Remote Monitoring for Equity in Advancing Control of Hypertension (REACH)
概览
- 阶段
- 不适用
- 干预措施
- Cellular Home blood pressure (BP) monitoring
- 疾病 / 适应症
- Hypertension
- 发起方
- University of California, San Francisco
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Systolic blood pressure (SBP)
- 状态
- 已完成
- 最后更新
- 10天前
概览
简要总结
The goal of this study is to support patients with hypertension self-management using both home blood pressure monitors and digital messaging programs. The investigators will first engage patients with technology training to use home monitors, online portal websites to view their medical record information online, and texting and mobile phone applications. Then investigators will assess the effectiveness of home blood pressure monitors and enhanced patient-clinician digital communication on blood pressure control during a 12-month intervention.
详细描述
This study aims to launch an effectiveness-implementation hybrid randomized trial to adapt a multi-faceted hypertension (HTN) management program shown to work in integrated healthcare delivery systems to a safety net healthcare system, San Francisco Health Network (SFHN). In Aim 1 of this study, investigators will offer patients brief in-person training to support their use of the online patient portal and basics about text messaging. Investigators will examine pre-post training changes in technology use overall as well as by specific patient subgroups with known differences in technology uptake. In Aim 2 investigators will conduct a three-arm randomized controlled trial to compare varying levels of implementation support: 1) cellular-enabled blood pressure (BP) monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments). In Aim 3 investigators will use a mixed methods approach to evaluate key implementation outcomes, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, of adapting an existing, evidence-based home BP monitoring program.
研究者
入排标准
入选标准
- •English-and Spanish-speaking patients
- •Patient within the San Francisco Health Network (SFHN)
- •Has seen primary care provide within the past 2 years
- •Uncontrolled hypertension (HTN) in the HTN registry
- •Complete Aim 1 training, in addition to patients who have not completed Aim 1 training
- •Over the age of 18
排除标准
- •Under the age of 18
- •Controlled HTN
研究组 & 干预措施
Cellular Home blood pressure (BP) monitoring with minimal support
Patients will be instructed to write down their blood pressures (BP) in a BP log that will be provided to them at the time of enrollment. Study staff will access the patient's home BP measurements on the BP device dashboard and send a summary of the home BP measurements (mean, median, % of BP measurements at goal) to the primary care provider in a telephone encounter (TE) 3 to 5 days prior to the next scheduled visit.
干预措施: Cellular Home blood pressure (BP) monitoring
Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification
For patients randomized to this intervention arm, a pharmacist will review the home blood pressure (BP) measurements and use an evidence-based algorithm to make recommendations for medication intensification. If the patient has a primary care provider (PCP) appointment within 2 weeks, the pharmacist will send a telephone encounter (TE) with BP measurements and medication recommendations to the PCP 3 -5 days prior to the scheduled appointment. If the patients has no appointment scheduled within two weeks, the pharmacist will call the patient and prescribe medication intensification if the patient is amenable.
干预措施: Cellular Home blood pressure (BP) monitoring
Non-randomized usual care
To compare the two intervention arms with usual care, investigators will extract electronic health record (EHR) data on active San Francisco Health Network (SFHN) adult patients (age 18+) with diagnosis of hypertension who made at least one primary care visit during the study period.
结局指标
主要结局
Systolic blood pressure (SBP)
时间窗: 6 months
We will use clinic-based assessment of SBP as the primary outcome of interest, using all SBP measurements during any outpatient encounter in the 6 months prior to enrollment in the study and the 6 months during the active intervention period. Blood pressure (BP) is collected routinely during all patient encounters in our system, using a standardized BP measurement protocol that requires the use of automated BP machines at primary clinics broadly implemented as part of ongoing, previously described, qualify improvement efforts.
次要结局
- Medication intensification(6 months)
- Krousel-Wood Adherence Scale for medication adherence(6 months)
- Blood Pressure (BP) control(6 months)
- Change in Home BP(6 months)
- Patient Assessment of Chronic Illness Care (PACIC)(6 months)