AASAP: a program to increase recruitment and retention in clinical trials.

Abstract

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.