Feasibility of a practical clinical trial for asthma conducted in primary care.
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.
Hahn
David L
DL
Department of Family Practice, Dean Medical Center, Madison, Wisconsin 53716, USA. dlhahn@wisc.edu
Plane
Mary Beth
MB
D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D017963:Azithromycin / Q000627:therapeutic use; D003625:Data Collection / Q000379:methods; D005240:Feasibility Studies; D006801:Humans; D018579:Patient Selection; D011320:Primary Health Care; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013689:Telephone; D014922:Wisconsin
D000900:Anti-Bacterial Agents; D017963:Azithromycin