Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05780918
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Communication Tool to Improve Communication in the ICU
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial of Scenario Planning for Older Adults With Serious Injury
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the effectiveness of the Best Case/Worst Case-ICU communication tool on quality of communication, clinician moral distress, and ICU length of stay for older adults with serious traumatic injury. Investigators will follow an estimated 4500 patients aged 50 years and older who are in the ICU for 3 or more days and survey 1500 family members and up to 1600 clinicians from 8 sites nationwide.
Detailed Description:
This is a multisite, stepped-wedge, randomized clinical trial. At the start of the study, investigators will randomly assign each site to the time when the intervention team will train all trauma surgeons, trainees, and ICU clinicians to use the Best Case/Worst Case-ICU tool. Participants in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool. Participants in the control group will receive usual care.
The study team will follow an estimated 4,500 patients with the highest post-injury mortality: aged 50 years and older with an ICU length of stay of 3 or more days. They will administer surveys to family members (quality of communication) and clinicians (moral distress) and obtain patient-level outcomes (ICU length of stay (LOS)), clinical data, and demographics from the Trauma Quality Improvement Program (TQIP) national registry.
Objectives:
* Aim 1: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on improving the quality of communication in the trauma ICU.
* Aim 2: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing clinician moral distress in the ICU.
* Aim 3: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing ICU length of stay.
The study team will follow an estimated 4,500 patients with the highest post-injury mortality: aged 50 years and older with an ICU length of stay of 3 or more days. They will administer surveys to family members (quality of communication) and clinicians (moral distress) and obtain patient-level outcomes (ICU length of stay (LOS)), clinical data, and demographics from the Trauma Quality Improvement Program (TQIP) national registry.
Objectives:
* Aim 1: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on improving the quality of communication in the trauma ICU.
* Aim 2: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing clinician moral distress in the ICU.
* Aim 3: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing ICU length of stay.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AG078242-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| Protocol Version 5/5/2025 | OTHER | UW Madison | View | |
| A539750 | OTHER | UW Madison | View |