Telemedicine Control Tower for the Post-Anesthesia Care Unit

Study Overview
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Brief Summary
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A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.

Detailed Description
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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.

Official Title
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A Proof-of-concept Observational Study Evaluating the Acceptability and Utility of a Telemedicine Solution for the Post Anesthesia Care Unit

Conditions
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Elective Surgery

Intervention / Treatment
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* Device: Alertwatch - Interaction


Participation Criteria
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Eligibility Criteria
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Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The first phase is an observation phase and the next phase is an interaction phase.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation Phase<br>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. | |
| Experimental: Interaction Phase<br>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. | Device: Alertwatch - Interaction<br>* Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Post Anesthesia Care Unit (PACU)