Clinical trial NCT06118359: Development and Pilot Testing the SITe Intervention
Official title: Development and Pilot Testing of an Intervention to Support Interhospital Transfer Decisions (SITe) Regarding Older Adults With Emergency General Surgery Diagnoses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emergency General Surgery
Keywords: Older adults
Communication
Health care provider
Interhospital transfer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-11-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention will target UW Health accepting providers. Referring providers do not receive the intervention. Patients have waiver of informed consent.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Patients (n=100): patients age 60 and older with an EGS diagnosis transferred from a referring ED or inpatient floor in Wisconsin to the UW ED or inpatient floor under care of UW surgeons
* Providers: all UW (accepting) surgeons and all referring providers who execute transfers of the 100 eligible patients. There will be no exclusions regarding referring providers' position (e.g., physician, mid-level provider), specialty (e.g., emergency medicine, internal medicine), or affiliation (e.g., UW or non-UW).

Exclusion Criteria:

* Providers who do not speak English
* Patients younger than 60 years
* Other interhospital transfers other than EGS transfers
* Prisoners

Primary outcomes:
measure: Acceptability of the Intervention to Support Interhospital Transfer Decisions (SITe)
timeFrame: 3 months
measure: Fidelity to the Intervention to Support Interhospital Transfer Decisions (SITe)
timeFrame: 3 months
measure: Feasibility of Study Procedures
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
measure: Potential to Avoid Transfer: Chart Review
timeFrame: 7 months
measure: Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
measure: Efficiency of Transfer Communication
timeFrame: 7 months
measure: Efficiency of Transfer Execution
timeFrame: 7 months
measure: Emotional Labor - First Related Question on Survey - Respect
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
measure: Patient Health Outcomes
timeFrame: 7 months
measure: Emotional Labor - Second Related Question on Survey - Listening
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
measure: Emotional Labor - Third Related Question on Survey - Understanding
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
measure: Emotional Labor - Fourth Related Question on Survey - Doubt
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
measure: Potential to Avoid Transfer- First Related Question on Survey - Justifiable
timeFrame: pre-intervention at 3 months, post-intervention at 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Angela Ingraham, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: