Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01232621 | The Approach Study | PHASE2 | COMPLETED | 138 | — | — | Jul 1, 2011 | Nov 1, 2012 | Jan 7, 2013 | 1 | Canada |
Feasibility of the pilot study will be assessed by the following: 1. We expect that (i) ≤ 15% of physician introductions will be missed due to lack of physician availability (physician introduction arm) and (ii) cross-overs (from either arm to the other) will occur in ≤ 15% on introductions. 2. Following randomization, we expect that ≤ 20% of introductions will be missed due to inability of the RC to contact existing SDMs once identified (either intervention or control arm). 3. We will obtain at least 70% of initial SDM questionnaires Part A and at least 50% of questionnaires Part B.
| Arm | Type | Description |
|---|---|---|
| Physician introduction | EXPERIMENTAL | Physicians will introduce Research Coordinators (RCs) by name to SDMs and acknowledge patient eligibility to participate in a study using a standardized script. |
| Non-physician introduction (usual approach) | ACTIVE_COMPARATOR | RCs will either introduce themselves or be introduced by a non-physician member of the health care team. |
| Name | Type | Description |
|---|---|---|
| Physician Introduction of research personnel | OTHER | Physicians will introduce Research Coordinators (RCs) by name and acknowledge patient eligibility to participate in a research study using a standardized script. |
Inclusion Criteria: * SDMs of critically ill adults who are eligible (meet all inclusion criteria and have no exclusion criteria) to participate in a critical care research study in progress in the ICU Exclusion Criteria: * Eligible critically ill adults who die or are transferred out of a partic...