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073 Comparative effectiveness of patient decision aids vs. encounter decision aids for shared decision making about stroke prevention in patients with atrial fibrillation - a multi-center cluster randomized trial
  1. Angela Fagerlin1,
  2. Geoffrey D Barnes2,
  3. Juan P Brito3,
  4. Kenzie A Cameron4,
  5. Kerri L Cavanaugh5,
  6. Tom Greene1,
  7. Elizabeth A Jackson6,
  8. Victor M Montori3,
  9. Benjamin A Steinberg1,
  10. Daniel M Witt1,
  11. Peter Noseworthy3,
  12. Rod S Passman4,
  13. Preeti Kansal4,
  14. George Crossley5,
  15. Dan M Roden5,
  16. Joshua T Christensen1,
  17. Aubrey Jones1,
  18. Anthony Ariotti1,
  19. Tyler Bardsley1,
  20. Chaorong Wu1,
  21. Elissa Ozanne1,
  22. Writing Group Step-Up1
  1. 1University of Utah – United States of America
  2. 2University of Michigan – United States of America
  3. 3Mayo Clinic – United States of America
  4. 4Northwestern University – United States of America
  5. 5Vanderbilt University – United States of America
  6. 6University of Alabama at Birmingham – United States of America


Background Guidelines recommend shared decision making (SDM) for anticoagulation selection in patients with atrial fibrillation (AF). Decision aids (DAs) are tools that facilitate SDM. However, the comparative effectiveness between an encounter decision aid (EDA) and a pre- encounter patient decision aid (PDA) remains unexplored. Our objective was to assess the comparative effectiveness of these two DA types on SDM during clinical encounters discussing stroke prevention strategies for patients with AF.

Methods We conducted a cluster randomized multi-center trial in patients with AF comparing usual care (no DA) vs. one DA (EDA or PDA) or both DAs. Using a 2×2 factorial design, eligible clinicians and patients were randomized independently, yielding four study arms. Clinicians were randomized to use the EDA or usual care for all study visits, and patients were randomized to use or not use the PDA. The three co-primary outcome domains were: (1) quality of SDM (2) patient decision making, and (3) patient knowledge. Secondary endpoints included anticoagulation treatment and drug choice, and adherence with anticoagulation therapy.

Results Between December 2020 and July 2023, investigators in 6 U.S. healthcare systems enrolled 1118 patients (mean age 70, 63% male, 90% White) and 156 clinicians. Data collection is complete, and data will be cleaned and ready for analysis as of February 1. We will test the impact of each tool on shared decision making (measured by OPTION12), patient knowledge, decisional conflict, decisional regret, anticoagulation-specific decisions (whether and how to anticoagulate [warfarin or direct oral anticoagulant]), and measures of anticoagulation use (initiation, persistence). We will explore interactions with tool, patient and clinical characteristics across each of these outcome measures.

Discussion This is the one of the first randomized trials examining the comparative effectiveness of EDAs and PDAs on SDM in clinical medicine.

Conclusions Forthcoming once data analysis is complete (prior to conference).

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