Can Diabetes Distress be Reduced by Improving Entry to Care for People With Type 2 Diabetes Mellitus: A Cluster-randomized Trial

1. Background When diagnosed with type 2 diabetes mellitus (T2DM), patients face numerous challenges such as emotional reactions to the diagnosis, acquiring new knowledge to better comprehend the disease, management of the disease, altering of diet, fear of complications, and potentially disrupted relationships with family and friends. To support these patients, care recommendations are clearly defined in the clinical guidelines for the treatment of T2DM (1,2). It is suggested that three consultations with the general practice (GP) are adequate to provide the patient with information about the disease, disease management, and treatment. Moreover, patients are recommended to be referred for health-education programs, lifestyle interventions, and complication screenings (1). However, it has been reported that a large proportion of patients are in fact not referred to these programs, in the municipalities, even though they explicitly wanted to (3). Also, the continuity of care and cross-sectoral collaboration between sectors have been reported to be deficient, with patients requesting more cross-sectoral collaboration and information sharing (4). These shortcomings in the organizational structure of diabetes care may result in psychological or psychosocial complications such as depression and/or diabetes-related distress (DD) Diabetes distress is the most prevalent complication in T2DM patients, with 36% reporting high or severe levels of DD (5,6). Diabetes distress refers to the negative emotional experiences resulting from receiving the disease and the challenges of living with diabetes in day-to-day activities. DD is positively associated with glycemic control and self-care, increasing the risk of complications and the higher the level of DD (7).

Additionally, recent studies point towards an association between high levels of DD and increased mortality rate among men (8). Thus, it is of immense importance to address DD timely to prevent/reduce further exacerbation, which might lead to more severe complications. Hence, this project evaluates a structural entry-to-care intervention, created by Steno Diabetes Centre Odense (SDCO), aiming at increasing the cross-sectoral collaboration and structuring of the treatment of the first three months when diagnosed, while reducing DD among recently diagnosed T2DM patients. The intervention will facilitate cross-sectoral collaboration, provide novel, data-driven individualized recommendations to GPs, guidelines, and checklists for patients, and inclusion of the "one-stop-shop". 2. Design and Methods A: Design The design is a cluster-randomized, controlled trial conducted in the primary- and secondary sectors in the Region of Southern Denmark. It is designed to examine the effect of a structured start-up routine on recently diagnosed T2DM patients. GP will be randomly allocated to either intervention or control.

B: Intervention The intervention progresses throughout the first three months for the recently diagnosed T2DM patients and is divided into four core components: 1) Improve of cross-sectoral communication and information sharing, 2) ensure systematism in care, 3) guarantee participation at a "one-stop-shop" and a start-up conversation at the municipality, and 4) improve patients coping skills.

B1. Improve cross-sectoral communication and information sharing To increase cross-sectoral communication and information sharing, meetings between GP, municipalities, and regional hospitals will be facilitated by SDCO. Based on previous reports by SDCO, patients did not experience satisfactory cross-sectoral collaboration as part of their treatment; indeed, coherence of treatment was for some patients non-existing. Coherence to treatment has a positive and negative association with DD severity (6). Hence, the cross-sectoral meetings include knowledge sharing concerning the specific healthcare services each sector provides regarding the treatment/care of the recently diagnosed T2DM patients.

These elements are expected to increase the cross-sectoral collaboration, thus increasing care coherence felt by the patients.