David L Hahn1, Mary Beth Plane. 1. Department of Family Practice, Dean Medical Center, Madison, Wisconsin 53716, USA. dlhahn@wisc.edu
Abstract
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.
RCT Entities:
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 asthmapatients was feasible. The utility of IVR in primary care research requires further study.
Authors: Juliet M Foster; Susan M Sawyer; Lorraine Smith; Helen K Reddel; Tim Usherwood Journal: BMC Med Res Methodol Date: 2015-03-12 Impact factor: 4.615
Authors: Nada Elmagboul; Brian W Coburn; Jeffrey Foster; Amy Mudano; Joshua Melnick; Debra Bergman; Shuo Yang; David Redden; Lang Chen; Cooper Filby; Jeffrey R Curtis; Ted R Mikuls; Kenneth G Saag Journal: Arthritis Res Ther Date: 2019-06-29 Impact factor: 5.156