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A Randomized Controlled Trial

Malcolm Man-Son-Hing, MD, MSc; Andreas Laupacis, MD, MSc; Annette M. O'Connor, RN, PhD; Jennifer Biggs, RN; Elizabeth Drake, BA, MHA; Elizabeth Yetisir, MSc; Robert G. Hart, MD; for the Stroke Prevention in Atrial Fibrillation Investigators

JAMA. 1999;282:737-743.

Context  Decision aids are tools designed to help patients participate in the clinical decision-making process.

Objective  To determine whether use of an audiobooklet (AB) decision aid explaining the results of a clinical trial affected the decision-making process of study participants.

Design  Randomized controlled trial conducted from May 1997 to April 1998.

Setting  Fourteen centers that participated in the Stroke Prevention in Atrial Fibrillation (SPAF) III trial.

Participants  A total of 287 patients from the SPAF III aspirin cohort study, in which patients with atrial fibrillation and a relatively low risk of stroke received 325 mg/d of aspirin and were followed up for a mean of 2 years.

Intervention  At the end of SPAF III, participants were randomized to be informed of the study results with usual care plus use of an AB (AB group) vs usual care alone (control group). The AB included pertinent information to help patients decide whether to continue taking aspirin or switch to warfarin.

Main Outcome Measures  Patients' ability to make choices regarding antithrombotic therapy, and 6-month adherence to these decisions. Their knowledge, expectations, decisional conflict (the amount of uncertainty about the course of action to take), and satisfaction with the decision-making process were also measured.

Results  More patients in the AB group made a choice about antithrombotic therapy than in the control group (99% vs 94%; P=.02). Patients in the AB group were more knowledgeable and had more realistic expectations about the risk of stroke and hemorrhage (in the AB group, 53%-80% correctly estimated different risks; in the control group, 16%-28% gave correct estimates). Decisional conflict and satisfaction were similar for the 2 groups. After 6 months, a similar percentage of patients were still taking their initial choice of antithrombotic therapy (95% vs 93%; P=.44).

Conclusions  For patients with atrial fibrillation who had participated in a major clinical trial, the use of an AB decision aid improved their understanding of the benefits and risks associated with different treatment options and helped them make definitive choices about which therapy to take. Further studies are necessary to evaluate the acceptability and impact of decision aids in other clinical settings.

Author Affiliations: Clinical Epidemiology Unit, Loeb Health Research Institute (Drs Man-Son-Hing, Laupacis, and O'Connor and Mss Biggs, Drake, and Yetisir), Geriatric Assessment Unit (Dr Man-Son-Hing), Ottawa Hospital, Ottawa, Ontario; Department of Medicine (Drs Man-Son-Hing and Laupacis), School of Nursing (Dr O'Connor), University of Ottawa; and Department of Medicine (Neurology), University of Texas, San Antonio (Dr Hart).

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