Diabetes Mellitus (DM)PREVENTDNCT02685384
Post ACA Reform: Evaluation of Community Health Center Care of Diabetes
An observational study of Diabetes Mellitus (DM), run by Oregon Health and Science University.
Trial summary
This innovative and timely study will measure the impact of Affordable Care Act (ACA) Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health outcomes. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Diabetes Mellitus (DM)
- What is being tested?
- Medicaid Expansion
- How many people
- 1,938,375 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to 29 Sep 2021
- 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 ADVANCE clinical data research network (CDRN) of PCORnet
Who may be able to join
- Patients in intervention and control states aged 20-64
Who cannot join
- Patients at intervention and control clinics outside of the age range 20-64 Pregnant women to eliminate the possibility of having gestational diabetes mellitus diagnoses
About this study
This innovative and timely study will measure the impact of Affordable Care Act (ACA) Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health outcomes. To assess this natural policy experiment, the investigators will use electronic health record data from the ADVANCE clinical data research network (CDRN) of the National Patient-Centered Clinical Research Network (PCORnet).
Read the detailed description
Diabetes mellitus (DM) is one of the most prevalent chronic diseases, affecting over 29 million people in the United States (US). The number of people with DM is expected to increase by 200% between 2005 and 2050, from 16 to 48 million. Health insurance and continued access to healthcare services are essential for optimal DM care and management; thus, it is hypothesized that Affordable Care Act (ACA) Medicaid expansions could substantially improve access to health insurance and essential healthcare services for patients with DM risk (aged ≥45 + overweight) and patients diagnosed with DM. Studies of single state Medicaid expansions showed increased utilization of healthcare services, access to providers, receipt of preventive care services, and improved health outcomes post-expansion; however, past studies did not have concurrent control states. In 2012, the US Supreme Court ruled that states were not legally required to implement ACA Medicaid expansion, creating a 'natural policy experiment' - a unique national opportunity to test the effect of ACA Medicaid expansion on healthcare access and services for patients at risk for DM or diagnosed with DM ('with DM risk or DM'). By January 1, 2015, 28 states and the District of Columbia had implemented the expansion; Medicaid enrollment increased by an estimated 12.9% in expansion states, compared to 2.6% in non-expansion states. The investigators propose to use this unprecedented natural policy experiment to study the effect of state-level Medicaid expansions on DM prevention, treatment, expenditures, and health outcomes. As many persons affected by both DM and the ACA Medicaid expansions receive primary care in safety net community health centers (CHCs), the proposed analyses will use electronic health record (EHR) data from the national ADVANCE clinical data research network (CDRN) of CHCs (ADVANCE is one of 11 CDRNs in the national PCORnet data network). The ADVANCE CDRN has patient-level data from 470 CHCs in 12 Medicaid expansion states (n=1,242,823 patients) and 248 CHCs in 9 non-expansion states (n=830,399 patients). This nationally unique data resource will let the investigators measure pre-post DM-related utilization and receipt of preventive services in expansion versus non-expansion states, illuminating the impact of ACA Medicaid expansions on DM prevention and treatment Our proposed study, Post ACA Reform: EValuation of community hEalth ceNTer care of Diabetes (PREVENT-D) has the following specific aims:
Aim 1. Compare pre-post insurance status, overall visits, and chronic disease management visits among patients with DM risk or DM, in expansion versus non-expansion states.
Aim 2. Compare pre-post receipt of primary and secondary DM preventive services (e.g., screening for obesity, lipid levels, glycosylated hemoglobin) among patients with DM risk or DM, in expansion versus non-expansion states.
Aim 3. Compare pre-post changes in DM-related biomarkers (e.g., body mass index, blood pressure, lipid levels) in patients with DM risk or DM among newly insured (gained Medicaid in post-period), already insured (had coverage in pre- and post-period), and continuously uninsured (no coverage in pre- and post-period) patients in states that expanded Medicaid.
Aim 4: Measure pre-post changes in Oregon Medicaid expenditures among newly insured compared to already insured patients with DM risk or DM.
- Conditions
- Diabetes Mellitus (DM)
- Being tested
- Medicaid Expansion
- Keywords
- healthcare access, healthcare utilization, health expenditures, preventive services, biomarkers
- Medical subject headings
- Diabetes Mellitus
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.
