TY - JOUR
T1 - Diabetes Rescue, Engagement and Management (D-REM)
T2 - Rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care
AU - Juntunen, Michael B.
AU - Liedl, Chad P.
AU - Carlson, Peter N.
AU - Myers, Lucas A.
AU - Stickler, Zachary R.
AU - Ryan Schultz, Jill A.
AU - Meilander, Angela K.
AU - Behnken, Emma
AU - Lampman, Michelle A.
AU - Rogerson, M. Carson
AU - Fischer, Karen M.
AU - McCoy, Rozalina G.
N1 - Funding Information:
hypertension and hyperlipidaemia, has worsened since 2010.18 Thus, there is great need for innovative care delivery models that can support patient-centred, accessible and affordable diabetes care. Community paramedicine has emerged across the USA and in other countries around the world as an effective and efficient care delivery model to improve healthcare access for underserved communities and populations.19–26 Community paramedics (CPs) are uniquely positioned to provide multidisciplinary, interprofessional care for patients with both medical and socioeconomic complexities with the goals of improving access to care, health outcomes and reducing costs.27–29 CPs are experienced paramedics with advanced training in the management of low acuity and chronic health conditions, primary/preventive care and social determinant of health. They practice under the supervision of a physician medical director to provide a wide range of services tailored to each patient’s medical, educational and social needs. In contrast to traditional emergency medical services (EMS), which focuses on high acuity medical care, CPs deliver longitudinal low and intermediate acuity care with emphasis on primary care, education, social support and wellness.21 24–28 30–41 In the US fee-for-service healthcare system, financial sustainability is one of the biggest challenges facing CP programmes as a novel care delivery model. Minnesota is currently the only state to legislatively require Medicaid to reimburse for CP services as professional services. Additionally, and not limited to Minnesota, CP services can be billed to Medicare as ‘incident-to’ to other physician services. Finally, CP services can be funded under the umbrella of Accountable Care Organisations, Medicaid Integrated Health Partnerships and other value-based care models.42 For this study, CP services will be supported by institutional grant funding seeking to improve diabetes care in rural and underserved communities, with plans for broader implementation and dissemination using established funding streams once programme effectiveness is established. Thus far, most CP programmes have primarily focused on specific high-risk patient populations, most often those with history of frequent hospital, emergency department (ED) and/or EMS utilisation, multimorbidity and frailty.21 26 36 38 43–46 While, to our knowledge, there has been no diabetes-specific CP programme, community paramedicine is uniquely suited to meet the multifaceted needs of patients with diabetes living in rural and underserved communities.27 47 48 Our objective in this prospective single-arm pragmatic trial is therefore to evaluate the effectiveness of a CP-led intervention—Diabetes Rescue, Engagement and Management (D-REM)—on reducing diabetes distress and improving diabetes self-efficacy, glycaemic control and quality of life. Our ultimate goal is to bring care to the communities and homes where people live, and thereby improve health outcomes and quality of life for people living with this serious, progressive, chronic disease.
Publisher Copyright:
©
PY - 2022/4/21
Y1 - 2022/4/21
N2 - Introduction Diabetes 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 analysis We 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 dissemination The 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 number NCT04385758.
AB - Introduction Diabetes 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 analysis We 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 dissemination The 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 number NCT04385758.
KW - Diabetes & endocrinology
KW - General diabetes
KW - Organisation of health services
UR - http://www.scopus.com/inward/record.url?scp=85128593997&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85128593997&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-057224
DO - 10.1136/bmjopen-2021-057224
M3 - Article
C2 - 35450906
AN - SCOPUS:85128593997
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e057224
ER -