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.