Change of 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 (5)
Change in number of internal services utilization
Number of internal services utilized including number and ratio of "traditional" face to face visits vs. "nontraditional" encounters and communication via phone, personal health record, and email
Measured: 24 months prior to Medicaid expansion vs 24 months post
Change in type of internal services utilization
Type of internal services utilized including number and ratio of "traditional" face to face visits vs. "nontraditional" encounters and communication via phone, personal health record, and email
Measured: 24 months prior to Medicaid expansion vs 24 months post
Change in number of preventive services received
Number of all billed encounters overall and yearly, number of primary care visits overall and yearly, number of mental and behavioral health encounters, number of dental visits overall and yearly, services received at visit
Measured: 24 months prior to Medicaid expansion vs 24 months post
Change in type of preventive services received
Types of all billed encounters overall and yearly, number of primary care visits overall and yearly, number of mental and behavioral health encounters, number of dental visits overall and yearly, services received at visit
Measured: 24 months prior to Medicaid expansion vs 24 months post
Change of Medicaid expenditures
The investigators 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 posted18 Feb 2016 (estimated)
- Study startJan 2012
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
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 Diabetes Mellitus (DM)Studies 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
- Prospective
- Enrolment
- 1,938,375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., Health Choice Network, Fenway Community Health, Centers for Disease Control and Prevention, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685384
- Sponsor's protocol ID
- U18DP006116
- Acronym
- PREVENTD
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2016
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Marino M, Angier H, Fankhauser K, Valenzuela S, Hoopes M, Heintzman J, DeVoe J, Moreno L, Huguet N. Disparities in Biomarkers for Patients With Diabetes After the Affordable Care Act. Med Care. 2020 Jun;58 Suppl 6 Suppl 1(Suppl 6 1):S31-S39. doi: 10.1097/MLR.0000000000001257.
PubMed 32412951Marino M, Angier H, Springer R, Valenzuela S, Hoopes M, O'Malley J, Suchocki A, Heintzman J, DeVoe J, Huguet N. The Affordable Care Act: Effects of Insurance on Diabetes Biomarkers. Diabetes Care. 2020 Sep;43(9):2074-2081. doi: 10.2337/dc19-1571. Epub 2020 Jul 1.
PubMed 32611609Gemelas J, Marino M, Valenzuela S, Schmidt T, Suchocki A, Huguet N. Changes in diabetes prescription patterns following Affordable Care Act Medicaid expansion. BMJ Open Diabetes Res Care. 2021 Dec;9(Suppl 1):e002135. doi: 10.1136/bmjdrc-2021-002135.
PubMed 34933870Lindner SR, Marino M, O'Malley J, Angier H, Bailey SR, Hoopes M, Springer R, McConnell KJ, DeVoe J, Huguet N. Health Care Expenditures Among Adults With Diabetes After Oregon's Medicaid Expansion. Diabetes Care. 2020 Mar;43(3):572-579. doi: 10.2337/dc19-1343. Epub 2019 Dec 19.
PubMed 31857442Huguet N, Springer R, Marino M, Angier H, Hoopes M, Holderness H, DeVoe JE. The Impact of the Affordable Care Act (ACA) Medicaid Expansion on Visit Rates for Diabetes in Safety Net Health Centers. J Am Board Fam Med. 2018 Nov-Dec;31(6):905-916. doi: 10.3122/jabfm.2018.06.180075.
PubMed 30413546Angier H, Huguet N, Ezekiel-Herrera D, Marino M, Schmidt T, Green BB, DeVoe JE. New hypertension and diabetes diagnoses following the Affordable Care Act Medicaid expansion. Fam Med Community Health. 2020 Dec;8(4):e000607. doi: 10.1136/fmch-2020-000607.
PubMed 33334850Angier H, Ezekiel-Herrera D, Marino M, Hoopes M, Jacobs EA, DeVoe JE, Huguet N. Racial/Ethnic Disparities in Health Insurance and Differences in Visit Type for a Population of Patients with Diabetes after Medicaid Expansion. J Health Care Poor Underserved. 2019;30(1):116-130. doi: 10.1353/hpu.2019.0011.
PubMed 30827973Hoopes M, Angier H, Raynor LA, Suchocki A, Muench J, Marino M, Rivera P, Huguet N. Development of an algorithm to link electronic health record prescriptions with pharmacy dispense claims. J Am Med Inform Assoc. 2018 Oct 1;25(10):1322-1330. doi: 10.1093/jamia/ocy095.
