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

University of California San Francisco (UCSF)

Status: Invitation-only

Conditions: Hypertension; Blood Pressure Monitoring, Home

Treatments: Behavioral: Educational text messages that encourage seeking support from a support person; Behavioral: BP monitor use training and app training; Behavioral: Education about self-management of hypertension; Behavioral: Involvement of caregiver or support person; Behavioral: Online patient portal enrollment and training; Behavioral: Group classes; Behavioral: SMS reminders to take blood pressure

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06871462

24-42092

R18HS029817 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

Low-Intensity (Usual Care)

Active Comparator group

Description:

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

Treatment:

Behavioral: SMS reminders to take blood pressure

Behavioral: Online patient portal enrollment and training

Behavioral: Education about self-management of hypertension

Behavioral: BP monitor use training and app training

High-Intensity

Experimental group

Description:

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

Treatment:

Behavioral: SMS reminders to take blood pressure

Behavioral: Group classes

Behavioral: Online patient portal enrollment and training

Behavioral: Involvement of caregiver or support person

Behavioral: Education about self-management of hypertension

Behavioral: Educational text messages that encourage seeking support from a support person

Behavioral: BP monitor use training and app training