Table 3.
Primary and Secondary Outcomes
| Month 1 | Month 6 | |||||
|---|---|---|---|---|---|---|
| Usual care (N=506) | Tool intervention (N=495) | P value | Usual care (N=506) | Tool intervention (N=495) | P value | |
| DCS | 0.007* | 0.06 | ||||
| n (%) | 482 (95) | 461 (93) | 455 (90) | 440 (89) | ||
| Median (min, max) | 16.4 (0, 89.1) | 9.4 (0, 81.3) | 10.9 (0, 90.6) | 6.2 (0, 81.3) | ||
| DRS | 0.078† | 0.35 | ||||
| n (%) | 482 (95) | 461 (93) | 454 (90) | 440 (89) | ||
| Median (min, max) | 10.0 (0, 90.0) | 5.0 (0, 80.0) | 5.0 (0, 75.0) | 5.0 (0, 100) | ||
| Weighted DCS and DRS composite score | 0.0009† | 0.043 | ||||
| Preparation for decision making | <0.0001 | <0.0001 | ||||
| n (%) | 482 (95) | 461 (93) | 454 (90) | 440 (89) | ||
| Median (min, max) | 72.5 (0, 100) | 82.5 (0, 100) | 75.0 (0, 100) | 87.5 (0, 100) | ||
| Change of AF knowledge from baseline | 0.009 | 0.007 | ||||
| n (%) | 481 (95) | 461 (93) | 454 (90) | 440 (89) | ||
| Median (min, max) | 0.0 (−4.0, 7.0) | 1.0 (−4.0, 6.0) | 0.0 (−4.0, 7.0) | 1.0 (−4.0, 6.0) | ||
AF indicates atrial fibrillation; DCS, Decision Conflict Scale; and DRS, Decision Regret Scale.
*
Primary end point.
†
Key secondary end points: P values were adjustment for 2 end points using the Holm–Bonferroni method.