Subject Recruitment and Retention in Alcohol Pharmacotherapy Controlled Clinical Trials

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Subject Recruitment and Retention in Alcohol
Pharmacotherapy Controlled Clinical Trials

• Center for Addiction and Behavioral Health
  Research (CABHR) Clinical Trials Unit
• University of Wisconsin-Milwaukee
• Aurora Health Care, Inc.
• Dr. Allen Zweben Lisa Berger, MSW

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Presentation Purpose

• To describe cost-effective strategies for subject
  recruitment in alcohol pharmacotherapy controlled
  clinical trials
• To describe effective subject retention strategies

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Definition of Subject Recruitment

• Recruitment is a continuous process from initial
  recruitment activities through the act of
  randomizing participants into a clinical trial
  (Spilker Cramer, 1992).

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Definition of Subject Retention

• Retention is also a continuous process and
  involves keeping participants involved in
  research activities across the duration of the
  study.

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Why are Subject Recruitment Retention Important?

• To obtain large enough sample sizes to test study
  hypotheses
• To enhance sample diversity for the
  generalizability of trial findings
• Women and Ethnic/Racial Minorities

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Why are Subject Recruitment Retention
Important? (cont.)

• To retain adequate numbers of participants
  throughout the trial for hypothesis testing
• Database completeness

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Recruitment Strategies

• Community Provider Referrals
• Physicians
• Alcohol Drug Counselors
• Social Service Agencies
• Media
• Newspapers, television, radio

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Recruitment Methods

• Community Provider Methods
• Physician Letters
• Presentations at Provider Staff Meetings
• Provider Carry Cards
• Rolodex Cards
• Study Brochures

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Recruitment Methods (cont.)

• Media
• City Bus Advertisements
• Easel Posters
• Flyers
• Newsletters
• Newspaper Advertising
• Publicity
• Radio Advertising
• Television Advertising

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Recruitment Methods Cost-Effectiveness

• Of 152 participants randomized into 4 separate
  CABHR alcohol pharmacotherapy trials
• 18 (28) were referred by community providers
• 81 (123) were referred by media
• Note Percentages do not add to 100 because of
  missing data.

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Recruitment Methods Cost-Effectiveness (cont.)

• Of the 28 participants randomized by community
  provider referral
• Aurora Health Care, Inc. was the most
  cost-effective referral source
• 54 (15) of participants randomized
• 0 in direct costs/randomization

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Recruitment Methods Cost-Effectiveness (cont.)

• Of the 123 participants randomized by media
  referral
• Aurora Health Care Community Newsletters were the
  most cost-effective
• 20 (25) of participants randomized
• 0 in direct costs/randomization

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Recruitment Methods Cost-Effectiveness (cont.)

• Of the 123 participants randomized by media
  referral
• Television Advertising was the second most
  cost-effective
• 41 (51) of participants randomized
• 103 in direct costs/randomization

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Managing Recruitment Enrollment

• Timing of Recruitment Efforts
• To meet recruitment goals
• Staff Availability

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Managing Recruitment Enrollment (cont.)

• Waiting List Management
• Stabilization of Drinking Behavior
• Providing Referrals

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Managing Recruitment Enrollment (cont.)

• Research Role Induction
• Participant Responsibilities

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Retention Strategies

• Participant-focused
• Routine
• Enhanced
• System-focused
• Routine
• Enhanced

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Retention Methods

• Participant-focused Routine
• Monetary Incentives
• Refreshments
• Transportation (e.g., bus tickets)
• Appointment Reminders (e.g., phone calls and
  letters)

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Retention Methods (cont.)

• Participant-focused Enhanced
• Locators
• Tailored Letters
• Increased Monetary Incentives

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Retention Methods (cont.)

• System-focused Routine
• Participant Tracking Systems
• Participant Updates
• Retention Risk Levels

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Retention Methods (cont.)

• System-focused Enhanced
• Flexible Appointment Scheduling
• Opportunistic Data Collection

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Retention Methods Effectiveness

• If retention efforts are persistent, retention
  rates of over 90 can be achieved.

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Recruitment Retention Tricks of the Trade

• Recruitment Retention Specialist
• Consider a Recruitment Retention Committee

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Recruitment Retention Tricks of the Trade
(cont.)

• Set Recruitment Goals
• Monitor Recruitment Progress

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Recruitment Retention Tricks of the Trade
(cont.)

• Follow-up with Community Providers
• Anticipate Address Concerns

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Recruitment Retention Tricks of the Trade
(cont.)

• Recruitment and retention are related (e.g.,
  establish a geographic recruitment radius to
  minimize transportation barriers)

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Recruitment Retention Tricks of the Trade
(cont.)

• Positive Staff Attitudes

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Conclusion

• By implementing these strategies and methods
  consistently, high recruitment and retention
  rates can be achieved!