Abstract
Background: The Healthy Hearts in the Heartland (H3) study is part of a nationwide effort, EvidenceNOW, seeking to better understand the ability of small primary care practices to improve “ABCS” clinical quality measures: appropriate Aspirin therapy, Blood pressure control, Cholesterol management, and Smoking cessation. H3 aimed to assess feasibility of implementing Point-of-Care (POC) or POC plus Population Management (POC + PM) quality improvement (QI) strategies to improve ABCS at practices in Illinois, Indiana, and Wisconsin. We describe the design and randomization of the H3 study. Methods: We conducted a two-arm (1:1, POC:POC + PM), practice-randomized, comparative effectiveness study in 226 primary care practices across four “waves” of randomization with a 12-month intervention period, followed by a six-month sustainability period. Randomization controlled imbalance in nine baseline variables through a modified constrained algorithm. Among others, we used initial, unverified estimates of baseline ABCS values. Results: We randomized 112 and 114 practices to POC and POC + PM arms, respectively. Randomization ensured baseline comparability for all nine key variables, including the ABCS measures indicating proportion of patients at the practice level meeting each quality measure. Median(Inner Quartile Range) values were A: 0.78(0.66–0.86) in POC arm vs. 0.77(0.63–0.86) in POC + PM arm, B: 0.64(0.53–0.73) vs. 0.64(0.53–0.75), C: 0.78(0.63–0.86) vs. 0.75(0.64–0.81), S: 0.80(0.65–0.81) vs. 0.79(0.61–0.91). Discussion: Surrogate estimates for the true ABCS at baseline coupled with the unique randomization logic achieved adequate baseline balance on these outcomes. Similar practice- or cluster-randomized trials may consider adaptations of this design. Final analyses on 12- and 18-month ABCS outcomes for the H3 study are forthcoming. Trial registration: This trial is registered on ClinicalTrials.gov (Initial post: 11/05/2015; identifier: NCT02598284; https://clinicaltrials.gov/ct2/show/NCT02598284?term=NCT02598284&rank=1).
Original language | English (US) |
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Pages (from-to) | 47-54 |
Number of pages | 8 |
Journal | Contemporary Clinical Trials |
Volume | 71 |
DOIs | |
State | Published - Aug 2018 |
Funding
The H3 study is part of a larger, nationwide effort known as EvidenceNOW [ 12 ], funded by the Agency for Healthcare Research and Quality (AHRQ, Grant #R18HS023921), in which seven regional cooperatives seek to study and implement mechanisms of support for small primary care practices. Individual primary care clinicians from practices in the Midwest Region of the United States consented to participate in the H3 study. Since the interventions for this study were largely employed at the practice level, the practice served as the unit of randomization and the primary unit of measurement. Clinicians were eligible if, at the time of consent, they practiced in Wisconsin, Illinois, or Indiana; practiced at an adult primary care-focused facility; practiced at a site with 20 or fewer primary care clinicians; and were primarily English speaking. Originally practices that were part of networks with significant QI infrastructure were excluded, but a further protocol modification allowed for inclusion of practices that were part of two multi-practice networks in the greater Chicago area. Practices were recruited from lists of practices participating in existing Health Information Technology Regional Extension Centers (REC)/Quality Improvement Organization (QIO) programs, and also programs with no previous relationships to participating H3 partners. Northwestern University's Institutional Review Board (IRB) approved the H3 protocol. Funding acknowledgement: This project was supported by grant number R18HS023921 from the Agency for Healthcare Research and Quality . The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality .
Keywords
- Cardiovascular health
- Constrained randomization
- Covariate
- Quality improvement
ASJC Scopus subject areas
- Pharmacology (medical)