Elective Surgery
Conditions
Keywords
Telemedicine, Post Anesthesia Care Unit (PACU)
Brief summary
A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.
Detailed description
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.
Interventions
DEVICEAlertwatch - Interaction
Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The first phase is an observation phase and the next phase is an interaction phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Time to PACU Discharge Determination From Observation to Interaction Phase | up to 1 day | The difference in discharge readiness time between the observation and interaction phases will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | up to 1 day | 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. |
| Detection of Physiological Derangements in PACU Patients | approximately 1 day | The proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases |
| Identification of Symptoms Requiring Treatment in PACU Patients | approximately 1 day | Number of patients identified with symptoms requiring treatment in PACU such as pain or nausea in both the observation and interaction phases |
| Recognition of Situations Requiring Emergency Medical Intervention | approximately 1 day | The number of patients identified requiring emergency medical intervention in both the observation and interaction phases |
| Determination of Patient Readiness for PACU Discharge | approximately 1 day | Number of patients determined to be ready for PACU discharge prior to documentation by the PACU Team in both the observation and interaction phases |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 304 |
| 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 | 256 |
| Total | 560 |
Baseline characteristics
| Characteristic | Interaction Phase | Observation Phase | Total |
|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 15 | 55.9 years STANDARD_DEVIATION 15.7 | 55.8 years STANDARD_DEVIATION 15.4 |
| ASA Physical Status ASA 1 | 9 Participants | 10 Participants | 19 Participants |
| ASA Physical Status ASA 2 | 127 Participants | 157 Participants | 284 Participants |
| ASA Physical Status ASA 3 | 119 Participants | 129 Participants | 248 Participants |
| ASA Physical Status ASA 4 | 1 Participants | 8 Participants | 9 Participants |
| ASA Physical Status ASA 5 | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index (BMI) | 31.5 kg/m^2 STANDARD_DEVIATION 9.9 | 30.7 kg/m^2 STANDARD_DEVIATION 8.6 | 31.0 kg/m^2 STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 248 Participants | 295 Participants | 543 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 64 Participants | 113 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 201 Participants | 230 Participants | 431 Participants |
| Region of Enrollment United States | 256 participants | 304 participants | 560 participants |
| Sex: Female, Male Female | 157 Participants | 194 Participants | 351 Participants |
| Sex: Female, Male Male | 99 Participants | 110 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 304 | 0 / 256 |
| other Total, other adverse events | 0 / 304 | 0 / 256 |
| serious Total, serious adverse events | 0 / 304 | 0 / 256 |
Outcome results
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
Time frame: up to 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Observation Phase | Difference in Time to PACU Discharge Determination From Observation to Interaction Phase | 84.5 Minutes |
| Interaction Phase | Difference in Time to PACU Discharge Determination From Observation to Interaction Phase | 91.5 Minutes |
Comparison: Difference in time to PACU discharge determination from observation to interaction phase \[ Time Frame: 6 months\]: The difference in discharge readiness time between the observation and interaction phases will be compared.95% CI: [-6.01, 18.01]
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.
Time frame: up to 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observation Phase | Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | Hand-off participation Yes | 205 Participants |
| Observation Phase | Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | Hand-off participation No | 99 Participants |
| Interaction Phase | Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | Hand-off participation Yes | 249 Participants |
| Interaction Phase | Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. | Hand-off participation No | 7 Participants |
95% CI: [23.82, 35.66]
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
Time frame: approximately 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observation Phase | Detection of Physiological Derangements in PACU Patients | 39 Participants |
| Interaction Phase | Detection of Physiological Derangements in PACU Patients | 26 Participants |
95% CI: [-8.18, 3.02]
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
Time frame: approximately 1 day
Population: For cases where patients were discharged from the PACU during ePACU operational hours (M-F; 0700- 1600).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observation Phase | Determination of Patient Readiness for PACU Discharge | 233 Participants |
| Interaction Phase | Determination of Patient Readiness for PACU Discharge | 199 Participants |
95% CI: [3.13, 12.71]
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
Time frame: approximately 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observation Phase | Identification of Symptoms Requiring Treatment in PACU Patients | 72 Participants |
| Interaction Phase | Identification of Symptoms Requiring Treatment in PACU Patients | 94 Participants |
95% CI: [5.16, 20.79]
Secondary
Recognition of Situations Requiring Emergency Medical Intervention
The number of patients identified requiring emergency medical intervention in both the observation and interaction phases
Time frame: approximately 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observation Phase | Recognition of Situations Requiring Emergency Medical Intervention | 2 Participants |
| Interaction Phase | Recognition of Situations Requiring Emergency Medical Intervention | 3 Participants |
95% CI: [-1.63, 3.07]