PubMed 30113681Huguet N, Angier H, Marino M, McConnell KJ, Hoopes MJ, O'Malley JP, Raynor LA, Likumahuwa-Ackman S, Holderness H, DeVoe JE. Protocol for the analysis of a natural experiment on the impact of the Affordable Care Act on diabetes care in community health centers. Implement Sci. 2017 Feb 10;12(1):14. doi: 10.1186/s13012-017-0543-6.
PubMed 28183354
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post ACA Reform: Evaluation of Community Health Center Care of Diabetes
- ClinicalTrials.gov ID
- NCT02685384
- Acronym / sponsor ID
- PREVENTD / U18DP006116
- Conditions
- Diabetes Mellitus (DM)
- Keywords
- healthcare access, healthcare utilization, health expenditures, preventive services, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,938,375 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- OCHIN, Inc., Health Choice Network, Fenway Community Health, Centers for Disease Control and Prevention, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2012
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 18 Feb 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 and timely study will measure the impact of Affordable Care Act (ACA) Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health outcomes. To assess this natural policy experiment, the investigators will use electronic health record data from the ADVANCE clinical data research network (CDRN) of the National Patient-Centered Clinical Research Network (PCORnet).
Detailed description
Diabetes mellitus (DM) is one of the most prevalent chronic diseases, affecting over 29 million people in the United States (US). The number of people with DM is expected to increase by 200% between 2005 and 2050, from 16 to 48 million. Health insurance and continued access to healthcare services are essential for optimal DM care and management; thus, it is hypothesized that Affordable Care Act (ACA) Medicaid expansions could substantially improve access to health insurance and essential healthcare services for patients with DM risk (aged ≥45 + overweight) and patients diagnosed with DM. Studies of single state Medicaid expansions showed increased utilization of healthcare services, access to providers, receipt of preventive care services, and improved health outcomes post-expansion; however, past studies did not have concurrent control states. In 2012, the US Supreme Court ruled that states were not legally required to implement ACA Medicaid expansion, creating a 'natural policy experiment' - a unique national opportunity to test the effect of ACA Medicaid expansion on healthcare access and services for patients at risk for DM or diagnosed with DM ('with DM risk or DM'). By January 1, 2015, 28 states and the District of Columbia had implemented the expansion; Medicaid enrollment increased by an estimated 12.9% in expansion states, compared to 2.6% in non-expansion states. The investigators propose to use this unprecedented natural policy experiment to study the effect of state-level Medicaid expansions on DM prevention, treatment, expenditures, and health outcomes. As many persons affected by both DM and the ACA Medicaid expansions receive primary care in safety net community health centers (CHCs), the proposed analyses will use electronic health record (EHR) data from the national ADVANCE clinical data research network (CDRN) of CHCs (ADVANCE is one of 11 CDRNs in the national PCORnet data network). The ADVANCE CDRN has patient-level data from 470 CHCs in 12 Medicaid expansion states (n=1,242,823 patients) and 248 CHCs in 9 non-expansion states (n=830,399 patients). This nationally unique data resource will let the investigators measure pre-post DM-related utilization and receipt of preventive services in expansion versus non-expansion states, illuminating the impact of ACA Medicaid expansions on DM prevention and treatment Our proposed study, Post ACA Reform: EValuation of community hEalth ceNTer care of Diabetes (PREVENT-D) has the following specific aims:
Aim 1. Compare pre-post insurance status, overall visits, and chronic disease management visits among patients with DM risk or DM, in expansion versus non-expansion states.
Aim 2. Compare pre-post receipt of primary and secondary DM preventive services (e.g., screening for obesity, lipid levels, glycosylated hemoglobin) among patients with DM risk or DM, in expansion versus non-expansion states.
Aim 3. Compare pre-post changes in DM-related biomarkers (e.g., body mass index, blood pressure, lipid levels) in patients with DM risk or DM among newly insured (gained Medicaid in post-period), already insured (had coverage in pre- and post-period), and continuously uninsured (no coverage in pre- and post-period) patients in states that expanded Medicaid.
Aim 4: Measure pre-post changes in Oregon Medicaid expenditures among newly insured compared to already insured patients with DM risk or DM.
