Severe hypoglycemia in the management of diabetes is associated with high morbidity, mortality, psychological distress, and impaired quality of life (QoL). Preventing hypoglycemia is challenging as high risk patients, including those who have already experienced severe hypoglycemia, are often not identified; risk factors for hypoglycemia are broad, spanning clinical and non-clinical domains; and diabetes management is often not altered despite a high risk profile. Recognizing, actively engaging, and providing comprehensive care to at-risk patients to address hypoglycemia risk factors and enhance diabetes self-management skills may help reduce the frequency/severity of hypoglycemic events, alleviate diabetes distress, and improve QoL. Community paramedics (CPs) are trained in disease prevention, management, and wellness in addition to emergency response. They are uniquely positioned to deliver comprehensive patient-centered care, particularly to clinically and psychosocially complex patients. They can engage patients in their homes, identify clinical and non-clinical needs, provide education, and engage medical and social support services. Our team has demonstrated that CP interventions for patients with high prior healthcare utilization can reduce emergency department (ED) visits and hospitalizations by 25% and 56%, respectively, over a 6-month period. We hypothesize that comprehensive management by CPs after being treated for severe hypoglycemia will improve diabetes self-management, prevent hypoglycemia, reduce diabetes distress, and improve QoL. The overall objective of this application is to assess the feasibility, preliminary efficacy, and acceptability of Diabetes-REM (Rescue, Engagement, and Management) to improve diabetes self-management among adults in southeast Minnesota who had been treated for hypoglycemia by Mayo Clinic Ambulance. CPs will receive formal training on diabetes and its management, which will be developed by the study team. Using a two-group parallel design, 150 adults will be randomly assigned to 1 month of Diabetes-REM or usual care. Both groups will receive education materials on hypoglycemia/diabetes and clinical/community resources.
In Aim 1, we will evaluate the feasibility and efficacy of Diabetes-REM in improving diabetes self-management (primary outcome), with secondary outcomes of hypoglycemia, hyperglycemia, diabetes distress, and QoL, all assessed at month 1 (end of intervention) and month 4 (for durability of effect).
In Aim 2, we will qualitatively examine patient perceptions of Diabetes-REM, focusing on specific Diabetes-REM components of that did, or did not, meet their needs. This work naturally builds on our robust preliminary data and Dr. McCoy?s ongoing evaluation of clinical and sociodemographic hypoglycemia risk factors supported by a NIDDK K23 Award, and will provide preliminary data for broader implementation and evaluation of Diabetes-REM in a R01-funded randomized controlled trial.
This pilot study will assess the feasibility, preliminary efficacy, and acceptability of the Diabetes-REM (Rescue, Engagement, and Management), a comprehensive patient-centered intervention delivered by community paramedics in the community setting to improve diabetes self-management, prevent recurrent hypoglycemia, reduce diabetes distress, and improve quality of life among adults in southeast Minnesota who were treated for hypoglycemia by emergency medical services. This scalable and generalizable intervention may help address the persistent gaps in health care access, quality, and outcomes among patients with diabetes, particularly in rural and other underserved areas. This work will expand the breadth of community paramedic expertise and will directly inform the large-scale implementation, evaluation, and dissemination of Diabetes-REM in a subsequent R01-funded randomized controlled trial.
