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A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.
A proof-of-concept study in perioperative telemedicine that aims to demonstrate the (i) acceptability and (ii) utility of integrating telemedicine into the PACU environment. This proof-of-concept study will be conducted in the PACU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Phase | No Intervention | In the first three months of this proof-of-concept study, a telemedicine center for the PACU will monitor patients assigned to PACU bays. Both telemedicine center clinicians and nurses caring for patients in these PACU bays will independently record information on patient physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness (based on the modified Aldrete scale). During this phase of the study, clinicians in the telemedicine center will not communicate with clinicians in the PACU (nurses or physicians), unless there was a patient safety event. | |
| Interaction Phase | Experimental | In the three months following the observation phase, clinicians in the telemedicine center will interact with clinicians and patients in the two designated PACU bays using audio-visual technology. The clinicians in the telemedicine center will continue to document information on physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alertwatch - Interaction | Device | Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Time to PACU Discharge Determination From Observation to Interaction Phase | The difference in discharge readiness time between the observation and interaction phases will be compared | up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | Percent of patients the telemedicine center participated in the hand-off process from OR to the PACU in both the observation and interaction phases. Participation by the telemedicine center was successful if the telemedicine center could both remotely join the hand-off process and collect relevant patient care information. |
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Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Avidan, MBBcH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33214879 | Derived | Budelier TP, King CR, Goswami S, Bansal A, Gregory SH, Wildes TS, Abraham J, McKinnon SL, Cooper A, Kangrga I, Martin JL Jr, Milbrandt M, Evers AS, Avidan MS. Protocol for a proof-of-concept observational study evaluating the potential utility and acceptability of a telemedicine solution for the post-anesthesia care unit. F1000Res. 2020 Oct 20;9:1261. doi: 10.12688/f1000research.26794.1. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observation Phase | In the first three months of this proof-of-concept study, a telemedicine center for the PACU will monitor patients assigned to PACU bays. Both telemedicine center clinicians and nurses caring for patients in these PACU bays will independently record information on patient physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness (based on the modified Aldrete scale). During this phase of the study, clinicians in the telemedicine center will not communicate with clinicians in the PACU (nurses or physicians), unless there was a patient safety event. |
| FG001 | Interaction Phase | In the three months following the observation phase, clinicians in the telemedicine center will interact with clinicians and patients in the two designated PACU bays using audio-visual technology. The clinicians in the telemedicine center will continue to document information on physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness. Alertwatch - Interaction: Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observation Phase | In the first three months of this proof-of-concept study, a telemedicine center for the PACU will monitor patients assigned to PACU bays. Both telemedicine center clinicians and nurses caring for patients in these PACU bays will independently record information on patient physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness (based on the modified Aldrete scale). During this phase of the study, clinicians in the telemedicine center will not communicate with clinicians in the PACU (nurses or physicians), unless there was a patient safety event. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Difference in Time to PACU Discharge Determination From Observation to Interaction Phase | The difference in discharge readiness time between the observation and interaction phases will be compared | Posted | Median | Inter-Quartile Range | Minutes | up to 1 day |
|
approximately 1 day
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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 | Observation Phase | In the first three months of this proof-of-concept study, a telemedicine center for the PACU will monitor patients assigned to PACU bays. Both telemedicine center clinicians and nurses caring for patients in these PACU bays will independently record information on patient physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness (based on the modified Aldrete scale). During this phase of the study, clinicians in the telemedicine center will not communicate with clinicians in the PACU (nurses or physicians), unless there was a patient safety event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thaddeus Budelier | Washington University School of Medicine | 314-273-8646 | thaddeus.budelier@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2020 | Dec 14, 2022 | Prot_SAP_000.pdf |
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The first phase is an observation phase and the next phase is an interaction phase.
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| up to 1 day |
| Detection of Physiological Derangements in PACU Patients | The proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases | approximately 1 day |
| Identification of Symptoms Requiring Treatment in PACU Patients | Number of patients identified with symptoms requiring treatment in PACU such as pain or nausea in both the observation and interaction phases | approximately 1 day |
| Recognition of Situations Requiring Emergency Medical Intervention | The number of patients identified requiring emergency medical intervention in both the observation and interaction phases | approximately 1 day |
| Determination of Patient Readiness for PACU Discharge | Number of patients determined to be ready for PACU discharge prior to documentation by the PACU Team in both the observation and interaction phases | approximately 1 day |
| BG001 | Interaction Phase | In the three months following the observation phase, clinicians in the telemedicine center will interact with clinicians and patients in the two designated PACU bays using audio-visual technology. The clinicians in the telemedicine center will continue to document information on physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness. Alertwatch - Interaction: Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | 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 |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| ASA Physical Status | Range, 1 to 6; 1 indicates healthy, 2 indicates mild systemic disease, 3 indicates severe systemic disease, 4 indicates severe systemic disease that is a constant threat to life, 5 indicates not expected to survive without surgery, 6 indicates neurologically deceased organ donor. In this study, only patients with an ASA 1 to 5 were collected. | Count of Participants | Participants |
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| OG001 | Interaction Phase | In the three months following the observation phase, clinicians in the telemedicine center will interact with clinicians and patients in the two designated PACU bays using audio-visual technology. The clinicians in the telemedicine center will continue to document information on physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness. Alertwatch - Interaction: Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU |
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| Secondary | Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | Percent of patients the telemedicine center participated in the hand-off process from OR to the PACU in both the observation and interaction phases. Participation by the telemedicine center was successful if the telemedicine center could both remotely join the hand-off process and collect relevant patient care information. | Posted | Count of Participants | Participants | up to 1 day |
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| Secondary | Detection of Physiological Derangements in PACU Patients | The proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases | Posted | Count of Participants | Participants | approximately 1 day |
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| Secondary | Identification of Symptoms Requiring Treatment in PACU Patients | Number of patients identified with symptoms requiring treatment in PACU such as pain or nausea in both the observation and interaction phases | Posted | Count of Participants | Participants | approximately 1 day |
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| Secondary | Recognition of Situations Requiring Emergency Medical Intervention | The number of patients identified requiring emergency medical intervention in both the observation and interaction phases | Posted | Count of Participants | Participants | approximately 1 day |
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| Secondary | Determination of Patient Readiness for PACU Discharge | Number of patients determined to be ready for PACU discharge prior to documentation by the PACU Team in both the observation and interaction phases | For cases where patients were discharged from the PACU during ePACU operational hours (M-F; 0700- 1600). | Posted | Count of Participants | Participants | approximately 1 day |
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| 304 |
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| EG001 | Interaction Phase | In the three months following the observation phase, clinicians in the telemedicine center will interact with clinicians and patients in the two designated PACU bays using audio-visual technology. The clinicians in the telemedicine center will continue to document information on physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness. Alertwatch - Interaction: Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU | 0 | 256 | 0 | 256 | 0 | 256 |
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