Clinical Inertia: Time to Intervention of Critical A1C Values in Two Primary Care Models for Patients with Type 2 Diabetes: PharmacistCARE vs. Usual Care

Background: Although it has been demonstrated that long-term glycemic control, as measured by glycosylated hemoglobin (A I C), is associated with significant decreases in mortality and microvascular complications, many primary care practitioners do not perform or intensify diabetes intervention in patients. despite recognizing that glycemic levels of the patient are not at goal. Evidence suggests that patients with Type 2 Diabetes suffer from a high rate of "clinical inertia" or "recognition of the problem but failure to act." Furthennore, studies have reported the short term benefits of intense glycemic control, which include improved quality of life, reduced primary care visits, and a decrease in overall healthcare costs. The impact of clinical inertia on diabetes outcomes and quality of life, howe\er, is not well reported. Pharmacists can counteract clinical inertia and improve the quality of care patients with Type 2 Diabetes receive by implementation of a pharmacist-managed diabetes education and management program (PharmacistCARE). Objective: The objective of this one year project is to characterize clinical inertia in terms of time to intervention of critical A IC values. This study will measure the amount of time from discovery of A IC values in patients with Type 2 Diabetes until intervention among two different primary care models, PharmacistCARE VS. usual medical care. Methods: Approximately 300 patients with Type 2 Diabetes will be included in this observational, longitudinal, case-control study in a major academic medical center. Patients in the intervention group were participants in a University of Kentucky pharmacist-managed diabetes education and management program (PharmacistCARE) and control patients received usual medical care. A retrospective chart review will be conducted to identify patients and collect data to determine the primary and secondary outcomes. Interventions will be defined as the provision of patient education, performance of laboratory monitoring or diabetes screening, medication initiation/optimization and/or providing referral. Outcomes: The primary outcome, measured by regression analysis, will be the time to intervention of critical A IC values in patients in PharmacistCARE VS. usual medical care. In a subgroup analysis of patients who reach goal outcome measures, we \vill determine time to goal Ale, blood pressure. and LDL and compare those times with the Kaplan Meier method between groups. Other outcomes of interest include: investigating morbidity and hospitalizations associated with time to achieving goal or time at goal and measuring compliance with current ADA standards of care to include: performance of: nephropathy and retinopathy screening, foot care, smoking cessation, immunization, self-monitoring of blood glucose and diet therapy. Expected Findings: We expect to find that patients enrolled in PharmacistCARE will have an improved time to intervention of critical A IC values which will translate into an increased rate of change in A IC. This project will demonstrate that pharmacists can improve the quality of care in patients with chronic diseases, such as diabetes, by counteracting clinical inertia. This study will also demonstrate the clinical impact of pharmacists and their value in collaborative care relationships with primal) care physicians and other specialists. Furthermore, characterization of the time to intervention could be used to evaluate the effectiveness of multi-disciplinary teams and identify opportunities to reduce clinical inertia and ensure patient disease state management is optimized. Significance: ASHP should support this study because it directly addresses how pharmacists can improve medication use and improve public health by counteracting clinical inertia. The findings from this study will support pharmacists' role as integral members of the healthcare team. Additionally, we developed a model to assess clinical inertia, which can be applied to clinical practice and research in all academic settings. The methodology proposed in this study to assess pharmacist impact has not previously been reported and represents a novel approach to justifying collaborative care with pharmacists. Finally, th.is research p ~ oject ~ill provide Dr. Yam (the pharmacy resident) with ample opportunity to d~ velo~ ~IS research skIlls. HIS research committee consists of experts in diabetes care, primary care, bIOSt~tIStJCS, and research methodology. All co-investigators have dedicated their time and expertise to contnbute to the development of this research project and ensure that the resident acquires and builds upon basic and essential research skills. This will be done through an experiential, didactic and seminar approach.