Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation (COPILOT-Sim)

This multicenter randomized trial will employ in-situ cardiac arrest simulations ("mock codes") to test whether using telemedicine technology to add an intensive care physician as the "copilot" for cardiac arrest resuscitation teams influences chest compression quality, resuscitation protocol adherence, team function, and provider experience.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Tele-intensivist consultation; Other: Simulated "observation" by ICU physician

Detailed Description

Only 15-30% of patients who suffer in-hospital cardiac arrest (IHCA) survive to hospital discharge. Factors associated with lower mortality and improved function include provision of high-quality, minimally-interrupted chest compressions and swift defibrillation of eligible arrhythmias. Unfortunately, resuscitation teams provide suboptimal care to 25-40% of IHCA victims. A dedicated IHCA team "copilot" may improve resuscitation team performance by providing the team leader with parallel analysis, situational awareness augmentation, action checking, protocol verification, and error correction. Critical care physician involvement via a telemedicine link could allow experienced specialists to fill the "copilot" role in a cost and resource-efficient manner, particularly in smaller hospitals with fewer available physicians.

The current study will evaluate how consultation by an off-site intensive care physician via a telemedicine link influences local IHCA teams' quality of care, team function and provider experience during simulated cardiac arrest events ("mock codes").

• Study Type: Interventional
• Enrollment (Actual): 1001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • American Fork, Utah, United States, 84003
      • American Fork Hospital
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Murray, Utah, United States, 84107
      • The Orthopedic Specialty Hospital
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Park City, Utah, United States, 84060
      • Park City Hospital
    • Riverton, Utah, United States, 84065
      • Riverton Hospital
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria (on-site cardiac arrest team):

• Are 18 years of age or older

Inclusion criteria (teleintensivist cardiac arrest team copilot):

• Are 18 years of age or older
• Are a board-certified or board-eligible critical care physician
• Provide clinical care through the Intermountain Healthcare Telecritical Care program

Exclusion criteria (both groups):

• Are under 18 years of age
• Are a member of the study research team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-intensivist consultation; Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart	Other: Tele-intensivist consultation; Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
Placebo Comparator: Control; Simulated "observation" by ICU physician by displaying a silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site participants will be told that an intensive care physician is observing the mock code.	Other: Simulated "observation" by ICU physician; Display of silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site cardiac arrest team will be told that an intensive care physician is observing the mock code.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fraction of Pulseless Time With no Chest Compressions	From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Onset of Shockable Rhythm to Defibrillation		From onset of simulated VF or VT until first defibrillation or end of simulation
Fraction of Chest Compressions With Complete Release		From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Fraction of Chest Compressions at Target Rate		From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Time to First Dose of Epinephrine		From initiation of simulation through termination of simulation, an average of 15 minutes
Overall ACLS Protocol Adherence (Using Checklist Adapted From McEvoy ACLS Assessment Tool)		From initiation of simulation through termination of simulation, an average of 15 minutes
ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool)		From initiation of simulation through termination of simulation, an average of 15 minutes
Team Emergency Assessment Measure Score	The validated "Team Emergency Assessment Measure (TEAM)" evaluates non-technical performance of the on-site resuscitation team. The score (range 0-4) for each simulation was obtained by averaging the mean score for each of 11 component scores (each component item scored 0-4, with higher values representing better performance).	From initiation of simulation through termination of simulation, an average of 15 minutes
Types of Input by Telemedical Intensivist Copilot		From initiation of simulation through termination of simulation, an average of 15 minutes
Opinions of Study Subjects About Experience Participating in Simulated Cardiac Arrest, Using a Locally-developed and Validated Survey Instrument	Measured domains: understanding of telemedicine intensivist copilot's role, beliefs about telemedicine intensivist copilot's ability to integrate with on site team, ability to influence on-site team performance, comfort with telemedicine intensivist copilot's role, and function of telemedicine interface	Immediately after simulation
Short-form State-Trait Anxiety Inventory Score	The short-form State-Trait Anxiety Inventory (STAI) measures acute stress experienced by respondents using 6 questions (scores for each question range from 1 to 4, with higher values indicating more stress). Analyzed respondent-level values use the total score (range 4-24) obtained by summing the score for each of the six questions, with higher values indicating more respondent-reported acute stress.	Immediately after simulation
Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event		From initiation of simulation through termination of simulation, an average of 15 minutes

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Ithan Peltan, MD, Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.
• Silva JAM, Mininel VA, Fernandes Agreli H, Peduzzi M, Harrison R, Xyrichis A. Collective leadership to improve professional practice, healthcare outcomes and staff well-being. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD013850. doi: 10.1002/14651858.CD013850.pub2.
• Cooper S, Cant R, Porter J, Sellick K, Somers G, Kinsman L, Nestel D. Rating medical emergency teamwork performance: development of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2010 Apr;81(4):446-52. doi: 10.1016/j.resuscitation.2009.11.027. Epub 2010 Feb 1.
• Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
• McKay A, Walker ST, Brett SJ, Vincent C, Sevdalis N. Team performance in resuscitation teams: comparison and critique of two recently developed scoring tools. Resuscitation. 2012 Dec;83(12):1478-83. doi: 10.1016/j.resuscitation.2012.04.015. Epub 2012 May 3.
• Peltan ID, Guidry D, Brown K, Kumar N, Beninati W, Brown SM. Telemedical Intensivist Consultation During In-Hospital Cardiac Arrest Resuscitation: A Simulation-Based, Randomized Controlled Trial. Chest. 2022 Jul;162(1):111-119. doi: 10.1016/j.chest.2022.01.017. Epub 2022 Jan 19.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimated): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Cardiopulmonary resuscitation; Simulation; In-hospital cardiac arrest; Code blue; Code team; Crisis team leadership; Mock code
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: COPILOT-SIMULATION; 1050317 (Other Identifier: Intermountain Health IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No