Development and Pilot Testing the SITe Intervention

NCT06118359 | Terminated Results

• 4 other identifiers: 2022-08381R03AG078889-01Approval Date 6/23/2022SMPH/SURGERY/TRAUMA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergency General Surgery

Keywords

Older adults; Communication; Health care provider; Interhospital transfer

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.)

  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

  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

  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

  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

  pre-intervention at 3 months, post-intervention at 7 months

Study Arms (1)

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.

Behavioral: Intervention to Support Interhospital Transfer Decisions (SITe)

Interventions

Intervention to Support Interhospital Transfer Decisions (SITe) BEHAVIORAL

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.

SITe training for accepting providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

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.

Results Point of Contact

• Title: Angela Ingraham
• Organization: University of Wisconsin

aingraham.md.ms@gmail.com

513-833-5205

Study Officials

• Angela Ingraham, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: November 7, 2023
• Study Start: October 9, 2023
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)