Clinical trial NCT06871462: Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
Official title: Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure Monitoring, Home
Hypertension
Keywords: INSPIRED
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Beth Israel Deaconess Medical Center
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2025-03-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in clinic systolic BP
timeFrame: Baseline, 12 months, 18 months
measure: BP Control
timeFrame: Monthly (-6 to 18 months)
Secondary outcomes:
measure: BP Control
timeFrame: Baseline, 12 months, 18 months
measure: Home Systolic BP (SBP)
timeFrame: Baseline, 12 months, 18 months
measure: Patient Adoption
timeFrame: 12 months
measure: Clinic adoption
timeFrame: Monthly (-6 to 18 months)
measure: Reach
timeFrame: 12 months
measure: Costs
timeFrame: During trial; 12 months
measure: Patient Activation
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elaine Khoong, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: