Uncontrolled Diabetes(CHW-SYSTIM)NCT06926855
Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes.
A study of Uncontrolled Diabetes and Uncontrolled Hypertension, run by Morehouse School of Medicine at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Diabetes, Uncontrolled Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72,726 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2025to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- People who are less than 18 years old
- Pregnant people
- People who don't meet the Type 2 diabetes or hypertension criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Morehouse School of Medicine
Atlanta, Georgia, 30310
Health Choice Network (HCN)
Miami, Florida, 33172
OCHIN
Portland, Oregon, 97201
About this study
Official title: 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.
Read the 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:
- 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).
- 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.
- 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
- Uncontrolled Diabetes, Uncontrolled Hypertension
- Being tested
- CHC-level cluster randomized control trial
- 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
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHC-level cluster randomized control trialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured at 6 months and 12 months after the first CHW contact.
Secondary outcomes (8)
Biomarker Screening
Percent new BP measures - Limited to patients enrolled into the study with uncontrolled hypertension.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed during and after study completion (up to 12 months after the first CHW contact)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 May 2025
- Primary completion28 Feb 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 72,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Health Choice Network, OCHIN, Inc., National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Westat, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Megan Douglas, JD, Principal investigator, Morehouse School of MedicineRachel Gold, PhD, MPH, Principal investigator, OCHIN, Inc.Katherine Chung-Bridges, MD, MPH, Principal investigator, Health Choice Network (HCN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926855
- Sponsor's protocol ID
- 2168673-4
- Other IDs
- NHLBI Sub-Other Transaction
- Acronym
- (CHW-SYSTIM)
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34387188Carter 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.
PubMed 34014324Greenwood-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.
PubMed 34264836Cockerham 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.
PubMed 27989293Balfour 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.
PubMed 26401192Yan 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.
PubMed 35801145Krieger 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.
PubMed 10358675Kangovi 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.
PubMed 30422224Hartzler 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.
PubMed 29760028Sandhu 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.
PubMed 35896446Browne 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.
PubMed 33576286Wan 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.
PubMed 35896473Daly 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.
PubMed 33854855Milani 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.
PubMed 35868877
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers Systematically Assessing and Addressing Social Determinants of Health to Improve Outcomes in Community Health Centers (CHW-SYSTIM)
- ClinicalTrials.gov ID
- NCT06926855
- Acronym / sponsor ID
- (CHW-SYSTIM) / 2168673-4
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72,726 participants (actual)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- Health Choice Network, OCHIN, Inc., National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Westat, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Community Health Centers | Experimental | Other: CHC-level cluster randomized control trialCommunity 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- People who are less than 18 years old
- Pregnant people
- People who don't meet the Type 2 diabetes or hypertension criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHC-level cluster randomized control trialCHW (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. | Other | Intervention Community Health Centers |
Primary outcome
Test the hypothesis that CHW-led process will improve health outcomes among DM patients post 12 month intervention
Time frame: Measured at 6 months and 12 months after the first CHW contact.
Percentage of participants with a clinically significant improvement in HbA1c, defined as ≥0.5% improvement in HbA1c
Test the hypothesis that CHW-led process will improve health outcomes among HTN patients post 12 month intervention
Time frame: Measured at 6 months and 12 months after the first CHW contact.
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).
8 secondary outcomes
Biomarker Screening
Time frame: New BP measure documented ≥3 months after first contact with the CHW.
Biomarker Screening
Time frame: New HbA1c measure documented ≥6 months after first contact with the CHW.
Referral provided and completed
Time frame: Assessed at 6 months after first CHW contact.
Referral provided and completed
Time frame: Assessed at 12 months after first CHW contact.
Referral impact on social risk
Time frame: Assessed at 6 months after first CHW contact.
Referral impact on social risk
Time frame: Assessed during and after study completion (up to 12 months after the first CHW contact)
Referral impact on social risk
Time frame: Assessed during and after study completion (up to 12 months after the first CHW contact)
Referral impact on social risk
Time frame: Assessed during and after study completion (up to 12 months after the first CHW contact)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 34387188Ruiz 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.
- Background: PubMed 34014324Carter 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.
- Background: PubMed 34264836Greenwood-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.
- Background: PubMed 27989293Cockerham 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.
- Background: PubMed 26401192Balfour 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.
- Background: PubMed 35801145Yan 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.
- Background: PubMed 10358675Krieger 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.
- Background: PubMed 30422224Kangovi 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.
- Background: PubMed 29760028Hartzler 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.
- Background: PubMed 35896446Sandhu 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.
- Background: PubMed 33576286Browne 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.
- Background: PubMed 35896473Wan 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.
- Centers for Disease Control and Prevention. (2030). Healthy People.Link provided by the sponsor.
- Community health center chartbook 2023.Link provided by the sponsor.
- National Academies of Sciences, Engineering, and Medicine. Investing in interventions that address non-medical, health-related social needs: Proceedings of a workshop.Link provided by the sponsor.
- Building the evidence base for social determinants of health interventionsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Douglas, JD principal investigator
Morehouse School of Medicine
Rachel Gold, PhD, MPH principal investigator
OCHIN, Inc.
Katherine Chung-Bridges, MD, MPH principal investigator
Health Choice Network (HCN)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Uncontrolled Diabetes and Uncontrolled Hypertension, run by Morehouse School of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the hypothesis that CHW-led process will improve health outcomes among DM patients post 12 month intervention (time frame: Measured at 6 months and 12 months after the first CHW contact.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06926855, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.