Pharm-MD; an open-label, randomized controlled, phase II study to evaluate the efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients – study protocol for a randomized controlled trial

BACKGROUND: Millions of Americans are currently living with diabetes and approximately 1.5 million cases are being diagnosed each year. Diabetes is now the seventh leading cause of death in the United States. In addition, the economic burden of the disease has resulted in billions of dollars in health care costs. In spite of these investments, the United States lags behind other developed countries on diabetes life expectancy and disease-related deaths. The purpose of this study is to assess the impact of a pharmacist-managed diabetes clinic (PMDC) model on diabetes core measures. Our hypothesis is that a PMDC would have a significant positive impact on the diabetes measures and will result in higher-quality care at a lower price. METHODS: This study is a randomized, open-label, controlled, parallel-group trial which will be conducted in the outpatient clinic at Beaumont Hospital, Royal Oak, Michigan. Patients will be randomly assigned to one of two groups: standard of care (SOC) or standard of care plus PMDC (SOC + PMDC). Included in the study will be patients older than 18 years of age with a diagnosis of type 2 diabetes mellitus and a hemoglobin A1c ≥ 9%, who are established with a primary care resident and who have not been seen in the PMDC within the last 3 months. The primary outcome is the change in hemoglobin A1c, measured at 6 and 12 months. Secondary outcomes include the impact on all diabetes core measures, patient quality of life, harms, and cost impact related to the intervention. DISCUSSION: If the results of this trial are consistent with the previous retrospective analysis that a pharmacy clinic has a significant impact in controlling hemoglobin A1c levels as well as other diabetes core measures to improve clinical outcomes, it will constitute a scaffold for a future multicenter, randomized controlled trial. In addition, these results may influence future diabetes guidelines, leading to the inclusion of a PMDC as the standard of care. The impact of these results on the economic burden, life expectancy, and diabetes-related deaths are needed and have yet to be studied. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03377127. Protocol version: registered on 10 February 2018; version #1. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2836-8) contains supplementary material, which is available to authorized users.