- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05319743
Evaluating Quality and Value of US Ambulatory Care Delivered Among Medicaid Expansion/Non-Expansion States, 2012-2015
Evaluating the Quality and Value of U.S. Ambulatory Care Delivered Among Medicaid Expansion States and Non-Expansion States, 2012-2015
Study Overview
Status
Intervention / Treatment
Detailed Description
Data Source: Visit level data obtained from the National Ambulatory Medical Care Survey (NAMCS) between January 1, 2012-December 31, 2015.
Identification of Observations (Visits) for Primary Analysis: Adult visits in states that did expand Medicaid January 1, 2014 (experimental group) and states that did not expand Medicaid January 1, 2014 (control group). Eight Medicaid expansion states (experimental group): Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington Five states that did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia. Visits will be included only if they could receive a low value service (visits for back pain, headache, general medical exam, URI) or high value service (visits with patients who have CAD, DM, CVD, Depression, CHF, Osteoporosis and no exclusion to receive the indicated high value service) when evaluating low value service counts and high value service counts respectively as opposed to all adult visits regardless of the opportunity to receive a high value or low value care service (e.g. visit for hand pain and none of the high or low value areas above.)
Identification of Observations (Visits) for Secondary Analyses: Medicaid patient subpopulation will be defined as those visits for primary analysis that are coded with Medicaid as a pay type for the visit. "New" Medicaid patient subpopulation will be defined as those visits for primary analysis that are coded with Medicaid as a pay type, have not seen before, to a provider who is accepting new patients and accepts Medicaid for new patients.
Create Indicator Variables for Primary and Secondary Outcome Analyses: Develop a set of low value and high value services with distinct inclusion and exclusion criteria for each service. Create indicator variable for each high value and low value service. Low value care measures (Imaging for Low Back Pain, Opioid for Low Back Pain, Opioid for Headache, Imaging for Headache, Antibiotic for Upper Respiratory Infection, General Medical Examination with ECG ordered, General Medical Examination with Urinalysis ordered.) High value care measures (Antiplatelet for CAD, Beta Blocker for CAD, Statin for CAD, Anticoagulation for Atrial Fibrillation, Statin for DM, Antiplatelet CVD, Treatment for Depression, Beta Blocker for CHF, ACE/ARB/ARNI for CHF, Treatment for Osteoporosis)
Analysis: Evaluate for pre-intervention (Medicaid Expansion) parallel trends (This has already been established). Then perform pre-post difference-in-differences analyses of primary and secondary outcomes between the experimental group (states that expanded Medicaid) and control group (states that did not expand Medicaid). Regression analysis will be performed to adjust for respondent age, sex, race/ethnicity, number of chronic illnesses, and clinic rural/urban location. Stratified models based on payer type will allow for analyses of the Medicaid population. Perform sensitivity analyses of primary and secondary outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- The University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Medicaid expansion states
Eight Medicaid expansion states: (experimental group): Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington
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Expansion of Medicaid, 01/01/2014
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Non-Medicaid expansion states
Five states that did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of low-value and high-value services for adult ambulatory visits.
Time Frame: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Ex. Numerator = count of high value services provided for adult visits in Medicaid expansion states in 2012/ Denominator = Count of adult visits in Medicaid expansion state in 2012 that had the potential to receive a high value service.
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pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adult ambulatory visit volume changes
Time Frame: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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All adults, Medicaid adults, "New" Medicaid adults
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pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Rate of low-value and high-value services for Medicaid adult ambulatory visits
Time Frame: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Ex. Numerator = count of high value services provided for Medicaid adult visits in Medicaid expansion states in 2012/ Denominator = Count of Medicaid adult visits in Medicaid expansion state in 2012 that had the potential to receive a high value service
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pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Rate of low-value and high-value services for "New" Medicaid adult ambulatory visits.
Time Frame: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Ex. Numerator = count of high value services provided for "New" Medicaid adult visits in Medicaid expansion states in 2012/ Denominator = Count of "New" Medicaid adult visits in Medicaid expansion state in 2012 that had the potential to receive a high value service.
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pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity analysis: repeat primary and secondary analysis with all adult visits, Medicaid visits, and "New" Medicaid visits
Time Frame: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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1. Repeat primary and secondary analysis with all adult visits, Medicaid visits and "New" Medicaid visits with a denominator of all visits (not the denominator of visits with potential to receive low or high value service as described for the primary analyses)
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pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- No unique protocol ID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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