Recovery Control Tower Feasibility Pilot (RCT Pilot)

Protocol for a Pilot Interventional Study Evaluating the Efficiency and Safety of a Telemedicine Solution for the Post-Anesthesia Care Unit

A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. If this pilot study proves to be successful, the study team intends subsequently to expand such a telemedicine solution to multiple clinical locations.

Study Overview

• Status: Active, not recruiting
• Conditions: Elective Surgery
• Intervention / Treatment: Device: Alertwatch - Recovery Control Tower

• Study Type: Interventional
• Enrollment (Estimated): 8500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Adults (18 years and older)
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Recovery Control Tower (RCT); Clinicians in the RCT will remotely work with PACU clinicians to care for patients assigned to one of the two study bays. A version of AlertWatch® (AlertWatch, Ann Arbor, Michigan) decision-support software, customized for the PACU environment, will assist clinicians in the RCT to perform core PACU-related functions remotely. Caregility's iObserver, from the Caregility Cloud™ Virtual Care Platform, will be used for two-way video communication When feasible, RCT clinicians will join handoff activities from the OR to the PACU and discuss pertinent intraoperative events with clinical teams on the ground. RCT clinicians will document patient specific recovery tasks within AlertWatch to assist in tracking patient recovery progresses. RCT clinicians will be the initial point of contact for ongoing recovery care, such as order placements. The attending anesthesiologist in the RCT will assess patients' discharge readiness throughout their PACU stay.

Device: Alertwatch - Recovery Control Tower; 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
Time spent in PACU	Time patient enters PACU to time patient leaves PACU	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to PACU sign-out by anesthesia clinician	Time patient enters PACU to time discharge note is signed in EHR by anesthesiologist	From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Pain score in PACU	0 to 10 (numeric rating scale [NRS]) - 0 correspond to no pain, ≤ 3 to mild pain, 4-6 to moderate, and scores ≥7 to severe pain	From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
PONV status in PACU	None, resolved, resolved and tolerable, persists despite treatment, unable to evaluate	From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Clinician interactions - Number of contacts RCT clinicians receive from PACU clinicians	Reason for contact will be logged (i.e. order placement requests, patient assessments)	From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Clinician interactions - Number of contacts RCT clinicians make to PACU clinicians for on-the-ground intervention	Reason for contact will be logged	From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Safety events - Return to hospital	New admission notes, and ED/urgent care notes	24 hours
Safety events - Number of participants with elevation of care	Patients with floor to ICU transfer, and unplanned floor to OR (return to OR)	24 Hours
Safety events - Number of participants with administration of rescue drugs	Events of Naloxone (opioid overdose) and Flumazenil (benzodiazepine overdose) administration	24 Hours
Safety events - Significant event notes	To identify death events	24 Hours
PACU clinician satisfaction	From monthly surveys	Through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 202305152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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