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TerminatedNCT06118359Updated Jun 14, 2024Results posted

Development and Pilot Testing the SITe Intervention

An interventional study of Intervention to Support Interhospital Transfer Decisions (SITe) in Emergency General Surgery, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research

Why this study was terminated
Principal Investigator taking a new position.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Emergency General Surgery

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Keywords

  • Older adults
  • Communication
  • Health care provider
  • Interhospital transfer
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In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 25 is below the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    SITe training for accepting providers

    UW Health (accepting) providers will participate in a training to learn how to utilize SITe intervention tools during EGS transfer calls.

    Behavioral: Intervention to Support Interhospital Transfer Decisions (SITe)

Interventions

  • BehavioralIntervention 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

  4. 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.

    Time frame: 7 months

  5. 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

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

  6. 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.

    Time frame: 7 months

  7. 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.

    Time frame: 7 months

  8. 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.

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

  9. 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.)

    Time frame: 7 months

  10. 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

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

  11. 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

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

  12. 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

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

  13. 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

    Time frame: pre-intervention at 3 months, post-intervention at 7 months

07

Results

Posted Jun 14, 2024
Limitations and caveats
Although the study team did complete pre-intervention activities and implemented the intervention (training of accepting providers), most outcome data were not collected because the study ended prematurely. The team was not able to collect post-intervention data.

Participant flow

For the intervention training, 9 accepting surgeons were invited to be trained on the transfer tools; 3 accepting surgeons have accepted the invitation and were trained. Six accepting surgeons were invited but did not accept the invitation to complete the training. 25 unique providers took surveys, 3 accepting surgeons trained on the intervention were among them.

Participant flow — Overall Study
MilestoneReferring ProvidersAccepting Providers
Started1312
Providers enrolled in intervention training03
Completed1312
Not completed00

Outcome measures

PrimaryAcceptability 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.

Time frame:
3 months

No measurements were reported for this outcome.

PrimaryFidelity 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.

Time frame:
3 months

No measurements were reported for this outcome.

PrimaryFeasibility 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.

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Count of units · Surveys
Feasibility of Study Procedures
SurveysReferring ProvidersAccepting Providers
Pre-Intervention Surveys1341
Post-Intervention Surveys00
PrimaryPotential 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.

Time frame:
7 months

No measurements were reported for this outcome.

PrimaryPotential 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

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Number · surveys
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
surveysAccepting Providers - Pre-Intervention
Strongly agree4
Agree12
Neutral15
Disagree8
Strongly Disagree2
PrimaryEfficiency 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.

Time frame:
7 months

No measurements were reported for this outcome.

PrimaryEfficiency of Transfer Execution

The team will evaluate the efficiency of transfer execution. The team will review the time from initial call to patient arrival.

Time frame:
7 months

No measurements were reported for this outcome.

PrimaryEmotional 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.

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Number · surveys
Emotional Labor - First Related Question on Survey - Respect
surveysReferring Providers Pre-InterventionAccepting Providers Pre-Intervention
Strongly disagree00
Disagree02
Neutral25
Agree524
Strongly agree610
PrimaryPatient 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.)

Time frame:
7 months

No measurements were reported for this outcome.

PrimaryEmotional 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

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Number · surveys
Emotional Labor - Second Related Question on Survey - Listening
surveysReferring Providers Pre-Intervention
Strongly disagree0
Disagree1
Neutral0
Agree5
Strongly agree7
PrimaryEmotional 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

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Number · surveys
Emotional Labor - Third Related Question on Survey - Understanding
surveysReferring Providers Pre-Intervention
Strongly disagree0
Disagree1
Neutral0
Agree5
Strongly agree7
PrimaryEmotional 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

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Number · surveys
Emotional Labor - Fourth Related Question on Survey - Doubt
surveysReferring Providers Pre-Intervention
Strongly disagree8
Disagree4
Neutral0
Agree0
Strongly agree1
PrimaryPotential 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

Time frame:
pre-intervention at 3 months, post-intervention at 7 months
Reported as:
Number · surveys
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
surveysAccepting Providers Pre-Intervention
Strongly Disagree3
Disagree4
Neutral13
Agree13
Strongly agree8

Adverse events

Collected over Adverse event data were not collected for this study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SITe Training for Accepting Providers———

Baseline characteristics

13 unique referring providers completed study survey, 12 unique accepting providers completed study surveys, and 3 accepting providers completed intervention training.

Age, Continuous
Age, Continuous(years)Referring ProvidersAccepting ProvidersTotal
Mean45.46 (31 to 68)45.4 (36 to 58)45.42 (31 to 68)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Referring ProvidersAccepting ProvidersTotal
Man10515
Woman279
Non-binary000
Prefer to self describe000
Prefer not to say101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Referring ProvidersAccepting ProvidersTotal
Hispanic or Latino101
Not Hispanic or Latino111223
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Referring ProvidersAccepting ProvidersTotal
American Indian or Alaska Native000
Asian022
Native Hawaiian or Other Pacific Islander000
Black or African American000
White121022
More than one race000
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)Referring ProvidersAccepting ProvidersTotal
United States131225
Profession
Profession(Participants)Referring ProvidersAccepting ProvidersTotal
Physician121224
Advanced Practice Provider (NP, PA)000
Other101
Number of years practiced since training was finished
Number of years practiced since training was finished(years)Referring ProvidersAccepting ProvidersTotal
Mean12.12 (0 to 32)10.2 (1 to 21)11.18 (0 to 32)
08

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53792, United States
09

References and documents

Study documents

  • Study protocol · Oct 9, 2023
  • Informed consent form · Sep 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06118359
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Oct 9, 2023
Primary completion
Mar 11, 2024
Completion
Mar 11, 2024
Results posted
Jun 14, 2024
Last update
Jun 14, 2024

Study contacts

Angela Ingraham, MD, MS
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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