Telemedicine Control Tower for the Post-Anesthesia Care Unit (PACU Telemed)

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

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

Study Overview

• Status: Completed
• Conditions: Elective Surgery
• Intervention / Treatment: Device: Alertwatch - Interaction

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.

• Study Type: Interventional
• Enrollment (Actual): 560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: Alertwatch - Interaction; Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Michael S Avidan, MBBcH, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): December 6, 2021

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Post Anesthesia Care Unit (PACU)
• Other Study ID Numbers: 201901180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No