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Development and Pilot Testing the SITe Intervention

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06118359
Enrollment
25
Registered
2023-11-07
Start date
2023-10-09
Completion date
2024-03-11
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency General Surgery

Keywords

Older adults, Communication, Health care provider, Interhospital transfer

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.

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The intervention will target UW Health accepting providers. Referring providers do not receive the intervention. Patients have waiver of informed consent.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the Intervention to Support Interhospital Transfer Decisions (SITe)3 monthsThe 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)3 monthsThe 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 Procedurespre-intervention at 3 months, post-intervention at 7 monthsThe 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 Review7 monthsThe 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 Ablepre-intervention at 3 months, post-intervention at 7 monthsThe 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 Communication7 monthsFollowing 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 Execution7 monthsThe 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 - Respectpre-intervention at 3 months, post-intervention at 7 monthsFollowing 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 Outcomes7 monthsThe 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 - Listeningpre-intervention at 3 months, post-intervention at 7 monthsFollowing 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 - Understandingpre-intervention at 3 months, post-intervention at 7 monthsFollowing 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 - Doubtpre-intervention at 3 months, post-intervention at 7 monthsFollowing 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 - Justifiablepre-intervention at 3 months, post-intervention at 7 monthsThe 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

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

60 calls met the initial screening criteria, 12 calls were excluded do to errors in screening, 48 transfer calls were eligible for 59 unique providers. Of those, 24 unique providers declined to take 28 surveys, and the team did not have contact information for 14 providers. Therefore 25 unique providers started the intervention.

Participants by arm

ArmCount
Referring Providers
Referring providers who called to discuss potential transfer of a patient (who was at least 60 years old with an emergency general surgery diagnosis) with an accepting provider
13
Accepting Providers
Accepting providers who discussed potential transfer of a patient (who was at least 60 years old with an emergency general surgery diagnosis) with a referring provider
12
Total25

Baseline characteristics

CharacteristicReferring ProvidersTotalAccepting Providers
Age, Continuous45.46 years45.42 years45.4 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants23 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Number of years practiced since training was finished12.12 years11.18 years10.2 years
Profession
Advanced Practice Provider (NP, PA)
0 Participants0 Participants0 Participants
Profession
Other
1 Participants1 Participants0 Participants
Profession
Physician
12 Participants24 Participants12 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
12 Participants22 Participants10 Participants
Region of Enrollment
United States
13 participants25 participants12 participants
Sex/Gender, Customized
Man
10 Participants15 Participants5 Participants
Sex/Gender, Customized
Non-binary
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Prefer not to say
1 Participants1 Participants0 Participants
Sex/Gender, Customized
Prefer to self describe
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Woman
2 Participants9 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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.

Time frame: 3 months

Population: The study terminated early and the team mainly completed pre-intervention surveys and training activities. The study team did not complete post-intervention activities and analysis.

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.

Time frame: 7 months

Population: Study terminated early and these data were not collected.

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.

Time frame: 7 months

Population: Study terminated early and these data were not collected.

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.

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (NUMBER)
Accepting Providers Trained on SITe ToolsEmotional Labor - First Related Question on Survey - RespectDisagree0 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - First Related Question on Survey - RespectAgree5 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - First Related Question on Survey - RespectNeutral2 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - First Related Question on Survey - RespectStrongly agree6 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - First Related Question on Survey - RespectStrongly disagree0 surveys
Accepting ProvidersEmotional Labor - First Related Question on Survey - RespectStrongly agree10 surveys
Accepting ProvidersEmotional Labor - First Related Question on Survey - RespectStrongly disagree0 surveys
Accepting ProvidersEmotional Labor - First Related Question on Survey - RespectDisagree2 surveys
Accepting ProvidersEmotional Labor - First Related Question on Survey - RespectNeutral5 surveys
Accepting ProvidersEmotional Labor - First Related Question on Survey - RespectAgree24 surveys
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

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (NUMBER)
Accepting Providers Trained on SITe ToolsEmotional Labor - Fourth Related Question on Survey - DoubtStrongly disagree8 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Fourth Related Question on Survey - DoubtDisagree4 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Fourth Related Question on Survey - DoubtAgree0 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Fourth Related Question on Survey - DoubtStrongly agree1 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Fourth Related Question on Survey - DoubtNeutral0 surveys
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

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (NUMBER)
Accepting Providers Trained on SITe ToolsEmotional Labor - Second Related Question on Survey - ListeningStrongly disagree0 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Second Related Question on Survey - ListeningDisagree1 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Second Related Question on Survey - ListeningNeutral0 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Second Related Question on Survey - ListeningAgree5 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Second Related Question on Survey - ListeningStrongly agree7 surveys
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

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (NUMBER)
Accepting Providers Trained on SITe ToolsEmotional Labor - Third Related Question on Survey - UnderstandingStrongly disagree0 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Third Related Question on Survey - UnderstandingDisagree1 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Third Related Question on Survey - UnderstandingNeutral0 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Third Related Question on Survey - UnderstandingAgree5 surveys
Accepting Providers Trained on SITe ToolsEmotional Labor - Third Related Question on Survey - UnderstandingStrongly agree7 surveys
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.

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (COUNT_OF_UNITS)
Accepting Providers Trained on SITe ToolsFeasibility of Study ProceduresPre-Intervention Surveys13 Surveys
Accepting Providers Trained on SITe ToolsFeasibility of Study ProceduresPost-Intervention Surveys0 Surveys
Accepting ProvidersFeasibility of Study ProceduresPre-Intervention Surveys41 Surveys
Accepting ProvidersFeasibility of Study ProceduresPost-Intervention Surveys0 Surveys
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.

Time frame: 3 months

Population: Study terminated early and these data were not collected.

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.)

Time frame: 7 months

Population: Study terminated early and these data were not collected.

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.

Time frame: 7 months

Population: Study terminated early and these data were not collected.

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

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (NUMBER)
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- First Related Question on Survey - JustifiableStrongly Disagree3 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- First Related Question on Survey - JustifiableDisagree4 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- First Related Question on Survey - JustifiableNeutral13 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- First Related Question on Survey - JustifiableAgree13 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- First Related Question on Survey - JustifiableStrongly agree8 surveys
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

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

Population: Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study.

ArmMeasureGroupValue (NUMBER)
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- Second Related Question on Survey - Should Have Been AbleStrongly agree4 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- Second Related Question on Survey - Should Have Been AbleAgree12 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- Second Related Question on Survey - Should Have Been AbleNeutral15 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- Second Related Question on Survey - Should Have Been AbleDisagree8 surveys
Accepting Providers Trained on SITe ToolsPotential to Avoid Transfer- Second Related Question on Survey - Should Have Been AbleStrongly Disagree2 surveys

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026