Quantitative patient measuresa | Enrollment (visit 1) | Intervention | Medical encounter (visit 2) | Follow-up (visit 3) |
---|---|---|---|---|
Timepoint | (− 7 to − 60 days before visit 2) | (After enrollment and before visit 2) | (appt. day) | (90–105 days after visit 2) |
Approximate time to complete | 15 to 30 min | 30 to 45 min | 60 min | 15 to 20 min |
Enrollment: | ||||
 Eligibility screening | X |  |  |  |
 Invitation to join study | X |  |  |  |
 Informed consent | X |  |  |  |
 HIPAA authorization | X |  |  |  |
 Baseline | X |  |  |  |
 Allocation (randomization) | X |  |  |  |
Intervention | ||||
 Decision-aid (training) |  | X |  |  |
Assessments | ||||
 Baseline | ||||
  Demographics | X |  |  |  |
  Health literacy | X |  |  |  |
Primary outcomes | ||||
 OPTION Scale [10] |  |  | X |  |
 Shared Decision Making-patient version [11] |  |  | X |  |
Secondary outcomes | ||||
 Prostate Cancer Knowledge [13] | X | X |  | X |
 Decisional Confidence [14] | X |  |  | X |
 Satisfaction with Decision [15] | X |  |  | X |
 Decisional Self-efficacy [16] | X |  | X |  |
 Intention-to-screen [17] | X | X | X | X |
 PSA screening test ordersb | X |  | X | X |
 Actual receipt of PSA testb | X |  | X | X |
Tertiary outcomes | ||||
 Acceptability and application of intervention (decision-aid) |  | X |  |  |
 Acceptability of study procedures, patient version [18] |  |  |  | X |