title: An informed shared decision making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care: protocol of a cluster randomised, controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN77300204 .
authors.affiliation: Faculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Martin-Luther-King-Platz 6, Hamburg, 20146, Germany. Susanne.Buhse@uni-hamburg.de.
authors.forename: Susanne
authors.initials: S
authors.lastname: Buhse
authors.affiliation: Faculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Martin-Luther-King-Platz 6, Hamburg, 20146, Germany. Ingrid_Muehlhauser@uni-hamburg.de.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Mühlhauser
authors.affiliation: Department of Internal Medicine III, Endocrinology and Metabolic Diseases, University Hospital Jena, Jena, Germany. Nadine.Kuniss@med.uni-jena.de.
authors.forename: Nadine
authors.initials: N
authors.lastname: Kuniss
authors.affiliation: Department of Internal Medicine III, Endocrinology and Metabolic Diseases, University Hospital Jena, Jena, Germany. UA.Mueller@med.uni-jena.de.
authors.forename: Ulrich Alfons
authors.initials: UA
authors.lastname: Müller
authors.affiliation: Centre for Clinical Studies, University Hospital Jena, Jena, Germany. Thomas.Lehmann@med.uni-jena.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lehmann
authors.affiliation: Faculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Martin-Luther-King-Platz 6, Hamburg, 20146, Germany. Katrin.Liethmann@uni-hamburg.de.
authors.forename: Katrin
authors.initials: K
authors.lastname: Liethmann
authors.affiliation: Faculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Martin-Luther-King-Platz 6, Hamburg, 20146, Germany. Matthias.Lenz@uni-hamburg.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Lenz
mesh_terms: D002985:Clinical Protocols; D003657:Decision Making; D003924:Diabetes Mellitus, Type 2; D003925:Diabetic Angiopathies / Q000517:prevention & control*; D019317:Evidence-Based Medicine; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D006973:Hypertension / Q000517:prevention & control; D009203:Myocardial Infarction / Q000517:prevention & control*; D010349:Patient Compliance; D010353:Patient Education as Topic; D011320:Primary Health Care; D011322:Primary Prevention
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors