Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial.
The prevalence of type 2 diabetes (T2D) is growing globally and hospital-based outpatient clinics are burdened with increasing numbers of patients. To ensure high quality treatment and care, it is necessary to structurally reorganise the management of patients with T2D. The objective of this study is to test if T2D patients (who are at intermediate risk of or are already having incipient diabetic complications) jointly managed by a hospital-based outpatient clinic and general practitioners (shared care programme) have a non-inferior outcome compared to an established programme in a specialised (hospital based) outpatient diabetes clinic.



The study is designed as a randomised controlled trial. The shared care model will be tested during a period of 3 years, with data collection at baseline and at 12, 24 and 36 months. All patients will be offered four medical visits a year; the shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at the general practitioners' office. The control group will be followed with four quarterly visits at the outpatient clinic, including an annual comprehensive check-up. In the outpatient clinic, the patients will be treated by a specialised diabetes team, including an endocrinologist. On the basis of a predefined stratification model, we will recruit patients stratified to be at intermediate risk of or already having incipient diabetic complications. We plan to include 140 patients. The primary outcome is glycated haemoglobin. Other outcome measures include (1) the proportion of patients who meet the Danish standard indicators reflecting quality of care; (2) quality of life measured by Short Form 36; and (3) the functionality of the patients' families measured by Family Assessment Measure III. The experiences of the patients and families when participating in the shared care program will be explored by collecting dyadic interviews.



This study will evaluate the quality of a shared care programme for patients with T2D, and provide evidence about advantages and disadvantages compared with a programme in a specialised outpatient clinic. The results may provide important information on how to organise the care for patients with T2D in the future.



This trial was registered with Clinicaltrials.gov on 21 October 2015, registration number: NCT02586545 .
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.|Institute of Nursing, Metropolitan University College, Copenhagen, Denmark.
Lene
L
Munch
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.|Institute of Nursing, Metropolitan University College, Copenhagen, Denmark.
Birgitte
B
Bennich
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.
Anne B
AB
Arreskov
Institute of Nursing, Metropolitan University College, Copenhagen, Denmark.
Dorthe
D
Overgaard
Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Hundinge, Sweden.
Hanne
H
Konradsen
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.|NNF Center for Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Filip K
FK
Knop
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.
Tina
T
Vilsbøll
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Kildegårdsvej 28, DK-2900, Hellerup, Denmark. michael.einar.roeder@regionh.dk.
Michael E
ME
Røder
D002985:Clinical Protocols; D003430:Cross-Sectional Studies; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D019981:Health Care Sector; D006801:Humans; D017063:Outcome Assessment, Health Care; D010346:Patient Care Management; D011788:Quality of Life
Diabetes care; Diabetes complications; Randomised controlled trial; Risk stratification; Shared care; Type 2 diabetes