and Practical Issues in the Recruitment and Retention of Participants OBSSR’s NIH Summer Institute on Behavioral and Social Intervention Research July 9-13, 2012 Allen Zweben, Ph.D. Associate Dean and Professor, Columbia University School of Social Work

2. 2 Why is Recruitment and Retention Important? ♦ Facilitate the flow of subjects ♦ Minimize compliance difficulties ♦ Test study hypotheses ♦ Enhance generalizability

3. 3 Issues in Fulfilling Recruitment and Retention Objectives in Combination Trials ♦ Stringent inclusion and exclusion criteria ♦ High task demands made on participants ♦ Severe everyday hardships of participants ♦ Resume drinking and drug use behavior during the course of the study ♦ Treatment assignment incompatible with preferences ♦ Concerns about receiving control condition

4. Stringent Inclusion Criteria ♦ Alcohol dependence only ♦ Limited number of detoxifications ♦ No legal problems ♦ Stable housing ♦ Need to have a locator 4

5. High Task Demands ♦ Blood and urine specimens ♦ Too many assessments ♦ Side effects of medication 5

6. Resume Drinking and Drug use ♦ RA will inform therapist about drinking and drug use 6

7. 7 − Community Provider Referral Networks ♦ Physicians ♦ Alcohol and drug counselors ♦ Social service agencies − Media and Publicity Strategies ♦ Newspapers, television, radio, buses, etc. ♦ Web-based screening Managing Recruitment

8. 8 Managing Enrollment ♦ What are the options available for individuals not meeting eligibility requirements at intake? − Are reasons for exclusion modifiable within a reasonable period of time? − Are they motivated or committed in carrying out the options?

9. 9 Managing Enrollment, continued ♦ How do you address barriers interfering with enrollment? − Helping to achieve sobriety to complete intake forms − Help with child care arrangements − Facilitate access to study – e.g., bus tickets − Stabilize the housing situation − Identify a locator − Flexible schedule for appointments

10. 10 Figure 1. Cumulative Recruitment of the COMBINE Trial

11. 11 Managing Retention (1) ♦ Preparation Phase

12. 12 Managing Retention continued ♦ Standardized training of research staff − Focus on goals, develop a tracking system and provide a manual of operations − Training in the management of retention  )  Separate research from treatment (i.e., intention to treat )  Learn reasons for nonadherence  Tape recording of assessment interview

13. Early Warning Signs of Nonadherence ♦ No shows or cancellations without rebooking, tardiness, etc. ♦ Dissatisfaction with treatment assignment or treating clinician ♦ Concerns about randomization ♦ Unexpected social or health problems ♦ Positive BAC at assessments 13

14. Early Warning Signs of Nonadherence ♦ Does not complete assessments ♦ Dissatisfaction with task demands (e.g., blood and urine specimens) ♦ Stress and other symptoms 14

15. Learn Reasons for Nonadherence ♦ Conduct preliminary adherence interview ♦ Prior history of nonadherence ♦ Ask the participant, what would interfere with coming regularly for research appointments. 15

16. Prior History of Nonadherence − Forgetting or carelessness about appointments − Drinking or drug use − Concerns about confidentiality − Work requirements − Lack of rapport with RA − Transportation problems − Child care arrangements − Dissatisfaction with treatment 16

17. Addressing Nonadherence ♦ Based upon reasons for nonadherence, develop a tailor-made plan for addressing nonadherence 17

18. Addressing Nonadherence ♦ Write up the plan and give a copy to participant ♦ Discuss any other anticipated nonadherence problems and future steps 18

19. ♦ Match strategies for reasons for nonadherence 19

20. Strategies for Unintentional Nonadherence ♦ Prompts, reminders, provide written schedule of appointments ♦ Flexible appointment hours ♦ Child care ♦ Bus tickets 20

21. Nonintentional Nonadherence − Provide regular reinforcement and support to participants − Based on an effective collaboration with a fully- informed participant 21

22. Strategies for Intentional Nonadherence Dissatisfaction with treatment: ♦ Separate out research from treatment participation (we want to hear from them even if no longer participating in treatment ) ♦ Importance of knowing about “all” participants 22

23. Intentional Nonadherence Confidentiality: ♦ Reinforce concerns about confidentiality - separate out research from clinical involvement ♦ Importance about knowing about “all outcomes” (even if they are drinking) 23

24. 24 Step-by-Step Plan for Addressing Intentional Nonadherence Step-by-Step Plan for Addressing Intentional Nonadherence Learn the participant’s explanation for non-attendance Meet resistance with understanding, empathy, and respect Normalize or legitimize problems with the study Review rationale for research involvement Give a range of possible options for meeting study expectations Remove aversive elements of the protocol (blood work, urine tests,etc) Obtain partial data Delay decision-making about dropping out of the study Accept participant refusal as temporary or situational and obtain permission to recontact at a later time.

25. 25 Tailoring the Approach to the Needs of Participants − Identifying the source of the problems − Identifying a range of options − Encouraging choice

26. 26 Monitoring Recruitment and Retention ♦ Generating a timeline for recruitment − Inform staff on number of months it would take to meet the recruitment goal − Regular meetings and ongoing trainings provided

27. 27 Monitoring Recruitment and Retention ♦ Develop performance expectations − COMBINE Study goals: 90% outcome data completeness rate within the treatment phase and an 85% outcome data completeness rate in the post-treatment follow-up phase − Ongoing monitoring ♦ Reports on data completeness and treatment attendance ♦ Assessing reasons for not fulfilling study objectives ♦ Recommendation offered to improve adherence rates (e.g., increase number of staff members, review options listed in the manual or operations – sending a “strategic” letter to the staff

28. 28 Table 5: Change in Retention over Time based on Outcome Data Completeness Time Frame InterventionWeek 16 Week 26 Week 52 Week 68 Year 1 Data reports67%NA a Year 2 Data reports Development of Performance Criteria 85%78%69%66% Year 3 Data Reports Performance letters Site visits 90%87%83%78% a NA = not applicable (data reports focused on week 16 data in Year 1 as the number of clients reaching the week 26, 52, and 68 time points were low).

29. 29 Summary ♦ Develop a recruitment and retention plan ♦ Staff training in recruitment and retention activities ♦ Develop manual of operations ♦ Employ a broad range of strategies for addressing recruitment and retention problems ♦ Match strategies/procedures to the reasons for nonadherence ♦ Monitor performance levels