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BMC Primary Care
Published in: BMC Primary Care 1/2013

Open Access 01-12-2013 | Research article

Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial

Authors: Iris Tinsel, Anika Buchholz, Werner Vach, Achim Siegel, Thorsten Dürk, Angela Buchholz, Wilhelm Niebling, Karl-Georg Fischer

Published in: BMC Primary Care | Issue 1/2013

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Abstract

Background

Hypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs.

Methods

The study was conducted as a cluster randomised controlled trial (cRCT) with GP practices in Southwest Germany. Each GP practice included patients with treated but uncontrolled hypertension and/or with relevant comorbidity. After baseline assessment (T0) GP practices were randomly allocated into an intervention and a control arm. GPs of the intervention group took part in the SDM training. GPs of the control group treated their patients as usual. The intervention was blinded to the patients. Primary endpoints on patient level were (1) change of patients’ perceived participation (SDM-Q-9) and (2) change of systolic BP (24h-mean). Secondary endpoints were changes of (1) diastolic BP (24h-mean), (2) patients’ knowledge about hypertension, (3) adherence (MARS-D), and (4) cardiovascular risk score (CVR).

Results

In total 1357 patients from 36 general practices were screened for blood pressure control by ambulatory blood pressure monitoring (ABPM). Thereof 1120 patients remained in the study because of uncontrolled (but treated) hypertension and/or a relevant comorbidity. At T0 the intervention group involved 17 GP practices with 552 patients and the control group 19 GP practices with 568 patients. The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints.

Conclusion

The study hypothesis that the SDM training enhanced patients’ perceived participation and lowered their BP could not be confirmed. Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care.

Trial registration

German Clinical Trials Register (DRKS): DRKS00000125
Appendix
Available only for authorised users
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Metadata
Title
Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial
Authors
Iris Tinsel
Anika Buchholz
Werner Vach
Achim Siegel
Thorsten Dürk
Angela Buchholz
Wilhelm Niebling
Karl-Georg Fischer
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2013
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/1471-2296-14-135

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