title: Feasibility of a randomized controlled trial to evaluate the impact of decision boxes on shared decision-making processes.
abstract: BACKGROUND
  Decision boxes (DBoxes) are two-page evidence summaries to prepare clinicians for shared decision making (SDM). We sought to assess the feasibility of a clustered Randomized Controlled Trial (RCT) to evaluate their impact.
  
  
  METHODS
  A convenience sample of clinicians (nurses, physicians and residents) from six primary healthcare clinics who received eight DBoxes and rated their interest in the topic and satisfaction. After consultations, their patients rated their involvement in decision-making processes (SDM-Q-9 instrument). We measured clinic and clinician recruitment rates, questionnaire completion rates, patient eligibility rates, and estimated the RCT needed sample size.
  
  
  RESULTS
  Among the 20 family medicine clinics invited to participate in this study, four agreed to participate, giving an overall recruitment rate of 20%. Of 148 clinicians invited to the study, 93 participated (63%). Clinicians rated an interest in the topics ranging 6.4-8.2 out of 10 (with 10 highest) and a satisfaction with DBoxes of 4 or 5 out of 5 (with 5 highest) for 81% DBoxes. For the future RCT, we estimated that a sample size of 320 patients would allow detecting a 9% mean difference in the SDM-Q-9 ratings between our two arms (0.02 ICC; 0.05 significance level; 80% power).
  
  
  CONCLUSIONS
  Clinicians' recruitment and questionnaire completion rates support the feasibility of the planned RCT. The level of interest of participants for the DBox topics, and their level of satisfaction with the Dboxes demonstrate the acceptability of the intervention. Processes to recruit clinics and patients should be optimized.
authors.affiliation: Research Centre for Excellence in Aging, CHU de Quebec, Saint-Sacrement Hospital, 1050 chemin Ste-Foy, Québec, Québec, G1S 4L8, Canada. anik.giguere@fmed.ulaval.ca.|Department of Family and Emergency Medicine, Laval University, Pavillon Ferdinand-Vandry, 1050 avenue de la Medecine, Quebec City, Quebec, G1V 0A6, Canada. anik.giguere@fmed.ulaval.ca.
authors.forename: Anik Mc
authors.initials: AM
authors.lastname: Giguere
authors.affiliation: Department of Family and Emergency Medicine, Research Center of the CHU de Quebec, Saint-Francois d'Assise Hospital, Laval University, 10 rue de l'Espinay, D6-730, Quebec City, QC, G1L 3L5, Canada.
authors.forename: Michel
authors.initials: M
authors.lastname: Labrecque
authors.affiliation: Department of Family and Emergency Medicine, Research Center of the CHU de Quebec, Saint-Francois d'Assise Hospital, Laval University, 10 rue de l'Espinay, D6-730, Quebec City, QC, G1L 3L5, Canada.
authors.forename: France
authors.initials: F
authors.lastname: Légaré
authors.affiliation: Department of Family Medicine, McGill University, Herzl Family Practice Centre, 3755 Cote Sainte Catherine, Montreal, QC H3T 1E2, Canada.
authors.forename: Roland
authors.initials: R
authors.lastname: Grad
authors.affiliation: Department of Family and Emergency Medicine, Laval University, Pavillon Ferdinand-Vandry, 1050 avenue de la Medecine, Quebec City, Quebec, G1V 0A6, Canada.
authors.forename: Michel
authors.initials: M
authors.lastname: Cauchon
authors.affiliation: Department of Family Medicine, McMaster University, 118 Lake Street, St. Catharines, ON, Canada.
authors.forename: Matthew
authors.initials: M
authors.lastname: Greenway
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, CRL-125, Hamilton, ON, L8S 4K1, Canada.|Department of Medicine, DeGroote School of Medicine, McMaster University, 1280 Main Street West, CRL-125, Hamilton, ON, L8S 4K1, Canada.
authors.forename: R Brian
authors.initials: RB
authors.lastname: Haynes
authors.affiliation: Department of Family Medicine, McGill University, 5858 Côte-des-neiges, 3rd Floor, Suite 300, Montreal, QC, H3S 1Z1, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Pluye
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, CRL-125, Hamilton, ON, L8S 4K1, Canada.
authors.forename: Iqra
authors.initials: I
authors.lastname: Syed
authors.affiliation: The University of Toronto, Faculty of Medicine, 1 King's College Circle, Medical Sciences Building (Rm. 2109), Toronto, ON, M5S-1A8, Canada.
authors.forename: Debi
authors.initials: D
authors.lastname: Banerjee
authors.affiliation: Research Centre for Excellence in Aging, CHU de Quebec, Saint-Sacrement Hospital, 1050 chemin Ste-Foy, Québec, Québec, G1S 4L8, Canada.
authors.forename: Pierre-Hugues
authors.initials: PH
authors.lastname: Carmichael
authors.affiliation: Research Centre for Excellence in Aging, CHU de Quebec, Saint-Sacrement Hospital, 1050 chemin Ste-Foy, Québec, Québec, G1S 4L8, Canada.|Department of Family and Emergency Medicine, Laval University, Pavillon Ferdinand-Vandry, 1050 avenue de la Medecine, Quebec City, Quebec, G1V 0A6, Canada.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Martin
mesh_terms: D003657:Decision Making; D020000:Decision Support Systems, Clinical; D003661:Decision Support Techniques; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design