Chronic DiseasePACENCT02657499
Post Affordable Care Act Evaluation
An observational study of Chronic Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Medicaid Expansion
- How many people
- 1,939,848 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 24 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study eligible patients within electronic health record data from the OCHIN community health information network
Who may be able to join
- Patients in intervention and control states aged 20-64
Who cannot join
- Patients outside of age range 20-64
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Medicaid Expansion
- Keywords
- healthcare access, utilization, expenditures, preventive services
- Medical subject headings
- Chronic Disease, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicaid ExpansionOther
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
| Study group | Role | What they receive |
|---|---|---|
| Medicaid Expansion States | Patients receiving care in community health centers in states that expanded Medicaid (intervention group) Receives: Other: Medicaid Expansion | |
| Non Medicaid Expansion States | Patients receiving care in community health centers in states that did not expand Medicaid (control group) Receives: Other: Medicaid Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Insurance Status
Health insurance status derived from EHR data and is primarily based on information collected at each visit
Measured: 24 months prior to Medicaid expansion vs 24 months post
Secondary outcomes (3)
Healthcare service utilization
Number and type of internal services utilized
Measured: 24 months prior to Medicaid expansion vs 24 months post
Preventive Service utilization
Number and type of preventive services received
Measured: 24 months prior to Medicaid expansion vs 24 months post
Medicaid Expenditures
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
Measured: 24 months prior to Medicaid expansion vs 24 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2012
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,939,848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
- Investigators
- Jennifer E DeVoe, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657499
- Sponsor's protocol ID
- ARQHR01HS024270
- Acronym
- PACE
- Status last verified
- Mar 2019
- First submitted
- 13 Jan 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 30116701Hoopes 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.
PubMed 26765808Springer 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.
PubMed 29578955Angier, 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.
PubMed 28893813Huguet 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.
PubMed 28513249Heintzman 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.
PubMed 27105630Hatch 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.
PubMed 28374214Bailey 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.
PubMed 27329121
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Affordable Care Act: Evaluation of Community Health Centers
- ClinicalTrials.gov ID
- NCT02657499
- Acronym / sponsor ID
- PACE / ARQHR01HS024270
- Conditions
- Chronic Disease
- Keywords
- healthcare access, utilization, expenditures, preventive services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,939,848 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- OCHIN, Inc., Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jan 2012
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicaid Expansion States | – | Other: Medicaid ExpansionPatients receiving care in community health centers in states that expanded Medicaid (intervention group) |
| Non Medicaid Expansion States | – | Other: Medicaid ExpansionPatients receiving care in community health centers in states that did not expand Medicaid (control group) |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study eligible patients within electronic health record data from the OCHIN community health information network
Key inclusion criteria (1 listed)
- Patients in intervention and control states aged 20-64
Key exclusion criteria (1 listed)
- Patients outside of age range 20-64
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicaid ExpansionThere will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not | Other | Medicaid Expansion States, Non Medicaid Expansion States |
Primary outcome
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
3 secondary outcomes
Healthcare service utilization
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Preventive Service utilization
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Medicaid Expenditures
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Background: PubMed 30116701Marino 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.
- Results publication: PubMed 26765808Hoopes 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.
- Results publication: PubMed 29578955Springer 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.
- Results publicationAngier, 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).
- Results publication: PubMed 28893813Angier 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.
- Results publication: PubMed 28513249Huguet 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.
- Results publication: PubMed 27105630Heintzman 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.
- Results publication: PubMed 28374214Hatch 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.
- Results publication: PubMed 27329121Bailey 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E DeVoe, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Insurance Status (time frame: 24 months prior to Medicaid expansion vs 24 months post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657499, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.