Rationale, design and prerandomization 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

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-02-03 DOI:10.1016/j.ahj.2025.01.019

M. Julia Machline-Carrion MD, PhD , Alysson Nathan Girotto BSc , Priscila Raupp MD, PhD , Pedro Marton Pereira BA , Frederico Monfardini MSc , Raul D. Santos MD, PhD , Karla Santo MD, PhD , Kausik Ray MD , Christopher P. Cannon MD , Otávio Berwanger MD, PhD

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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 2-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.

Trial Registration

ClinicalTrials.gov NCT05622929.

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一项旨在评估数字化质量改善干预对已确诊的动脉粥样硬化性心血管疾病患者LDL-C控制效果的聚类随机试验的基本原理、设计和预随机化数据：SAPPHIRE-LDL试验

背景：将证据转化为临床实践在管理已建立的动脉粥样硬化性心血管疾病患者是具有挑战性的。很少有质量改善干预措施成功地改善了病人的护理。目的：主要目的是评估数字化多面质量改善（QI）干预对动脉粥样硬化性心血管疾病（ASCVD）患者ldl -胆固醇（LDL-C）控制的影响。设计：我们设计了一项实用的双组随机试验，涉及28个组（来自公立或私立医院的门诊诊所或私人诊所）。随机分组接受数字化多面QI干预或常规实践（对照组）。QI干预包括提醒、电子临床决策支持算法、审计和反馈报告、向卫生保健提供者分发教育材料，以及用于药物依从性控制、血脂控制和参与者沟通的电子教育材料和基于应用程序的工具。主要终点是干预期后06个月的LDL-C。所有分析都遵循意向处理原则，并通过使用个人水平回归模型（广义估计方程- gee）考虑聚类设计。总结：如果证明有效，这种低成本、数字化的多面QI干预将在促进ASCVD患者的LDL-C最佳控制方面非常有用。试验注册：ClinicalTrials.gov NCT05622929。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

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.