Conceptual, Methodological and Practical Issues in the Recruitment and Retention of Participants

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

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

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

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

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

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. 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. Figure 1. Cumulative Recruitment of the COMBINE Trial

11. Managing Retention (1) • Preparation Phase

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

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

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.

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

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

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

19. Match strategies for reasons for nonadherence

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

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

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

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)

24. Step-by-Step Plan for Addressing Intentional Nonadherence

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

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. 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. Table 5: Change in Retention over Time based on Outcome Data Completeness aNA = 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. 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