Protocol for the analysis of a natural experiment on the impact of the Affordable Care Act on diabetes care in community health centers.

Background: It is hypothesized that Affordable Care Act (ACA) Medicaid expansions could substantially improve access to health insurance and healthcare services for patients at risk for diabetes mellitus (DM), with pre-DM, or already diagnosed with DM. The ACA called for every state to expand Medicaid coverage by 2014. In a 2012 legal challenge, the US Supreme Court ruled that states were not required to implement Medicaid expansions. This 'natural experiment' presents a unique opportunity to learn whether and to what extent Medicaid expansion can affect healthcare access and services for patients with DM risk, pre-DM, or DM.

Methods/design: Data from electronic health records (EHRs) from the Accelerating Data Value Across a National Community Health Center Network (ADVANCE) clinical data research network, which has data from >700 community health centers (CHCs), was included in the study. EHR data will be linked to Oregon Medicaid claims data. Data collection will include information on changes in health insurance, service receipt, and health outcomes, spanning 9 years (pre- and post-expansion), comparing states that expanded Medicaid, and those that did not. Patients included in this study will be diagnosed with DM, be at risk for DM, or have pre-DM, between the ages of 19 and 64, with ≥1 ambulatory visit. Sample size is estimated to be roughly 275,000 patients. Biostatistical analyses will include the difference-in-differences (DID) methodology and a generalized linear mixed model. Econometric analyses will include a DID two-part method to calculate the difference in Medicaid expenditures in Oregon among newly insured CHC patients.

Discussion: Findings will have national relevance on DM health services and outcomes and will be shared through national conferences and publications. The findings will provide information needed to impact the policy as it is related to access to health insurance and receipt of healthcare among a vulnerable population.

Trial Registration: This project is registered with ClinicalTrials.gov ( NCT02685384 ). Registered 18 May 2016.