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

Susanne Buhse, Ingrid Mühlhauser, Tabitha Heller, Nadine Kuniss, Ulrich Alfons Müller, Jürgen Kasper, Thomas Lehmann, Matthias Lenz, Susanne Buhse, Ingrid Mühlhauser, Tabitha Heller, Nadine Kuniss, Ulrich Alfons Müller, Jürgen Kasper, Thomas Lehmann, Matthias Lenz

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.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Study flow (ISDM, informed shared decision-making).

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
    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
    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
    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
    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/
    1. Sheridan SL, Draeger LB, Pignone MP et al. . A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies. BMC Health Serv Res 2011;11:331 10.1186/1472-6963-11-331
    1. Inzucchi SE, Bergenstal RM, Buse JB et al. . Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012;55:1577–96. 10.1007/s00125-012-2534-0
    1. German Medical Association, National Association of Statutory Health Insurance Physicians, Association of the Scientific Medical Societies. National disease management guidelines programme: typ-2-diabetes mellitus—therapy 2013. (accessed 27 May 2015).
    1. Lenz M, Kasper J, Mühlhauser I. Searching for diabetes decision aids and related background information. Diabet Med 2006;23:912–16. 10.1111/j.1464-5491.2006.01917.x
    1. Lenz M, Kasper J, Mühlhauser I. Development of a patient decision aid for prevention of myocardial infarction in type 2 diabetes—rationale, design and pilot testing. Psychosoc Med 2009;6:Doc05 10.3205/psm000061
    1. Montori VM, Breslin M, Maleska M et al. . Creating a conversation: insights from the development of a decision aid. PLoS Med 2007;4:e233 10.1371/journal.pmed.0040233
    1. Health Dialog. Living with diabetes. Making lifestyle changes to last a lifetime. Boston: Foundation for Informed Medical Decision Making, 2007.
    1. Denig P, Schuling J, Haaijer-Ruskamp F et al. . Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial. BMJ 2014;349:g5651 10.1136/bmj.g5651
    1. Buhse S, Heller T, Kasper J et al. . An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial. BMC Fam Pract 2013;14:155 10.1186/1471-2296-14-155
    1. Kronsbein P, Jörgens V, Mühlhauser I et al. . Evaluation of a structured treatment and teaching programme on non-insulin-dependent diabetes. Lancet 1988;2:1407–11. 10.1016/S0140-6736(88)90595-8
    1. Craig P, Dieppe P, Macintyre S et al. . Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008;337:a1655 10.1136/bmj.a1655
    1. Lenz M, Mühlhauser I [Cardiovascular risk assessment for informed decision making. Validity of prediction tools]. Med Klin (Munich) 2004;99:651–61. 10.1007/s00063-004-1097-3
    1. Lenz M, Mühlhauser I. Decision aids in diabetes. In: Edwards A, Elwyn G, eds. Shared decision making in health care: achieving evidence based patient choice. 2nd edn Oxford: Oxford University Press, 2009;285–95.
    1. Busse R. Disease management programs in Germany's statutory health insurance system. Health Aff 2004;23:56–67. 10.1377/hlthaff.23.3.56
    1. German Medical Association, National Association of Statutory Health Insurance Physicians, Association of the Scientific Medical Societies. National guideline type 2 diabetes. Structured educational programmes—long version 2012. (accessed 27 May 2015).
    1. National Kidney Foundation. KDOQI Clinical practice guideline for diabetes and chronic kidney disease: 2012 update. Am J Kidney Dis 2012;60:850–86. 10.1053/j.ajkd.2012.07.005
    1. Lenz M, Steckelberg A, Mühlhauser I. Patient education programmes and decision aids—evaluation of complex interventions. Av Diabetol 2008;24:443–52.