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 ADVANCE clinical data research network (CDRN) of PCORnet
Key inclusion criteria (1 listed)
- Patients in intervention and control states aged 20-64
Key exclusion criteria (1 listed)
- Patients at intervention and control clinics outside of the age range 20-64 Pregnant women to eliminate the possibility of having gestational diabetes mellitus diagnoses
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
Change of 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
5 secondary outcomes
Change in number of internal services utilization
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Change in type of internal services utilization
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Change in number of preventive services received
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Change in type of preventive services received
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Change of 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 28 Apr 2022.
- Results publication: PubMed 32412951Marino M, Angier H, Fankhauser K, Valenzuela S, Hoopes M, Heintzman J, DeVoe J, Moreno L, Huguet N. Disparities in Biomarkers for Patients With Diabetes After the Affordable Care Act. Med Care. 2020 Jun;58 Suppl 6 Suppl 1(Suppl 6 1):S31-S39. doi: 10.1097/MLR.0000000000001257.
- Results publication: PubMed 32611609Marino M, Angier H, Springer R, Valenzuela S, Hoopes M, O'Malley J, Suchocki A, Heintzman J, DeVoe J, Huguet N. The Affordable Care Act: Effects of Insurance on Diabetes Biomarkers. Diabetes Care. 2020 Sep;43(9):2074-2081. doi: 10.2337/dc19-1571. Epub 2020 Jul 1.
- Results publication: PubMed 34933870Gemelas J, Marino M, Valenzuela S, Schmidt T, Suchocki A, Huguet N. Changes in diabetes prescription patterns following Affordable Care Act Medicaid expansion. BMJ Open Diabetes Res Care. 2021 Dec;9(Suppl 1):e002135. doi: 10.1136/bmjdrc-2021-002135.
- Results publication: PubMed 31857442Lindner SR, Marino M, O'Malley J, Angier H, Bailey SR, Hoopes M, Springer R, McConnell KJ, DeVoe J, Huguet N. Health Care Expenditures Among Adults With Diabetes After Oregon's Medicaid Expansion. Diabetes Care. 2020 Mar;43(3):572-579. doi: 10.2337/dc19-1343. Epub 2019 Dec 19.
- Results publication: PubMed 30413546Huguet N, Springer R, Marino M, Angier H, Hoopes M, Holderness H, DeVoe JE. The Impact of the Affordable Care Act (ACA) Medicaid Expansion on Visit Rates for Diabetes in Safety Net Health Centers. J Am Board Fam Med. 2018 Nov-Dec;31(6):905-916. doi: 10.3122/jabfm.2018.06.180075.
- Results publication: PubMed 33334850Angier H, Huguet N, Ezekiel-Herrera D, Marino M, Schmidt T, Green BB, DeVoe JE. New hypertension and diabetes diagnoses following the Affordable Care Act Medicaid expansion. Fam Med Community Health. 2020 Dec;8(4):e000607. doi: 10.1136/fmch-2020-000607.
- Results publication: PubMed 30827973Angier H, Ezekiel-Herrera D, Marino M, Hoopes M, Jacobs EA, DeVoe JE, Huguet N. Racial/Ethnic Disparities in Health Insurance and Differences in Visit Type for a Population of Patients with Diabetes after Medicaid Expansion. J Health Care Poor Underserved. 2019;30(1):116-130. doi: 10.1353/hpu.2019.0011.
- Derived from this study: PubMed 30113681Hoopes M, Angier H, Raynor LA, Suchocki A, Muench J, Marino M, Rivera P, Huguet N. Development of an algorithm to link electronic health record prescriptions with pharmacy dispense claims. J Am Med Inform Assoc. 2018 Oct 1;25(10):1322-1330. doi: 10.1093/jamia/ocy095.
- Derived from this study: PubMed 28183354Huguet N, Angier H, Marino M, McConnell KJ, Hoopes MJ, O'Malley JP, Raynor LA, Likumahuwa-Ackman S, Holderness H, DeVoe JE. Protocol for the analysis of a natural experiment on the impact of the Affordable Care Act on diabetes care in community health centers. Implement Sci. 2017 Feb 10;12(1):14. doi: 10.1186/s13012-017-0543-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus (DM), 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 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 28 Apr 2022. 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?
Change of 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 NCT02685384, 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 28 Apr 2022.