Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial

Abstract

ObjectiveTo evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions.DesignRandomised, single-blinded trial with sham control intervention and follow-up of 6 months.SettingSingle-centre diabetes clinic providing care according to the national disease management programme in Germany.Participants154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke.InterventionsThe 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.Main outcome measuresPrimary 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.Results72 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.ConclusionsThe 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.Trial registration numberISRCTN84636255.

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

“…Three of the PtDAs [31,39,41] were evaluated in multiple studies. One PtDA [41] was used in two RCTs [23,34] as part of a more complex informed shared decision-making intervention, whereas the remaining nine were stand-alone PtDAs. Four PtDAs focused on involving people with Type 2 diabetes in decisions about medication, four focused on prioritizing and setting treatment goals (such as glucose or BP control) or lifestyle goals (such as smoking cessation, healthy eating or physical activity), whereas two PtDAs focused on both.…”

“…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].…”

“…No difference was evident between intervention and control groups in two studies that assessed empowerment in decision-making regarding In the 2015 study of Buhse [34], the PtDA was delivered to the intervention arm before a group teaching session conducted by diabetes educators. No difference was evident between intervention and control groups in two studies that assessed empowerment in decision-making regarding In the 2015 study of Buhse [34], the PtDA was delivered to the intervention arm before a group teaching session conducted by diabetes educators.…”

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

“…In fact, a recent randomised controlled trial on patients with T2DM has demonstrated promising results of an informed shared decision-making programme, including a decision aid, with regard to patients' risk comprehension for myocardial infarction. 38 …”

A Systematic Literature Review of Shared Decision Making in Cancer Care (Preprint)

“…Broadly defined, SDM approaches have been applied in a wide variety of chronic diseases including diabetes, [5][6][7] hypertension, [8,9] cardiovascular disease, [10][11][12] osteoarthritis, [13] asthma, [14] fibromyalgia, [15] and depression. [16,17] A diagnosis of cancer, however, challenges patients with an array of treatment options often far more complex than other chronic diseases.…”