Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County

NCT06359691 | Active Not Recruiting DMC

• 1 other identifier: 4UH3HL154302
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to promote equitable hypertension (HTN) management across the diverse patient population found in Los Angeles County Department of Health Services (LAC DHS) clinics. To achieve this goal, the study team will conduct provider- and patient-focused outreach strategies to understand how to best support adoption of blood pressure management practices already available within LAC DHS. LAC DHS clinics will be randomly assigned to one of three study conditions: 1) provider-focused outreach, 2) patient-focused outreach, and 3) usual outreach. The study will occur across 3 years with patient- and provider-focused outreach occurring in Year 1 and 2. In Year 3, study initiated patient- and provider-focused outreach will stop, and clinic use of patient- and provider-focused outreach practices will be observed by the study team. Provider-focused outreach includes increasing cultural awareness of factors that hinder and support blood pressure control, increasing access to blood pressure medications, and providing blood pressure management education. Patient-focused outreach includes using culturally sensitive educational materials and reminders to improve patient understanding of blood pressure, education on how to manage the condition, and increasing awareness of available blood pressure management resources. Clinics assigned to the usual outreach condition will operate as per usual in Year 1 but will receive patient- and provider-focused outreach in Year 2.

Conditions

Hypertension

Keywords

Hypertension; Health disparities; Healthcare safety-net; Health equity

Outcome Measures

Primary Outcomes (1)

• Overall provider adoption of evidence based practices

  A composite score, at the DHS provider level, to evaluate the adoption of nine culturally tailored EBP components \[home blood pressure (BP) monitor documented or acquired, home BP readings uploaded into patient portal, primary care visit attended within 1-12 weeks of uncontrolled BP reading, hypertension clinic nurse visit within 1-12 weeks of uncontrolled BP reading. patient referral to DHS hypertension resources, social needs screening conducted, CHW assigned and met with patient, provider uptake of hypotension education and training and combination medications prescribed\]. The score for a provider ranges from 0 to 9, a higher score indicates higher level of adoption of EBPs.

  Yearly

Secondary Outcomes (2)

• Provider/Care Team EBP Acceptability, Appropriateness, Feasibility

  Yearly

• Blood Pressure (BP) Control

  Yearly

Study Arms (3)

Usual Strategies - Year1

EXPERIMENTAL

Usual strategies implemented in year 1, patient-focused and provider-focused strategies implemented in year 2, and sustainment in year 3.

Behavioral: Patient- and provider-focused strategies

Patient-Focused Strategies - Year1

EXPERIMENTAL

Patient-focused strategies implemented in year 1, provider-focused strategies implemented in year 2, and sustainment in year 3.

Behavioral: Patient-focused strategies; Behavioral: Provider-focused strategies

Provider-Focused Strategies - Year1

EXPERIMENTAL

Provider-focused strategies implemented in year 1, patient-focused strategies implemented in year 2, and sustainment in year 3.

Behavioral: Patient-focused strategies; Behavioral: Provider-focused strategies

Interventions

Patient-focused strategies BEHAVIORAL

Patient-focused strategies to increase HTN management practices: 1. Hypertension registry: notify patients of their status, target education and resources to patients 2. Home BP monitoring: provide BP monitors, encourage reporting of home BP readings 3. Enhance standardization of home and office BP readings: patients trained by care staff, posters in clinics on how to measure BP correctly 4. Nurse-directed BP medication titration with CHW/Health Educator reinforcement: self-directed referrals to nurse-directed clinics and CHW/health educators 5. Enhance patient understanding of BP using culturally- and linguistically- tailored materials: tailored educational materials offered to patients in clinic, via text and the patient portal. 6. Social needs screening and linkage to community resources: awareness of and self-referrals to community resources 7. Behavioral science intervention messaging: posters in clinic waiting rooms, scripts for RN/PCP, texts to patients

Patient-Focused Strategies - Year1; Provider-Focused Strategies - Year1

Provider-focused strategies BEHAVIORAL

Provider-focused strategies to increase HTN management practices: 1. Hypertension registry: identify patients with uncontrolled BP, notify care team 2. Home BP monitoring: provide home BP monitors, encourage reporting of BP readings 3. Enhance standardization of home/office BP readings: staff training, posters in clinic 4. Simplify treatment protocols using fixed-dose combo meds: education on fixed-dose combo meds 5. Nurse-directed BP med titration w/ CHW/Health Educator support: system for team-based care, referral to nurse-directed clinics \& CHWs/health educators 6. Enhance patient understanding of BP using culturally- and linguistically- tailored materials: Increased availability of tailored materials 7. Social needs screening and linkage to community resources: referral system to resources 8. CHW assigned to patients with complex medical and social needs: referral of complex patients to CHWs 9. Behavioral science messaging: posters in charting rooms, scripts for RNs

Patient-Focused Strategies - Year1; Provider-Focused Strategies - Year1

Patient- and provider-focused strategies BEHAVIORAL

A combination of the 7 patient-focused strategies (see patient-focused strategies outlined above) and 9 provider-focused strategies (see provider-focused strategies outlined above) implemented simultaneously.

Usual Strategies - Year1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension code in EHR ((ICD-9 codes: 401, 402, 403, 404, 405, 437.2 and ICD-10 codes: I10, I11.0, I11.9. I12.0, I12.9, I13.0, I13.10, I13.11, I13.2, I15.0, I15.8, I67.4)
• Accessing primary care at participating clinic in LAC DHS
• years or older.

You may not qualify if:

• No hypertension codes in EHR
• Primary care outside of participating clinic or LAC DHS
• Under 18 years old

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Related Publications (1)

• Takada S, Wali S, Park N, Sadia A, Weldon AR, Liang LJ, Vassar SD, Carson SL, Dopp AR, Korn AR, Hamilton AB, Mittman BS, Lo J, Sandesara U, Huang YC, Jara J, Robles N, Casillas A, Brown AF. Protocol for a Type 3 hybrid effectiveness-implementation cluster randomized trial to evaluate multi-ethnic, multilevel strategies and community engagement to eliminate hypertension disparities in Los Angeles County. Implement Sci. 2025 Oct 6;20(1):42. doi: 10.1186/s13012-025-01452-5.

  PMID: 41053767 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arleen F Brown, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-armed crossover trial design to test effectiveness and sustainment of our implementation strategies across LAC DHS clinics and the communities they serve.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)