title: Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Comparative effectiveness research (CER) documents important differences in antidepressants in terms of efficacy, safety, cost, and burden to the patient. Decision aids can adapt this evidence to help patients participate in making informed choices. In turn, antidepressant therapy will more likely reflect patients' values and context, leading to improved adherence and mood outcomes.
  
  
  METHODS
  The objective of this study is to develop the Depression Medication Choice decision aid for use during primary care encounters, and to test its efficacy by conducting a clustered practical randomized trial comparing the decision aid to usual depression care in primary care practices.We will use a novel practice-based, patient-centered approach based on participatory action research that involves a multidisciplinary team of designers, investigators, clinicians, patient representatives, and other stakeholders for the development of the decision aid. We will then conduct a clustered practical randomized trial enrolling clinicians and their patients (n = 300) with moderate to severe depression from rural, suburban and inner city primary care practices (n = 10). The intervention will consist of the use of the depression medication choice decision aid during the clinical encounter. This trial will generate preliminary evidence of the relative impact of the decision aid on patient involvement in decision making, decision making quality, patient knowledge, and 6-month measures of medication adherence and mental health compared to usual depression care.
  
  
  CONCLUSIONS
  Upon completion of the proposed research, we will have developed and evaluated the efficacy of the decision aid depression medication choice as a novel translational tool for CER in depression treatment, engaged patients with depression in their care, and refined the process by which we conduct practice-based trials with limited research footprint.
  
  
  BACKGROUND
  Clinical Trials.gov: NCT01502891.
authors.affiliation: Department of Health Sciences Research, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA. leblanc.annie@mayo.edu.
authors.forename: Annie
authors.initials: A
authors.lastname: LeBlanc
authors.forename: Amy E
authors.initials: AE
authors.lastname: Bodde
authors.forename: Megan E
authors.initials: ME
authors.lastname: Branda
authors.forename: Kathleen J
authors.initials: KJ
authors.lastname: Yost
authors.forename: Jeph
authors.initials: J
authors.lastname: Herrin
authors.forename: Mark D
authors.initials: MD
authors.lastname: Williams
authors.forename: Nilay D
authors.initials: ND
authors.lastname: Shah
authors.forename: Holly Van
authors.initials: HV
authors.lastname: Houten
authors.forename: Kari L
authors.initials: KL
authors.lastname: Ruud
authors.forename: Laurie J
authors.initials: LJ
authors.lastname: Pencille
authors.forename: Victor M
authors.initials: VM
authors.lastname: Montori
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D057186:Comparative Effectiveness Research; D003661:Decision Support Techniques; D003863:Depression / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D055118:Medication Adherence; D008603:Mental Health; D015146:Midwestern United States; D018579:Patient Selection; D018802:Patient-Centered Care; D011320:Primary Health Care; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents