Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 5:03 AM
Study NCT ID:
NCT06118359
Status:
TERMINATED
Last Update Posted:
2024-06-14
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Pilot Testing the SITe Intervention
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Development and Pilot Testing of an Intervention to Support Interhospital Transfer Decisions (SITe) Regarding Older Adults With Emergency General Surgery Diagnoses
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator taking a new position.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Every year, nearly 240,000 patients age 60 and older are transferred between acute care hospitals for nontraumatic surgical emergencies, and these patients experience worse outcomes than patients admitted directly from an emergency department within a given hospital. Care coordination for older patients with emergency general surgery (EGS) diagnoses suffers because conversations between referring and accepting providers regarding decisions to transfer are ineffective, incomplete, and inefficient. To standardize a method to support transfer decisions that is tailored to older adults within extant transfer processes, the team will (1) engage key stakeholders to develop the intervention to Support Interhospital Transfer Decisions (SITe) for older EGS patients by adapting an existing intervention for interhospital handoffs and (2) assess the acceptability of the SITe intervention, test the feasibility of study procedures, and explore efficacy outcomes for evaluation in a future, larger clinical trial.
Detailed Description:
Aim 2 of the protocol qualifies as a clinical trial. Aim 2 will assess the acceptability of the intervention to Support Interhospital Transfer Decisions (SITe), test the feasibility of study procedures, and explore efficacy outcomes for evaluation in a future, larger clinical trial. Modeling a similar and successful pilot, the investigators will conduct a pre (control)/post (intervention) study with 50 transfers in each arm. They will collect pre- and post-intervention data after each eligible transfer through (1) chart review and transfer center logs and (2) Qualtrics surveys of referring and accepting providers. The team will collect baseline (pre) and post-intervention measures of the potential to avoid transfers, efficiency of transfer communication and execution, provider emotional labor, and patient health outcomes. accepting providers will utilize the SITe intervention during calls discussing transfer decisions regarding older emergency general surgery patients. Transfer center nurses and referring providers will be informed of the SITe intervention tool.
The study was terminated early. The research team completed pre-intervention data collection and intervention training. No post-intervention data was collected. As of 3/21/2024, the UW-Madison IRB no longer considers training accepting surgeons on the intervention research.
The study was terminated early. The research team completed pre-intervention data collection and intervention training. No post-intervention data was collected. As of 3/21/2024, the UW-Madison IRB no longer considers training accepting surgeons on the intervention research.
Study Oversight
Has Oversight DMC:
False
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 |
|---|---|---|---|---|
| 1R03AG078889-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| Approval Date 6/23/2022 | OTHER | UW Madison | View | |
| SMPH/SURGERY/TRAUMA | OTHER | UW Madison | View |