title: Impact of effectiveness information format on patient choice of therapy and satisfaction with decisions about chronic disease medication: the "Influence of intervention Methodologies on Patient Choice of Therapy (IMPACT)" cluster-randomised trial in general practice.
abstract: BACKGROUND
  Risk communication is an integral part of shared decision-making in health care. In the context of interventions for chronic diseases it represents a particular challenge for all health practitioners. By using two different quantitative formats to communicate risk level and effectiveness of a cholesterol-lowering drug, we posed the research question: how does the format of risk information influence patients' decisions concerning therapy, patients' satisfaction with the communication as well as confidence in the decision. We hypothesise that patients are less prone to accept therapy when the benefits of long-term intervention are presented in terms of prolongation of life (POL) in months compared to the absolute risk reduction (ARR). We hypothesise that patients presented with POL will be more satisfied with the communication and confident in their decision, suggesting understanding of the time-related term.
  
  
  METHODS
  In 2009 a sample of 328 general practitioners (GPs) in the Region of Southern Denmark was invited to participate in a primary care-based clinical trial among patients making real-life clinical decisions together with their GP. Interested GPs were cluster-randomised to inform patients about cardiovascular disease (CVD) risk and the effectiveness of statin therapy using either POL or ARR. The GPs attended a training session before informing their patients. Before training and after the trial period they received a questionnaire about their attitudes to risk communication and the use of numerical information. Patients' redemptions of statin prescriptions will be registered in a regional prescription database to evaluate a possible association between redemption rates and effectiveness format. The Combined Outcome Measure for Risk Communication And Treatment Decision Making Effectiveness (COMRADE) questionnaire will be used to measure patients' confidence and satisfaction with the risk communication immediately after the conversation with their GPs.
  
  
  CONCLUSIONS
  This randomised clinical trial compares the impact of two effectiveness formats on real-life risk communication between patients and GPs, including affective patient outcomes and actual choices about acceptance of therapy. Though we found difficulties in recruiting GPs, according to the study protocol we have succeeded in engaging sufficient GPs for the trial, enabling us to perform the planned analyses.
authors: Research Unit of General Practice, University of Southern Denmark, Southern Denmark, Denmark. charmsen@health.sdu.dk
authors: Charlotte Gry
authors: CG
authors: Harmsen
authors: Dorte Ejg
authors: DE
authors: Jarbøl
authors: Jørgen
authors: J
authors: Nexøe
authors: Henrik
authors: H
authors: Støvring
authors: Dorte
authors: D
authors: Gyrd-Hansen
authors: Jesper Bo
authors: JB
authors: Nielsen
authors: Adrian
authors: A
authors: Edwards
authors: Ivar Sønbø
authors: IS
authors: Kristiansen
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control; D002755:Choice Behavior; D002908:Chronic Disease / Q000188:drug therapy*; D016000:Cluster Analysis; D003142:Communication; D003718:Denmark; D058005:General Practitioners; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000188:drug therapy; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D018570:Risk Assessment; D011795:Surveys and Questionnaires
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors