Maximizing Retention with High Risk Participants in a Clinical Trial

• Published in: American journal of health promotion Vol. 28; no. 4; pp. 268 - 274
• Main Authors: Kim, Romina, Hickman, Norval, Gali, Kathleen, Orozco, Nicholas, Prochaska, Judith J.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-03-2014
• Subjects: Adult; Assessment; Clinical trials; Drug abuse; Female; Follow-Up Studies; High risk; Hospitals, General; Hospitals, Public; Humans; Male; Mental Disorders; Middle Aged; Outreach programmes; Patient Dropouts - statistics & numerical data; Poverty; Retention; Risk Factors; San Francisco; Smoking Cessation; Tobacco Use Disorder - psychology; Tobacco Use Disorder - therapy; San Francisco; Health focus: smoking control; Target population circumstances: all education and income levels; Clinical Trial; Manuscript format: research; Study design: randomized trial; Outcome measure: behavioral/productivity; Vulnerable Populations; Retention; Prevention Research; Strategy: skill building/behavior change; Target population age: adults; Setting: clinic/health care and local community; San Francisco; California, ethnically/racially diverse population; Outreach; Research purpose: intervention testing/program evaluation
• ISSN: 0890-1171; 2168-6602
• DOI: 10.4278/ajhp.120720-QUAN-355

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.