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

摘要: Abstract Background The Healthy Hearts in the Heartland (H3) study is part of a nationwide effort, EvidenceNOW, seeking to better understand ability small primary care practices improve “ABCS” clinical quality measures: appropriate Aspirin therapy, Blood pressure control, Cholesterol management, and Smoking cessation. H3 aimed assess feasibility implementing Point-of-Care (POC) or POC plus Population Management (POC + PM) improvement (QI) strategies ABCS at Illinois, Indiana, Wisconsin. We describe design randomization study. Methods conducted two-arm (1:1, POC:POC + PM), practice-randomized, comparative effectiveness 226 across four “waves” with 12-month intervention period, followed by six-month sustainability period. Randomization controlled imbalance nine baseline variables through modified constrained algorithm. Among others, we used initial, unverified estimates values. Results randomized 112 114 POC + PM arms, respectively. ensured comparability for all key variables, including measures indicating proportion patients practice level meeting each measure. Median(Inner Quartile Range) values were A: 0.78(0.66–0.86) arm vs. 0.77(0.63–0.86) arm, B: 0.64(0.53–0.73) 0.64(0.53–0.75), C: 0.78(0.63–0.86) 0.75(0.64–0.81), S: 0.80(0.65–0.81) 0.79(0.61–0.91). Discussion Surrogate true coupled unique logic achieved adequate balance on these outcomes. Similar practice- cluster-randomized trials may consider adaptations this design. Final analyses 12- 18-month outcomes are forthcoming. Trial registration This trial registered ClinicalTrials.gov (Initial post: 11/05/2015; identifier: NCT02598284 ; https://clinicaltrials.gov/ct2/show/NCT02598284?term=NCT02598284&rank=1 ).