AASAP: A program to increase recruitment and retention in clinical trials

Objective: To evaluate a theory based, subject-centered, staff/subject communication program, AASAP (anticipate, acknowledge, standardize, accept, plan), to increase recruitment and retention in RCTs. Methods: AASAP was evaluated with logistical regression by comparing rates of recruitment (at telephone screening, baseline assessment, initial intervention) and intervention retention (over 16 weeks) before (-AASAP) and after (+AASAP) it was introduced to a 3-arm RCT to reduce disease distress among highly distressed subjects with type 2 diabetes. Results: Included were 250 subjects in -AASAP and 338 in +AASAP. Significant improvement in recruitment occurred at each of the 3 recruitment stages: agreed at screening (OR = 2.52; p < 0.001), attended baseline assessment (OR = 1.91; p < 0.001), attended initial intervention (OR = 1.46; p < 0.03). Higher education and shorter diabetes duration predicted better recruitment in -AASAP (OR = 2.23: p < 0.001). but not in +AASAP. AASAP also improved intervention retention over 16 weeks (OR = 3.46; p < 0.05). Conclusion: AASAP is a structured program of subject/staff communication that helps improve external validity by enhancing both subject recruitment and retention. Practical implications: AASAP can be taught to non-professional staff and can be adapted to a variety of health settings. It can also be used by clinicians to engage patients in programs of ongoing care. Published by Elsevier Ireland Ltd.