Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation

Cardiac Arrest Clinical Trial

— COPILOT-Sim  

Official title:

Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000829
• Other study ID #: COPILOT-SIMULATION
• Secondary ID: 1050317
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2023
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	American Fork Hospital	American Fork	Utah
United States	Intermountain Medical Center	Murray	Utah
United States	The Orthopedic Specialty Hospital	Murray	Utah
United States	McKay-Dee Hospital	Ogden	Utah
United States	Park City Hospital	Park City	Utah
United States	Riverton Hospital	Riverton	Utah
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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.2022.0 — View Citation

Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time From Onset of Shockable Rhythm to Defibrillation		From onset of simulated VF or VT until first defibrillation or end of simulation
Secondary	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)
Secondary	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)
Secondary	Time to First Dose of Epinephrine		From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary	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
Secondary	ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool)		From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary	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
Secondary	Types of Input by Telemedical Intensivist Copilot		From initiation of simulation through termination of simulation, an average of 15 minutes
Secondary	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
Secondary	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
Secondary	Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event		From initiation of simulation through termination of simulation, an average of 15 minutes