Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Nov 13;5(11):e009116.
doi: 10.1136/bmjopen-2015-009116.

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

Susanne Buhse  1 , Ingrid Mühlhauser  1 , Tabitha Heller  2 , Nadine Kuniss  2 , Ulrich Alfons Müller  2 , Jürgen Kasper  3 , Thomas Lehmann  4 , Matthias Lenz  1
Affiliations
Randomized Controlled Trial

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

Susanne Buhse et al. BMJ Open. .

Abstract

Objective: To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions.

Design: Randomised, single-blinded trial with sham control intervention and follow-up of 6 months.

Setting: Single-centre diabetes clinic providing care according to the national disease management programme in Germany.

Participants: 154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke.

Interventions: The 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 measures: Primary 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.

Results: 72 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.

Conclusions: The 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 number: ISRCTN84636255.

Keywords: MEDICAL EDUCATION & TRAINING.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study flow (ISDM, informed shared decision-making).
See this image and copyright information in PMC

References

    1. Gerstein HC, Miller ME, Byington RP et al. . Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545–59. 10.1056/NEJMoa0802743 - DOI - PMC - PubMed
    1. Schedlbauer A, Davies P, Fahey T. Interventions to improve adherence to lipid lowering medication. Cochrane Database Syst Rev 2010;(3):CD004371 10.1002/14651858.CD004371.pub3 - DOI - PubMed
    1. Nieuwlaat R, Wilczynski N, Navarro T et al. . Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014;11:CD000011 10.1002/14651858.CD000011.pub4 - DOI - PMC - PubMed
    1. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ 1998;317:703–13. 10.1136/bmj.317.7160.703 - DOI - PMC - PubMed
    1. Costa J, Borges M, David C et al. . Efficacy of lipid lowering drug treatment for diabetic and non-diabetic patients: meta-analysis of randomised controlled trials. BMJ 2006;332:1115–24. 10.1136/bmj.38793.468449.AE - DOI - PMC - PubMed

Publication types

Substances

Associated data