title: Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict.
abstract: BACKGROUND
  Patients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification. Intensification decisions can be difficult because of many available options and their many benefits and risks. The American Diabetes Association recommends patient-centered, evidence-based tools supporting shared decision-making between patients and clinicians. We developed a patient decision aid (PDA) targeting decisions about treatment intensification for T2DM. Our objective was to determine the effectiveness of this PDA for patients with T2DM on metformin who require treatment intensification.
  
  
  METHODS
  This study was a pragmatic randomized controlled trial conducted in 27 US primary care and endocrinology clinics. Subjects were English-speaking adults with T2DM receiving metformin with persistent hyperglycemia who were recommended to consider medication intensification. Subjects were randomized to receive either the PDA or usual care (UC). Main outcome measures were change in knowledge, decisional self-efficacy, and decisional conflict.
  
  
  RESULTS
  Of 225 subjects enrolled, 114 were randomized to the PDA and 111 to UC. Mean [SD] age was 52 [1] years, time since T2DM diagnosis was 6 [+/-6] years, 45.3% were male, and most (55.5%) were non-Caucasian. Compared to UC, PDA users had significantly larger knowledge gains (35.0% [22.3] vs 9.9% [22.2]; P < 0.0001) and larger improvements in self-efficacy (3.7 [16.7] vs-3.9 [19.2]; P < 0.0001) and decisional conflict (-22.2 [20.6] vs-7.5 [16.6]; P < 0.0001).
  
  
  CONCLUSIONS
  The PDA resulted in substantial and significant improvements in knowledge, decisional conflict and decisional self-efficacy. Decisional conflict scores after PDA use were within the range that correlates with effective decision-making. This PDA has the potential to facilitate shared-decision-making for patients with T2DM.
  
  
  BACKGROUND
  NCT02110979.
authors.affiliation: Janssen Scientific Affairs, LLC, Raritan, NJ, USA. RBailey5@its.jnj.com.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Bailey
authors.affiliation: Janssen Scientific Affairs, LLC, Raritan, NJ, USA. mpfeifer@its.jnj.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Pfeifer
authors.affiliation: EPI-Q Inc, 1315 W 22nd Street, Suite 410, Oakbrook, IL, 60523, USA. alicia.shillington@epi-q.com.
authors.forename: Alicia C
authors.initials: AC
authors.lastname: Shillington
authors.affiliation: EPI-Q Inc, 1315 W 22nd Street, Suite 410, Oakbrook, IL, 60523, USA. qing.harshaw@epi-q.com.
authors.forename: Qing
authors.initials: Q
authors.lastname: Harshaw
authors.affiliation: Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA. mfunnell@med.umich.edu.
authors.forename: Martha M
authors.initials: MM
authors.lastname: Funnell
authors.affiliation: Family Medicine Specialists, Grand Rapids, MI, USA. jvwmd@yahoo.com.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: VanWingen
authors.affiliation: Five Islands Consulting, Georgetown, ME, USA. nananda@sdmresources.info.
authors.forename: Nanada
authors.initials: N
authors.lastname: Col
mesh_terms: D000328:Adult; D000368:Aged; D003220:Conflict, Psychological; D003657:Decision Making; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology* / Q000628:therapy; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology* / Q000706:statistics & numerical data; D011320:Primary Health Care; D020377:Self Efficacy; D014481:United States / Q000453:epidemiology