New model of integrated care for uncontrolled type 2 diabetes in a retrospective, underserved adult population in the USA: a study protocol for an effectiveness and cost-effectiveness analysis

Introduction Type 2 diabetes prevalence is increasing in the USA, especially in underserved populations. Patient outcomes can be improved by providing access to specialty care within Federally Qualified Health Centers, possibly improving the cost-effectiveness of diabetes care. Methods and analysis A new model of diabetes care based on multidisciplinary teams of clinical fellows, supported by an endocrinologist for underserved adult populations, is presented. The study uses a retrospective, non-randomised cohort of patients with diabetes who visited the community clinic between 1 January 2012 and 31 December 2018. A quasi-experimental method to analyse the causal evidence of the effect of the new model is presented. Discontinuity regression is used to compare two interventions, the intervention by a Clinical Fellow Endocrinology Programme and usual care by a primary care physician. Patients are referred to the Clinical Fellow Endocrinology Programme in case of uncontrolled diabetes (glycated haemoglobin (HbA1c)>= 9%). The regression discontinuity design allows the construction of a treatment group for patients with an HbA1c equal or above the threshold in comparison with a control group for patients with an HbA1c below the threshold. The patient outcomes and cost-effectiveness of the new model are analysed. Regression models will be used to assess the differences between treatment and control groups. Ethics and dissemination Quantitative patient data are received by the study team in a de-identified format for analysis via an institutional review board-approved protocol. The quantitative study has been approved by the Houston Methodist Research Institute Institutional Review Board, Houston, Texas, USA. Anticipated results will not only provide evidence about the impact of patient outcomes in underserved diabetic populations, but also give an idea of the cost-effectiveness of the new model and whether or not cost savings can be attained for patients, third-party payers and society. The results will help set up evidence-based policy guidelines in diabetes care. Results will be disseminated through papers, conferences and public health/policy fora.