Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes.
NCT ID: NCT06926855
Last Updated: 2025-10-24
Study Results
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Basic Information
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RECRUITING
NA
3120 participants
INTERVENTIONAL
2025-05-01
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
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.
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).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant people
* People who don't meet the Type 2 diabetes or hypertension criteria.
18 Years
ALL
No
Sponsors
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Health Choice Network
OTHER
OCHIN, Inc.
OTHER
National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Westat
OTHER
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Morehouse School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Megan Douglas, JD
Role: PRINCIPAL_INVESTIGATOR
Morehouse School of Medicine
Rachel Gold, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
OCHIN, Inc.
Katherine Chung-Bridges, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Health Choice Network (HCN)
Locations
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Health Choice Network (HCN)
Miami, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
OCHIN
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
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NHLBI Sub-Other Transaction
Identifier Type: OTHER
Identifier Source: secondary_id
2168673-4
Identifier Type: -
Identifier Source: org_study_id
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