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Open Access Highly Accessed Study protocol

Improvement of primary health care of patients with poorly regulated diabetes mellitus type 2 using shared decision-making – the DEBATE trial

Eva Drewelow1*, Anja Wollny1, Michael Pentzek2, Janine Immecke2, Sarah Lambrecht2, Stefan Wilm23, Iris Schluckebier3, Susanne Löscher3, Karl Wegscheider4 and Attila Altiner1

Author Affiliations

1 Rostock University Medical Center, Rostock, Germany

2 Institute of General Practice, University of Düsseldorf, Düsseldorf, Germany

3 Institute of General Practice and Family Medicine, University Witten/Herdecke, Herdecke, Germany

4 Department of Medical Biometry and Epidemiology, University Medical Center Hamburg, Hamburg, Germany

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BMC Family Practice 2012, 13:88  doi:10.1186/1471-2296-13-88

Published: 22 August 2012

Abstract

Background

Since 2004, a national Disease Management Program (DMP) has been implemented in Germany, which includes educational measures aimed at patients with type-2 diabetes (T2D). However, about 15-20% of T2D patients remain in poor metabolic control. Qualitative research shows that one reason for this might be an increasing frustration of general practitioners (GPs) with the management of their poorly regulated T2D patients over time. We aim at approaching this problem by improving the GP-patient-communication and fostering shared decision-making.

Methods/Design

An educative intervention will be tested within a multi-centred cluster-randomized controlled trial (RCT) in Germany. We include 20 GPs in three regions. Each of the 60 GPs will recruit about 13 patients meeting the inclusion criteria (total of 780 patients). GPs allocated to the intervention group will receive a peer-visit from a specifically trained GP-colleague who will motivate them to apply patient-centred communication techniques including patient-centred decision aids. GPs allocated to the control group will not take part in any intervention program, but will provide care as usual to their patients. The primary inclusion criterion for patients at the time of the recruitment is an HbA1c-level of over 8.0. Primary outcome is the change of HbA1c at 6, 12, 18, and 24 months compared to HbA1c at baseline. Secondary outcomes include patient’s participation in the process of shared decision-making and quality of life.

Discussion

If this intervention proves to be effective it may be integrated into the existing Disease Management Program for T2D in Germany.

Keywords:
Diabetes mellitus type 2; Shared decision-making; Primary care; Randomised controlled trial