Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-05-01

Brief Summary

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This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.

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Detailed Description

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This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, culturally and linguistically diverse patients with hypertension in an urban safety net. The investigators propose a hybrid type 1 effectiveness-implementation trial of implementation strategies to increase use of SMBP monitoring with clinical support in an urban safety net system. 330 patients will be randomized to a low-intensity vs high-intensity implementation strategy for SMBP monitoring. The low-intensity strategy will replicate frequently used implementation efforts (provision of BP monitor with training on using a monitor) while the high-intensity strategy will address additional factors identified in prior work (e.g., digital literacy, social support). In six adult primary clinics, the investigators will concurrently provide a stepped-wedge clinic-level implementation strategy (clinical champions, electronic health record \[EHR\] tools) to increase provision of clinical support for SMBP data. To guide dissemination in other under-resourced settings, an economic evaluation will also be conducted.

Conditions

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Blood Pressure Monitoring, Home Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-Intensity (Usual Care)

Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials.

Clinic level: training on standardized workflows and EHR tools, audit and feedback

Group Type ACTIVE_COMPARATOR

BP monitor use training and app training

Intervention Type BEHAVIORAL

Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.

Online patient portal enrollment and training

Intervention Type BEHAVIORAL

Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.

SMS reminders to take blood pressure

Intervention Type BEHAVIORAL

Patients will receive reminders via SMS to take their blood pressure.

Education about self-management of hypertension

Intervention Type BEHAVIORAL

One-time training with action planning, access to website with language concordant patient education, and educational text messages

High-Intensity

Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.

Clinic level: training on standardized workflows and EHR tools, audit and feedback

Group Type EXPERIMENTAL

BP monitor use training and app training

Intervention Type BEHAVIORAL

Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.

Online patient portal enrollment and training

Intervention Type BEHAVIORAL

Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.

SMS reminders to take blood pressure

Intervention Type BEHAVIORAL

Patients will receive reminders via SMS to take their blood pressure.

Education about self-management of hypertension

Intervention Type BEHAVIORAL

One-time training with action planning, access to website with language concordant patient education, and educational text messages

Educational text messages that encourage seeking support from a support person

Intervention Type BEHAVIORAL

Educational text messages about behavioral changes that explicitly encourage seeking support from a support person

Involvement of caregiver or support person

Intervention Type BEHAVIORAL

Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.

Group classes

Intervention Type BEHAVIORAL

Patients will be asked to attend in-person or online group education classes on hypertension management

Interventions

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BP monitor use training and app training

Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.

Intervention Type BEHAVIORAL

Online patient portal enrollment and training

Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.

Intervention Type BEHAVIORAL

SMS reminders to take blood pressure

Patients will receive reminders via SMS to take their blood pressure.

Intervention Type BEHAVIORAL

Education about self-management of hypertension

One-time training with action planning, access to website with language concordant patient education, and educational text messages

Intervention Type BEHAVIORAL

Educational text messages that encourage seeking support from a support person

Educational text messages about behavioral changes that explicitly encourage seeking support from a support person

Intervention Type BEHAVIORAL

Involvement of caregiver or support person

Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.

Intervention Type BEHAVIORAL

Group classes

Patients will be asked to attend in-person or online group education classes on hypertension management

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years old/order
* Any sex or gender
* Any race or ethnicity
* Must be receiving primary care at any of the six enrolled clinics
* Have uncontrolled hypertension (BP \>=140/90 mmHg at any two encounters in the previous 18 months, including the most recent encounter prior to enrollment)
* Can read and write English, Spanish, or Cantonese
* Be able to provide consent
* Must own a cell phone that receives SMS or text messages

Exclusion Criteria

* Those with conditions that might complicate remote BP monitoring:

* Pregnancy (and 12 months postpartum)
* Acute myocardial infarction or stroke in the last 12 months
* End-stage renal disease on dialysis
* Stage D heart failure
* Active treatment for cancer (except for nonmelanoma skin cancers)
* Pacemaker use
* Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No