title: Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.
  
  
  METHODS
  A two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.
  
  
  CONCLUSIONS
  An individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.
authors.affiliation: Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. yuca@smh.ca.|Department of Medicine, University of Toronto, Toronto, ON, Canada. yuca@smh.ca.|Dalla Lana School of Public Health, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. yuca@smh.ca.
authors.forename: Catherine H
authors.initials: CH
authors.lastname: Yu
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. noah.ivers@utoronto.ca.|Family Practice Health Centre, Women's College Hospital, University of Toronto, 76 Grenville Street, Toronto, ON, M5S 1B3, Canada. noah.ivers@utoronto.ca.|Institute for Health System Solutions and Virtual Care, Women's College Hospital, University of Toronto, 76 Grenville Street, Toronto, ON, M5S 1B3, Canada. noah.ivers@utoronto.ca.
authors.forename: Noah M
authors.initials: NM
authors.lastname: Ivers
authors.affiliation: School of Nursing, University of Ottawa, Ottawa, ON, Canada. dstacey@uottawa.ca.|Clinical Epidemiology Program, Ottawa Hospital Research Institute, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada. dstacey@uottawa.ca.
authors.forename: Dawn
authors.initials: D
authors.lastname: Stacey
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. jeremy.rezmovitz@sunnybrook.ca.|Department of Family and Community Medicine, University of Toronto, Sunnybrook Hospital, Room 101, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada. jeremy.rezmovitz@sunnybrook.ca.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Rezmovitz
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. deanna.telner@utoronto.ca.|Southeast Toronto Family Health Team, Toronto East General Hospital, 833 Coxwell Avenue, East York, ON, M4C 3E8, Canada. deanna.telner@utoronto.ca.
authors.forename: Deanna
authors.initials: D
authors.lastname: Telner
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. kevin.thorpe@utoronto.ca.
authors.forename: Kevin
authors.initials: K
authors.lastname: Thorpe
authors.affiliation: Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. halls@smh.ca.
authors.forename: Susan
authors.initials: S
authors.lastname: Hall
authors.affiliation: Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. settinom@smh.ca.
authors.forename: Marc
authors.initials: M
authors.lastname: Settino
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. david@davidkaplanmd.com.|North York Family Health Team, 703-240 Duncan Mill Road, Toronto, ON, M3B 3S6, Canada. david@davidkaplanmd.com.
authors.forename: David M
authors.initials: DM
authors.lastname: Kaplan
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. michael.coons@utoronto.ca.|Department of Psychology, York University, 4700 Keele Street, Toronto, ON, M3J 1P3, Canada. michael.coons@utoronto.ca.
authors.forename: Michael
authors.initials: M
authors.lastname: Coons
authors.affiliation: Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada. sumeet.sodhi@uhn.ca.|Department of Family and Community Medicine, Toronto Western Hospital, University Health Network, Toronto, ON,, Canada. sumeet.sodhi@uhn.ca.
authors.forename: Sumeet
authors.initials: S
authors.lastname: Sodhi
authors.affiliation: Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. salej@smh.ca.
authors.forename: Joanna
authors.initials: J
authors.lastname: Sale
authors.affiliation: Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. sharon.straus@utoronto.ca.|Department of Medicine, University of Toronto, Toronto, ON, Canada. sharon.straus@utoronto.ca.
authors.forename: Sharon E
authors.initials: SE
authors.lastname: Straus
mesh_terms: D001291:Attitude of Health Personnel; D002908:Chronic Disease; D002985:Clinical Protocols; D015897:Comorbidity; D003220:Conflict, Psychological; D003299:Cooperative Behavior; D003657:Decision Making; D003661:Decision Support Techniques; D003920:Diabetes Mellitus / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D019983:Guideline Adherence; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006801:Humans; D033183:Interdisciplinary Communication; D009864:Ontario / Q000453:epidemiology; D010348:Patient Care Team / Q000592:standards; D010353:Patient Education as Topic; D010865:Pilot Projects; D017410:Practice Guidelines as Topic; D012107:Research Design