Development and Pilot Testing the SITe Intervention

Emergency General Surgery Clinical Trial

Official title:

Development and Pilot Testing of an Intervention to Support Interhospital Transfer Decisions (SITe) Regarding Older Adults With Emergency General Surgery Diagnoses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06118359
• Other study ID #: 2022-0838
• Secondary ID: 1R03AG078889-01A
• Status: Terminated
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: March 11, 2024

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency General Surgery

Intervention

Behavioral:
• Intervention to Support Interhospital Transfer Decisions (SITe)
The SITe intervention and implementation toolkit was developed in Aim 1 through stakeholder activities. SITe, an intervention to support interhospital transfer decisions regarding older EGS patients, includes a checklist and script to be utilized by accepting providers during their conversations with referring providers. The investigators and stakeholders also developed a toolkit for implementation with resources to reduce barriers to and support facilitators of utilizing the tools. The toolkit includes: (1) the checklist and script; (2) methods to train accepting providers on the tools including a PowerPoint presentation and demonstration video; and (3) resources to familiarize other parties (transfer center nurses, referring providers, referring hospitals) with the SITe intervention.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the Intervention to Support Interhospital Transfer Decisions (SITe)	The team will identify 50 study-eligible patient transfers post-intervention training.; The team will ask the accepting provider and referring provider who executed the eligible transfer to rate the following statements on a Likert-scale (1=completely disagree to 5=completely agree): This intervention meets my approval.; This intervention is appealing to me.; I like this intervention.; I welcome this intervention.; Acceptability is defined as a minimum average score of 4 per item.	3 months
Primary	Fidelity to the Intervention to Support Interhospital Transfer Decisions (SITe)	The team will identify 50 study-eligible patient transfers post-intervention training. The team will measure missingness of the tool elements. Fidelity is defined as <15% missing patient information.	3 months
Primary	Feasibility of Study Procedures	The team will measure the rate of survey completion for study-eligible patient transfers and examine rates of and reasons for missing outcome data.	pre-intervention at 3 months, post-intervention at 7 months
Primary	Potential to Avoid Transfer: Chart Review	The team will evaluate the quality outcome: potential to avoid transfer. Through chart review, the team will look at number of transfers with no intervention and discharge to home within 72 hours.	7 months
Primary	Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able	The team will evaluate the quality outcome: potential to avoid transfer.; Accepting Providers were asked: "I felt that the referring hospital should have been able to care for the patient." A similar question was not asked of Referring Providers	pre-intervention at 3 months, post-intervention at 7 months
Primary	Efficiency of Transfer Communication	Following the Relational Model of Organizational Change and through chart review and review of transfer center logs, the team will evaluate the efficiency of transfer communication. The team will review the number of calls required to complete the transfer and time required to complete transfer calls.	7 months
Primary	Efficiency of Transfer Execution	The team will evaluate the efficiency of transfer execution. The team will review the time from initial call to patient arrival.	7 months
Primary	Emotional Labor - First Related Question on Survey - Respect	Following the Relational Model of Organizational Change and specific Qualtrics questions, the team will evaluate the emotional labor of providers. The team will ask about providers' feelings about being listened to and supported when discussing patient care and difficult patient issues.; Question for Referring Providers: I felt respected by the referring provider. Question for Accepting Providers: I felt respected by the UW surgeon.	pre-intervention at 3 months, post-intervention at 7 months
Primary	Patient Health Outcomes	The team will evaluate patient health outcomes. The team will measure the number of admissions to the emergency department vs inpatient floor, the number of changes in level of patient care (general, intermediate, intensive) within 24 hours of arrival, and the number of adverse events (inpatient mortality, morbidity, extended length of stay.)	7 months
Primary	Emotional Labor - Second Related Question on Survey - Listening	Following the Relational Model of Organizational Change and specific Qualtrics questions, the team will evaluate the emotional labor of providers. The team will ask about providers' feelings about being listened to and supported when discussing patient care and difficult patient issues.; Question for Referring Providers: The UW Surgeon listened to my concerns about the patient.; A similar question was not asked of Accepting Providers	pre-intervention at 3 months, post-intervention at 7 months
Primary	Emotional Labor - Third Related Question on Survey - Understanding	Following the Relational Model of Organizational Change and specific Qualtrics questions, the team will evaluate the emotional labor of providers. The team will ask about providers' feelings about being listened to and supported when discussing patient care and difficult patient issues.; Question for Referring Providers: I felt that the UW Surgeon understood my reason for transfer.; A similar question was not asked of Accepting Providers	pre-intervention at 3 months, post-intervention at 7 months
Primary	Emotional Labor - Fourth Related Question on Survey - Doubt	Following the Relational Model of Organizational Change and specific Qualtrics questions, the team will evaluate the emotional labor of providers. The team will ask about providers' feelings about being listened to and supported when discussing patient care and difficult patient issues.; Question for Referring Providers: I felt that the UW Surgeon doubted whether the transfer was necessary.; A similar question was not asked of Accepting Providers	pre-intervention at 3 months, post-intervention at 7 months
Primary	Potential to Avoid Transfer- First Related Question on Survey - Justifiable	The team will evaluate the quality outcome: potential to avoid transfer.; Accepting Providers were asked: "I felt that the reason for transfer was justifiable." A similar question was not asked of Referring Providers	pre-intervention at 3 months, post-intervention at 7 months