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Randomized Controlled Trial
. 2014 Mar-Apr;28(4):268-74.
doi: 10.4278/ajhp.120720-QUAN-355. Epub 2013 Jul 22.

Maximizing retention with high risk participants in a clinical trial

Romina Kim, Norval Hickman, Kathleen Gali, Nicholas Orozco, Judith J Prochaska
Randomized Controlled Trial

Maximizing retention with high risk participants in a clinical trial

Romina Kim et al. Am J Health Promot. 2014 Mar-Apr.

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 x = 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.

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Figures

Figure 1
Figure 1
Consort Diagram
Figure 2
Figure 2
Staff time and effort demand by outreach strategy Low Demand (few minutes): Direct outreach to participant via phone or internet Moderate Demand (less than an hour): Involvement of one or multiple intermediaries High Demand (several hours): Field work and research *EMR: Electronic Medical Record
Figure 3
Figure 3
Follow-up rates at 3-, 6-, and 12-months and implementation of retention strategies throughout study period. Vertical lines represent implementation of new strategies: 1. Methadone Clinic EMR, 2. County EMR, 3. Field Outreach, 4. Updated Contact Form, 5. Calling Jails/Prisons, 6. Facebook, 7. MySpace
Figure 4
Figure 4
Participant characteristics predictive of study retention. The darker bar shows the improvement in retention rate from 3- to 12-months follow-up.
Figure 5
Figure 5
Frequency of strategies for maximizing retention at 12-month follow-up. NOTE: EMR: Electronic Medical Record; Residence: Board & Care and Hotels; Electronic Message includes contact via social networking sites and e-mail; and Field Visit includes visits to SROs, other residences, clinic appointments, and treatment facilities
See this image and copyright information in PMC

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