Abstract
BackgroundInternational and national societies claim a patient centred approach including shared decision making (SDM) in diabetes care. In a previous project, a SDM programme on the prevention of myocardial infarction has been developed. It is aimed at supporting patients with type 2 diabetes to make informed choices on preventive options, to share the decision making process with the health care team, and to improve adherence to the chosen treatment. In this study, the programme will be implemented and evaluated in primary care practices.Methods/DesignA cluster randomised, controlled trial will be conducted to compare the SDM programme with standard care enrolling patients with type 2 diabetes (N = 306) from primary care practices (N = 24). The intervention programme comprises a six hours provider training, a patient decision aid including evidence-based information, a 90 minutes structured teaching session provided by medical assistants, a sheet to document the patients’ individual treatment goals, and a structured consultation with the general practitioner for sharing information, setting treatment goals, and for adapting treatment regimens if necessary. Patients in the control group receive a brief extract of recommendations of the German National Disease Management Guideline on the treatment of patients with type 2 diabetes. Primary outcome measure is adherence to blood pressure treatment and statin treatment at 6 months follow-up. Secondary outcome measures comprise informed choice and the achievement of patients’ treatment goals. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods will be used to explore the implementation processes.DiscussionAt the end of this study, information on the efficacy of the SDM programme in the primary care context will be available. In addition, processes that might interfere with or that might promote a successful implementation will be identified.Trial registrationISRCTN77300204.
Highlights
International and national societies claim a patient centred approach including shared decision making (SDM) in diabetes care
The quality of the Disease Management Programme (DMP) is evaluated by the Central Research Institute of Ambulatory Health Care (ZI) and institutes commissioned by health insurances
The pseudonym list of practices in the Free State of Thuringia is kept under lock at the University Hospital Jena, the list of practices in Hamburg at the Unit of Health Sciences and Education of the University of Hamburg. In this Cluster randomised controlled trail (cRCT), a novel SDM intervention will be compared with usual care in the setting of primary diabetes care
Summary
International and national societies claim a patient centred approach including shared decision making (SDM) in diabetes care. A SDM programme on the prevention of myocardial infarction has been developed. It is aimed at supporting patients with type 2 diabetes to make informed choices on preventive options, to share the decision making process with the health care team, and to improve adherence to the chosen treatment. Patients frequently feel demotivated and overloaded by the plethora of medical prescriptions. This might contribute to poor long-term adherence [3,4] even to the most effective preventive interventions such as blood pressure control [5] and use of statins [6]. Lack of patient involvement in decision making has been suggested as an important reason for weak adherence and limited treatment success [7]
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