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药师血管预防病例发现与护理路径干预(PROACT)的实施:一项随机对照试验方案

Implementation of Pharmacist Case-Finding and Care Pathway Intervention for Vascular Prevention (PROACT): Protocol for a Randomized Controlled Trial.

作者信息

Liu Shania, Tsuyuki Ross T, Graham Michelle M, Nelson Dorothy, Semeniuk Gary, Al Hamarneh Yazid N

机构信息

Epidemiology Coordinating and Research (EPICORE) Data Management Centre, Department of Medicine, Division of Cardiology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.

Department of Medicine, Division of Cardiology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.

出版信息

CJC Open. 2025 Mar 20;7(6):821-831. doi: 10.1016/j.cjco.2025.03.011. eCollection 2025 Jun.

DOI:10.1016/j.cjco.2025.03.011
PMID:40586019
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12198587/
Abstract

UNLABELLED

Cardiovascular (CV) disease (CVD) is the leading cause of death worldwide. The risk factors contributing to CVD development have been well known for decades, but treatment gaps persist. Pharmacists are frontline primary healthcare providers whose interventions to lower CV risk are supported by rigorous evidence. However, efforts to support the widespread implementation of pharmacist interventions to reduce CV risk are needed. To support such implementation, we developed an electronic tool (the "Care Pathway") for guideline-directed assessment, prescription, and follow-up for CVD risk reduction that incorporates shared decision-making. The aim of this trial is to determine the impact of the pharmacist-led Care Pathway intervention on participants' estimated risk for major CV events. This investigator-initiated, multicentre, open-label, randomized controlled trial will include 982 patients (aged ≥ 18 years) with ≥ 1 risk factor for CVD. Patients will be randomized in a 1:1 ratio to receive either a pharmacist-led Care Pathway intervention or usual care. Participants' estimated CV risk will be calculated at baseline and at a 6-month follow-up evaluation. The primary outcome is the difference in change in estimated CV risk from baseline to the 6-month follow-up evaluation between the groups. Pharmacist-led assessment and management of patients' CV risk factors may serve as an effective intervention to reduce patients' estimated risk for major CV events. Formal evaluation of widespread implementation of a Care Pathway intervention will be conducted for the first time in a pharmacy practice CV risk-reduction trial.

CLINICAL TRIAL REGISTRATION

The University of Alberta Human Research Ethics Board (Pro00139142). NCT06405880.

摘要

未标注

心血管疾病(CVD)是全球主要的死亡原因。导致CVD发生的危险因素数十年来已为人熟知,但治疗差距依然存在。药剂师是一线初级医疗保健提供者,其降低心血管风险的干预措施有严格的证据支持。然而,需要努力支持广泛实施药剂师降低心血管风险的干预措施。为支持此类实施,我们开发了一种电子工具(“护理路径”),用于指导心血管疾病风险降低的评估、处方和随访,并纳入了共同决策。本试验的目的是确定药剂师主导的护理路径干预对参与者主要心血管事件估计风险的影响。这项由研究者发起的多中心、开放标签、随机对照试验将纳入982名年龄≥18岁且有≥1个心血管疾病危险因素的患者。患者将按1:1的比例随机分组,分别接受药剂师主导的护理路径干预或常规护理。将在基线和6个月的随访评估时计算参与者的估计心血管风险。主要结局是两组之间从基线到6个月随访评估时估计心血管风险变化的差异。药剂师主导的对患者心血管危险因素的评估和管理可能是降低患者主要心血管事件估计风险的有效干预措施。在一项药房实践中降低心血管风险的试验中,将首次对护理路径干预的广泛实施进行正式评估。

临床试验注册

阿尔伯塔大学人类研究伦理委员会(Pro00139142)。NCT06405880。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0735/12198587/a1d9d956ab12/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0735/12198587/f9f1b0ad6ef1/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0735/12198587/a1d9d956ab12/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0735/12198587/f9f1b0ad6ef1/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0735/12198587/a1d9d956ab12/gr2.jpg

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KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease.KDIGO 2024慢性肾脏病评估与管理临床实践指南
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