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Impact of Medicaid Health Home on Patients With Diabetes in New York City

Impact of Medicaid Health Home on Patients With Diabetes in New York City

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02713321
Enrollment
96759
Registered
2016-03-18
Start date
2017-01-24
Completion date
2021-08-31
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, vulnerable populations, comorbidity, patient-centered outcomes research, Medicaid reform, health disparities

Brief 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. 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.

Interventions

None listed

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
New York City Clinical Data Research Network
CollaboratorOTHER
Weill Medical College of Cornell University
CollaboratorOTHER
The New York Academy of Medicine
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Enrollees With Diabetes-related Preventable HospitalizationsBaseline and 12 monthsProportion 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.

Secondary

MeasureTime frameDescription
Number of Primary Care Visits12 monthsNumber 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.
Number of Months of Medicaid Coverage12 monthsNumber 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.

Countries

United States

Participant flow

Recruitment details

Patients with clinical diabetes were identified from the INSIGHT Clinical Research Network electronic health record (EHR) data from 6 large academic NYC healthcare systems from 2010-2017.

Participants by arm

ArmCount
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, or multiple chronic conditions). This group included patients who participated in the Health Home program.
11,646
Non-Health Home Patients
This group included patients who did participate in the Health Home program, but had type 2 diabetes, were insured by Medicaid, and met eligibility requirements for the Health Homes.
26,601
Total38,247

Baseline characteristics

CharacteristicHealth Home PatientsNon-Health Home PatientsTotal
Age, Customized
15-44 years
1986 Participants4535 Participants6521 Participants
Age, Customized
45-64 years
7287 Participants16644 Participants23931 Participants
Age, Customized
65+ years
2383 Participants5443 Participants7826 Participants
Alcohol or substance use disorder diagnosis3136 Participants7164 Participants10300 Participants
Cancer diagnosis1831 Participants4182 Participants6013 Participants
ED visits1.1 visits
STANDARD_DEVIATION 4
1.1 visits
STANDARD_DEVIATION 4
1.1 visits
STANDARD_DEVIATION 4
HIV diagnosis3699 Participants8448 Participants12147 Participants
Hospitalizations1.0 hospitalizations
STANDARD_DEVIATION 2.1
1.0 hospitalizations
STANDARD_DEVIATION 2.1
1.0 hospitalizations
STANDARD_DEVIATION 2.1
Medicare3841 Participants8773 Participants12614 Participants
Number of chronic condition indicator (CCI)17.0 indicators
STANDARD_DEVIATION 9.4
17.0 indicators
STANDARD_DEVIATION 9.4
17.0 indicators
STANDARD_DEVIATION 9.4
Race/Ethnicity, Customized
Hispanic
5674 Participants12960 Participants18634 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
3488 Participants7967 Participants11455 Participants
Race/Ethnicity, Customized
Non-Hispanic White
1228 Participants2804 Participants4032 Participants
Race/Ethnicity, Customized
Other/unknown
1266 Participants2892 Participants4158 Participants
Serious mental illness diagnosis6254 Participants14285 Participants20539 Participants
Sex: Female, Male
Female
6999 Participants15987 Participants22986 Participants
Sex: Female, Male
Male
4647 Participants10614 Participants15261 Participants
SSI due to age2344 Participants5355 Participants7699 Participants
SSI due to disability5720 Participants13066 Participants18786 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: Baseline and 12 months

Population: Results for HH enrollees and a matched comparison group of HH non-enrollees

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Health Home PatientsNumber of Enrollees With Diabetes-related Preventable HospitalizationsBaseline48 Participants
Health Home PatientsNumber of Enrollees With Diabetes-related Preventable Hospitalizations12 months48 Participants
Non-Health Home PatientsNumber of Enrollees With Diabetes-related Preventable HospitalizationsBaseline109 Participants
Non-Health Home PatientsNumber of Enrollees With Diabetes-related Preventable Hospitalizations12 months90 Participants
Secondary

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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Health Home PatientsNumber of Months of Medicaid Coverage11.7 monthsStandard Deviation 1.3
Non-Health Home PatientsNumber of Months of Medicaid Coverage10.7 monthsStandard Deviation 1.3
Secondary

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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Health Home PatientsNumber of Primary Care Visits10.9 visitsStandard Deviation 10.9
Non-Health Home PatientsNumber of Primary Care Visits8.7 visitsStandard Deviation 10.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026