RT Journal Article
SR Electronic
T1 Feasibility of a Practical Clinical Trial for Asthma Conducted in Primary Care
JF The Journal of the American Board of Family Practice
JO J Am Board Fam Med
FD American Board of Family Medicine
SP 190
OP 195
DO 10.3122/jabfm.17.3.190
VO 17
IS 3
A1 David L. Hahn
A1 Mary Beth Plane
YR 2004
UL http://www.jabfm.org/content/17/3/190.abstract
AB Background: 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 voice-response (IVR) telephone system useful to collect patient-reported data?Methods: The protocol included (1) broadly representative adult asthma eligibility criteria, (2) self-reported patient-oriented outcomes, and (3) use of IVR to collect these data. Physicians in practice-based 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.