GD06: Derivation and internal validation of a clinical prognostic tool for recurrent emergency visits for hyperglycemia in patients with diabetes mellitus: a multicentre prospective cohort study

Background: Patients with poorly controlled diabetes mellitus (DM) often visit the emergency department (ED) for management of hyperglycemic episodes, including diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS). It has been previously reported that risk factors for readmission to the intensive care unit (ICU) in DKA include older age, female sex and the presence of significant comorbidity including sepsis. However, there are no ED-based studies on this topic, particularly in a Canadian setting, and data on outcomes such as recurrent ED visits, hospital or ICU admission after discharge in these patients is lacking. Objectives: The primary objective of this study is to derive and internally validate a clinical risk tool for prognosis of patients presenting with hyperglycemic emergencies to identify those at higher risk of adverse outcomes within 30 days of initial ED presentation. Methods: This will be a multicentre prospective cohort study of eligible consecutive adult patients with an ED diagnosis of hyperglycemia, DKA or HHS. We will include all visits of adult (≥18 years) ED patients with either a known or unknown history of DM and a diagnosis of hyperglycemia (blood glucose >11.0 mmol/L), DKA or HHS. We will include patients with co-morbid diagnoses in addition to hyperglycemia. We will exclude patients: a) with advanced care directives for resuscitation involving refusal of treatment, and b) who are initially assessed at a peripheral hospital and transferred to our sites for ongoing management. Research assistants will then contact the enrolled participants via telephone for follow-up regarding clinical outcomes, including repeat visits to see a health care provider, changes in diabetic medications, and time taken off of work or school. Participants will be followed to determine if they have further ED visits, admissions or ICU admissions after their ED visit for hyperglycemia. Data on missed patients or those who refused consent will be collected to assess for selection/enrolment bias. Statistical considerations: The primary outcome will be an unplanned return ED visit for hyperglycemia within 30 days of initial presentation. Secondary outcomes will include unplanned admission to hospital or ICU for hyperglycemia, or death within 30 days of the index ED visit. Additionally, we hope to characterize patient-important and health-care system outcomes such as time taken off work or school and follow-up visits to see a healthcare provider. We will conduct descriptive statistics on investigations, treatments, disposition and patient-important outcomes. We will perform an initial univariate logistic regression, followed by a multivariate analysis to identify predictor variables associated with adverse events such as recurrent ED visits, and admission to hospital or ICU for hyperglycemia within 30 days. We will include individual patients who have multiple recurrent visits to the ED during the study period and statistically weight for these using generalized estimating equations (GEE), which are used to develop regression models for correlated data that arise from repeated measures of the same individuals over time. Finally, a clinical risk tool will be derived by rounding the beta co-efficients. Internal validation will be conducted using bootstrapping techniques. Importance: ED visits for hyperglycemia significantly affect both the healthcare system overall and the individual patient. The results of this project will assist clinicians to better identify these patients and enable them to intervene either medically or educationally to prevent subsequent visits to the ED. As a result, patients will have improved care, better blood glucose control, and be identified for closer follow-up with a family physician or diabetes specialist. Furthermore, by aiming to reduce the number of recurrent visits, this project may reduce ED utilization and the associated healthcare costs with frequent visits and admissions for hyperglycemia.