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

December 14, 2023 updated by: Intermountain Health Care, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1001

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time From Onset of Shockable Rhythm to Defibrillation
Time Frame: From onset of simulated VF or VT until first defibrillation or end of simulation
From onset of simulated VF or VT until first defibrillation or end of simulation
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)
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
Time Frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
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
Time Frame: From initiation of simulation through termination of simulation, an average of 15 minutes
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)
Time Frame: From initiation of simulation through termination of simulation, an average of 15 minutes
From initiation of simulation through termination of simulation, an average of 15 minutes
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
From initiation of simulation through termination of simulation, an average of 15 minutes
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).
From initiation of simulation through termination of simulation, an average of 15 minutes
Types of Input by Telemedical Intensivist Copilot
Time Frame: From initiation of simulation through termination of simulation, an average of 15 minutes
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
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
Immediately after simulation
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.
Immediately after simulation
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
From initiation of simulation through termination of simulation, an average of 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intermountain Health Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ithan Peltan, MD, Intermountain Health Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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