Remote Monitoring for Equity in Advancing Control of Hypertension (REACH)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- Systolic blood pressure (SBP)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Under the age of 18
- •Controlled HTN
Arms & Interventions
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.
Intervention: Cellular Home blood pressure (BP) monitoring (Device)
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.
Intervention: Cellular Home blood pressure (BP) monitoring (Device)
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.
Outcomes
Primary Outcomes
Systolic blood pressure (SBP)
Time Frame: 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.
Secondary Outcomes
- 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)