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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
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2 Why is Recruitment and Retention Important? ♦ Facilitate the flow of subjects ♦ Minimize compliance difficulties ♦ Test study hypotheses ♦ Enhance generalizability
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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
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Stringent Inclusion Criteria ♦ Alcohol dependence only ♦ Limited number of detoxifications ♦ No legal problems ♦ Stable housing ♦ Need to have a locator 4
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High Task Demands ♦ Blood and urine specimens ♦ Too many assessments ♦ Side effects of medication 5
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Resume Drinking and Drug use ♦ RA will inform therapist about drinking and drug use 6
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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
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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?
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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
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10 Figure 1. Cumulative Recruitment of the COMBINE Trial
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11 Managing Retention (1) ♦ Preparation Phase
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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
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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
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Early Warning Signs of Nonadherence ♦ Does not complete assessments ♦ Dissatisfaction with task demands (e.g., blood and urine specimens) ♦ Stress and other symptoms 14
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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
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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
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Addressing Nonadherence ♦ Based upon reasons for nonadherence, develop a tailor-made plan for addressing nonadherence 17
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Addressing Nonadherence ♦ Write up the plan and give a copy to participant ♦ Discuss any other anticipated nonadherence problems and future steps 18
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♦ Match strategies for reasons for nonadherence 19
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Strategies for Unintentional Nonadherence ♦ Prompts, reminders, provide written schedule of appointments ♦ Flexible appointment hours ♦ Child care ♦ Bus tickets 20
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Nonintentional Nonadherence − Provide regular reinforcement and support to participants − Based on an effective collaboration with a fully- informed participant 21
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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
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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
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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.
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25 Tailoring the Approach to the Needs of Participants − Identifying the source of the problems − Identifying a range of options − Encouraging choice
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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
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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
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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).
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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
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