Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial

Abstract

ObjectiveTo assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece.DesignOpen-label cluster randomised controlled trial.SettingPrimary and secondary care practices across Greece.Participants5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients).InterventionClinicians 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 measuresThe 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.ResultsPatients 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.ConclusionsThe 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 numberNCT01861756. Pre-results.

Decision aids for people with Type 2 diabetes mellitus: an effectiveness rapid review and meta‐analysis

“…When synthesizing data for five trials, we did not detect any difference between use of PtDAs and usual care in terms of self-reported medication adherence (RR 1.06, 95% CI 0.96 to 1.17, I 2 = 38%) (Fig. Moreover, three studies used pharmacy records to measure adherence to medication prescription and reported results either as a dichotomous [22] or a continuous outcome [27,29], whereas one study assessed adherence to anti-hypertensive or statin therapy using both pharmacy records and self-reported uptake after 6 months [23]. Moreover, three studies used pharmacy records to measure adherence to medication prescription and reported results either as a dichotomous [22] or a continuous outcome [27,29], whereas one study assessed adherence to anti-hypertensive or statin therapy using both pharmacy records and self-reported uptake after 6 months [23].…”

“…In one study, risk of bias assessment was based only on data presented in a conference abstract without contacting the corresponding authors [23]. Overall, eight studies were considered low risk [22,24,28,29,31,[34][35][36], four raised some concerns [23,30,33,37] and three studies were deemed at high risk of bias [25,27,38] due to concerns about the randomization process [25], high attrition rate [38] and inclusion of a participating practice after randomization [27].…”

“…Eleven studies [22,25,[27][28][29][30][31]33,[36][37][38] evaluating seven PtDAs assessed decision quality using the Decisional Conflict Scale (DCS), a validated instrument measuring uncertainty in health-related decision-making [45]. Eleven studies [22,25,[27][28][29][30][31]33,[36][37][38] evaluating seven PtDAs assessed decision quality using the Decisional Conflict Scale (DCS), a validated instrument measuring uncertainty in health-related decision-making [45].…”

“…Data on HbA 1c value at trial endpoint were available in six studies [24,[27][28][29]34,36]. We conducted a meta-analysis with four trials that reported HbA 1c values at endpoint.…”

“…In three studies, clinicians that used the Diabetes Medication Choice decision aid within the consultation, considered it helpful, easy to use and expressed their desire to use it again in the future [22,27,29]. In three studies, clinicians that used the Diabetes Medication Choice decision aid within the consultation, considered it helpful, easy to use and expressed their desire to use it again in the future [22,27,29].…”