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Post ACA Reform: Evaluation of Community Health Center Care of Diabetes (PREVENTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685384
Recruitment Status : Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : January 11, 2019
Sponsor:
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)
Information provided by (Responsible Party):
Jennifer E DeVoe, MD DPhil, Oregon Health and Science University

Tracking Information
First Submitted Date February 4, 2016
First Posted Date February 18, 2016
Last Update Posted Date January 11, 2019
Study Start Date January 2012
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02685384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 12, 2016)
  • Change in number of internal services utilization [ Time Frame: 24 months prior to Medicaid expansion vs 24 months post ]
    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
  • Change in type of internal services utilization [ Time Frame: 24 months prior to Medicaid expansion vs 24 months post ]
    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
  • Change in number of preventive services received [ Time Frame: 24 months prior to Medicaid expansion vs 24 months post ]
    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
  • Change in type of preventive services received [ Time Frame: 24 months prior to Medicaid expansion vs 24 months post ]
    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
  • Change of Medicaid expenditures [ Time Frame: 24 months prior to Medicaid expansion vs 24 months post ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post ACA Reform: Evaluation of Community Health Center Care of Diabetes
Official Title Post ACA Reform: Evaluation of Community Health Center Care of Diabetes
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).
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study eligible patients within electronic health record data from the ADVANCE clinical data research network (CDRN) of PCORnet
Condition Diabetes Mellitus (DM)
Intervention Other: Medicaid Expansion
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
Study Groups/Cohorts
  • Medicaid Expansion States
    Patients receiving care in community health centers in states that expanded Medicaid (intervention group)
    Intervention: Other: Medicaid Expansion
  • Non Medicaid Expansion States
    Patients receiving care in community health centers in states that did not expand Medicaid (control group)
    Intervention: Other: Medicaid Expansion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 12, 2016)
2073222
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients in intervention and control states aged 20-64

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02685384
Other Study ID Numbers U18DP006116( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
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)
Investigators Not Provided
PRS Account Oregon Health and Science University
Verification Date January 2019