Trial Outcomes & Findings for Development and Pilot Testing the SITe Intervention (NCT NCT06118359)

NCT ID: NCT06118359

Last Updated: 2024-06-14

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

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

Results posted on

2024-06-14

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.

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.

Unit of analysis: Surveys

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
13 13
12 41
Overall Study
Providers Enrolled in Intervention Training
0 0
3 0
Overall Study
COMPLETED
13 13
12 41
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One accepting provider declined to provide age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Referring Providers
n=13 Participants
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
Accepting Providers
n=12 Participants
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
Total
n=25 Participants
Total of all reporting groups
Age, Continuous
45.46 years
n=13 Participants • One accepting provider declined to provide age.
45.4 years
n=11 Participants • One accepting provider declined to provide age.
45.42 years
n=24 Participants • One accepting provider declined to provide age.
Sex/Gender, Customized
Man
10 Participants
n=13 Participants
5 Participants
n=12 Participants
15 Participants
n=25 Participants
Sex/Gender, Customized
Woman
2 Participants
n=13 Participants
7 Participants
n=12 Participants
9 Participants
n=25 Participants
Sex/Gender, Customized
Non-binary
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Sex/Gender, Customized
Prefer to self describe
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Sex/Gender, Customized
Prefer not to say
1 Participants
n=13 Participants
0 Participants
n=12 Participants
1 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=13 Participants
0 Participants
n=12 Participants
1 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=13 Participants
12 Participants
n=12 Participants
23 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=13 Participants
0 Participants
n=12 Participants
1 Participants
n=25 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Race (NIH/OMB)
Asian
0 Participants
n=13 Participants
2 Participants
n=12 Participants
2 Participants
n=25 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Race (NIH/OMB)
White
12 Participants
n=13 Participants
10 Participants
n=12 Participants
22 Participants
n=25 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=13 Participants
0 Participants
n=12 Participants
1 Participants
n=25 Participants
Region of Enrollment
United States
13 participants
n=13 Participants
12 participants
n=12 Participants
25 participants
n=25 Participants
Profession
Physician
12 Participants
n=13 Participants
12 Participants
n=12 Participants
24 Participants
n=25 Participants
Profession
Advanced Practice Provider (NP, PA)
0 Participants
n=13 Participants
0 Participants
n=12 Participants
0 Participants
n=25 Participants
Profession
Other
1 Participants
n=13 Participants
0 Participants
n=12 Participants
1 Participants
n=25 Participants
Number of years practiced since training was finished
12.12 years
n=13 Participants
10.2 years
n=12 Participants
11.18 years
n=25 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

The team will measure the rate of survey completion for study-eligible patient transfers and examine rates of and reasons for missing outcome data.

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=34 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
Accepting Providers
n=48 Surveys
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
Feasibility of Study Procedures
Pre-Intervention Surveys
13 Surveys
41 Surveys
Feasibility of Study Procedures
Post-Intervention Surveys
0 Surveys
0 Surveys

PRIMARY outcome

Timeframe: 7 months

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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=41 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
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
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
Strongly agree
4 surveys
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
Agree
12 surveys
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
Neutral
15 surveys
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
Disagree
8 surveys
Potential to Avoid Transfer- Second Related Question on Survey - Should Have Been Able
Strongly Disagree
2 surveys

PRIMARY outcome

Timeframe: 7 months

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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7 months

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

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=13 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
Accepting Providers
n=41 Surveys
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
Emotional Labor - First Related Question on Survey - Respect
Strongly agree
6 surveys
10 surveys
Emotional Labor - First Related Question on Survey - Respect
Strongly disagree
0 surveys
0 surveys
Emotional Labor - First Related Question on Survey - Respect
Disagree
0 surveys
2 surveys
Emotional Labor - First Related Question on Survey - Respect
Neutral
2 surveys
5 surveys
Emotional Labor - First Related Question on Survey - Respect
Agree
5 surveys
24 surveys

PRIMARY outcome

Timeframe: 7 months

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

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.)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=13 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
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
Emotional Labor - Second Related Question on Survey - Listening
Strongly disagree
0 surveys
Emotional Labor - Second Related Question on Survey - Listening
Disagree
1 surveys
Emotional Labor - Second Related Question on Survey - Listening
Neutral
0 surveys
Emotional Labor - Second Related Question on Survey - Listening
Agree
5 surveys
Emotional Labor - Second Related Question on Survey - Listening
Strongly agree
7 surveys

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=13 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
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
Emotional Labor - Third Related Question on Survey - Understanding
Strongly disagree
0 surveys
Emotional Labor - Third Related Question on Survey - Understanding
Disagree
1 surveys
Emotional Labor - Third Related Question on Survey - Understanding
Neutral
0 surveys
Emotional Labor - Third Related Question on Survey - Understanding
Agree
5 surveys
Emotional Labor - Third Related Question on Survey - Understanding
Strongly agree
7 surveys

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=13 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
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
Emotional Labor - Fourth Related Question on Survey - Doubt
Strongly disagree
8 surveys
Emotional Labor - Fourth Related Question on Survey - Doubt
Disagree
4 surveys
Emotional Labor - Fourth Related Question on Survey - Doubt
Neutral
0 surveys
Emotional Labor - Fourth Related Question on Survey - Doubt
Agree
0 surveys
Emotional Labor - Fourth Related Question on Survey - Doubt
Strongly agree
1 surveys

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Accepting Providers Trained on SITe Tools
n=41 Surveys
UW Health (accepting) providers will have been trained on the SITe intervention tools to use during EGS transfer calls. We will measure the acceptability of those tools by those providers.
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
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
Strongly Disagree
3 surveys
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
Disagree
4 surveys
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
Neutral
13 surveys
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
Agree
13 surveys
Potential to Avoid Transfer- First Related Question on Survey - Justifiable
Strongly agree
8 surveys

Adverse Events

SITe Training for Accepting Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Ingraham

University of Wisconsin

Phone: 513-833-5205

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place