چکیده (انگلیسی):

Background:International 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/Design:A 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.
Discussion:At 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 registration:ISRCTN77300204.