Clinical trial NCT06926855: Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes.
Official title: Community Health Workers Systematically Assessing and Addressing Social Determinants of Health to Improve Outcomes in Community Health Centers (CHW-SYSTIM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uncontrolled Diabetes
Uncontrolled Hypertension
Keywords: Uncontrolled diabetes
Federally Qualified Health Center (FQHC)
Health Inequities
Community Health Worker (CHW)
CEAL
Randomized Controlled Trial (RCT)
Social Determinants of Health (SDOH)
Social Needs
Diabetes Mellitus
Hemoglobin A1C
Advanced Encryption Standard
Uncontrolled hypertension
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: Health Choice Network
name: OCHIN, Inc.
name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Westat
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-04-15
Enrollment: 3120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: SCREENING

Brief summary: The goal of this mixed-methods study is to assess the impact of a Community Health Worker (CHW)-led social risk screening and referral in improving management of uncontrolled diabetes (DM) and hypertension (HTN) among patients receiving care in community health centers (CHCs or health centers). The intervention is focused on adult health center patients with uncontrolled DM and/or HTN. Study findings will provide important evidence to guide CHCs in implementing programs to address social risks in their patient populations. Findings will illuminate whether and how CHW-led interventions to address social needs yield the hypothesized outcomes. The aims of the study are:

* AIM 1: Measure how effective the CHW-led social risk program is at reducing blood sugar levels (A1C) in CHC patients with uncontrolled DM and lowering blood pressure in CHC patients with uncontrolled HTN.
* AIM 2: Identify effective strategies for increasing and expanding CHW-led social risk programs.

Detailed description: BACKGROUND: Social determinants of health (SDOH) are the conditions of the environment in which people are born, live, work, and age; they are non-medical factors that impact health. Adverse SDOH are often called social risks; when patients report having such risks and desiring strategies for mitigating them, it is often called social needs. Exposure to social risks contributes to numerous poor health outcomes and is associated with negative impacts on chronic disease outcomes like diabetes (DM) and hypertension (HTN) control.

People with HTN have high rates of social risks, and these rates are higher among African American, Alaskan Native, American Indian, Native Hawaiian and Pacific Islander patients than white patients. Social risks often occur in clusters, and patients with multiple social risks are more likely to have uncontrolled DM and / or uncontrolled HTN. Given the many negative health impacts of social risks, numerous national guidelines recommend screening for and addressing social risks through referral to social services. The impacts of social risks on DM and HTN outcomes are most profound in the communities served by community health centers (CHCs). CHC patients with DM have high rates of unmet social needs. Therefore, the need for interventions that mitigate the impacts of social risks on these chronic disease outcomes - and the need for evidence on how to implement such interventions effectively and sustainably - is critical in the CHC setting.

Many CHCs strive to assess and address social risks but lack an approach to doing so systematically; as a result, not all patients who could benefit from such efforts - such as those with uncontrolled DM and / or HTN - do so. The many known barriers to widespread adoption of systematic social risk screening and referral-making include challenges associated with fitting social risk screening, documentation, and referral-making into clinic workflows.

Preliminary evidence suggests that Community Health Workers (CHWs) could play a critical part in CHC approaches to identifying social risks and referring patients with social needs to social services. CHW models of care have been shown to have a significant and positive impact on health outcomes, including hospitalization readmission rates and continuity of care. Thus, CHW-based approaches in CHCs might mitigate the impacts of social risks on DM and HTN. However, given the substantial barriers to implementing social risk-related activities in clinical settings, research is needed on how to optimize CHW-focused social risk interventions, and how to implement such interventions so they are adopted systematically and sustainably. Yet there are barriers specific to CHWs' potential ability to support CHCs' social risk efforts, including CHWs' large caseloads, competing demands, and time pressure, limited ability to enter data in the electronic health record, and CHWs lacking needed information to connect patients with social services. Thus, there is a clear need for research on: the impact on DM and HTN outcomes of CHW-led interventions to address social risks, whether and how CHW-led interventions support implementing this model in CHCs, and strategies for enhancing the sustained implementation of CHW-led interventions in this setting. The proposed study will generate some of this needed evidence.

SETTING: The RCT will be conducted in CHCs. NCPCR, comprised of two research networks (OCHIN, Morehouse School of Medicine (MSM)), will engage three primary care networks (OCHIN, Health Choice Network (HCN), and the Southeast Regional Clinicians Network (SERCN)) and these existing networks will be leveraged to recruit CHCs to participate in the RCT.

