- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02713321
Impact of Medicaid Health Home on Patients With Diabetes in New York City
October 17, 2022 updated by: Victoria Mayer, Icahn School of Medicine at Mount Sinai
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes-related preventable hospitalizations
Time Frame: up to 5 years
|
Incidence 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.
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of outpatient visits
Time Frame: up to 5 years
|
Number of outpatient 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.
|
up to 5 years
|
Number of months of Medicaid coverage
Time Frame: up to 5 years
|
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.
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Victoria L Mayer, MD, MS, Icahn School of Medicine at Mount Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2017
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
March 15, 2016
First Submitted That Met QC Criteria
March 15, 2016
First Posted (Estimate)
March 18, 2016
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 15-1545
- NEN-1508-32252 (Other Grant/Funding Number: PCORI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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