title: Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  German Clinical Trials Register (DRKS): DRKS00000125.
authors.affiliation: Department of Medicine, Division of General Practice, University Medical Centre Freiburg, Elsässerstr 2m, 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: 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: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D018660:Blood Pressure Monitoring, Ambulatory; D002318:Cardiovascular Diseases; D003142:Communication; D003657:Decision Making; D005260:Female; D058006:General Practice / Q000193:education* / Q000379:methods; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010353:Patient Education as Topic; D010358:Patient Participation / Q000379:methods*; D010817:Physician-Patient Relations; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents
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