Design of healthy hearts in the heartland (H3): A practice-randomized, comparative effectiveness study

Jody D. Ciolino*, Kathryn L. Jackson, David T. Liss, Tiffany Brown, Theresa L. Walunas, Linda Murakami, Isabel Chung, Stephen D. Persell, Abel N. Kho

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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 languageEnglish (US)
Pages (from-to)47-54
Number of pages8
JournalContemporary Clinical Trials
Volume71
DOIs
StatePublished - Aug 2018

Keywords

  • Cardiovascular health
  • Constrained randomization
  • Covariate
  • Quality improvement

ASJC Scopus subject areas

  • Pharmacology (medical)

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