NCT02685384

Brief 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. 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,938,375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

9.8 years

First QC Date

February 4, 2016

Last Update Submit

April 20, 2022

Conditions

Diabetes Mellitus (DM)

Keywords

healthcare accesshealthcare utilizationhealth expenditurespreventive servicesbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change of health insurance status

    Health insurance status derived from EHR data and is primarily based on information collected at each visit

    24 months prior to Medicaid expansion vs 24 months post

Secondary Outcomes (5)

  • Change in number of internal services utilization

    24 months prior to Medicaid expansion vs 24 months post

  • Change in type of internal services utilization

    24 months prior to Medicaid expansion vs 24 months post

  • Change in number of preventive services received

    24 months prior to Medicaid expansion vs 24 months post

  • Change in type of preventive services received

    24 months prior to Medicaid expansion vs 24 months post

  • Change of Medicaid expenditures

    24 months prior to Medicaid expansion vs 24 months post

Study Arms (2)

Medicaid Expansion States

Patients receiving care in community health centers in states that expanded Medicaid (intervention group)

Other: Medicaid Expansion

Non Medicaid Expansion States

Patients receiving care in community health centers in states that did not expand Medicaid (control group)

Other: Medicaid Expansion

Interventions

Medicaid ExpansionOTHER

There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not

Medicaid Expansion StatesNon Medicaid Expansion States

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study eligible patients within electronic health record data from the ADVANCE clinical data research network (CDRN) of PCORnet

You may qualify if:

  • Patients in intervention and control states aged 20-64

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 32412951RESULT

  • Marino 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.

    PMID: 32611609RESULT

  • Gemelas 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.

    PMID: 34933870RESULT

  • Lindner 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.

    PMID: 31857442RESULT

  • Huguet 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.

    PMID: 30413546RESULT

  • Angier 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.

    PMID: 33334850RESULT

  • Angier 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.

    PMID: 30827973RESULT

  • Hoopes 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.

    PMID: 30113681DERIVED

  • Huguet 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.

    PMID: 28183354DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 18, 2016

Study Start

January 1, 2012

Primary Completion

September 29, 2021

Study Completion

September 29, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04