STUDY POPULATION: Adult patients ≥18 years old receiving care in one of the participating CHCs, with a DM diagnosis and most recent A1c \>9, and / or a HTN diagnosis and last systolic BP \>140 or last diastolic BP \>90.

DATA COLLECTION:

1. Electronic Health Record (EHR) data: The study will obtain de-identified EHR data from CHCs for patients ages 18 years and older. This data has already been collected as part of regular patient care. All data will be de-identified, so there is minimal risk of identification. EHR data will also be de-identified, and it is not practical to attain consent for the utilization of EHR data. The data will include patient demographics, health center characteristics, SDOH data, and clinical outcomes (i.e., % targeted patients with improved BP, % targeted patients with improved HbA1c, % targeted patients with new BP measures documented every \>=3 months after first CHW contact, % targeted patients with DM with new HbA1c measures documented every \>=3 months after first CHW contact).
2. CHW-collected REDCap data (Intervention sites): The study will also collect common prospective data elements to assess the delivery of the intervention. This data will be collected in a separate data management system (i.e., REDCap) by the CHWs. The data will include % targeted patients with up-to-date SDOH screening by end of follow-up period, % patients with social risks that received a referral, % of patients with patient self-reported receipt of the recommended services. The no Intervention CHCs will receive access to standard online CHW training modules free of charge to them.
3. Qualitative data: The study team will conduct 1) virtual semi-structured interviews with a subset of the CHW staff to explore their experiences, perspectives, successes, and challenges; 2) CHC-specific virtual group interviews will focus on context/setting and referral processes; hopes, expectations and perceived challenges regarding the intervention; perceived impact of the intervention on social risk screening and referral; patient care access and quality (including any negative impacts); clinical workflow and staff reactions/satisfaction; expectations met or unmet and challenges encountered during the intervention; and lessons learned; and 3) cross-CHC virtual patient focus groups or interviews to explore patient experience with and reactions to the CHW-led screening and referral process, including any impact (positive or negative) on their perception of the care they received, their relationships with members of the care team, their ability to access material support, and their health.

In this concurrent mixed methods study, quantitative and qualitative data are collected in parallel and initially analyzed separately. Once preliminary analyses are complete, quantitative and qualitative analysts will meet to share results and work to integrate the mixed method data and present the combined data, organized by RE-AIM domain.

Eligibility criteria: Inclusion Criteria

* 18 years or older
* People with Type 2 diabetes with their most recent hemoglobin A1c test result (a blood test that reflects average blood sugar levels over the past 2-3 months) is greater than or equal to 9%.
* People with essential hypertension with their last systolic blood pressure (BP) (the top number in a BP reading) is greater than or equal to 140 mmHg or diastolic BP (the bottom number in a BP reading) is greater than or equal to 90 mmHg.

Exclusion Criteria

* People who are less than 18 years old
* Pregnant people
* People who don't meet the Type 2 diabetes or hypertension criteria.

Primary outcomes:
measure: Test the hypothesis that CHW-led process will improve health outcomes among DM patients post 12 month intervention
timeFrame: Measured at 6 months and 12 months after the first CHW contact.
measure: Test the hypothesis that CHW-led process will improve health outcomes among HTN patients post 12 month intervention
timeFrame: Measured at 6 months and 12 months after the first CHW contact.
Secondary outcomes:
measure: Assess the provision of appropriate social need screening
timeFrame: Social needs screening conducted during the 6 months intervention period.
measure: Assess percentage of patients referred to social services
timeFrame: Referral assessed at 6 months after first CHW contact.
measure: Assessing successful patient service linkage rate
timeFrame: Successful linkage assessed at 12 months after first CHW contact.
measure: Evaluating Staff Experiences through Interviews and Surveys on Implementation Strategies
timeFrame: Assessed at study completion (up to 12 months after the first CHW contact)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Health Choice Network (HCN)
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Portland
country: United States
facility: OCHIN
state: Oregon
Study officials:
affiliation: Morehouse School of Medicine
name: Megan Douglas, JD
role: PRINCIPAL_INVESTIGATOR
affiliation: OCHIN, Inc.
name: Rachel Gold, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Choice Network (HCN)
name: Katherine Chung-Bridges, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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