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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03AG078889-01 | U.S. NIH Grant/Contract | View source | |
| Approval Date 6/23/2022 | Other Identifier | UW Madison | |
| SMPH/SURGERY/TRAUMA | Other Identifier | UW Madison |
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Principal Investigator taking a new position.
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Ingraham, MD, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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13 unique referring providers completed study survey, 12 unique accepting providers completed study surveys, and 3 accepting providers completed intervention training.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Accepting Providers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One accepting provider declined to provide age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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):
Acceptability is defined as a minimum average score of 4 per item. | 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. | Posted | 3 months |
|
Adverse event data were not collected for this study
Adverse event data were not collected for this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Intervention 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Ingraham | University of Wisconsin | 513-833-5205 | aingraham.md.ms@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2023 | Apr 4, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2023 | Apr 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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The intervention will target UW Health accepting providers. Referring providers do not receive the intervention. Patients have waiver of informed consent.
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| 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 |
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
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Profession | Count of Participants | Participants |
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| Number of years practiced since training was finished | Mean | Full Range | years |
|
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| 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. | Study terminated early and these data were not collected. | Posted | 3 months |
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| 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. | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Count of Units | Surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| 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. | Study terminated early and these data were not collected. | Posted | 7 months |
|
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| 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 | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Number | surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| 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. | Study terminated early and these data were not collected. | Posted | 7 months |
|
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| 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. | Study terminated early and these data were not collected. | Posted | 7 months |
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| 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. | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Number | surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| 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.) | Study terminated early and these data were not collected. | Posted | 7 months |
|
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| 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 | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Number | surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| 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 | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Number | surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| 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 | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Number | surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| 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 | Data was collected over 3 months prior to intervention, planned post-intervention data collection did not occur due to termination of the study. | Posted | Number | surveys | pre-intervention at 3 months, post-intervention at 7 months | Surveys | Surveys |
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| Non-binary |
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| Prefer to self describe |
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| Prefer not to say |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other |
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| Post-Intervention Surveys |
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| Disagree |
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| Strongly Disagree |
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| Neutral |
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| Agree |
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| Strongly agree |
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| Agree |
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| Strongly agree |
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| Agree |
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| Strongly agree |
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| Agree |
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| Strongly agree |
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