Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care

Abstract

IntroductionDiabetes is one of the most common serious chronic health conditions in the USA. People living with diabetes face multiple barriers to optimal diabetes care, including gaps in access to medical care and self-management education, diabetes distress, and high burden of treatment. Community paramedics (CPs) are uniquely positioned to support multidisciplinary care for patients with diabetes by delivering focused diabetes self-management education and support and bridging the gaps between patients and the clinical and community resources they need to live well with their disease.Methods and analysisWe will conduct a pragmatic single-arm prospective trial of a CP-led Diabetes Rescue, Engagement and Management (D-REM) programme that seeks to reduce diabetes distress. We will enrol 70 adults (≥18 years) with diabetes who have haemoglobin A1c (HbA1c)≥9.0%, experienced an emergency department (ED) visit or hospitalisation for any cause within the prior 6 months, and reside in areas with available CP support in Southeast Minnesota (Olmsted, Freeborn and Mower counties) and Northwest Wisconsin (Barron, Rusk and Dunn counties). Participants will be identified using Mayo Clinic electronic health records, contacted for consent and enrolled into the D-REM programme. Visit frequency will be individualised for each patient, but will be an average of four CP visits over the course of approximately 1 month. Outcomes will be change in diabetes distress (primary outcome), confidence in diabetes self-management, health-related quality of life, self-reported hypoglycaemia and hyperglycaemia, HbA1c, ED visits and hospitalisations. Outcomes will be assessed on enrolment, programme completion and 3 months after programme completion.Ethics and disseminationThe study was approved by Mayo Clinic Institutional Review Board. Findings will be disseminated through peer-reviewed publications and presentations. If demonstrated to be successful, this model of care can be implemented across diverse settings and populations to support patients living with diabetes.Trial registration numberNCT04385758.

Reducing burden and building goodwill for practice-embedded trials: Results of rapid qualitative methods in the preimplementation phase of a community paramedic trial to reduce hospitalizations

“…Likewise, there are limitations related to the exclusion of patient input in this preimplementation period. Members of this study team collected patient feedback during an earlier study of CP care for patients with diabetes, and those data informed the current trial intervention [20]. Surveys, as well as interviews with patients who received care in the CACP program, are planned for the implementation and postimplementation periods of this trial.…”

“…19 Since 2016, CPs in the Mayo Clinic Ambulance Service have provided care in community and home settings for a range of chronic conditions. 20,21 The Care Anywhere with Community Paramedics (CACP) program was developed to extend care in the ambulatory setting (e.g. private residence, hotel, shelter) for patients with intermediate acuity health needs.…”

“…CPs are paramedics with specialized training in chronic disease management and the social determinants of health [19]. Since 2016, CPs in the Mayo Clinic Ambulance Service have provided care in community and home settings for a range of chronic conditions [20,21]. The Care Anywhere with Community Paramedics (CACP) program was developed to extend care in the ambulatory setting (e.g.…”