Trial Outcomes & Findings for Telemedicine Control Tower for the Post-Anesthesia Care Unit (NCT NCT04020887)
NCT ID: NCT04020887
Last Updated: 2023-07-19
Results Overview
The difference in discharge readiness time between the observation and interaction phases will be compared
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
560 participants
Primary outcome timeframe
up to 1 day
Results posted on
2023-07-19
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
304
|
256
|
|
Overall Study
COMPLETED
|
304
|
256
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telemedicine Control Tower for the Post-Anesthesia Care Unit
Baseline characteristics by cohort
| Measure |
Observation Phase
n=304 Participants
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
n=256 Participants
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
|
Total
n=560 Participants
Total of all reporting groups
|
|---|---|---|---|
|
ASA Physical Status
ASA 3
|
129 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
ASA Physical Status
ASA 4
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
ASA Physical Status
ASA 5
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 15 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
295 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
230 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
304 participants
n=5 Participants
|
256 participants
n=7 Participants
|
560 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.7 kg/m^2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 9.9 • n=7 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
ASA Physical Status
ASA 1
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
ASA Physical Status
ASA 2
|
157 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 dayThe difference in discharge readiness time between the observation and interaction phases will be compared
Outcome measures
| Measure |
Observation Phase
n=304 Participants
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
n=256 Participants
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
|
|---|---|---|
|
Difference in Time to PACU Discharge Determination From Observation to Interaction Phase
|
84.5 Minutes
Interval 54.0 to 116.5
|
91.5 Minutes
Interval 62.0 to 145.0
|
SECONDARY outcome
Timeframe: up to 1 dayPercent 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.
Outcome measures
| Measure |
Observation Phase
n=304 Participants
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
n=256 Participants
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
|
|---|---|---|
|
Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions.
Hand-off participation Yes
|
205 Participants
|
249 Participants
|
|
Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions.
Hand-off participation No
|
99 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: approximately 1 dayThe proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases
Outcome measures
| Measure |
Observation Phase
n=304 Participants
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
n=256 Participants
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
|
|---|---|---|
|
Detection of Physiological Derangements in PACU Patients
|
39 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: approximately 1 dayNumber of patients identified with symptoms requiring treatment in PACU such as pain or nausea in both the observation and interaction phases
Outcome measures
| Measure |
Observation Phase
n=304 Participants
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
n=256 Participants
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
|
|---|---|---|
|
Identification of Symptoms Requiring Treatment in PACU Patients
|
72 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: approximately 1 dayThe number of patients identified requiring emergency medical intervention in both the observation and interaction phases
Outcome measures
| Measure |
Observation Phase
n=304 Participants
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
n=256 Participants
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
|
|---|---|---|
|
Recognition of Situations Requiring Emergency Medical Intervention
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: approximately 1 dayPopulation: For cases where patients were discharged from the PACU during ePACU operational hours (M-F; 0700- 1600).
Number of patients determined to be ready for PACU discharge prior to documentation by the PACU Team in both the observation and interaction phases
Outcome measures
| Measure |
Observation Phase
n=260 Participants
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
n=204 Participants
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
|
|---|---|---|
|
Determination of Patient Readiness for PACU Discharge
|
233 Participants
|
199 Participants
|
Adverse Events
Observation Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interaction Phase
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
Thaddeus Budelier
Washington University School of Medicine
Phone: 314-273-8646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place