Maximizing Retention with High Risk Participants in a Clinical Trial

Abstract

Purpose.

To describe effective retention strategies in a clinical trial with a high risk, low-income, and vulnerable patient population with serious mental illness.

Design.

Follow-up assessments were conducted for a randomized clinical tobacco treatment trial at 3, 6, and 12 months postbaseline. Initial follow-up rates of < 40% at 3 months led to implementation of proactive retention strategies including obtaining extensive contact information; building relationships with case managers and social workers; contacting jails and prisons; text messaging, e-mailing, and messaging via social networking sites; identifying appointments via electronic medical record; and field outreach to treatment facilities, residences, and parks.

Setting.

Large urban public hospital.

Subjects.

Participants were current smokers recruited from 100% smoke-free locked psychiatry units.

Measures.

Assessments covered demographics, substance use, and mental health functioning.

Analysis.

Retention rates were plotted over time in relation to key retention strategies. Chi-square and t-tests were used to examine participant predictors of retention at each follow-up. At the 12-month follow-up, the retention strategies that most frequently led to assessment completion were identified.

Results.

The sample (N = 100) was 65% male; age × = 39.5 years (SD = 11.3); 44% non-Hispanic white; 46% on Medicaid and 34% uninsured; 79% unemployed; and 48% unstably housed. Proactive retention strategies dramatically increased follow-up rates, concluding at 3 months = 82.65%, 6 months = 89.69%, and 12 months = 92.78%. Married and divorced/separated/widowed participants, those with higher income, and participants with alcohol or illicit drug problems had increased retention from 3- to 12-month follow-up.

Conclusion.

Follow-up rates improved as proactive methods to contact participants were implemented. Dedicated research staff, multiple methods, community networking, and outreach within drug treatment settings improved retention.

Keywords

Retention Clinical Trial Outreach Vulnerable Populations Prevention Research Manuscript format: research Research purpose: intervention testing/program evaluation Study design: randomized trial Outcome measure: behavioral/productivity Setting: clinic/health care and local community Health focus: smoking control Strategy: skill building/behavior change Target population age: adults Target population circumstances: all education and income levels San Francisco California,ethnically/racially diverse population

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