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在服务不足社区采用自测血压监测(ASPIRE):一项试点随机对照试验。

Adopting Self-Measured Blood Pressure Monitoring Among Underserved Communities (ASPIRE): A Pilot Randomized Controlled Trial.

作者信息

Khatib Rasha, Glowacki Nicole, Guzman Iridian, Ozoani Osondi, Brill John, Lauffenburger Julie C, Biskis Alex, Gordon Melanie

机构信息

Advocate Aurora Research Institute, Advocate Health, Milwaukee, WI, USA.

Enterprise Population Health, Advocate Health, Milwaukee, WI, USA.

出版信息

J Gen Intern Med. 2025 Jun 25. doi: 10.1007/s11606-025-09646-9.

Abstract

BACKGROUND

Addressing barriers to self-measured blood pressure (SMBP) engagement through tailored implementation strategies is critical for improving hypertension-related outcomes.

OBJECTIVE

To evaluate the feasibility of implementing the ASPIRE Clinical Integration Package, a multifaceted intervention designed to support SMBP adoption and engagement in under-resourced primary care settings.

DESIGN

This randomized trial was conducted in 2024 at one large primary care clinic serving racially and ethnically diverse populations.

PARTICIPANTS

Patients were eligible if they had hypertension, were prescribed ≥1 blood pressure-lowering medication, and presented to the clinic with an elevated blood pressure reading.

APPROACH

Patients were randomized to receive a free SMBP device (control; n=25) or a free SMBP device and the ASPIRE Clinical Integration Package (intervention; n=25) which included 6 components; 1. Cuff sizing, 2. Training on accurate readings, 3. ASPIRE log, 4. Reminders/support for sharing readings, 5. Social needs screening, 6. Clinic workflow for SMBP documentation. The primary outcomes included feasibility metrics (referral, recruitment, and retention) and fidelity described in terms of the proportion of patients who received each of the 6 ASPIRE components. Secondary outcomes included SMBP engagement (1+ reading documented in the electronic health record) and change in systolic blood pressure.

KEY RESULTS

In total, 50 patients were randomized and included in analyses. Referral (60.0%), recruitment (60.2%), and retention (90.0%) targets were met. Fidelity evaluation revealed that 100% of patients received components 1 - 4, 96% and 93% received components 5 and 6, respectively. At 6-months the difference in SMBP engagement was 52.0% (95% confidence interval [CI] 29.3%-74.7%) favoring the intervention arm, and the difference in change in systolic blood pressure was -11.9mmHg (95% CI -21.7, -2.1) favoring the intervention arm.

CONCLUSIONS

The ASPIRE Clinical Integration Package demonstrates feasibility and acceptability in promoting SMBP adoption in under-resourced primary care settings. These findings lay the groundwork for a larger trial to assess effectiveness in improving hypertension control and reducing disparities.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT06175793.

摘要

背景

通过量身定制的实施策略来消除自我测量血压(SMBP)参与的障碍,对于改善高血压相关结局至关重要。

目的

评估实施ASPIRE临床整合包的可行性,该整合包是一项多方面干预措施,旨在支持资源匮乏的基层医疗环境中采用和参与自我测量血压。

设计

这项随机试验于2024年在一家为种族和民族多样化人群服务的大型基层医疗诊所进行。

参与者

患有高血压、被处方使用≥1种降压药物且就诊时血压读数升高的患者符合入选条件。

方法

患者被随机分配接受免费的自我测量血压设备(对照组;n = 25)或免费的自我测量血压设备以及ASPIRE临床整合包(干预组;n = 25),该整合包包括6个组成部分;1. 袖带尺寸测量,2. 准确读数培训,3. ASPIRE日志,4. 分享读数的提醒/支持,5. 社会需求筛查,6. 自我测量血压记录的诊所工作流程。主要结局包括可行性指标(转诊、招募和留存)以及按照接受6个ASPIRE组成部分的患者比例描述的保真度。次要结局包括自我测量血压参与情况(电子健康记录中记录有≥1次读数)和收缩压变化。

关键结果

总共50名患者被随机分组并纳入分析。达到了转诊(60.0%)、招募(60.2%)和留存(90.0%)目标。保真度评估显示,100%的患者接受了组成部分1 - 4,分别有96%和93%的患者接受了组成部分5和6。在6个月时,自我测量血压参与情况的差异为52.0%(95%置信区间[CI] 29.3% - 74.7%),有利于干预组,收缩压变化的差异为 - 11.9mmHg(95% CI - 21.7, - 2.1),有利于干预组。

结论

ASPIRE临床整合包在资源匮乏的基层医疗环境中促进自我测量血压采用方面显示出可行性和可接受性。这些发现为一项更大规模的试验奠定了基础,以评估在改善高血压控制和减少差异方面的有效性。

试验注册

ClinicalTrials.gov标识符NCT06175793。

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