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NCT06118359

Development and Pilot Testing the SITe Intervention

Terminated NA Results posted Last updated 14 June 2024
What this trial tests

NA trial testing Intervention to Support Interhospital Transfer Decisions (SITe) in Emergency General Surgery in 25 participants. Terminated before completion.

Timeline
9 October 2023
Primary endpoint
11 March 2024
11 March 2024

Quick facts

Lead sponsorUniversity of Wisconsin, Madison
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment25
Start date9 October 2023
Primary completion11 March 2024
Estimated completion11 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Emergency General Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Study Procedures Primary · pre-intervention at 3 months, post-intervention at 7 months

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 Surveys
GroupValue95% CI
Referring Providers13
Accepting Providers41
Post-Intervention Surveys
GroupValue95% CI
Referring Providers0
Accepting Providers0
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able Primary · pre-intervention at 3 months, post-intervention at 7 months

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

Strongly agree
GroupValue95% CI
Accepting Providers - Pre-Intervention4
Agree
GroupValue95% CI
Accepting Providers - Pre-Intervention12
Neutral
GroupValue95% CI
Accepting Providers - Pre-Intervention15
Disagree
GroupValue95% CI
Accepting Providers - Pre-Intervention8
Strongly Disagree
GroupValue95% CI
Accepting Providers - Pre-Intervention2
Emotional Labor - First Related Question on Survey - Respect Primary · pre-intervention at 3 months, post-intervention at 7 months

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.

Strongly disagree
GroupValue95% CI
Referring Providers Pre-Intervention0
Accepting Providers Pre-Intervention0
Disagree
GroupValue95% CI
Referring Providers Pre-Intervention0
Accepting Providers Pre-Intervention2
Neutral
GroupValue95% CI
Referring Providers Pre-Intervention2
Accepting Providers Pre-Intervention5
Agree
GroupValue95% CI
Referring Providers Pre-Intervention5
Accepting Providers Pre-Intervention24
Strongly agree
GroupValue95% CI
Referring Providers Pre-Intervention6
Accepting Providers Pre-Intervention10
Emotional Labor - Second Related Question on Survey - Listening Primary · pre-intervention at 3 months, post-intervention at 7 months

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

Strongly disagree
GroupValue95% CI
Referring Providers Pre-Intervention0
Disagree
GroupValue95% CI
Referring Providers Pre-Intervention1
Neutral
GroupValue95% CI
Referring Providers Pre-Intervention0
Agree
GroupValue95% CI
Referring Providers Pre-Intervention5
Strongly agree
GroupValue95% CI
Referring Providers Pre-Intervention7
Emotional Labor - Third Related Question on Survey - Understanding Primary · pre-intervention at 3 months, post-intervention at 7 months

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

Strongly disagree
GroupValue95% CI
Referring Providers Pre-Intervention0
Disagree
GroupValue95% CI
Referring Providers Pre-Intervention1
Neutral
GroupValue95% CI
Referring Providers Pre-Intervention0
Agree
GroupValue95% CI
Referring Providers Pre-Intervention5
Strongly agree
GroupValue95% CI
Referring Providers Pre-Intervention7
Emotional Labor - Fourth Related Question on Survey - Doubt Primary · pre-intervention at 3 months, post-intervention at 7 months

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

Strongly disagree
GroupValue95% CI
Referring Providers Pre-Intervention8
Disagree
GroupValue95% CI
Referring Providers Pre-Intervention4
Neutral
GroupValue95% CI
Referring Providers Pre-Intervention0
Agree
GroupValue95% CI
Referring Providers Pre-Intervention0
Strongly agree
GroupValue95% CI
Referring Providers Pre-Intervention1
Potential to Avoid Transfer- First Related Question on Survey - Justifiable Primary · pre-intervention at 3 months, post-intervention at 7 months

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

Strongly Disagree
GroupValue95% CI
Accepting Providers Pre-Intervention3
Disagree
GroupValue95% CI
Accepting Providers Pre-Intervention4
Neutral
GroupValue95% CI
Accepting Providers Pre-Intervention13
Agree
GroupValue95% CI
Accepting Providers Pre-Intervention13
Strongly agree
GroupValue95% CI
Accepting Providers Pre-Intervention8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06118359.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing