title: Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial.
abstract: OBJECTIVE
  To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions.
  
  
  METHODS
  Randomised, single-blinded trial with sham control intervention and follow-up of 6 months.
  
  
  METHODS
  Single-centre diabetes clinic providing care according to the national disease management programme in Germany.
  
  
  METHODS
  154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke.
  
  
  METHODS
  The ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues.
  
  
  METHODS
  Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity.
  
  
  RESULTS
  72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0-12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0-6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups.
  
  
  CONCLUSIONS
  The ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making.
  
  
  BACKGROUND
  ISRCTN84636255.
authors.affiliation: Faculty of Mathematics, Informatics and Natural Sciences, Unit of Health Sciences and Education, University of Hamburg, Hamburg, Germany.
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, Hamburg, Germany.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Mühlhauser
authors.affiliation: Department of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
authors.forename: Tabitha
authors.initials: T
authors.lastname: Heller
authors.affiliation: Department of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
authors.forename: Nadine
authors.initials: N
authors.lastname: Kuniss
authors.affiliation: Department of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany.
authors.forename: Ulrich Alfons
authors.initials: UA
authors.lastname: Müller
authors.affiliation: Faculty of Health Sciences, Department of Health and Caring Sciences, University of Tromsø, Tromsø, Norway.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Kasper
authors.affiliation: Jena University Hospital, Centre for Clinical Studies, Jena, Germany.
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, Hamburg, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Lenz
mesh_terms: D000368:Aged; D001794:Blood Pressure; D003657:Decision Making; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005260:Female; D005858:Germany; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control*; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic / Q000379:methods*; D020521:Stroke / Q000517:prevention & control*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: MEDICAL EDUCATION & TRAINING