Evaluation of the effectiveness of a digital-intelligent-system-based implementation strategy in improving the quality of prehospital medical care: rationale and design of a stepped-wedge cluster randomized controlled trial

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BACKGROUND: Currently, prehospital emergency medical care procedures and quality vary among different medical institutions, and there is no effective implementation strategy for improving medical quality. Acute cardiovascular disease imposes major burdens to all involved parties and is associated with high morbidity and mortality. Prehospital care for acute cardiovascular disease requires scientific implementation strategies. The use of implementation science research to explore new strategies may improve the quality of prehospital care and reduce the burden of acute cardiovascular disease. METHOD: The research design is a stepped-wedge cluster randomized controlled trial. A digital intelligent system has been created previously. Researchers will develop a new implementation strategy based on improving ambulance equipment and integration of the intelligent software systems to drive evidence-based prehospital interventions and will select emergency teams in public hospitals to practice it randomly. Data from the entire emergency treatment process will be collected to analyze the impact of strategies in terms of outcomes tailored according to the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. To identify possible areas of refinement and examine the feasibility of the research, the first phase will be carried out in five hospitals. DISCUSSION: This study integrates digital and intelligent technologies with implementation science in the design of a prehospital emergency care strategy on the basis of a literature review and expert recommendations, addressing limitations in previous prehospital emergency care approaches. The digital-intelligent-system-based strategy will undergo iterative optimization according to practical feedback and are expected to facilitate the implementation of evidence-based interventions, thereby improving the quality of patient care. TRIAL REGISTRATION: This study was prospectively registered on the Chinese Clinical Trial Registry (ChiCTR2400088833; Version 1.0; Date of registration: 27 August 2024; URL: https://www.chictr.org.cn/ ).

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