Post ACA Reform: Evaluation of Community Health Center Care of Diabetes (PREVENTD)

April 20, 2022 updated by: Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
This innovative and timely study will measure the impact of Affordable Care Act (ACA) Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health outcomes. To assess this natural policy experiment, the investigators will use electronic health record data from the ADVANCE clinical data research network (CDRN) of the National Patient-Centered Clinical Research Network (PCORnet).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetes mellitus (DM) is one of the most prevalent chronic diseases, affecting over 29 million people in the United States (US). The number of people with DM is expected to increase by 200% between 2005 and 2050, from 16 to 48 million. Health insurance and continued access to healthcare services are essential for optimal DM care and management; thus, it is hypothesized that Affordable Care Act (ACA) Medicaid expansions could substantially improve access to health insurance and essential healthcare services for patients with DM risk (aged ≥45 + overweight) and patients diagnosed with DM. Studies of single state Medicaid expansions showed increased utilization of healthcare services, access to providers, receipt of preventive care services, and improved health outcomes post-expansion; however, past studies did not have concurrent control states. In 2012, the US Supreme Court ruled that states were not legally required to implement ACA Medicaid expansion, creating a 'natural policy experiment' - a unique national opportunity to test the effect of ACA Medicaid expansion on healthcare access and services for patients at risk for DM or diagnosed with DM ('with DM risk or DM'). By January 1, 2015, 28 states and the District of Columbia had implemented the expansion; Medicaid enrollment increased by an estimated 12.9% in expansion states, compared to 2.6% in non-expansion states. The investigators propose to use this unprecedented natural policy experiment to study the effect of state-level Medicaid expansions on DM prevention, treatment, expenditures, and health outcomes. As many persons affected by both DM and the ACA Medicaid expansions receive primary care in safety net community health centers (CHCs), the proposed analyses will use electronic health record (EHR) data from the national ADVANCE clinical data research network (CDRN) of CHCs (ADVANCE is one of 11 CDRNs in the national PCORnet data network). The ADVANCE CDRN has patient-level data from 470 CHCs in 12 Medicaid expansion states (n=1,242,823 patients) and 248 CHCs in 9 non-expansion states (n=830,399 patients). This nationally unique data resource will let the investigators measure pre-post DM-related utilization and receipt of preventive services in expansion versus non-expansion states, illuminating the impact of ACA Medicaid expansions on DM prevention and treatment Our proposed study, Post ACA Reform: EValuation of community hEalth ceNTer care of Diabetes (PREVENT-D) has the following specific aims:

Aim 1. Compare pre-post insurance status, overall visits, and chronic disease management visits among patients with DM risk or DM, in expansion versus non-expansion states.

Aim 2. Compare pre-post receipt of primary and secondary DM preventive services (e.g., screening for obesity, lipid levels, glycosylated hemoglobin) among patients with DM risk or DM, in expansion versus non-expansion states.

Aim 3. Compare pre-post changes in DM-related biomarkers (e.g., body mass index, blood pressure, lipid levels) in patients with DM risk or DM among newly insured (gained Medicaid in post-period), already insured (had coverage in pre- and post-period), and continuously uninsured (no coverage in pre- and post-period) patients in states that expanded Medicaid.

Aim 4: Measure pre-post changes in Oregon Medicaid expenditures among newly insured compared to already insured patients with DM risk or DM.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1938375

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study eligible patients within electronic health record data from the ADVANCE clinical data research network (CDRN) of PCORnet

Description

Inclusion Criteria:

  • Patients in intervention and control states aged 20-64

Exclusion Criteria:

  • Patients at intervention and control clinics outside of the age range 20-64 Pregnant women to eliminate the possibility of having gestational diabetes mellitus diagnoses

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Medicaid Expansion States
Patients receiving care in community health centers in states that expanded Medicaid (intervention group)
Other: Medicaid Expansion
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
Non Medicaid Expansion States
Patients receiving care in community health centers in states that did not expand Medicaid (control group)
Other: Medicaid Expansion
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of health insurance status
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Health insurance status derived from EHR data and is primarily based on information collected at each visit
24 months prior to Medicaid expansion vs 24 months post

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in number of internal services utilization
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Number of internal services utilized including number and ratio of "traditional" face to face visits vs. "nontraditional" encounters and communication via phone, personal health record, and email
24 months prior to Medicaid expansion vs 24 months post
Change in type of internal services utilization
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Type of internal services utilized including number and ratio of "traditional" face to face visits vs. "nontraditional" encounters and communication via phone, personal health record, and email
24 months prior to Medicaid expansion vs 24 months post
Change in number of preventive services received
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Number of all billed encounters overall and yearly, number of primary care visits overall and yearly, number of mental and behavioral health encounters, number of dental visits overall and yearly, services received at visit
24 months prior to Medicaid expansion vs 24 months post
Change in type of preventive services received
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Types of all billed encounters overall and yearly, number of primary care visits overall and yearly, number of mental and behavioral health encounters, number of dental visits overall and yearly, services received at visit
24 months prior to Medicaid expansion vs 24 months post
Change of Medicaid expenditures
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
The investigators will calculate the average pre-post expansion difference in total Medicaid expenditures. We will attach an expenditure for each service based on its average Medicaid Fee-For-Service reimbursement in the first year for those who were insured or uninsured pre or post expansion
24 months prior to Medicaid expansion vs 24 months post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Centers for Disease Control and Prevention
Fenway Community Health
OCHIN, Inc.
Health Choice Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U18DP006116 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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