- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118359
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angela Ingraham, MD, MS
- Phone Number: 513-833-5205
- Email: ingraham@surgery.wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 identify the number of transfers for which accepting providers utilized the SITe intervention tools. Adequate acceptability is defined as >85% utilization of the SITe tools for eligible patient transfers. 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):
Acceptability is defined as a minimum average score of 4 per item. |
3 months
|
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.
|
3 months
|
Feasibility of study procedures
Time Frame: 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.
|
7 months
|
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.
|
7 months
|
Potential to avoid transfer: survey
Time Frame: 7 months
|
The team will evaluate the quality outcome: potential to avoid transfer.
From Qualtrics surveys, the team will review responses to questions about "was the transfer potentially avoidable."
|
7 months
|
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.
|
7 months
|
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.
|
7 months
|
Emotional Labor
Time Frame: 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.
|
7 months
|
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.)
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Angela Ingraham, MD, MS, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0838
- SMPH/SURGERY/TRAUMA (Other Identifier: UW Madison)
- 1R03AG078889-01 (U.S. NIH Grant/Contract)
- Approval Date 6/23/2022 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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