Post ACA Reform: Evaluation of Community Health Center Care of Diabetes

NCT ID: NCT02685384

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1938375 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2021-09-29

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes Mellitus (DM)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Medicaid Expansion States

Patients receiving care in community health centers in states that expanded Medicaid (intervention group)

Medicaid Expansion

Intervention Type OTHER

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)

Medicaid Expansion

Intervention Type OTHER

There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not

Interventions

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Medicaid Expansion

There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OCHIN, Inc.

OTHER

Sponsor Role collaborator

Health Choice Network

OTHER

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer E DeVoe, MD DPhil

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Marino M, Angier H, Fankhauser K, Valenzuela S, Hoopes M, Heintzman J, DeVoe J, Moreno L, Huguet N. Disparities in Biomarkers for Patients With Diabetes After the Affordable Care Act. Med Care. 2020 Jun;58 Suppl 6 Suppl 1(Suppl 6 1):S31-S39. doi: 10.1097/MLR.0000000000001257.

Reference Type RESULT
PMID: 32412951 (View on PubMed)

Marino M, Angier H, Springer R, Valenzuela S, Hoopes M, O'Malley J, Suchocki A, Heintzman J, DeVoe J, Huguet N. The Affordable Care Act: Effects of Insurance on Diabetes Biomarkers. Diabetes Care. 2020 Sep;43(9):2074-2081. doi: 10.2337/dc19-1571. Epub 2020 Jul 1.

Reference Type RESULT
PMID: 32611609 (View on PubMed)

Gemelas J, Marino M, Valenzuela S, Schmidt T, Suchocki A, Huguet N. Changes in diabetes prescription patterns following Affordable Care Act Medicaid expansion. BMJ Open Diabetes Res Care. 2021 Dec;9(Suppl 1):e002135. doi: 10.1136/bmjdrc-2021-002135.

Reference Type RESULT
PMID: 34933870 (View on PubMed)

Lindner SR, Marino M, O'Malley J, Angier H, Bailey SR, Hoopes M, Springer R, McConnell KJ, DeVoe J, Huguet N. Health Care Expenditures Among Adults With Diabetes After Oregon's Medicaid Expansion. Diabetes Care. 2020 Mar;43(3):572-579. doi: 10.2337/dc19-1343. Epub 2019 Dec 19.

Reference Type RESULT
PMID: 31857442 (View on PubMed)

Huguet N, Springer R, Marino M, Angier H, Hoopes M, Holderness H, DeVoe JE. The Impact of the Affordable Care Act (ACA) Medicaid Expansion on Visit Rates for Diabetes in Safety Net Health Centers. J Am Board Fam Med. 2018 Nov-Dec;31(6):905-916. doi: 10.3122/jabfm.2018.06.180075.

Reference Type RESULT
PMID: 30413546 (View on PubMed)

Angier H, Huguet N, Ezekiel-Herrera D, Marino M, Schmidt T, Green BB, DeVoe JE. New hypertension and diabetes diagnoses following the Affordable Care Act Medicaid expansion. Fam Med Community Health. 2020 Dec;8(4):e000607. doi: 10.1136/fmch-2020-000607.

Reference Type RESULT
PMID: 33334850 (View on PubMed)

Angier H, Ezekiel-Herrera D, Marino M, Hoopes M, Jacobs EA, DeVoe JE, Huguet N. Racial/Ethnic Disparities in Health Insurance and Differences in Visit Type for a Population of Patients with Diabetes after Medicaid Expansion. J Health Care Poor Underserved. 2019;30(1):116-130. doi: 10.1353/hpu.2019.0011.

Reference Type RESULT
PMID: 30827973 (View on PubMed)

Hoopes M, Angier H, Raynor LA, Suchocki A, Muench J, Marino M, Rivera P, Huguet N. Development of an algorithm to link electronic health record prescriptions with pharmacy dispense claims. J Am Med Inform Assoc. 2018 Oct 1;25(10):1322-1330. doi: 10.1093/jamia/ocy095.

Reference Type DERIVED
PMID: 30113681 (View on PubMed)

Huguet N, Angier H, Marino M, McConnell KJ, Hoopes MJ, O'Malley JP, Raynor LA, Likumahuwa-Ackman S, Holderness H, DeVoe JE. Protocol for the analysis of a natural experiment on the impact of the Affordable Care Act on diabetes care in community health centers. Implement Sci. 2017 Feb 10;12(1):14. doi: 10.1186/s13012-017-0543-6.

Reference Type DERIVED
PMID: 28183354 (View on PubMed)

Other Identifiers

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U18DP006116

Identifier Type: NIH

Identifier Source: org_study_id

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