Diabetes Mellitus, Type 2THRIVE-DMNCT07043426
Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
A study testing THRIVE-DM in people with Diabetes Mellitus, Type 2, run by Boston Medical Center at 1 site in United States.
Trial summary
The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- THRIVE-DM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years.
- Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening.
- Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN.
Who cannot join
- Patients enrolled in Complex Care Management (CCM).
- Patients receiving hospice care.
- Patients who are deceased
- Patients with Type 1 Diabetes Mellitus (T1DM).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Micheal Fischer, MD, 617-414-7288, Michael.Fischer@bmc.org
About this study
Official title: THRIVE-DM: Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations.
This study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- THRIVE-DM, Standard of care
- Keywords
- THRIVE-DM, Community-based organizations, Triage
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE-DMOther
Low-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs.
Standard of careOther
Standard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory.
| Study group | Role | What they receive |
|---|---|---|
| Intervention- THRIVE-DM | Experimental | Participants randomized to the intervention group will receive care through the enhanced THRIVE-DM model. A Community Health Worker (CHW) will utilize the triage tool - an EPIC based tool- an EPIC based tool that categorizes patients into Low-SS or High-SS classifications based on their HRSN complexity and self-efficacy proxies. Receives: Other: THRIVE-DM |
| Control- Standard of care | Active comparator | Participants randomized to the control group will be evaluated under an intention-to-treat framework. These participants will continue to receive routine clinical care. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that connect to Community-Based Organizations
Connection to Community-Based Organizations will be assessed through several sources and documented in REDCap
Measured: 3 months, 6 months, 3 months post intervention
Number of participants that are helped by Community-Based Organizations
Data will be collected from participant interviews
Measured: 3 months, 6 months, 12 months post intervention
Changes in HbA1c
HbA1c data will be extracted from the EPIC electronic health record (EHR).
Measured: 3 months, 6 months, 12 months post intervention
Secondary outcomes (2)
Number of participants hospitalized
Data will be obtained from the EHR.
Measured: 3 months, 6 months, 12 months post intervention
Number of participants that had an emergency department visit
Data will be obtained from the EHR.
Measured: 3 months, 6 months, 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start26 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be categorized into low social services need (Low-SS) and high social services need (High-SS) and then randomized into intervention or control arms using block randomization in REDCap.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Fischer, MD, Principal investigator, Boston Medical Center, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043426
- Sponsor's protocol ID
- H-45851
- Other IDs
- 1R01DK140570-01
- Acronym
- THRIVE-DM
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE-DM: Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
- ClinicalTrials.gov ID
- NCT07043426
- Acronym / sponsor ID
- THRIVE-DM / H-45851
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- THRIVE-DM, Community-based organizations, Triage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Jun 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 study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations.
This study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be categorized into low social services need (Low-SS) and high social services need (High-SS) and then randomized into intervention or control arms using block randomization in REDCap.
| Arm | Type | Receives |
|---|---|---|
| Intervention- THRIVE-DM | Experimental | Other: THRIVE-DMParticipants randomized to the intervention group will receive care through the enhanced THRIVE-DM model. A Community Health Worker (CHW) will utilize the triage tool - an EPIC based tool- an EPIC based tool that categorizes patients into Low-SS or High-SS classifications based on their HRSN complexity and self-efficacy proxies. |
| Control- Standard of care | Active comparator | Other: Standard of careParticipants randomized to the control group will be evaluated under an intention-to-treat framework. These participants will continue to receive routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years.
- Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening.
- Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN.
Key exclusion criteria (4 listed)
- Patients enrolled in Complex Care Management (CCM).
- Patients receiving hospice care.
- Patients who are deceased
- Patients with Type 1 Diabetes Mellitus (T1DM).
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 |
|---|---|---|
| THRIVE-DMLow-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs. | Other | Intervention- THRIVE-DM |
| Standard of careStandard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory. | Other | Control- Standard of care |
Primary outcome
Number of participants that connect to Community-Based Organizations
Time frame: 3 months, 6 months, 3 months post intervention
Connection to Community-Based Organizations will be assessed through several sources and documented in REDCap
Number of participants that are helped by Community-Based Organizations
Time frame: 3 months, 6 months, 12 months post intervention
Data will be collected from participant interviews
Changes in HbA1c
Time frame: 3 months, 6 months, 12 months post intervention
HbA1c data will be extracted from the EPIC electronic health record (EHR).
2 secondary outcomes
Number of participants hospitalized
Time frame: 3 months, 6 months, 12 months post intervention
Number of participants that had an emergency department visit
Time frame: 3 months, 6 months, 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Michael Fischer, MD principal investigator
Boston Medical Center, Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE-DM in people with Diabetes Mellitus, Type 2, run by Boston Medical Center at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Fischer, MD (617-414-7288, Michael.Fischer@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that connect to Community-Based Organizations (time frame: 3 months, 6 months, 3 months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.