Cardiovascular DiseaseAMRICNCT02355132
Assessing a Medicaid Randomized Insurance Experiment Within Community Clinics
An observational study of Cardiovascular Disease and Cancer, run by Oregon Health and Science University.
Trial summary
This study examines the impact of a randomized insurance experiment on preventive services receipt and healthcare utilization in safety net patients using linked public insurance claims and safety net clinics' electronic health record (EHR) data. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Cancer
- What is being tested?
- Insurance Intervention
- How many people
- 308,283 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Mar 2016
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult individuals on the Oregon Experiment 'reservation list' (applied for the Oregon Experiment) linked to individual patients in an Oregon safety net clinic that is part of the OCHIN, Inc network using Link Plus software and demographic variables common to both datasets.
Who may be able to join
- must have applied for the Oregon Experiment in 2006
- must have been a patient in an Oregon safety net clinic that is part of the OCHIN, Inc network
- for preventive services outcomes only, matched patients had to have been at a clinic with an electronic health record system by 3/11/08
Who cannot join
- under 19 years of age
- over 64 years of age
- not alive at the end of the 36 month post-period
- unknown/missing gender
About this study
This study examines the impact of a randomized insurance experiment on preventive services receipt and healthcare utilization in safety net patients using linked public insurance claims and safety net clinics' electronic health record (EHR) data.
Read the detailed description
In 2008, the Oregon Medicaid program used a "lottery" (Oregon Experiment) to allocate limited insurance resources to low income adults who did not categorically qualify for traditional Medicaid coverage. Thousands were randomly selected to apply for Medicaid; many others were not selected. This "natural policy experiment" is the first population-level randomization of insurance coverage since Rand's 1971-1982 experiment. We will use data from safety net clinics that share a common electronic health record (EHR) operated by OCHIN, a non-profit organization in Portland, Oregon. As one of the nation's largest linked community health center networks, the OCHIN EHR database records nearly all visits to safety net clinics in Oregon with one patient chart linked across >100 community health centers. We will link Medicaid claims data and the OCHIN database to determine patients that had applied to participate in the Oregon Experiment, as well as to determine those that gained insurance via this experiment. We will test the hypothesis that public insurance coverage is associated with higher rates of receiving preventive care services and increased healthcare utilization among persons with a usual source of primary care. To that end, we will analyze preventive care and utilization patterns among the OCHIN clinic patients affected by Oregon's Medicaid Experiment. This study capitalizes on two unique opportunities: an EHR database linking >100 community health centers, and the quasi-experimental design of Oregon's randomized Medicaid experiment.
The specific aims related to the Oregon Experiment are:
- To compare post-intervention rates of preventive services receipt among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group); and 3) To compare post-intervention rates of ambulatory healthcare utilization among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group).
- Conditions
- Cardiovascular Disease, Cancer
- Being tested
- Insurance Intervention
- Keywords
- Medicaid, public insurance, cardiovascular disease, prevention, community health centers, electronic health records, cancer prevention
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insurance InterventionOther
Random selection to apply for Medicaid coverage through Oregon Experiment drawings held between March and October 2008
| Study group | Role | What they receive |
|---|---|---|
| Insurance Intervention Arm | Oregon OCHIN patients that put their names on the reservation list for the Oregon Experiment and were randomly chosen to apply for insurance coverage via the Oregon Experiment Receives: Other: Insurance Intervention | |
| Control | Oregon OCHIN patients that put their names on the reservation list for the Oregon Experiment and were not chosen to apply for insurance coverage via the Oregon Experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive service receipt
Number of patients with receipt of the following preventive services in the post-period (each outcome assessed individually by whether person met age, gender, and diagnosis criteria (if applicable): body mass index, blood pressure, smoking, pap test, mammography, colorectal cancer screening, chlamydia screening, lipid test, flu vaccination, pneumococcal vaccination, HbA1c test, glucose test) using ICD-9-CM diagnosis and procedure codes, CPT and HCPCS codes, LOINC codes, medication codes, relevant code groupings and codes specific to the OCHIN EHR.
Measured: 36 months post Oregon Experiment selection (post-period)
Secondary outcomes (1)
Ambulatory healthcare utilization
Number of visits in the post-period for the following services: total primary care office visits, total behavioral/mental health visits, labs, referrals, immunizations, imaging)
Measured: 36 months post Oregon Experiment selection (post-period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startAug 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 308,283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Hospitals, Center for Health Research, OCHIN, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
- Investigators
- Jennifer E DeVoe, MD, DPhil, Principal investigator, Oregon Health and Science UniversityHeather Angier, MPH, Study director, Oregon Health & Science Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355132
- Sponsor's protocol ID
- IRB00007327
- Other IDs
- R01HL107647
- Acronym
- AMRIC
- Status last verified
- Oct 2015
- First submitted
- 30 Jan 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28374214Bailey SR, Heintzman JD, Marino M, Hoopes MJ, Hatch BA, Gold R, Cowburn SC, Nelson CA, Angier HE, DeVoe JE. Measuring Preventive Care Delivery: Comparing Rates Across Three Data Sources. Am J Prev Med. 2016 Nov;51(5):752-761. doi: 10.1016/j.amepre.2016.07.004. Epub 2016 Aug 10.
PubMed 27522472DeVoe JE, Marino M, Gold R, Hoopes MJ, Cowburn S, O'Malley JP, Heintzman J, Gallia C, McConnell KJ, Nelson CA, Huguet N, Bailey SR. Community Health Center Use After Oregon's Randomized Medicaid Experiment. Ann Fam Med. 2015 Jul-Aug;13(4):312-20. doi: 10.1370/afm.1812.
