Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety

NCT ID: NCT03923699

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 79560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-01-31

Brief Summary

Medical errors account for thousands of potentially preventable deaths each year. With the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.

Detailed Description

This will be a single center, randomized, controlled, phase 3 pragmatic clinical trial. Forty-eight operating rooms will be randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms will be included and followed until 30-days after their surgery. Clinicians in operating rooms randomized to 'intervention' will receive decision support from clinicians in the ACT. In operating rooms not randomized to receive decision support from the ACT, the current standard of anesthesia care will be delivered. The intention-to-treat principle will be followed for all analyses.

Conditions

Surgery; Surgery--Complications; Perioperative/Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard of care arm

Operating rooms in the standard of care group will be monitored but, the ACT clinicians will not contact the operating room unless it is clinically necessary for patient safety purposes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Anesthesia Control Tower monitoring

Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room using AlertWatch and integrating machine-learning forecasting algorithms for adverse outcomes.

Group Type: EXPERIMENTAL

Anesthesia Control Tower monitoring

Intervention Type: DEVICE

Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

Interventions

Anesthesia Control Tower monitoring

Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael S Avidan, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

King CR, Fritz BA, Gregory SH, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon SL, Tripathi S, Abdelhack M, Goswami S, Montes de Oca A, Mehta D, Valdez MA, Karanikolas E, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST collaborator group. Effect of telemedicine support for intraoperative anaesthesia care on postoperative outcomes: the TECTONICS randomised clinical trial. Br J Anaesth. 2025 Mar;134(3):671-680. doi: 10.1016/j.bja.2024.11.017. Epub 2025 Jan 3.

Reference Type: DERIVED

PMID: 39753404 (View on PubMed)

King CR, Fritz BA, Gregory SH, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon SL, Tripathi S, Abdelhack M, Goswami S, de Oca AM, Mehta D, Valdez MA, Karanikolas E, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST collaborator group. Effect of Telemedicine Support for Intraoperative Anaesthesia Care on Postoperative Outcomes: The TECTONICS Randomised Clinical Trial. medRxiv [Preprint]. 2024 Nov 26:2024.05.21.24307593. doi: 10.1101/2024.05.21.24307593.

Reference Type: DERIVED

PMID: 38826207 (View on PubMed)

Fritz B, King C, Chen Y, Kronzer A, Abraham J, Ben Abdallah A, Kannampallil T, Budelier T, Montes de Oca A, McKinnon S, Tellor Pennington B, Wildes T, Avidan M. Protocol for the perioperative outcome risk assessment with computer learning enhancement (Periop ORACLE) randomized study. F1000Res. 2022 Sep 29;11:653. doi: 10.12688/f1000research.122286.2. eCollection 2022.

Reference Type: DERIVED

PMID: 37547785 (View on PubMed)

King CR, Abraham J, Kannampallil TG, Fritz BA, Ben Abdallah A, Chen Y, Henrichs B, Politi M, Torres BA, Mickle A, Budelier TP, McKinnon S, Gregory S, Kheterpal S, Wildes T, Avidan MS; TECTONICS Research Group. Protocol for the Effectiveness of an Anesthesiology Control Tower System in Improving Perioperative Quality Metrics and Clinical Outcomes: the TECTONICS randomized, pragmatic trial. F1000Res. 2019 Nov 29;8:2032. doi: 10.12688/f1000research.21016.1. eCollection 2019.

Reference Type: DERIVED

PMID: 32201572 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01NR017916

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201903026

Identifier Type: -

Identifier Source: org_study_id