    1. Mühlhauser I, Berger M. Patient education—evaluation of a complex intervention. Diabetologia 2002;45:1723–33. 10.1007/s00125-002-0987-2
    1. Ajzen I. The theory of planned behaviour. Org Behav Hum Decis Process 1991;50:179–211. 10.1016/0749-5978(91)90020-T
    1. Thompson-Leduc P, Clayman ML, Turcotte S et al. . Shared decision-making behaviours in health professionals: a systematic review of studies based on the Theory of Planned Behaviour. Health Expect 2015;18:754–74. 10.1111/hex.12176
    1. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes study (UKPDS) Group. Lancet 1998;352:837–53. 10.1016/S0140-6736(98)07019-6
    1. Vollmer-Rupprecht R. Stress 2013. (accessed 27 May 2015).
    1. Anderson LW, Krathwohl DR. A taxonomy for learning, teaching, and assessing: a revision of bloom's taxonomy of educational objectives. New York: Longman, 2001.
    1. Buhse S, Mühlhauser I, Kuniss N et al. . An informed shared decision making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care: protocol of a cluster randomised, controlled trial. BMC Fam Pract 2015;16:43 10.1186/s12875-015-0257-2
    1. Van Buuren S, Brand JPL, Groothuis-Oudshoorn CGM et al. . Fully conditional specification in multivariate imputation. J Stat Comput Simul 2006;76:1049–64. 10.1080/10629360600810434
    1. Cokely ET, Galesic M, Schulz E et al. . Measuring risk literacy: the Berlin Numeracy Test. Judgm Decis Mak 2012;7:25–47.
    1. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect 2001;4:99–108. 10.1046/j.1369-6513.2001.00140.x
    1. Bellg AJ, Borrelli B, Resnick B et al. . Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol 2004;23:443–51. 10.1037/0278-6133.23.5.443
    1. Kulzer B, Hermanns N, Reinecker H et al. . Effects of self-management training in type 2 diabetes: a randomized, prospective trial. Diabet Med 2007;24:415–23. 10.1111/j.1464-5491.2007.02089.x
    1. Hermanns N, Kulzer B, Maier B et al. . The effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes. Patient Educ Couns 2012;86:226–32. 10.1016/j.pec.2011.05.017
    1. Deakin TA, McShane CE, Cade JE et al. . Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev 2005;(2):CD003417 10.1002/14651858.CD003417.pub2
    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
    1. Stacey D, Légaré F, Col NF et al. . Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014;1:CD001431 10.1002/14651858.CD001431.pub4
    1. Edwards A, Elwyn G. Shared decision making in health care: achieving evidence based patient choice. 2nd edn Oxford: Oxford University Press, 2009.
    1. Bunge M, Mühlhauser I, Steckelberg A. What constitutes evidence-based patient information? Overview of discussed criteria. Patient Educ Couns 2010;78:316–28. 10.1016/j.pec.2009.10.029
    1. Elwyn G, Frosch D, Volandes AE et al. . Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions. Med Decis Making 2010;30:701–11. 10.1177/0272989X10386231
    1. Weymiller AJ, Montori VM, Jones LA et al. . Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med 2007;167:1076–82. 10.1001/archinte.167.10.1076
    1. Mullan RJ, Montori VM, Shah ND et al. . The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med 2009;169:1560–8. 10.1001/archinternmed.2009.293
    1. Mann DM, Ponieman D, Montori VM et al. . The Statin Choice decision aid in primary care: a randomized trial. Patient Educ Couns 2010;80:138–40. 10.1016/j.pec.2009.10.008
    1. Mathers N, Ng CJ, Campbell MJ et al. . Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice. BMJ Open 2012;2:pii: e001469 10.1136/bmjopen-2012-001469
    1. Joseph-Williams N, Elwyn G, Edwards A. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns 2014;94:291–309. 10.1016/j.pec.2013.10.031
    1. Dulon M, Bardehle D, Blettner M. [Assessing social inequality in microcensus data and German national health examination survey]. Gesundheitswesen 2003;65:629–35.

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