The Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on cardiovascular outcomes.

Hadii M Mamudu, James E Bailey, Satya Surbhi, Susan Butterworth, Ming Chen, Asos Mahmood, Cori C Grant, Fawaz Mzayek, Ashley Ellis, Deborah Ogunsanmi, Jennifer Ride, Gladys Hunt

Journal: Contemporary clinical trials 2024;144():107616

PMID: 38971302

Abstract

BACKGROUND

Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes.

METHODS/DESIGN

The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS).

CONCLUSIONS

This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation.

Copyright © 2024 Elsevier Inc. All rights reserved.

Address: Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: [email protected].; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Health Services Management and Policy, College of Public Health, East Tennessee State University, Johnson City, TN, United States of America; Center for Cardiovascular Risk Research, College of Public Health, East Tennessee State University, Johnson City, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; QSource, Center for Health System Improvement, College of Medicine, University of Tennessee Health Science Center, 956 Court Ave, Coleman D224, Memphis, TN 38163, USA.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.; Tennessee Population Health Consortium, University of Tennessee Health Science Center, Memphis, TN, United States of America; Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.
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