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

NCT ID: NCT06359691

Last Updated: 2025-09-24

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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The UCLA DECIPHeR Alliance study, Multi-ethnic Multi-level Strategies, and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County, is led by Dr. Arleen Brown and Dr. Alejandra Casillas. The study will focus on the racial and ethnic gaps in evidence-based treatment that contribute to hypertension disparities in the Los Angeles County Department of Health Services (LAC DHS). Of the 43% of LAC DHS patients with hypertension, 60% are uncontrolled. Racial and ethnic differences in hypertension rates and blood pressure control in the LAC DHS result from a multitude of factors such as diet, exercise, obesity, poverty, social support, hypertension measurement access, hypertension medication education, use, and adherence, hypertension community awareness and education, and variable health and socioeconomic resource access.

During the study's planning phase (UG3), barriers to and preferences for interventions and implementation strategies were identified at the patient, provider, clinic, health system, and community levels to tailor hypertension interventions with the goal of improving blood pressure control among racially and ethnically diverse safety net health system patients with uncontrolled HTN. This three-year phase included the formation of routine meetings with the study Steering Committee and five race- and ethnic-specific community action boards (CABs), a LAC DHS health system intervention and implementation planning group, a study meta-analysis team, a behavioral science subcommittee, and Technical Assistance meetings with NIH statisticians.

The intervention partners with LAC DHS to randomize clinics to one of three strategies: 1) provider-focused strategies, 2) patient-focused strategies, and 3) usual care strategies. Provider-focused strategies center on increasing provider knowledge of evidence-based blood pressure management, increasing cultural awareness of barriers to and facilitators of control, increasing access to medications, and integrating gained knowledge into practice. Patient-focused strategies include using culturally tailored materials and reminders to improve patient understanding of hypertension, how to manage the condition, and the available resources; increasing access to home blood pressure monitors; and social needs screening with linkage to community resources.

The UCLA DECIPHeR Team employs the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to guide the implementation process. The team will use the RE-AIM framework to test the effectiveness of their implementation strategies.

Primary implementation aim:

To test the effectiveness of the implementation strategies (usual care, patient-focused strategies, and provider-focused strategies) on change in adoption of culturally tailored evidence-based practices (at the end of Year 1).

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Strategies - Year1

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

Group Type EXPERIMENTAL

Patient- and provider-focused strategies

Intervention Type 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.

Patient-Focused Strategies - Year1

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

Group Type EXPERIMENTAL

Patient-focused strategies

Intervention Type 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

Provider-focused strategies

Intervention Type 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

Provider-Focused Strategies - Year1

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

Group Type EXPERIMENTAL

Patient-focused strategies

Intervention Type 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

Provider-focused strategies

Intervention Type 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

Interventions

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Patient-focused strategies

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

Intervention Type BEHAVIORAL

Provider-focused strategies

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

Intervention Type BEHAVIORAL

Patient- and provider-focused strategies

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* 18 years or older.

Exclusion Criteria

* No hypertension codes in EHR
* Primary care outside of participating clinic or LAC DHS
* Under 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Arleen F. Brown, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arleen F Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Olive View-UCLA Medical Center

Sylmar, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41053767 (View on PubMed)

Other Identifiers

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4UH3HL154302

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4UH3HL154302

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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