- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359691
Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County
UCLA Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County
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.
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arleen F Brown, MD, PhD
- Phone Number: 310-794-6047
- Email: abrown@mednet.ucla.edu
Study Contact Backup
- Name: Amelia Weldon
- Phone Number: 310-794-0989
- Email: aweldon@mednet.ucla.edu
Study Locations
-
-
California
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Sylmar, California, United States, 91342
- Olive View-UCLA Medical Center
-
Contact:
- Soma Wali, MD
- Phone Number: 747-210-3205
- Email: swali@dhs.lacounty.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Usual Strategies - Year1
Usual strategies implemented in year 1, patient-focused and provider-focused strategies implemented in year 2, and sustainment in year 3.
|
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.
|
Experimental: Patient-Focused Strategies - Year1
Patient-focused strategies implemented in year 1, provider-focused strategies implemented in year 2, and sustainment in year 3.
|
Patient-focused strategies to increase HTN management practices:
Provider-focused strategies to increase HTN management practices:
|
Experimental: Provider-Focused Strategies - Year1
Provider-focused strategies implemented in year 1, patient-focused strategies implemented in year 2, and sustainment in year 3.
|
Patient-focused strategies to increase HTN management practices:
Provider-focused strategies to increase HTN management practices:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall provider adoption of evidence based practices
Time Frame: Yearly
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider/Care Team EBP Acceptability, Appropriateness, Feasibility
Time Frame: Yearly
|
Implementation Outcome: Provider EBP Acceptability, Appropriateness, Feasibility
|
Yearly
|
Blood Pressure (BP) Control
Time Frame: Yearly
|
BP control is defined by a representative systolic BP of <140 mm Hg and a representative diastolic BP of <90 mm Hg..
A Representative BP is defined as the most recent BP reading during the measurement year or, if multiple BP measurements occur on the same date or noted in the chart on the same date, use the lowest systolic and lowest diastolic BP reading.
If there is no recorded BP during the measurement year, and the participant is still empaneled at LAC DHS, we will identify the member as "not controlled" per the HEDIS guidelines.
|
Yearly
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Arleen F Brown, MD, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4UH3HL154302 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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