- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657499
Post Affordable Care Act Evaluation (PACE)
March 14, 2019 updated by: Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
Post Affordable Care Act: Evaluation of Community Health Centers
This innovative study will measure the impact of Affordable Care Act-sponsored Medicaid expansions on access to and utilization of community health center (CHC) services.
Building on the investigators prior work that developed a robust community-based research infrastructure within the OCHIN community health information network, the investigator will utilize linked electronic health record data from the OCHIN network of >400 CHC clinics in 8 states that expanded Medicaid coverage and 8 states that did not expand.
Study Overview
Detailed Description
The Affordable Care Act (ACA) called for every state in the United States (US) to expand Medicaid coverage to individuals at ≤138% of the federal poverty level by 2014.
In a 2012 legal challenge, the Supreme Court ruled that states were not required to implement the ACA-sponsored Medicaid expansion; thus (by December 31, 2014), only 27 states and the District of Columbia expanded Medicaid, while 23 states did not.
Little is known about the impact of ACA-sponsored Medicaid expansions on access to and changes in receipt of healthcare services among vulnerable populations.
Yet this knowledge is essential to informing deliberations in 'non-expansion' states regarding whether to expand their Medicaid programs, and will also be helpful to 'expansion' states eager to learn about the impact of their expansions.
The natural experiment created by the Supreme Court decision to make expansion optional for states provides a unique opportunity to assess the extent to which Medicaid expansions improve access to healthcare for low-income patients and other vulnerable populations.
The proposed project will be one of the first to examine changes in access to and receipt of healthcare services and to Medicaid expenditures following ACA Medicaid expansions among a large population of safety net clinic patients.
The investigators will use electronic health record data (EHR) from the OCHIN practice-based research network, which serves >1 million patients in 442 community health centers (CHCs) in 8 expansion states and 8 non-expansion states.
Moreover, using CHC data from the 8 expansion-states, the investigators will examine differences in utilization among patients gaining new Medicaid coverage (newly insured), as compared to those already insured by Medicaid (already insured), and those who remain uninsured (uninsured).
Finally, the investigators will link EHR data from the 213 OCHIN clinics in Oregon to Medicaid administrative claims data to assess overall healthcare utilization (including care received outside of CHCs, such as hospitalization) and to compare Medicaid expenditures among newly insured individuals versus those already insured.
The investigators will address the following specific aims: Aim 1: compare pre-post health insurance status, primary care, mental health, and dental visits, and receipt of preventive services, as well as changes in payer mix among OCHIN CHCs in states that did and did not expand Medicaid; Aim 2: Examine pre-post utilization of CHC services (including receipt of preventive services) by newly insured patients compared to already insured patients and uninsured patients; and, Aim 3: Measure pre-post Medicaid expansion changes in overall utilization of healthcare services and costs to the Oregon Medicaid program among newly insured compared to already insured.
The findings from this project will be extremely relevant to policy and practice, informing further improvements in the US healthcare system to ensure access to healthcare for vulnerable populations.
Study Type
Observational
Enrollment (Actual)
1939848
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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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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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
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 OCHIN community health information network
Description
Inclusion Criteria:
- Patients in intervention and control states aged 20-64
Exclusion Criteria:
- Patients outside of age range 20-64
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 |
Intervention / Treatment |
---|---|
Medicaid Expansion States
Patients receiving care in community health centers in states that expanded Medicaid (intervention group)
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There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
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Non Medicaid Expansion States
Patients receiving care in community health centers in states that did not expand Medicaid (control group)
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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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Insurance Status
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
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Health insurance status derived from EHR data and is primarily based on information collected at each visit
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24 months prior to Medicaid expansion vs 24 months post
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare service utilization
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
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Number and type of internal services utilized
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24 months prior to Medicaid expansion vs 24 months post
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Preventive Service utilization
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
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Number and type of preventive services received
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24 months prior to Medicaid expansion vs 24 months post
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Medicaid Expenditures
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
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We 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
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24 months prior to Medicaid expansion vs 24 months post
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer E DeVoe, MD, Oregon Health and Science University
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
- Marino M, Angier H, Valenzuela S, Hoopes M, Killerby M, Blackburn B, Huguet N, Heintzman J, Hatch B, O'Malley JP, DeVoe JE. Medicaid coverage accuracy in electronic health records. Prev Med Rep. 2018 Jul 27;11:297-304. doi: 10.1016/j.pmedr.2018.07.009. eCollection 2018 Sep.
- Hoopes MJ, Angier H, Gold R, Bailey SR, Huguet N, Marino M, DeVoe JE. Utilization of Community Health Centers in Medicaid Expansion and Nonexpansion States, 2013-2014. J Ambul Care Manage. 2016 Oct-Dec;39(4):290-8. doi: 10.1097/JAC.0000000000000123.
- Springer R, Marino M, O'Malley JP, Lindner S, Huguet N, DeVoe JE. Oregon Medicaid Expenditures After the 2014 Affordable Care Act Medicaid Expansion: Over-time Differences Among New, Returning, and Continuously Insured Enrollees. Med Care. 2018 May;56(5):394-402. doi: 10.1097/MLR.0000000000000907.
- Angier, H., C. J. Tillotson, L. S. Wallace, M. Marino, J. P. O' Malley, A. Sumic, L. Baker, C. Nelson, N. Huguet, A. Suchocki, H. Holderness and J. E. DeVoe (2018).
- Angier H, Hoopes M, Marino M, Huguet N, Jacobs EA, Heintzman J, Holderness H, Hood CM, DeVoe JE. Uninsured Primary Care Visit Disparities Under the Affordable Care Act. Ann Fam Med. 2017 Sep;15(5):434-442. doi: 10.1370/afm.2125.
- Huguet N, Hoopes MJ, Angier H, Marino M, Holderness H, DeVoe JE. Medicaid Expansion Produces Long-Term Impact on Insurance Coverage Rates in Community Health Centers. J Prim Care Community Health. 2017 Oct;8(4):206-212. doi: 10.1177/2150131917709403. Epub 2017 May 17.
- Heintzman J, Bailey SR, DeVoe J, Cowburn S, Kapka T, Duong TV, Marino M. In Low-Income Latino Patients, Post-Affordable Care Act Insurance Disparities May Be Reduced Even More than Broader National Estimates: Evidence from Oregon. J Racial Ethn Health Disparities. 2017 Jun;4(3):329-336. doi: 10.1007/s40615-016-0232-1. Epub 2016 Apr 22.
- Hatch B, Marino M, Killerby M, Angier H, Hoopes M, Bailey SR, Heintzman J, O'Malley JP, DeVoe JE. Medicaid's Impact on Chronic Disease Biomarkers: A Cohort Study of Community Health Center Patients. J Gen Intern Med. 2017 Aug;32(8):940-947. doi: 10.1007/s11606-017-4051-9. Epub 2017 Apr 3.
- Bailey SR, Hoopes MJ, Marino M, Heintzman J, O'Malley JP, Hatch B, Angier H, Fortmann SP, DeVoe JE. Effect of Gaining Insurance Coverage on Smoking Cessation in Community Health Centers: A Cohort Study. J Gen Intern Med. 2016 Oct;31(10):1198-205. doi: 10.1007/s11606-016-3781-4. Epub 2016 Jun 21.
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
January 1, 2012
Primary Completion (Actual)
October 24, 2018
Study Completion (Actual)
October 24, 2018
Study Registration Dates
First Submitted
January 13, 2016
First Submitted That Met QC Criteria
January 14, 2016
First Posted (Estimate)
January 15, 2016
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARQHR01HS024270
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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