A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak

Abstract Background The National Chest Pain Center Accreditation Program (CHANGE) is the first hospital-based, multifaceted, nationwide quality improvement (QI) initiative, to monitor and improve of ST segment elevation myocardial infarction (STEMI) care in China. QI initiatives, as implementation strategies, include a bundle evidence-based interventions adapted for During pandemic coronavirus disease 2019 (COVID-19), fear infection with severe acute respiratory syndrome 2, national lockdowns, altered health priorities have highlighted program’s importance improving STEMI quality. This study aims minimize adverse impact COVID-19 on care, by developing that optimize implementing evaluating optimized scale-up activities initiatives response other public emergencies. Methods A stepped wedge cluster randomized control trial will be conducted three selected cities China: Wuhan, Suzhou, Shenzhen. Two districts been randomly each city, yielding total 24 registered hospitals. conduct rollout these hospitals every 3 months. assigned four clusters, commence intervention (optimized initiatives) at one steps. We hospital-based assessments, questionnaire surveys among providers, community-based household surveys, key informant interviews during trial. All outcome measures organized using RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, including outcomes, service outcomes (e.g., treatment time), patient in-hospital mortality 1-year complication). Consolidated Framework Implementation Research framework used identify factors influence interventions. Discussion findings could translated into systematic solution future potential major Such actionable knowledge critical implementors low- middle-income settings. Trial registration ChiCTR 2100043319 . Registered 10 February 2021