Table 1.
Anticipated power to detect patient and stakeholder-important outcomes on completion of the trial
| Outcome (n = 884) | Usual Care* | Decision Aid* | Difference | Power |
|---|---|---|---|---|
|
Patient knowledge |
44% (23.3) |
60% (20.9) |
16% (9.5%, 22.5%) |
99% |
|
Patient engagement in the decision-making process (n = 221) |
7.0 (5.5) |
26.3 (8.2) |
19.3 (18.4, 20.2) |
99% |
|
Decisional conflict† |
35.9 (18.9) |
22.3 (21.1) |
13.6 (11.0, 16.2) |
99% |
|
Trust in the physician |
79.3 (19.9) |
83.4 (19.8) |
4.1 (1.5, 6.7) |
86% |
|
Patient satisfaction with the decision made (% agree or strongly agree they are satisfied) |
69.7 (25.6) |
80 (25.6) |
10.3 (4.6%, 16.0%) |
99% |
|
Safety (major adverse cardiovascular events)‡ |
0% |
0% |
0% (−−) |
78% |
|
Proportion of patients admitted for cardiac testing |
77% |
67% |
10% (4.1, 15.9) |
90% |
| Healthcare utilization | 8.3 (0.8) | 7.0 (0.7) | 1.3 (1.2, 1.4) | 99% |
*Estimates were determined from our completed pilot randomized trial [11].
†Lower decisional conflict scores indicate less conflict experienced by patients related to feeling uninformed.
‡Non-inferiority, one-sided test with alpha = 0.05 with a maximum difference of 5%.