Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes.

NCT06926855 | Active Not Recruiting

• 2 other identifiers: 2168673-4NHLBI Sub-Other Transaction
• Study Type: interventional
• Target: 3,120
• Locations: 1 country
• Sites: 3

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.

Conditions

Uncontrolled Diabetes; Uncontrolled Hypertension

Keywords

Uncontrolled diabetes; Federally Qualified Health Center (FQHC); 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; health differences

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Biomarker Screening

  New BP measure documented ≥3 months after first contact with the CHW.

• Biomarker Screening

  New HbA1c measure documented ≥6 months after first contact with the CHW.

• Referral provided and completed

  Assessed at 6 months after first CHW contact.

• Referral provided and completed

  Assessed at 12 months after first CHW contact.

• Referral impact on social risk

  Assessed at 6 months after first CHW contact.

Study Arms (2)

Intervention Community Health Centers

EXPERIMENTAL

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

Control Community Health Centers

NO INTERVENTION

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).

Interventions

CHC-level cluster randomized control trial OTHER

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.

Intervention Community Health Centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Health Choice Network: collaborator
• OCHIN, Inc.: collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Westat: collaborator
• Morehouse School of Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Health Choice Network (HCN)

Miami, Florida, 33172, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

OCHIN

Portland, Oregon, 97201, United States

Location

Related Publications (14)

• 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.

  PMID: 34387188 BACKGROUND

• 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.

  PMID: 34014324 BACKGROUND

• 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.

  PMID: 34264836 BACKGROUND

• 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.

  PMID: 27989293 BACKGROUND

• 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.

  PMID: 26401192 BACKGROUND

• 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.

  PMID: 35801145 BACKGROUND

• 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.

  PMID: 10358675 BACKGROUND

• 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.

  PMID: 30422224 BACKGROUND

• 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.

  PMID: 29760028 BACKGROUND

• 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.

  PMID: 35896446 BACKGROUND

• 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.

  PMID: 33576286 BACKGROUND

• 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.

  PMID: 35896473 BACKGROUND

• 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.

  PMID: 33854855 BACKGROUND

• 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.

  PMID: 35868877 BACKGROUND

Related 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

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: April 15, 2025
• Study Start: May 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: July 1st, 2026 - June 30th, 2028

Locations

US (3)