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Feedback post: Moderator review and reinstatement processes. Linked Related Hot Network Questions. Question feed. Methods Study design We conducted an open-label cluster randomised controlled trial aiming to implement and evaluate the efficacy of the Diabetes Medication Choice Decision Aid in patients with T2DM in primary and secondary care practices in Greece.
Recruitment of practices Eligible practices were selected based on the ability to participate in the study ie, if they had at least one physician and an additional healthcare professional interested in participating , as well as having an on-site coordinator until completion of the trial.see
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Patient population With the intention of maximising the applicability of our results, we adopted a pragmatic approach by applying broad and inclusive patient eligibility criteria. Sample size Sample size calculation was based on results from the Statin Choice study, a cluster randomised trial that evaluated decisional quality comparing a decision aid to usual care.
Randomisation procedure Eligible practices were matched based on level of care primary or secondary by the study statistician, and were randomly allocated within each pair, using a computer-generated allocation sequence, to either the use of the Diabetes Medication Choice Decision Aid or to usual care.
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Intervention At practices allocated to the intervention arm, clinicians and patients used the Greek version of the Diabetes Medication Choice Decision Aid during the initial clinical encounter. Comparison Patients in practices assigned to the control arm received usual care for T2DM in Greece, without the use of the decision aid. Clinician outcomes The clinician's satisfaction with decision-making was measured by a simple question answered after the index encounter see online supplementary table S4. Statistical analysis We conducted our analysis following the intention-to-treat principle, with the exception of medical adherence and clinical outcomes which were analysed based on completed data available.
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Results Participant flow and characteristics Participant flow is depicted in figure 1. View inline View popup. Clinician outcomes Clinicians in both arms were equally satisfied with the decision-making process table 4. Deviations from the study protocol In the study protocol, we report decisional quality as our primary outcome, defined as decisional conflict measured with a modified item version of the Decisional Conflict Scale. Discussion In this cluster randomised trial, we implemented the Diabetes Medication Choice Decision Aid in primary and secondary care practices across Greece.
Strengths and limitations To the best of our knowledge, this is the first randomised trial to assess a decision aid in patients with T2DM in Greece.
Comparison with other studies The Diabetes Medication Choice Decision Aid has been previously assessed in two cluster randomised trials enrolling rural and suburban primary care practices in the USA. Implications for practice and research There is considerable policy support for shared decision-making for chronic conditions, including T2DM, from many associations, agencies and research groups.
Management of hyperglycemia in type 2 diabetes, Diabetes Care ; Comparative efficacy and safety of antidiabetic drug regimens added to stable and inadequate metformin and thiazolidinedione therapy in type 2 diabetes. Int J Clin Pract ; Efficacy and safety of antihyperglycaemic drug regimens added to metformin and sulphonylurea therapy in type 2 diabetes: Diabet Med ; Lancet ; How does feeling informed relate to being informed? Med Decis Making ; 30 5 Suppl: Medication adherence affects treatment modifications in patients with type 2 diabetes.
The safe and effective use of medicines to enable best possible outcomes. Decision aids for people facing health treatment or screening decisions.
Patient Educ Couns ; The diabetes mellitus medication choice decision aid: Arch Intern Med ; The impact of decision aids to enhance shared decision making for diabetes the DAD study: Shared decision making for patients with type 2 diabetes: Palliat Med ; Value Health ; Helping patients with type 2 diabetes mellitus make treatment decisions: Intra-cluster correlation coefficients in adults with diabetes in primary care practices: Validation of a decisional conflict scale. Design and analysis of cluster randomization trials in health research.
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