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
TERMINATED
NA
25 participants
pre-intervention at 3 months, post-intervention at 7 months
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
| 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
| 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 monthsPopulation: 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 monthsPopulation: 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 monthsPopulation: 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
| 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 monthsPopulation: 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 monthsPopulation: 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
| 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 monthsPopulation: 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 monthsPopulation: 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 monthsPopulation: 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
| 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 monthsPopulation: 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place