Abstract
Objective: To evaluate the effectiveness of multiple decision aid strategies in promoting high quality shared decision making for prevention of stroke in patients with non-valvular atrial fibrillation. Design: Cluster randomized controlled trial. Setting: Six academic medical centers in the United States. Participants: Patient participants were aged ≥18 with a diagnosis of non-valvular atrial fibrillation, at risk for stroke (CHA2DS2-VASc ≥1 for men, ≥2 for women), and scheduled for a clinical appointment to discuss stroke prevention strategies. Participating clinicians were those who manage stroke prevention strategies for participating patients. Intervention: Patients were randomized to use a patient decision aid or usual care; clinicians were randomized to use an encounter decision aid or usual care with all participating patients. Main outcome measures: Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict. Results: 1117 participants across six sites were included in the analysis. Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients' knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients' decisional conflict (adjusted mean difference -6.3 (95% CI -9.6 to -3.1; P<0.001). Statistically significant improvements were also observed with the encounter decision aid alone versus usual care for all three outcomes and with the patient decision aid alone versus usual care for quality of shared decision making and knowledge. No important differences were observed in treatment choices for stroke prevention or in participants' satisfaction. No statistically significant difference in the length of visit across study groups was detected. Conclusion: Patients who received any decision aid (encounter decision aid, patient decision aid, or both) had lower decisional conflict, better shared decision making, and greater knowledge than those receiving no decision aid, except for the effect of the patient decision aid on decisional conflict, which did not reach statistical significance. The study establishes that use of either pre-visit or in-visit decision aids individually or in combination is advantageous compared with usual care.
| Original language | English (US) |
|---|---|
| Article number | e079976 |
| Journal | BMJ |
| DOIs | |
| State | Accepted/In press - 2025 |
Funding
Funding: The American Heart Association (AHA) and the Patient-Centered Outcomes Research Institute (PCORI) funded the trial (18SFRN34230142). The AHA had no role in considering the study design or in the collection, analysis, or interpretation of data, the writing of the report, or the decision to submit the article for publication. PCORI approved the study design but had no role in the collection, analysis, or interpretation of data, the writing of the report, or the decision to submit the article for publication. All researchers had independence from the funders and all authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data. Northwestern University Feinberg School of Medicine study staff is supported by an AHA SFRN grant (18SFRN34250013) to RSP. Vanderbilt University Medical Center study staff is supported by an AHA SFRN grant (18SFRN34110369/201) to DMR. Research reported in this publication was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health under award numbers UM1TR004409, UL1TR001422, and 5UL1TR002243-03. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
ASJC Scopus subject areas
- General Medicine