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Randomized Controlled Trial
. 2018 Dec 14;8(12):e024004.
doi: 10.1136/bmjopen-2018-024004.

Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial

Susanne Buhse  1 , Nadine Kuniss  2   3 , Kathrin Liethmann  1   4 , Ulrich Alfons Müller  2   3 , Thomas Lehmann  5 , Ingrid Mühlhauser  1
Affiliations
Randomized Controlled Trial

Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial

Susanne Buhse et al. BMJ Open. .

Erratum in

Abstract

Objective: To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting.

Design: Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data.

Setting: 22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes.

Participants: 279 of 363 eligible patients without myocardial infarction or stroke.

Interventions: The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care.

Primary and secondary outcome measures: Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors.

Results: ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%.

Conclusions: The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable.

Trial registration number: ISRCTN77300204; Results.

Keywords: decision support techniques; diabetes mellitus, Type 2; health educators; health knowledge, attitudes, practice; patient education as topic; primary care.

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Conflict of interest statement

Competing interests: NK reports grant from the Diabetes Centre Thuringia during the conduct of the study.

Figures

Figure 1
Figure 1
Study flow chart. GP, general practitioner; ISDM-P, informed shared decision-making programme; T1, directly after counselling or usual care; T2, 6-month follow-up.
See this image and copyright information in PMC

References

    1. German Medical Association, National Association of Statutory Health Insurance Physicians, Association of the Scientific Medical Societies. Nationale VersorgungsLeitlinie Therapie des Typ-2-Diabetes – Langfassung. 2013. http://www.leitlinien.de/nvl/diabetes/therapie (Accessed 19 Mar 2018).
    1. Inzucchi SE, Bergenstal RM, Buse JB, et al. . Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015;38:140–9. 10.2337/dc14-2441 - DOI - PubMed
    1. Rutten G, Alzaid A. Person-centred type 2 diabetes care: time for a paradigm shift. Lancet Diabetes Endocrinol 2018;6 10.1016/S2213-8587(17)30193-6 - DOI - PubMed
    1. Rodriguez-Gutierrez R, Gionfriddo MR, Ospina NS, et al. . Shared decision making in endocrinology: present and future directions. Lancet Diabetes Endocrinol 2016;4:706–16. 10.1016/S2213-8587(15)00468-4 - DOI - PubMed
    1. Joseph-Williams N, Lloyd A, Edwards A, et al. . Implementing shared decision making in the NHS: lessons from the MAGIC programme. BMJ 2017;357:j1744 10.1136/bmj.j1744 - DOI - PMC - PubMed

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