Jody D Ciolino1, Kathryn L Jackson2, David T Liss3, Tiffany Brown3, Theresa L Walunas4, Linda Murakami5, Isabel Chung2, Stephen D Persell3, Abel N Kho4. 1. Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: jody.ciolino@northwestern.edu. 2. Center for Health Information Partnerships (CHiP), Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. 3. Department of Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. 4. Center for Health Information Partnerships (CHiP), Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. 5. Health Outcomes, American Medical Association, Chicago, IL, sUSA.
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).
RCT Entities:
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).
Authors: Tiffany Brown; Theresa A Rowe; Ji Young Lee; Lucia C Petito; Ryan Chmiel; Jody D Ciolino; Jason N Doctor; Craig R Fox; Noah J Goldstein; Darren Kaiser; Jeffrey A Linder; Daniella Meeker; Yaw Peprah; Stephen D Persell Journal: Contemp Clin Trials Date: 2021-12-08 Impact factor: 2.226
Authors: Jingzhi Yu; Ann A Wang; Lindsay P Zimmerman; Yu Deng; Thanh-Huyen T Vu; Yacob G Tedla; Nicholas D Soulakis; Faraz S Ahmad; Abel N Kho Journal: J Gen Intern Med Date: 2022-01-08 Impact factor: 6.473
Authors: Faraz S Ahmad; Luke V Rasmussen; Stephen D Persell; Joshua E Richardson; David T Liss; Pauline Kenly; Isabel Chung; Dustin D French; Theresa L Walunas; Andy Schriever; Abel N Kho Journal: JAMIA Open Date: 2019-09-20
Authors: Theresa L Walunas; Jiancheng Ye; Jennifer Bannon; Ann Wang; Abel N Kho; Justin D Smith; Nicholas Soulakis Journal: Implement Sci Date: 2021-03-31 Impact factor: 7.327
Authors: Sahnah Lim; Laura C Wyatt; Shinu Mammen; Jennifer M Zanowiak; Sadia Mohaimin; Andrea B Troxel; Stacy Tessler Lindau; Heather T Gold; Donna Shelley; Chau Trinh-Shevrin; Nadia S Islam Journal: BMC Endocr Disord Date: 2021-11-23 Impact factor: 3.263