title: Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial.
abstract: To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece.
  
  
  
  Open-label cluster randomised controlled trial.
  
  
  
  Primary and secondary care practices across Greece.
  
  
  
  5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients).
  
  
  
  Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both consider important when choosing among antihyperglycaemic medications. Patients in the control arm received usual care.
  
  
  
  The primary outcome was patient's level of decisional comfort after the initial clinical encounter. Secondary outcomes included patient's knowledge about type 2 diabetes and medications, and patient's and clinician's satisfaction. Adherence to prescribed antihyperglycaemic medication and change in glycated haemoglobin were assessed at 24 weeks.
  
  
  
  Patients in both arms had similar scores in overall decisional comfort (mean difference between the usual care and decision aid arms -6.9, 95% CI -21.5 to 7.7) and its subscales. Patients' knowledge was high in both arms (mean difference 2.3%, 95% CI -15.7% to 20.4%). Patients and clinicians in both groups were equally satisfied with the decision-making. No significant difference in medication adherence and glycaemic control was found across arms. Clinicians found the decision aid useful and reported that its integration in their daily routine was easy.
  
  
  
  The decision aid was implemented and positively received in the clinical setting in Greece, in line with the patient-centred approach endorsed by current guidelines. However, this trial yielded imprecise results in terms of patient outcomes. Further research is needed to investigate the interaction between the patient and the clinician in order to clarify the association between the use of decision aids and implementation of shared decision-making.
  
  
  
  NCT01861756. Pre-results.
authors.affiliation: Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece.|Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.
authors.forename: Thomas
authors.initials: T
authors.lastname: Karagiannis
authors.affiliation: Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece.|Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.
authors.forename: Aris
authors.initials: A
authors.lastname: Liakos
authors.affiliation: Knowledge and Evaluation Research Unit, Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Megan E
authors.initials: ME
authors.lastname: Branda
authors.affiliation: Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece.
authors.forename: Eleni
authors.initials: E
authors.lastname: Athanasiadou
authors.affiliation: Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece.|Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.
authors.forename: Maria
authors.initials: M
authors.lastname: Mainou
authors.affiliation: Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.
authors.forename: Panagiota
authors.initials: P
authors.lastname: Boura
authors.affiliation: Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynaecology, Aristotle University Thessaloniki, Thessaloniki, Greece.
authors.forename: Dimitrios G
authors.initials: DG
authors.lastname: Goulis
authors.affiliation: Knowledge and Evaluation Research Unit, Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Annie
authors.initials: A
authors.lastname: LeBlanc
authors.affiliation: Knowledge and Evaluation Research Unit, Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Victor M
authors.initials: VM
authors.lastname: Montori
authors.affiliation: Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece.|Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.|Harris Manchester College, University of Oxford, Oxford, UK.
authors.forename: Apostolos
authors.identifier: 0000-0003-0221-4072
authors.initials: A
authors.lastname: Tsapas
mesh_terms: D000328:Adult; D002755:Choice Behavior; D016000:Cluster Analysis; D003657:Decision Making; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006115:Greece / Q000453:epidemiology; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010358:Patient Participation; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011320:Primary Health Care; D063127:Secondary Health Care; D016903:Drug Monitoring
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human
keywords: Cluster randomised trial; Decision aid; Shared decision making; Type 2 diabetes mellitus