Type 2 Diabetes MellitusNCT02713321
Impact of Medicaid Health Home on Patients With Diabetes in New York City
An observational study of Type 2 Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Type 2 diabetes is common in the United States; about 1 in 10 people have the disease. Diabetes can cause devastating health events, such as hospitalizations, kidney failure, blindness, amputation, heart attack, stroke, painful nerve damage (neuropathy), and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 96,759 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 31 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population includes patients with data in the New York City Clinical Data Research Network (NYC-CDRN). The NYC-CDRN brings together 22 organizations, including 7 independent health systems (Columbia University College of Physicians and Surgeons, Montefiore Medical Center and Albert Einstein College of Medicine, Mount Sinai Health System and the Icahn School of Medicine, New York-Presbyterian Hospital, New York University Langone Medical Center and New York University School of Medicine, Weill Cornell Medical College, and the Clinical Directors Network). This data network includes longitudinal data from both inpatient and outpatient facilities from throughout New York City.
Who may be able to join
- adults over age 18
- Type II diabetes
- insured by Medicaid
- low income
- data included in the New York City Clinical Data Research Network (NYC-CDRN)
- for intervention group,Health Home enrollment
- comparison group will be obtained through propensity score matching
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Type 2 diabetes is common in the United States; about 1 in 10 people have the disease. Diabetes can cause devastating health events, such as hospitalizations, kidney failure, blindness, amputation, heart attack, stroke, painful nerve damage (neuropathy), and death. There are many barriers for patients with diabetes that get in the way of controlling risk factors, following recommendations, and getting the care they need from the health system to help prevent these complications; this is especially true for those with other health problems too. Those living in poverty and racial/ethnic minorities are more likely to have complications from diabetes, and less likely to get recommended care from health systems. In order to improve care and outcomes for people with complex medical problems, several states have started the Medicaid Health Home (HH) program, including New York State (NYS) in 2012. This program is for people with two or more chronic health conditions, such as diabetes and heart disease, people with HIV, and people with a serious mental health condition. HHs are meant to manage and coordinate care, by helping health care providers, social service agencies, community-based organizations, and health insurance plans work together. Similar programs have been shown, on a smaller scale, to improve some results for patients with diabetes, such as lab tests indicating level of diabetes control. Studies have not yet looked at how a large program like HHs impacts the way healthcare is delivered and impacts the health events that matter most to patients with diabetes. Also, few studies include stakeholders on the research team, even though they stand to benefit the most from such programs, and have the experience needed as patients, clinicians, advocates, and administrators to guide efforts. The investigators have gathered a research team that includes scientific investigators along with a diverse group of partners, including patients, clinicians, and program administrators. The investigators plan to use two data sources that show what happens to individual patients over time: 1) NYS Medicaid insurance data 2) the New York City-Clinical Data Research Network (NYC-CDRN). The NYC-CDRN has identified a group of patients with diabetes from 7 large health systems; it has also developed a system for putting together the same set of information for each patient, and removing any identifying information. The investigator will look at patients who have diabetes and are part of a HH and study what happened to them over time. The investigator will also look at a comparison group of patients who are very similar to the HH patients, but they did not join a HH, and follow them over time. The investigator will then compare these two groups to each other. The investigator will look at the quality of healthcare they received and their health outcomes. The investigator will focus on health outcomes that are meaningful to patients. This study can provide important knowledge about the effects of the HH program on patients with diabetes.
