Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial

Abstract

BackgroundThe 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.MethodsThe 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.DiscussionThis 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.Trial RegistrationThis trial was registered with Clinicaltrials.gov on 21 October 2015, registration number: NCT02586545.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1409-y) contains supplementary material, which is available to authorized users.

Effectiveness of integrated care model for type 2 diabetes: A population-based study in Reggio Emilia (Italy)

“…A third RCT [ 26 ] included in the review was not taken into consideration because it compared all-cause mortality between “specialty care” (i.e., consultation care provided by an endocrinologist or a general internist in concert with the patient’s primary care doctor) and “primary care” (cared for by family doctors alone). A further RCT aimed at evaluating the quality of a shared care programme for patients with T2D; providing evidence on the advantages and disadvantages compared with a programme in a specialised outpatient clinic is ongoing and the results are still unpublished [ 27 ].…”

Patient Assessment of Family Function, Glycemic Control and Quality of Life in Adult Patients With Type 2 Diabetes and Incipient Complications

“…The study used an explorative, descriptive cross-sectional design. The sample comprised 140 patients with T2D and was embedded baseline in a randomized controlled trial comparing two diabetes care programs [19]. Eligible patients were recruited either from the diabetes outpatient clinic at Gentofte Hospital, University of Copenhagen, Denmark or at their general practitioner according to where the patient received regular diabetes care.…”

“…The inclusion and exclusion criteria have been described in detail elsewhere [19]. Briefly, patients over the age of 18 years with T2D and at risk stratification characterized by either hyperglycemia (A1C: 7-9% (53-75 mmol/mol)), hypertension (blood pressure: 130/80-160/90 mm Hg) and/or incipient diabetic complications [20,21].…”

“…Since the Brief FAM-III has not previously been used in a diabetes population, the sample size estimate at 140 participants was based on the power calculation according to the criteria for the randomized controlled trial in which this study is embedded [19].…”

Experience of family function, family involvement, and self‐management in adult patients with type 2 diabetes: A thematic analysis

“…It was part of a larger mixed methods investigation exploring the patient perception of family function as a unique factor regarding diabetes self-management, glycemic control and QoL in adult patients with T2D (Bennich et al, 2018). The study was conducted at one-year follow-up after a randomized controlled trial comparing two diabetes care programs (Munch et al, 2016(Munch et al, , 2019. We used thematic analysis as described by Braun and Clark (Braun & Clarke, 2013) to investigate the experience of family function by people with T2D.…”