Table 3.
Study Outcomes
Original Consent (n=590) | ePRISM Consent (n=527) | Hospital-Average Odds Ratio (95% CI) | P-value | Median Relative Difference in OR Across Hospitals | |
---|---|---|---|---|---|
Reviewing and Understanding | |||||
Reviewed consent form | 263 (45.4%) | 376 (72.0%) | 2.85 (1.05, 7.72) | 0.04 | 3.20 |
Description of treatments were completely clear* | 59 (25.1%) | 184 (49.3%) | 2.24 (0.88, 5.72) | 0.08 | 2.64 |
Description of complications were completely clear* | 63 (27.2%) | 186 (50.3%) | 2.19 (1.03, 4.70) | 0.04 | 2.00 |
Completely understood the information* | 72 (30.6%) | 194 (52.0%) | 2.14 (1.03, 4.46) | 0.04 | 2.01 |
Consent was easy to read* | 55 (23.5%) | 167 (47.6%) | 2.98 (1.38, 6.45) | 0.01 | 2.04 |
Reading consent did not make me nervous at all* | 148 (62.2%) | 292 (77.0%) | 1.84 (0.88, 3.88) | 0.09 | 1.99 |
Knowledge transfer | |||||
Correctly identified purpose of the procedure | 542 (93.4%) | 509 (97.0%) | 2.17 (1.12, 4.20) | 0.02 | 1.08 |
Correctly identified purpose of balloon | 460 (79.9%) | 457 (87.0%) | 1.86 (1.03, 3.37) | 0.04 | 1.58 |
Correctly identified purpose of stent | 544 (94.3%) | 496 (94.8%) | 0.95 (0.35, 2.57) | 0.89 | 1.53 |
Recalled being told % risk of death | 206 (44.5%) | 299 (70.4%) | 2.79 (0.82, 9.51) | 0.09 | 4.02 |
Recalled being told % risk of bleeding | 177 (39.5%) | 284 (70.0%) | 3.88 (0.79, 19.00) | 0.08 | 6.19 |
Patient Engagement in Shared decision-making | |||||
Who should decide your treatment? | 0.86 (0.57, 1.29) | 0.43 | 1.45 | ||
Doctor alone | 63 (10.8%) | 35 (6.7%) | |||
Mostly the doctor | 93 (15.9%) | 113 (21.6%) | |||
Doctor and patient equally | 325 (55.7%) | 315 (60.1%) | |||
Mostly the patient | 58 (9.9%) | 46 (8.8%) | |||
Patient alone | 45 (7.7%) | 15 (2.9%) | |||
Who decided to use drug eluting or bare metal stent? | 2.13 (1.02, 4.43) | 0.05 | 2.22 | ||
Doctor alone | 411 (71.5%) | 267 (51.8%) | |||
Mostly the doctor | 82 (14.3%) | 123 (23.9%) | |||
Doctor and patient equally | 68 (11.8%) | 108 (21.0%) | |||
Mostly the patient | 6 (1.0%) | 7 (1.4%) | |||
Patient alone | 8 (1.4%) | 10 (1.9%) | |||
Discussed stent type with doctor before treatment | 179 (31.2%) | 300 (57.8%) | 2.71 (1.18, 6.26) | 0.02 | 2.60 |
Denominator restricted to those who reviewed the consent form.