Feasibility of a Practical Clinical Trial for Asthma Conducted in Primary Care

D. L. Hahn, M. B. Plane
2004 Journal of the American Board of Family Medicine  
Practical clinical trials (PCTs) are essential to generate relevant evidence-based information to improve patient health. Primary care physicians' experience performing randomized controlled trials (RCTs) on representative patient populations is limited. We implemented a pilot practice-based asthma PCT to answer the following feasibility questions: (1) Was clinician interest initiated and maintained? (2) Did clinicians enroll patients into an RCT and complete follow-up? (3) Was an interactive
more » ... as an interactive voice-response (IVR) telephone system useful to collect patient-reported data? Methods: The protocol included (1) broadly representative adult asthma eligibility criteria, (2) selfreported patient-oriented outcomes, and (3) use of IVR to collect these data. Physicians in practicebased research networks, managed care organizations, and academic networks volunteered to participate. Results: Of 13 physician volunteers, 10 (8 single-person office practices, 1 emergency department physician, 1 clinical researcher) from 4 states and 1 Canadian province enrolled 58 subjects and randomized 45 meeting final eligibility criteria; 39 (87%) attended the follow-up visit. However, only 34 (76%) provided adequate follow-up IVR self-report data, and subjects with less than a high school education provided significantly (P < .001) less data than other groups. Conclusions: Physician recruiting, randomizing, and completing a representative sample of adult asthma patients was feasible. The utility of IVR in primary care research requires further study. (J Am
doi:10.3122/jabfm.17.3.190 fatcat:5lsbd74ycjgznnjewklhdrmwuq