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Diabetes and endocrinology
Research
Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial
  1. Thomas Karagiannis1,2,
  2. Aris Liakos1,2,
  3. Megan E Branda3,
  4. Eleni Athanasiadou1,
  5. Maria Mainou1,2,
  6. Panagiota Boura2,
  7. Dimitrios G Goulis4,
  8. Annie LeBlanc5,
  9. Victor M Montori6,
  10. Apostolos Tsapas1,2,7
  1. 1Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece
  2. 2Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece
  3. 3Knowledge and Evaluation Research Unit, Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA
  4. 4Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynaecology, Aristotle University Thessaloniki, Thessaloniki, Greece
  5. 5Knowledge and Evaluation Research Unit, Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA
  6. 6Knowledge and Evaluation Research Unit, Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA
  7. 7Harris Manchester College, University of Oxford, Oxford, UK
  1. Correspondence to Dr Thomas Karagiannis; tkaragian{at}auth.gr

Abstract

Objective To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece.

Design Open-label cluster randomised controlled trial.

Setting Primary and secondary care practices across Greece.

Participants 5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients).

Intervention 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.

Outcome measures 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.

Results 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.

Conclusions 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.

Trial registration number NCT01861756. Pre-results.

  • Shared decision making
  • Type 2 diabetes mellitus
  • Decision aid
  • Cluster randomised trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012185

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    Footnotes

    • Collaborators S Alexiadis, M Benroumpi, T Chatziadamidou, E Giannakopoulos, S Irakleianou, K Kazakos, I Mygdalis, E Pagkalos, D Papazoglou, N Tentolouris.

    • Contributors TK, ALe, VMM and AT led the conception of the study. TK, ALi, ALe, VMM and AT led the design of the study protocol and MEB, MM, PB and DGG participated. AT applied for research funding. TK, MM and AT participated in the translation of the Diabetes Medication Choice Decision Aid and study surveys into Greek. TK, ALi, EA, MM and AT prepared and distributed the study material to participating sites. ALi and EA coordinated the data collection and TK participated. MEB led the statistical analysis and TK participated. All authors participated in the interpretation of the trial data. TK, ALi and AT had full access to the study data, and take responsibility for the integrity of the data and the accuracy of the data analysis. TK, MEB and AT drafted the article and all authors contributed to a critical revision of the manuscript. All authors have approved the final version of the manuscript. TK and AT are the study guarantors.

    • Funding This study was funded by a European Foundation for the Study of Diabetes (EFSD) research programme in patient education supported by an educational grant from AstraZeneca/BMS in 2012.

    • Competing interests None declared.

    • Ethics approval This study was approved by the Bioethics Committee of the Medical School of the Aristotle University of Thessaloniki (meeting no. 3/23-06/2012).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.