Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes. ((CHW-SYSTIM))

Community Health Workers Systematically Assessing and Addressing Social Determinants of Health to Improve Outcomes in Community Health Centers (CHW-SYSTIM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Uncontrolled Hypertension; Uncontrolled Diabetes
• Intervention / Treatment: Other: CHC-level cluster randomized control trial

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.

• Study Type: Interventional
• Enrollment (Estimated): 3120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33172
      • Health Choice Network (HCN)
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
  • Oregon
    • Portland, Oregon, United States, 97201
      • OCHIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Community Health Centers; Community Health Centers (CHC) will identify a Community Health Worker (CHW) or similar staff member who will conduct social risk activities as part of clinical services for all CHC patients with uncontrolled diabetes (DM) and hypertension (HTN) as defined by Uniform Data System (UDS). If needed due to resource constraints, a prioritization scheme may be applied to target patients with the most poorly controlled DM / HTN, those newly diagnosed, those at selected CHC-run sites, etc.; this scheme will be refined in the intervention development phase.	Other: CHC-level cluster randomized control trial; CHW (with clinic champion support) outreach to eligible patients, verbally consent patients, confirm eligibility, conduct social needs screening, make service or resource referrals, plan and support referral completion as needed, follow-up with patients to assess referral completion and outcomes Implementation supports: financial support for CHW, clinic champion, and CHC administration of trial activities; 12 weeks of preparatory CHW training and coaching; practice coaching and technical support for data collection at all sites; additional support for sites without existing research data infrastructure; CHW Learning Collaborative through intervention and follow-up period for implementation support and cross-training control sites.
No Intervention: Control Community Health Centers; Control CHC data on enabling services and associated workflows will be gathered through qualitative methods for a deeper understanding of the intervention impact. At the end of the intervention year, control CHCs will receive: (1) participation in the end of intervention summative CHW convening for crossover training led by the intervention arm CHWs; and 2) a toolkit designed to support their adoption of the intervention processes. This will both support the dissemination of intervention elements identified as effective (as feasible), and recruitment activities (by ensuring that all study FQHCs receive something through study participation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the hypothesis that CHW-led process will improve health outcomes among DM patients post 12 month intervention	Percentage of participants with a clinically significant improvement in HbA1c, defined as ≥0.5% improvement in HbA1c	Measured at 6 months and 12 months after the first CHW contact.
Test the hypothesis that CHW-led process will improve health outcomes among HTN patients post 12 month intervention	Percentage of participants with a clinically significant improvement in blood pressure, defined as either a ≥5 mmHg reduction in systolic BP, a ≥3 mmHg reduction in diastolic BP, or a return to normal BP (BP <140/90, requiring both systolic and diastolic values below threshold).	Measured at 6 months and 12 months after the first CHW contact.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker Screening	Percent new BP measures - Limited to patients enrolled into the study with uncontrolled hypertension.	New BP measure documented ≥3 months after first contact with the CHW.
Biomarker Screening	Percent new A1C measure - Limited to patient enrolled in the study with uncontrolled diabetes and at least 6 months of follow-up.	New HbA1c measure documented ≥6 months after first contact with the CHW.
Referral provided and completed	Percent of patients with a CHW-documented social service organization referral	Assessed at 6 months after first CHW contact.
Referral provided and completed	Among those with a referral, percent of patients with documented receipt of the recommended service	Assessed at 12 months after first CHW contact.
Referral impact on social risk	Among patients with both a second social risk assessment in the EHR and a documented SSO referral (intervention patients only), percent whose status changed from Yes Risk to No Risk in any domain	Assessed at 6 months after first CHW contact.
Referral impact on social risk	Among those with a SSO referral documented, percent of patients who required further CHW support	Assessed during and after study completion (up to 12 months after the first CHW contact)
Referral impact on social risk	Among those with a SSO referral documented, percent of patients who did not require further CHW support	Assessed during and after study completion (up to 12 months after the first CHW contact)
Referral impact on social risk	Among those with a SSO referral documented, percent of patients who either showed improved social risk status or received the service and required no additional support	Assessed during and after study completion (up to 12 months after the first CHW contact)

Collaborators and Investigators

• Sponsor: Morehouse School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH); Westat; OCHIN, Inc.; Health Choice Network
• Investigators: Principal Investigator: Megan Douglas, JD, Morehouse School of Medicine; Principal Investigator: Rachel Gold, PhD, MPH, OCHIN, Inc.; Principal Investigator: Katherine Chung-Bridges, MD, MPH, Health Choice Network (HCN)