PubMed 26195674
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Medicaid Randomized Insurance Experiment Within Community Clinics
- ClinicalTrials.gov ID
- NCT02355132
- Acronym / sponsor ID
- AMRIC / IRB00007327
- Conditions
- Cardiovascular Disease, Cancer
- Keywords
- Medicaid, public insurance, cardiovascular disease, prevention, community health centers, electronic health records, cancer prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308,283 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Kaiser Foundation Hospitals, Center for Health Research, OCHIN, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Feb 2015 (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 study examines the impact of a randomized insurance experiment on preventive services receipt and healthcare utilization in safety net patients using linked public insurance claims and safety net clinics' electronic health record (EHR) data.
Detailed description
In 2008, the Oregon Medicaid program used a "lottery" (Oregon Experiment) to allocate limited insurance resources to low income adults who did not categorically qualify for traditional Medicaid coverage. Thousands were randomly selected to apply for Medicaid; many others were not selected. This "natural policy experiment" is the first population-level randomization of insurance coverage since Rand's 1971-1982 experiment. We will use data from safety net clinics that share a common electronic health record (EHR) operated by OCHIN, a non-profit organization in Portland, Oregon. As one of the nation's largest linked community health center networks, the OCHIN EHR database records nearly all visits to safety net clinics in Oregon with one patient chart linked across >100 community health centers. We will link Medicaid claims data and the OCHIN database to determine patients that had applied to participate in the Oregon Experiment, as well as to determine those that gained insurance via this experiment. We will test the hypothesis that public insurance coverage is associated with higher rates of receiving preventive care services and increased healthcare utilization among persons with a usual source of primary care. To that end, we will analyze preventive care and utilization patterns among the OCHIN clinic patients affected by Oregon's Medicaid Experiment. This study capitalizes on two unique opportunities: an EHR database linking >100 community health centers, and the quasi-experimental design of Oregon's randomized Medicaid experiment.
The specific aims related to the Oregon Experiment are:
- To compare post-intervention rates of preventive services receipt among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group); and 3) To compare post-intervention rates of ambulatory healthcare utilization among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insurance Intervention Arm | – | Other: Insurance InterventionOregon OCHIN patients that put their names on the reservation list for the Oregon Experiment and were randomly chosen to apply for insurance coverage via the Oregon Experiment |
| Control | – | –Oregon OCHIN patients that put their names on the reservation list for the Oregon Experiment and were not chosen to apply for insurance coverage via the Oregon Experiment |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult individuals on the Oregon Experiment 'reservation list' (applied for the Oregon Experiment) linked to individual patients in an Oregon safety net clinic that is part of the OCHIN, Inc network using Link Plus software and demographic variables common to both datasets.
Key inclusion criteria (3 listed)
- must have applied for the Oregon Experiment in 2006
- must have been a patient in an Oregon safety net clinic that is part of the OCHIN, Inc network
- for preventive services outcomes only, matched patients had to have been at a clinic with an electronic health record system by 3/11/08
Key exclusion criteria (4 listed)
- under 19 years of age
- over 64 years of age
- not alive at the end of the 36 month post-period
- unknown/missing gender
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 |
|---|---|---|
| Insurance InterventionRandom selection to apply for Medicaid coverage through Oregon Experiment drawings held between March and October 2008 | Other | Insurance Intervention Arm |
Primary outcome
Preventive service receipt
Time frame: 36 months post Oregon Experiment selection (post-period)
Number of patients with receipt of the following preventive services in the post-period (each outcome assessed individually by whether person met age, gender, and diagnosis criteria (if applicable): body mass index, blood pressure, smoking, pap test, mammography, colorectal cancer screening, chlamydia screening, lipid test, flu vaccination, pneumococcal vaccination, HbA1c test, glucose test) using ICD-9-CM diagnosis and procedure codes, CPT and HCPCS codes, LOINC codes, medication codes, relevant code groupings and codes specific to the OCHIN EHR.
1 secondary outcome
Ambulatory healthcare utilization
Time frame: 36 months post Oregon Experiment selection (post-period)
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 May 2016.
- Derived from this study: 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.
- Derived from this study: PubMed 27522472Bailey SR, Heintzman JD, Marino M, Hoopes MJ, Hatch BA, Gold R, Cowburn SC, Nelson CA, Angier HE, DeVoe JE. Measuring Preventive Care Delivery: Comparing Rates Across Three Data Sources. Am J Prev Med. 2016 Nov;51(5):752-761. doi: 10.1016/j.amepre.2016.07.004. Epub 2016 Aug 10.
- Derived from this study: PubMed 26195674DeVoe JE, Marino M, Gold R, Hoopes MJ, Cowburn S, O'Malley JP, Heintzman J, Gallia C, McConnell KJ, Nelson CA, Huguet N, Bailey SR. Community Health Center Use After Oregon's Randomized Medicaid Experiment. Ann Fam Med. 2015 Jul-Aug;13(4):312-20. doi: 10.1370/afm.1812.
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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, DPhil principal investigator
Oregon Health and Science University
Heather Angier, MPH study director
Oregon Health & Science Univerisity
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Cancer, run by Oregon Health and Science University.
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 3 inclusion and 4 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Preventive service receipt (time frame: 36 months post Oregon Experiment selection (post-period)). 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 NCT02355132, which also lists 3 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 May 2016.