title: Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, Division of General Practice, University Medical Centre Freiburg, Elsässerstr, 2 m, Freiburg, 79110, Germany. iris.tinsel@uniklinik-freiburg.de
authors.forename: Iris
authors.initials: I
authors.lastname: Tinsel
authors.forename: Anika
authors.initials: A
authors.lastname: Buchholz
authors.forename: Werner
authors.initials: W
authors.lastname: Vach
authors.forename: Achim
authors.initials: A
authors.lastname: Siegel
authors.forename: Thorsten
authors.initials: T
authors.lastname: Dürk
authors.forename: Andreas
authors.initials: A
authors.lastname: Loh
authors.forename: Angela
authors.initials: A
authors.lastname: Buchholz
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Niebling
authors.forename: Karl-Georg
authors.initials: KG
authors.lastname: Fischer
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001291:Attitude of Health Personnel; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002318:Cardiovascular Diseases / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D002755:Choice Behavior; D003142:Communication; D058006:General Practice; D058005:General Practitioners / Q000193:education* / Q000523:psychology; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D055118:Medication Adherence; D010353:Patient Education as Topic; D010358:Patient Participation; D010817:Physician-Patient Relations; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents