Medicaid ExpansionNCT05319743
Evaluating Quality and Value of US Ambulatory Care Delivered Among Medicaid Expansion/Non-Expansion States, 2012-2015
An observational study of Medicaid Expansion, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Quasi-experimental pre-post analysis of the rate of high-value and low-value care services between states that expanded Medicaid and states that did not expand Medicaid January 1, 2014, for adult ambulatory visits, using visit-level survey data from the National Ambulatory Medical Care Survey January 1, 2012 … Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medicaid Expansion
- What is being tested?
- Medicaid Expansion
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 May 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NAMCS Adult Visits between 01/01/2012 and 12/31/2015. The data source is a nationally representative probability sample of U.S. ambulatory care visits
Who may be able to join
- ≥18 years old
- Visits between 01/01/2012 and 12/31/2015
Who cannot join
- <18 years old
- Visits before 01/01/2012
- Visits after 12/31/2015
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Evaluating the Quality and Value of U.S. Ambulatory Care Delivered Among Medicaid Expansion States and Non-Expansion States, 2012-2015
Quasi-experimental pre-post analysis of the rate of high-value and low-value care services between states that expanded Medicaid and states that did not expand Medicaid January 1, 2014, for adult ambulatory visits, using visit-level survey data from the National Ambulatory Medical Care Survey January 1, 2012 - December 31, 2015.
Read the 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.
- Conditions
- Medicaid Expansion
- Being tested
- Medicaid Expansion
- Keywords
- High-value care, Low-value care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicaid ExpansionOther
Expansion of Medicaid, 01/01/2014
| Study group | Role | What they receive |
|---|---|---|
| Medicaid expansion states | Eight Medicaid expansion states: (experimental group): Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington Receives: Other: Medicaid Expansion | |
| Non-Medicaid expansion states | Five states that did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of low-value and high-value services for adult ambulatory visits.
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.
Measured: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
Secondary outcomes (3)
Adult ambulatory visit volume changes
All adults, Medicaid adults, "New" Medicaid adults
Measured: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
Rate of low-value and high-value services for Medicaid adult ambulatory visits
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
Measured: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
Rate of low-value and high-value services for "New" Medicaid adult ambulatory visits.
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.
Measured: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Oct 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medicaid ExpansionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, John N. Mafi, MD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319743
- Sponsor's protocol ID
- 22-001139
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publicly available NAMCS data
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Quality and Value of U.S. Ambulatory Care Delivered Among Medicaid Expansion States and Non-Expansion States, 2012-2015
- ClinicalTrials.gov ID
- NCT05319743
- Acronym / sponsor ID
- 22-001139
- Conditions
- Medicaid Expansion
- Keywords
- High-value care, Low-value care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- 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.
Quasi-experimental pre-post analysis of the rate of high-value and low-value care services between states that expanded Medicaid and states that did not expand Medicaid January 1, 2014, for adult ambulatory visits, using visit-level survey data from the National Ambulatory Medical Care Survey January 1, 2012 - December 31, 2015.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicaid expansion states | – | Other: Medicaid ExpansionEight Medicaid expansion states: (experimental group): Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington |
| Non-Medicaid expansion states | – | –Five states that did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NAMCS Adult Visits between 01/01/2012 and 12/31/2015. The data source is a nationally representative probability sample of U.S. ambulatory care visits
Key inclusion criteria (2 listed)
- ≥18 years old
- Visits between 01/01/2012 and 12/31/2015
Key exclusion criteria (3 listed)
- <18 years old
- Visits before 01/01/2012
- Visits after 12/31/2015
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 ExpansionExpansion of Medicaid, 01/01/2014 | Other | Medicaid expansion states |
Primary outcome
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
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.
3 secondary outcomes
Adult ambulatory visit volume changes
Time frame: pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion
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
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
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 3 Feb 2023.
- Individual participant dataSharing planned: Yes. Publicly available NAMCS data
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medicaid Expansion, run by University of California, Los Angeles 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 2 inclusion and 3 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 3 Feb 2023. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023.