Rationale, design and pre-randomization data for a cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in established atherosclerotic cardiovascular disease patients: The SAPPHIRE-LDL Trial.
M Julia Machline-Carrion, Alysson Nathan Girotto, Priscila Raupp, Pedro Marton Pereira, Frederico Monfardini, Raul D Santos, Karla Santo, Kausik Ray, Christopher P Cannon, Otávio Berwanger
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引用次数: 0
Abstract
Background: Translating evidence into clinical practice in the management of established atherosclerotic cardiovascular disease patients is challenging. Few quality improvement interventions have successfully improved patient care.
Objectives: The main objectives are to evaluate the impact of a digitally enabled multifaceted quality improvement (QI) intervention on the control of LDL-cholesterol (LDL-C) in atherosclerotic cardiovascular disease (ASCVD).
Design: We designed a pragmatic two-arm cluster randomized trial involving 28 clusters (outpatient clinics from public or private hospitals or private practices). Clusters are randomized to receive a digitally enabled multifaceted QI intervention or to routine practice (control). The QI intervention includes reminders, electronic clinical decision support algorithms, audit and feedback reports, and distribution of educational materials to health care providers, as well as electronic educational materials and app-based tools for drug adherence control, lipid profile control, and communication to participants. The primary endpoint is the LDL-C at 06 months after the intervention period. All analyses are performed following the intention-to-treat principle and take the cluster design into consideration by using individual-level regression modeling (generalized estimating equations-GEE).
Summary: If proven effective, this low-cost, digitally enabled multifaceted QI intervention would be highly useful in promoting optimal LDL-C control in ASCVD patients.
期刊介绍：
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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