Clinical 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.
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.
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.
