Emergency General SurgeryNCT06118359
Development and Pilot Testing the SITe Intervention
A study testing Intervention to Support Interhospital Transfer Decisions (SITe) in people with Emergency General Surgery, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency General Surgery
- What is being tested?
- Intervention to Support Interhospital Transfer Decisions (SITe)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 11 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Providers who do not speak English
- Patients younger than 60 years
- Other interhospital transfers other than EGS transfers
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Pilot Testing of an Intervention to Support Interhospital Transfer Decisions (SITe) Regarding Older Adults With Emergency General Surgery Diagnoses
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.
- Conditions
- Emergency General Surgery
- Being tested
- Intervention to Support Interhospital Transfer Decisions (SITe)
- Keywords
- Older adults, Communication, Health care provider, Interhospital transfer
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to Support Interhospital Transfer Decisions (SITe)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SITe training for accepting providers | Experimental | UW Health (accepting) providers will participate in a training to learn how to utilize SITe intervention tools during EGS transfer calls. Receives: Behavioral: Intervention to Support Interhospital Transfer Decisions (SITe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: pre-intervention at 3 months, post-intervention at 7 months
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.
Measured: 7 months
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
Measured: pre-intervention at 3 months, post-intervention at 7 months
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: pre-intervention at 3 months, post-intervention at 7 months
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.)
Measured: 7 months
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
Measured: pre-intervention at 3 months, post-intervention at 7 months
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
Measured: pre-intervention at 3 months, post-intervention at 7 months
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
Measured: pre-intervention at 3 months, post-intervention at 7 months
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
Measured: pre-intervention at 3 months, post-intervention at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start9 Oct 2023
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Why it stopped: Principal Investigator taking a new position.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Emergency General SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention will target UW Health accepting providers. Referring providers do not receive the intervention. Patients have waiver of informed consent.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Angela Ingraham, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118359
- Sponsor's protocol ID
- 2022-0838
- Other IDs
- 1R03AG078889-01, Approval Date 6/23/2022, SMPH/SURGERY/TRAUMA
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2023
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of an Intervention to Support Interhospital Transfer Decisions (SITe) Regarding Older Adults With Emergency General Surgery Diagnoses
- ClinicalTrials.gov ID
- NCT06118359
- Acronym / sponsor ID
- 2022-0838
- Conditions
- Emergency General Surgery
- Keywords
- Older adults, Communication, Health care provider, Interhospital transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator taking a new position.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention will target UW Health accepting providers. Referring providers do not receive the intervention. Patients have waiver of informed consent.
| Arm | Type | Receives |
|---|---|---|
| SITe training for accepting providers | Experimental | Behavioral: Intervention to Support Interhospital Transfer Decisions (SITe)UW Health (accepting) providers will participate in a training to learn how to utilize SITe intervention tools during EGS transfer calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- Providers who do not speak English
- Patients younger than 60 years
- Other interhospital transfers other than EGS transfers
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SITe training for accepting providers |
Primary outcome
Acceptability of the Intervention to Support Interhospital Transfer Decisions (SITe)
Time frame: 3 months
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.
Fidelity to the Intervention to Support Interhospital Transfer Decisions (SITe)
Time frame: 3 months
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.
Feasibility of Study Procedures
Time frame: 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.
Potential to Avoid Transfer: Chart Review
Time frame: 7 months
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.
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
Time frame: 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
Efficiency of Transfer Communication
Time frame: 7 months
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.
Efficiency of Transfer Execution
Time frame: 7 months
The team will evaluate the efficiency of transfer execution. The team will review the time from initial call to patient arrival.
Emotional Labor - First Related Question on Survey - Respect
Time frame: 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.
Patient Health Outcomes
Time frame: 7 months
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.)
Emotional Labor - Second Related Question on Survey - Listening
Time frame: 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
Emotional Labor - Third Related Question on Survey - Understanding
Time frame: 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
Emotional Labor - Fourth Related Question on Survey - Doubt
Time frame: 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
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Ingraham, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to Support Interhospital Transfer Decisions (SITe) in people with Emergency General Surgery, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention to Support Interhospital Transfer Decisions (SITe) (time frame: 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.