An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial

BACKGROUND Lack of patient involvement in decision making has been suggested as one reason for limited treatment success. Concepts such as shared decision making may contribute to high quality healthcare by supporting patients to make informed decisions together with their physicians.A multi-component shared decision making programme on the prevention of heart attack in type 2 diabetes has been developed. It aims at improving the quality of decision-making by providing evidence-based patient information, enhancing patients' knowledge, and supporting them to actively participate in decision-making. In this study the efficacy of the programme is evaluated in the setting of a diabetes clinic. METHODS/DESIGN A single blinded randomised-controlled trial is conducted to compare the shared decision making programme with a control-intervention. The intervention consists of an evidence-based patient decision aid on the prevention of myocardial infarction and a corresponding counselling module provided by diabetes educators. Similar in duration and structure, the control-intervention targets nutrition, sports, and stress coping. A total of 154 patients between 40 and 69 years of age with type 2 diabetes and no previous diagnosis of ischaemic heart disease or stroke are enrolled and allocated either to the intervention or the control-intervention. Primary outcome measure is the patients' knowledge on benefits and harms of heart attack prevention captured by a standardised knowledge test. Key secondary outcome measure is the achievement of treatment goals prioritised by the individual patient. Treatment goals refer to statin taking, HbA1c-, blood pressure levels and smoking status. Outcomes are assessed directly after the counselling and at 6 months follow-up. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods are used to explore intervention fidelity and to gain insight into implementation processes. DISCUSSION Interventions to facilitate evidence-based shared decision making represent an innovative approach in diabetes care. The results of this study will provide information on the efficacy of such a concept in the setting of a diabetes clinic in Germany. TRIAL REGISTRATION ISRCTN84636255.