Read the detailed description
The current PCORI-funded study is evaluating the impact of the NYS Medicaid HH program on the process and outcomes of care for low-income NYC residents with diabetes, compared to non-enrolled residents with similar conditions and utilization histories. The HH program enrolls patients with 1) multiple chronic conditions, 2) serious mental illness, and/or 3) HIV, and provides care management services. The study team now proposes to extend this work to examine the impacts of the pandemic on this vulnerable population, a majority of which is Black or Latinx. The study team hypothesizes that HH participation will reduce pandemic-related disruptions in access to health care and social services and improve health outcomes among patients with diabetes in NYC. Using a quasi-experimental difference-in-differences design, the study team will contrast access and utilization of health care and social services and health outcomes among HH enrollees and non-enrollees during a baseline period prior to the pandemic (CY2019) with each month of the pandemic time period (January- September 2020). In addition, the study team will examine the associations of a range of social determinants and access to health care and social services during the pandemic among low-income patients with clinical diabetes using survey data.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, vulnerable populations, comorbidity, patient-centered outcomes research, Medicaid reform, health disparities
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health Home patients | The cohort is made up of patients with type 2 diabetes, insured by Medicaid, and eligible for participation in a Medicaid Health Home (either due to HIV infection, serious mental illness, substance abuse, or multiple chronic conditions). One group will include patients who participate in the Health Home program. | |
| non-Health Home patients | The second group will include patients who do not participate in the Health Home program, but have type 2 diabetes, are insured by Medicaid, and meet eligibility requirements for the Health Homes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Enrollees With Diabetes-related Preventable Hospitalizations
Proportion of hospitalizations related to diabetes that could have been prevented. Diabetes-related potentially preventable hospitalizations are admissions to a hospital for certain acute illnesses or worsening chronic conditions that might not have required hospitalization had these conditions been managed successfully by primary care providers in outpatient settings.
Measured: Baseline and 12 months
Secondary outcomes (2)
Number of Primary Care Visits
Number of primary care visits to assess the impact of Health Home (HH) enrollment compared to usual care among Medicaid-insured patients with diabetes and other chronic conditions on access to health care and social services and COVID-19 and non-COVID-19 clinical outcomes.
Measured: 12 months
Number of Months of Medicaid Coverage
Number of months of Medicaid coverage to assess the impact of Health Home (HH) enrollment compared to usual care among Medicaid-insured patients with diabetes and other chronic conditions on access to health care and social services and COVID-19 and non-COVID-19 clinical outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start24 Jan 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96,759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, New York City Clinical Data Research Network, Weill Medical College of Cornell University, The New York Academy of Medicine
- Responsible party
- Principal investigator, Victoria Mayer, Icahn School of Medicine at Mount Sinai
- Investigators
- Victoria L Mayer, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713321
- Sponsor's protocol ID
- GCO 15-1545
- Other IDs
- NEN-1508-32252
- Status last verified
- Jun 2025
- First submitted
- 15 Mar 2016
- Last updated
- 4 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayer V, Mijanovich T, Deshpande R, Calvo M, Egorova N, Goytia C, Horowitz C, Flory J, Mushlin A, Siscovick D. The Impact of Medicaid Health Homes on Patients with Diabetes [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2025 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK624132/
PubMed 42616955
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medicaid Health Home on Patients With Diabetes in New York City
- ClinicalTrials.gov ID
- NCT02713321
- Acronym / sponsor ID
- GCO 15-1545
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, vulnerable populations, comorbidity, patient-centered outcomes research, Medicaid reform, health disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96,759 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, New York City Clinical Data Research Network, Weill Medical College of Cornell University, The New York Academy of Medicine
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes is common in the United States; about 1 in 10 people have the disease. Diabetes can cause devastating health events, such as hospitalizations, kidney failure, blindness, amputation, heart attack, stroke, painful nerve damage (neuropathy), and death. There are many barriers for patients with diabetes that get in the way of controlling risk factors, following recommendations, and getting the care they need from the health system to help prevent these complications; this is especially true for those with other health problems too. Those living in poverty and racial/ethnic minorities are more likely to have complications from diabetes, and less likely to get recommended care from health systems. In order to improve care and outcomes for people with complex medical problems, several states have started the Medicaid Health Home (HH) program, including New York State (NYS) in 2012. This program is for people with two or more chronic health conditions, such as diabetes and heart disease, people with HIV, and people with a serious mental health condition. HHs are meant to manage and coordinate care, by helping health care providers, social service agencies, community-based organizations, and health insurance plans work together. Similar programs have been shown, on a smaller scale, to improve some results for patients with diabetes, such as lab tests indicating level of diabetes control. Studies have not yet looked at how a large program like HHs impacts the way healthcare is delivered and impacts the health events that matter most to patients with diabetes. Also, few studies include stakeholders on the research team, even though they stand to benefit the most from such programs, and have the experience needed as patients, clinicians, advocates, and administrators to guide efforts. The investigators have gathered a research team that includes scientific investigators along with a diverse group of partners, including patients, clinicians, and program administrators. The investigators plan to use two data sources that show what happens to individual patients over time: 1) NYS Medicaid insurance data 2) the New York City-Clinical Data Research Network (NYC-CDRN). The NYC-CDRN has identified a group of patients with diabetes from 7 large health systems; it has also developed a system for putting together the same set of information for each patient, and removing any identifying information. The investigator will look at patients who have diabetes and are part of a HH and study what happened to them over time. The investigator will also look at a comparison group of patients who are very similar to the HH patients, but they did not join a HH, and follow them over time. The investigator will then compare these two groups to each other. The investigator will look at the quality of healthcare they received and their health outcomes. The investigator will focus on health outcomes that are meaningful to patients. This study can provide important knowledge about the effects of the HH program on patients with diabetes.
