Implementation strategies for self-measured blood pressure monitoring in racially and ethnically diverse populations (InSPIRED): A study protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-10-06 DOI:10.1016/j.cct.2025.108101

Elaine C. Khoong , Hyunjin Cindy Kim , Junhong Li , Jorge Larreynaga , Isabel Luna , Andersen Yang , Dhruv S. Kazi , Courtney R. Lyles , Charles McCulloch , Sarah B. Rahman , Urmimala Sarkar , Natalie Curtis

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引用次数: 0

Abstract

Introduction

Self-measured blood pressure (SMBP) monitoring with clinical support is an evidence-based practice to improve hypertension control. However, it can be challenging to implement in safety-net systems that disproportionately serve low-income and/or racial/ethnic minority populations at risk of worse hypertension outcomes. We therefore propose a hybrid effectiveness-implementation trial to evaluate the effectiveness of multi-level implementation strategies to increase the use of SMBP monitoring in two urban safety-net systems.

Methods

We will conduct a patient-level randomized controlled trial with 330 English-, Spanish-, and Chinese (Cantonese)-speaking patients with uncontrolled hypertension across six study sites with patients randomized to a low-intensity (SMBP education, text message education and reminders) vs. high-intensity intervention (adds group classes and engagement of identified caregivers). To support increased use of SMBP data by the clinical team, we will concurrently deliver a staggered roll-out of a clinic-level implementation strategy (clinic education, shadowing, auditing with feedback, and optimization of electronic health record [EHR] use).

Results

The primary outcomes will be clinic-measured systolic BP (SBP) among enrolled participants for the patient-level intervention and among all patients assigned to the clinic for the clinic-level intervention. We will additionally collect secondary clinical outcomes (BP control, home SBP), implementation outcomes (adoption, reach, and costs), and patient-reported outcomes (patient activation).

Discussion

The results of this trial will address gaps in identifying cost-conscious implementation strategies for increasing adoption of SMBP in safety-net systems with the overarching goal of improving blood pressure control in low-income, diverse patient populations.

Trial registration

NCT, NCT06871462. Registered 4 March 2025, https://clinicaltrials.gov/study/NCT06871462

查看原文本刊更多论文

在不同种族和民族人群中自我测量血压监测的实施策略（启发）：一项研究方案。

自我测量血压（SMBP）监测与临床支持是改善高血压控制的循证实践。然而，在不成比例地服务于有更严重高血压结局风险的低收入和/或种族/少数民族人群的安全网系统中实施可能具有挑战性。因此，我们提出了一项混合有效性-实施试验，以评估在两个城市安全网系统中增加SMBP监测使用的多层次实施策略的有效性。方法：我们将在6个研究地点对330名说英语、西班牙语和中文（广东话）的未控制高血压患者进行患者水平的随机对照试验，患者随机分为低强度（SMBP教育、短信教育和提醒）和高强度干预（增加小组课程和确定护理人员的参与）。为了支持临床团队更多地使用SMBP数据，我们将同时提供一个交错推出的临床级实施策略（临床教育、跟踪、带反馈的审计和电子健康记录[EHR]使用的优化）。结果：主要结果将是参与患者水平干预的参与者和分配到临床进行临床水平干预的所有患者的临床测量收缩压（SBP）。我们还将收集次要临床结果（血压控制、家庭收缩压）、实施结果（采用、覆盖范围和成本）和患者报告的结果（患者激活）。讨论：该试验的结果将解决在确定具有成本意识的实施策略方面的差距，以提高安全网络系统中SMBP的采用，其总体目标是改善低收入、不同患者群体的血压控制。试验注册NCT， NCT06871462。2025年3月4日注册，网址：https://clinicaltrials.gov/study/NCT06871462。

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

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.