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

NCT02713321 | Completed Results

• 2 other identifiers: GCO 15-1545NEN-1508-32252
• Study Type: observational
• Target: 96,759
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months

Secondary Outcomes (2)

• Number of Primary Care Visits

  12 months

• Number of Months of Medicaid Coverage

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Patient-Centered Outcomes Research Institute: collaborator
• New York City Clinical Data Research Network: collaborator
• Weill Medical College of Cornell University: collaborator
• The New York Academy of Medicine: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Mayer V, Mijanovich T, Deshpande R, et al. (2024). The Impact of Medicaid Health Homes on Patients with Diabetes. Patient-Centered Outcomes Research Institute (PCORI).

  RESULT

Biospecimen

Retention: NONE RETAINED

Specify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Victoria Mayer
• Organization: Icahn School of Medicine at Mount Sinai

victoria.mayer@mountsinai.org

(212) 659-9194

Study Officials

• Victoria L Mayer, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: January 24, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)