Detailed description
The current PCORI-funded study is evaluating the impact of the NYS Medicaid HH program on the process and outcomes of care for low-income NYC residents with diabetes, compared to non-enrolled residents with similar conditions and utilization histories. The HH program enrolls patients with 1) multiple chronic conditions, 2) serious mental illness, and/or 3) HIV, and provides care management services. The study team now proposes to extend this work to examine the impacts of the pandemic on this vulnerable population, a majority of which is Black or Latinx. The study team hypothesizes that HH participation will reduce pandemic-related disruptions in access to health care and social services and improve health outcomes among patients with diabetes in NYC. Using a quasi-experimental difference-in-differences design, the study team will contrast access and utilization of health care and social services and health outcomes among HH enrollees and non-enrollees during a baseline period prior to the pandemic (CY2019) with each month of the pandemic time period (January- September 2020). In addition, the study team will examine the associations of a range of social determinants and access to health care and social services during the pandemic among low-income patients with clinical diabetes using survey data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Home patients | – | –The cohort is made up of patients with type 2 diabetes, insured by Medicaid, and eligible for participation in a Medicaid Health Home (either due to HIV infection, serious mental illness, substance abuse, or multiple chronic conditions). One group will include patients who participate in the Health Home program. |
| non-Health Home patients | – | –The second group will include patients who do not participate in the Health Home program, but have type 2 diabetes, are insured by Medicaid, and meet eligibility requirements for the Health Homes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with data in the New York City Clinical Data Research Network (NYC-CDRN). The NYC-CDRN brings together 22 organizations, including 7 independent health systems (Columbia University College of Physicians and Surgeons, Montefiore Medical Center and Albert Einstein College of Medicine, Mount Sinai Health System and the Icahn School of Medicine, New York-Presbyterian Hospital, New York University Langone Medical Center and New York University School of Medicine, Weill Cornell Medical College, and the Clinical Directors Network). This data network includes longitudinal data from both inpatient and outpatient facilities from throughout New York City.
Key inclusion criteria (7 listed)
- adults over age 18
- Type II diabetes
- insured by Medicaid
- low income
- data included in the New York City Clinical Data Research Network (NYC-CDRN)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Enrollees With Diabetes-related Preventable Hospitalizations
Time frame: Baseline and 12 months
Proportion of hospitalizations related to diabetes that could have been prevented. Diabetes-related potentially preventable hospitalizations are admissions to a hospital for certain acute illnesses or worsening chronic conditions that might not have required hospitalization had these conditions been managed successfully by primary care providers in outpatient settings.
2 secondary outcomes
Number of Primary Care Visits
Time frame: 12 months
Number of Months of Medicaid Coverage
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42616955Mayer V, Mijanovich T, Deshpande R, Calvo M, Egorova N, Goytia C, Horowitz C, Flory J, Mushlin A, Siscovick D. The Impact of Medicaid Health Homes on Patients with Diabetes [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2025 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK624132/
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Victoria L Mayer, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 0 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 4 Jul 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?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Enrollees With Diabetes-related Preventable Hospitalizations (time frame: Baseline and 12 months). 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 NCT02713321, which also lists 1 linked publication.
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 4 Jul 2025.