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Remote Monitoring for Equity in Advancing Control of Hypertension (REACH)

Primary Purpose

Hypertension

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cellular Home blood pressure (BP) monitoring
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Blood pressure, Telehealth, Telemedicine, Patient generated health data, Remote patient monitoring

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General Hospital/University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Cellular Home blood pressure (BP) monitoring with minimal support

Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification

Non-randomized usual care

Arm Description

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.

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.

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 Outcome Measures

Systolic blood pressure (SBP)
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 Outcome Measures

Medication intensification
We will review prescribing patterns for anti-hypertensive medications for each patient in the trial. This will be measured as total proportion of patients with medication intensification (new medication or increased dosage) over the study period.
Blood Pressure (BP) control
We will define BP control as Systolic blood pressure (SBP) <140mmg and Diastolic blood pressure (DBP) <90 mmHg in secondary analyses. This BP control analysis will also use all available BP readings and treat every clinic BP reading as separate repeated binary assessments.
Change in Home BP
We will also examine change in BP (systolic and diastolic) based on the Home BP measurements from the cellular monitors.
Patient Assessment of Chronic Illness Care (PACIC)
We will collect patient-reported outcomes on a baseline survey at onboarding, with a repeat follow-up survey at 6 months when they exit the study. The Patient Assessment of Care for Chronic Conditions (PACIC) is a 22-item self-measurement of how well patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding elements of the care of their chronic condition(s). Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "None of the time" and 5 signifying "Always". The mean is used to find an overall score of the PACIC. The higher scores mean a better outcome.
Krousel-Wood Adherence Scale for medication adherence
We will collect patient-reported outcomes on a baseline survey at onboarding, with a repeat follow-up survey at 6 months when they exit the study. Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4), is a hybrid tool developed to predict pharmacy refill and which captures four domains of adherence behavior: self-efficacy, physical function, intentional medication-taking, and forgetfulness. The 4-item scale categorized participants as low and high adherers using scores at least 1 and less than 1, respectively. The higher scores mean a better outcome.

Full Information

First Posted
July 28, 2022
Last Updated
July 31, 2023
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05481892
Brief Title
Remote Monitoring for Equity in Advancing Control of Hypertension
Acronym
REACH
Official Title
Remote Monitoring for Equity in Advancing Control of Hypertension (REACH)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure, Telehealth, Telemedicine, Patient generated health data, Remote patient monitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cellular Home blood pressure (BP) monitoring with minimal support
Arm Type
Experimental
Arm Description
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.
Arm Title
Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-randomized usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cellular Home blood pressure (BP) monitoring
Intervention Description
Patients receiving intervention will receive cellular home blood pressure (BP) monitoring devices. Some patients will also receive pharmacist support for treatment intervention.
Primary Outcome Measure Information:
Title
Systolic blood pressure (SBP)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication intensification
Description
We will review prescribing patterns for anti-hypertensive medications for each patient in the trial. This will be measured as total proportion of patients with medication intensification (new medication or increased dosage) over the study period.
Time Frame
6 months
Title
Blood Pressure (BP) control
Description
We will define BP control as Systolic blood pressure (SBP) <140mmg and Diastolic blood pressure (DBP) <90 mmHg in secondary analyses. This BP control analysis will also use all available BP readings and treat every clinic BP reading as separate repeated binary assessments.
Time Frame
6 months
Title
Change in Home BP
Description
We will also examine change in BP (systolic and diastolic) based on the Home BP measurements from the cellular monitors.
Time Frame
6 months
Title
Patient Assessment of Chronic Illness Care (PACIC)
Description
We will collect patient-reported outcomes on a baseline survey at onboarding, with a repeat follow-up survey at 6 months when they exit the study. The Patient Assessment of Care for Chronic Conditions (PACIC) is a 22-item self-measurement of how well patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding elements of the care of their chronic condition(s). Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "None of the time" and 5 signifying "Always". The mean is used to find an overall score of the PACIC. The higher scores mean a better outcome.
Time Frame
6 months
Title
Krousel-Wood Adherence Scale for medication adherence
Description
We will collect patient-reported outcomes on a baseline survey at onboarding, with a repeat follow-up survey at 6 months when they exit the study. Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4), is a hybrid tool developed to predict pharmacy refill and which captures four domains of adherence behavior: self-efficacy, physical function, intentional medication-taking, and forgetfulness. The 4-item scale categorized participants as low and high adherers using scores at least 1 and less than 1, respectively. The higher scores mean a better outcome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Lyles, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital/University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring for Equity in Advancing Control of Hypertension

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