Clinical trial NCT06359691: Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County
Official title: UCLA Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Health disparities
Healthcare safety-net
Health equity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-11
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-armed crossover trial design to test effectiveness and sustainment of our implementation strategies across LAC DHS clinics and the communities they serve.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall provider adoption of evidence based practices
timeFrame: Yearly
Secondary outcomes:
measure: Provider/Care Team EBP Acceptability, Appropriateness, Feasibility
timeFrame: Yearly
measure: Blood Pressure (BP) Control
timeFrame: Yearly
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Arleen F Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: