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

BMC Family Practice

Study Protocol

Thomas Lehmann¹  Tabitha Heller²  Ulrich Alfons Müller²  Ingrid Mühlhauser³  Matthias Lenz³  Susanne Buhse³  Jürgen Kasper⁴ 

[1] Centre for Clinical Studies, Jena University Hospital, Jena, Germany;Department of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany;Unit of Health Sciences and Education, Hamburg University, Hamburg, Germany;Unit of Health Sciences and Education, Hamburg University, Hamburg, Germany;Institute for Neuroimmunology and Clinical MS Research, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany;Department of Primary Medical Care, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany;

关键词: Diabetes mellitus;    Type 2;    Myocardial infarction;    Primary prevention;    Patient education;    Patient participation;    Decision making;    Evidence-based medicine;   

DOI  :  10.1186/1471-2296-14-155

 received in 2013-10-08, accepted in 2013-10-16,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundLack 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/DesignA 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.DiscussionInterventions 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 registrationISRCTN84636255

【 授权许可】

CC BY   
© Buhse et al.; licensee BioMed Central Ltd. 2013