Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations (InSPIRED): A study protocol

Elaine C Khoong; Hyunjin Cindy Kim; Junhong Li; Jorge Larreynaga; Isabel Luna; Andersen Yang; Dhruv S Kazi; Courtney R Lyles; Charles McCulloch; Sarah B Rahman; Urmimala Sarkar; Natalie Curtis

doi:10.1016/j.cct.2025.108101

Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations (InSPIRED): A study protocol

Contemp Clin Trials. 2025 Nov:158:108101. doi: 10.1016/j.cct.2025.108101. Epub 2025 Oct 6.

Authors

Affiliations

¹ Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA; UCSF Action Research Center for Health, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA. Electronic address: elaine.khoong@ucsf.edu.
² Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA; UCSF Action Research Center for Health, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
³ Harvard Medical School, Boston, MA, USA; Richard A. and Susan F. Smith Center for Outcomes Research, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
⁴ Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA; UCSF Action Research Center for Health, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA; Center for Healthcare Policy and Research, University of California Davis, Sacramento, CA, USA.
⁵ Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
⁶ Alameda Health System, Oakland, CA, USA.
⁷ Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA; UCSF Action Research Center for Health, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.

PMID: 41057081
DOI: 10.1016/j.cct.2025.108101

Abstract

Introduction: Self-measured blood pressure (SMBP) monitoring with clinical support is an evidence-based practice to improve hypertension control. However, it can be challenging to implement in safety-net systems that disproportionately serve low-income and/or racial/ethnic minority populations at risk of worse hypertension outcomes. We therefore propose a hybrid effectiveness-implementation trial to evaluate the effectiveness of multi-level implementation strategies to increase the use of SMBP monitoring in two urban safety-net systems.

Methods: We will conduct a patient-level randomized controlled trial with 330 English-, Spanish-, and Chinese (Cantonese)-speaking patients with uncontrolled hypertension across six study sites with patients randomized to a low-intensity (SMBP education, text message education and reminders) vs. high-intensity intervention (adds group classes and engagement of identified caregivers). To support increased use of SMBP data by the clinical team, we will concurrently deliver a staggered roll-out of a clinic-level implementation strategy (clinic education, shadowing, auditing with feedback, and optimization of electronic health record [EHR] use).

Results: The primary outcomes will be clinic-measured systolic BP (SBP) among enrolled participants for the patient-level intervention and among all patients assigned to the clinic for the clinic-level intervention. We will additionally collect secondary clinical outcomes (BP control, home SBP), implementation outcomes (adoption, reach, and costs), and patient-reported outcomes (patient activation).

Discussion: The results of this trial will address gaps in identifying cost-conscious implementation strategies for increasing adoption of SMBP in safety-net systems with the overarching goal of improving blood pressure control in low-income, diverse patient populations. Trial registration NCT, NCT06871462. Registered 4 March 2025, https://clinicaltrials.gov/study/NCT06871462.

Keywords: Cost; Digital health; Home blood pressure monitoring; Hypertension; Remote patient monitoring; Safety-net.

Publication types

Clinical Trial Protocol

MeSH terms

Blood Pressure
Blood Pressure Monitoring, Ambulatory* / methods
Electronic Health Records
Ethnicity
Female
Humans
Hypertension* / diagnosis
Hypertension* / ethnology
Hypertension* / therapy
Multicenter Studies as Topic
Patient Education as Topic / methods
Racial Groups
Randomized Controlled Trials as Topic
Safety-net Providers / organization & administration
Text Messaging

Associated data

ClinicalTrials.gov/NCT06871462

Grants and funding

R18 HS029817/HS/AHRQ HHS/United States