Publications and helpful links

General Publications

• Krieger J, Collier C, Song L, Martin D. Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Am J Public Health. 1999 Jun;89(6):856-61. doi: 10.2105/ajph.89.6.856.
• Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630.
• Hartzler AL, Tuzzio L, Hsu C, Wagner EH. Roles and Functions of Community Health Workers in Primary Care. Ann Fam Med. 2018 May;16(3):240-245. doi: 10.1370/afm.2208.
• Ruiz Escobar E, Pathak S, Blanchard CM. Screening and Referral Care Delivery Services and Unmet Health-Related Social Needs: A Systematic Review. Prev Chronic Dis. 2021 Aug 12;18:E78. doi: 10.5888/pcd18.200569.
• Carter J, Hassan S, Walton A, Yu L, Donelan K, Thorndike AN. Effect of Community Health Workers on 30-Day Hospital Readmissions in an Accountable Care Organization Population: A Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e2110936. doi: 10.1001/jamanetworkopen.2021.10936.
• Greenwood-Ericksen M, DeJonckheere M, Syed F, Choudhury N, Cohen AJ, Tipirneni R. Implementation of Health-Related Social Needs Screening at Michigan Health Centers: A Qualitative Study. Ann Fam Med. 2021 Jul-Aug;19(4):310-317. doi: 10.1370/afm.2690.
• Cockerham WC, Hamby BW, Oates GR. The Social Determinants of Chronic Disease. Am J Prev Med. 2017 Jan;52(1S1):S5-S12. doi: 10.1016/j.amepre.2016.09.010.
• Balfour PC Jr, Rodriguez CJ, Ferdinand KC. The Role of Hypertension in Race-Ethnic Disparities in Cardiovascular Disease. Curr Cardiovasc Risk Rep. 2015 Apr;9(4):18. doi: 10.1007/s12170-015-0446-5.
• Yan AF, Chen Z, Wang Y, Campbell JA, Xue QL, Williams MY, Weinhardt LS, Egede LE. Effectiveness of Social Needs Screening and Interventions in Clinical Settings on Utilization, Cost, and Clinical Outcomes: A Systematic Review. Health Equity. 2022 Jun 24;6(1):454-475. doi: 10.1089/heq.2022.0010. eCollection 2022.
• Sandhu S, Lian T, Smeltz L, Drake C, Eisenson H, Bettger JP. Patient Barriers to Accessing Referred Resources for Unmet Social Needs. J Am Board Fam Med. 2022 Jul-Aug;35(4):793-802. doi: 10.3122/jabfm.2022.04.210462.
• Browne J, Mccurley JL, Fung V, Levy DE, Clark CR, Thorndike AN. Addressing Social Determinants of Health Identified by Systematic Screening in a Medicaid Accountable Care Organization: A Qualitative Study. J Prim Care Community Health. 2021 Jan-Dec;12:2150132721993651. doi: 10.1177/2150132721993651.
• Wan W, Li V, Chin MH, Faldmo DN, Hoefling E, Proser M, Weir RC. Development of PRAPARE Social Determinants of Health Clusters and Correlation with Diabetes and Hypertension Outcomes. J Am Board Fam Med. 2022 Jul-Aug;35(4):668-679. doi: 10.3122/jabfm.2022.04.200462.
• Daly A, Sapra A, Albers CE, Dufner AM, Bhandari P. Food Insecurity and Diabetes: The Role of Federally Qualified Health Centers as Pillars of Community Health. Cureus. 2021 Mar 12;13(3):e13841. doi: 10.7759/cureus.13841.
• Milani RV, Price-Haywood EG, Burton JH, Wilt J, Entwisle J, Lavie CJ. Racial Differences and Social Determinants of Health in Achieving Hypertension Control. Mayo Clin Proc. 2022 Aug;97(8):1462-1471. doi: 10.1016/j.mayocp.2022.01.035. Epub 2022 Jul 19.

Helpful Links

• Centers for Disease Control and Prevention. (2030). Healthy People.
• Community health center chartbook 2023.
• National Academies of Sciences, Engineering, and Medicine. Investing in interventions that address non-medical, health-related social needs: Proceedings of a workshop.
• Building the evidence base for social determinants of health interventions

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Uncontrolled diabetes; Uncontrolled hypertension; Randomized Controlled Trial (RCT); Hemoglobin A1C; Community Health Worker (CHW); Social Needs; Federally Qualified Health Center (FQHC); CEAL; Social Determinants of Health (SDOH); Advanced Encryption Standard; health differences
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2168673-4; NHLBI Sub-Other Transaction (Other Identifier: National Institutes of Health(NIH)/National Heart, Lung and Blood Institute(NHLBI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

In alignment with NIH data sharing policies and organizational agreements, we will develop a process for sharing RCT data once the study is complete. RCT data will be available as follows:

For patients in the RCT intervention sites who provide informed consent, de-identified patient-level data will be available for future research, per NIH's DMSP. In alignment with NIH data sharing policies and organizational agreements, we will develop a process for sharing RCT data once the study is complete.

For patients who are not consented (i.e. ALL patients in control clinics and any patients in intervention clinics who are not consented), only aggregate data can be shared. Aggregate data are defined as a dataset or data display that consolidates data from multiple individuals (e.g., patients) and does not contain identifiers that can be used to identify individual patients.

• IPD Sharing Time Frame: July 1st, 2026 - June 30th, 2028
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No