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Open Access Study protocol

Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT

Iris Tinsel1*, Anika Buchholz2, Werner Vach3, Achim Siegel1, Thorsten Dürk1, Andreas Loh1, Angela Buchholz4, Wilhelm Niebling1 and Karl-Georg Fischer5

Author affiliations

1 Department of Medicine, Division of General Practice, University Medical Centre Freiburg, Elsässerstr. 2 m, Freiburg, 79110, Germany

2 Clinical Trials Unit, University Medical Centre Freiburg, Elsässerstr. 2, Freiburg, 79110, Germany

3 Institute of Medical Biometry and Medical Informatics, University Medical Centre Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104, Germany

4 Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany

5 Department of Medicine, Division of Nephrology, University Medical Centre Freiburg, Hugstetterstr. 55, Freiburg, 79106, Germany

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Citation and License

BMC Cardiovascular Disorders 2012, 12:73  doi:10.1186/1471-2261-12-73

Published: 11 September 2012

Abstract

Background

Hypertension is one of the key factors causing cardiovascular diseases which make up the most frequent cause of death in industrialised nations. However about 60% of hypertensive patients in Germany treated with antihypertensives do not reach the recommended target blood pressure. The involvement of patients in medical decision making fulfils not only an ethical imperative but, furthermore, has the potential of higher treatment success. One concept to enhance the active role of patients is shared decision making. Until now there exists little information on the effects of shared decision making trainings for general practitioners on patient participation and on lowering blood pressure in hypertensive patients.

Methods/Design

In a cluster-randomised controlled trial 1800 patients receiving antihypertensives will be screened with 24 h ambulatory blood pressure monitoring in their general practitioners’ practices. Only patients who have not reached their blood pressure target (approximately 1200) will remain in the study (T1 – T3). General practitioners of the intervention group will take part in a shared decision making-training after baseline assessment (T0). General practitioners of the control group will treat their patients as usual. Primary endpoints are change of systolic blood pressure and change of patients’ perceived participation. Secondary endpoints are changes of diastolic blood pressure, knowledge, medical adherence and cardiovascular risk. Data analysis will be performed with mixed effects models.

Discussion

The hypothesis underlying this study is that shared decision making, realised by a shared decision making training for general practitioners, activates patients, facilitates patients’ empowerment and contributes to a better hypertension control. This study is the first one that tests this hypothesis with a (cluster-) randomised trial and a large sample size.

Trial registration

WHO International Clinical Trials: http://apps.who.int/trialsearch/Trial.aspx?TrialID=DRKS00000125 webcite

Keywords:
Arterial hypertension; Cardiovascular diseases; Cardiovascular risk; Shared decision making; Educational training; Blood pressure control; Ambulatory blood pressure monitoring; Adherence; Primary care; Family medicine