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Completed

NCT Number: NCT03000829

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Fork Hospital, American Fork, Utah, United States

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About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-intensivist consultation

Other

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

Other

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.

Primary outcomes

  1. Fraction of Pulseless Time With no Chest Compressions

    Time frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)

Secondary outcomes

  1. Time From Onset of Shockable Rhythm to Defibrillation

    Time frame: From onset of simulated VF or VT until first defibrillation or end of simulation

  2. Fraction of Chest Compressions With Complete Release

    Time frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)

  3. Fraction of Chest Compressions at Target Rate

    Time frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)

  4. Time to First Dose of Epinephrine

    Time frame: From initiation of simulation through termination of simulation, an average of 15 minutes

  5. Overall ACLS Protocol Adherence (Using Checklist Adapted From McEvoy ACLS Assessment Tool)

    Time frame: From initiation of simulation through termination of simulation, an average of 15 minutes

  6. ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool)

    Time frame: From initiation of simulation through termination of simulation, an average of 15 minutes

  7. Team Emergency Assessment Measure Score

    Time frame: From initiation of simulation through termination of simulation, an average of 15 minutes

    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).

  8. Types of Input by Telemedical Intensivist Copilot

    Time frame: From initiation of simulation through termination of simulation, an average of 15 minutes

  9. Opinions of Study Subjects About Experience Participating in Simulated Cardiac Arrest, Using a Locally-developed and Validated Survey Instrument

    Time frame: Immediately after simulation

    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

  10. Short-form State-Trait Anxiety Inventory Score

    Time frame: Immediately after simulation

    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.

  11. Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event

    Time frame: From initiation of simulation through termination of simulation, an average of 15 minutes

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Acronym: COPILOT-Sim

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2016
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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