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

Contemp Clin Trials. 2018 Aug:71:47-54. doi: 10.1016/j.cct.2018.06.004. Epub 2018 Jun 2.

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).

Keywords: Cardiovascular health; Constrained randomization; Covariate; Quality improvement.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aspirin / administration & dosage
  • Blood Pressure Determination / methods
  • Cardiovascular Diseases / prevention & control*
  • Female
  • Health Facility Size
  • Humans
  • Hypercholesterolemia / therapy
  • Male
  • Outcome and Process Assessment, Health Care
  • Patient Care Management* / methods
  • Patient Care Management* / organization & administration
  • Patient Care Management* / standards
  • Platelet Aggregation Inhibitors / administration & dosage
  • Point-of-Care Systems / organization & administration*
  • Primary Health Care* / methods
  • Primary Health Care* / organization & administration
  • Primary Health Care* / standards
  • Quality Improvement*
  • Smoking Cessation / methods
  • United States

Substances

  • Platelet Aggregation Inhibitors
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT02598284