Table 4. Observed Encounter Outcomes.
| Outcome | No. (%) | Effect (95% CI) | Intracluster correlation | ||
|---|---|---|---|---|---|
| Intervention arm (n = 419) | Standard care arm (n = 411) | Clinic | Clinician/clinic | ||
| OPTION12 patient engagement score, mean (SD) | 33.0 (10.8) | 29.1 (13.1) | 4.2 (2.8 to 5.6) | 0.30 | 0.33 |
| Fidelity scorea | |||||
| Mean (SD) | 5.6 (1.4) | 0.2 (0.9) | NA | NA | NA |
| Median (IQR) | 6.0 (6.0-6.0) | 0 | NA | NA | NA |
| Fidelity score components | |||||
| Tool was usedb | 401 (95.7) | 9 (2.2) | NA | NA | NA |
| Tool sections used | |||||
| Current riskc | 399 (95.2) | 9 (2.2) | NA | NA | NA |
| Treated riskd | 389 (92.8) | 8 (1.9) | NA | NA | NA |
| Issuese | 361 (86.2) | 7 (1.7) | NA | NA | NA |
| Bleeding | 367 (87.6) | 320 (77.9) | NA | NA | NA |
| Anticoagulant treatment routine | 373 (89.0) | 306 (74.5) | NA | NA | NA |
| Reversing anticoagulant treatment | 333 (79.5) | 195 (47.4) | NA | NA | NA |
| Cost | 378 (90.2) | 261 (63.5) | NA | NA | NA |
| Diet and/or drug interaction | 345 (82.3) | 233 (56.7) | NA | NA | NA |
| How tool was used | |||||
| Presentationf | 28 (6.7) | 0 | NA | NA | NA |
| Interactiong | 359/401 (89.5) | 9/9 (100)h | NA | NA | NA |
| Discussion was led by patient priorityi | 53 (12.7) | 29 (7.1) | 2.0 (1.3 to 3.2)j | 0 | 0.44 |
| Duration of encounter, mean (SD), min | 32 (16) | 31 (17) | 1.1 (−0.3 to 2.5)k | 0.08 | 0.63 |
Abbreviations: IQR, interquartile range; NA, not applicable; OPTION12, Observing Patient Involvement in Decision Making 12-item scale.
Fidelity score range, 0 to 7, with higher scores indicating greater fidelity.
Clear visual and/or contextual evidence indicated that the tool was used by the clinician (1 point possible).
A risk calculator was used to assess the patient’s current risk (1 point possible).
A risk calculator was used to assess the patient’s future risk after anticoagulant treatment (1 point possible).
Issue cards were presented to the patient (1 point possible).
The tool was presented to the patient without interaction (1 point possible).
The clinician interacted with the patient while using the tool to aid decision-making (2 points possible).
Contamination occurred owing to the use of the SDM tool in the standard care arm.
The discussion first addressed the issue of greatest salience (ie, the highest priority) to the patient.
Relative risk. Adjusted by treatment arm, with the random effect of clinic and clinician.
Mean difference between the intervention and standard care arms.