Cardiac ArrestCOPILOT-SimNCT03000829
Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
A study testing Tele-intensivist consultation and Simulated "observation" by ICU physician in people with Cardiac Arrest, run by Intermountain Health Care, Inc. at 7 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Tele-intensivist consultation and Simulated "observation" by ICU physician
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,001 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Are under 18 years of age
- Are a member of the study research team
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
American Fork Hospital
American Fork, Utah, 84003
Intermountain Medical Center
Murray, Utah, 84107
The Orthopedic Specialty Hospital
Murray, Utah, 84107
McKay-Dee Hospital
Ogden, Utah, 84403
Park City Hospital
Park City, Utah, 84060
Riverton Hospital
Riverton, Utah, 84065
LDS Hospital
Salt Lake City, Utah, 84143
About this study
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.
Read the 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").
- Conditions
- Cardiac Arrest
- Being tested
- Tele-intensivist consultation, Simulated "observation" by ICU physician
- Keywords
- Code blue, Code team, Crisis team leadership, Cardiopulmonary resuscitation, Telemedicine, Simulation, Mock code, In-hospital cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-intensivist consultationOther
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 physicianOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-intensivist consultation | Experimental | Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart Receives: Other: Tele-intensivist consultation |
| Control | Placebo comparator | 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. Receives: Other: Simulated "observation" by ICU physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of Pulseless Time With no Chest Compressions
Measured: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
Secondary outcomes (11)
Time From Onset of Shockable Rhythm to Defibrillation
Measured: From onset of simulated VF or VT until first defibrillation or end of simulation
Fraction of Chest Compressions With Complete Release
Measured: 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
Measured: 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
Measured: 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)
Measured: From initiation of simulation through termination of simulation, an average of 15 minutes
ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool)
Measured: 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).
Measured: From initiation of simulation through termination of simulation, an average of 15 minutes
Types of Input by Telemedical Intensivist Copilot
Measured: 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
Measured: 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.
Measured: Immediately after simulation
Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event
Measured: From initiation of simulation through termination of simulation, an average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ithan Peltan, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000829
- Sponsor's protocol ID
- COPILOT-SIMULATION
- Other IDs
- 1050317
- Acronym
- COPILOT-Sim
- Status last verified
- Dec 2023
- First submitted
- 14 Sep 2016
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.
Publications
Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
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.
PubMed 1393159McKay 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.
PubMed 22561464Cooper 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.
PubMed 20117874Peltan 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.
PubMed 35063451Silva 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.
PubMed 36214207
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
- ClinicalTrials.gov ID
- NCT03000829
- Acronym / sponsor ID
- COPILOT-Sim / COPILOT-SIMULATION
- Conditions
- Cardiac Arrest
- Keywords
- Code blue, Code team, Crisis team leadership, Cardiopulmonary resuscitation, Telemedicine, Simulation, Mock code, In-hospital cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-intensivist consultation | Experimental | Other: Tele-intensivist consultationStandardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart |
| Control | Placebo comparator | Other: Simulated "observation" by ICU physicianSimulated "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are 18 years of age or older
- 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
Key exclusion criteria (2 listed)
- Are under 18 years of age
- Are a member of the study research team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-intensivist consultationStandardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart | Other | Tele-intensivist consultation |
| Simulated "observation" by ICU physicianDisplay 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. | Other | Control |
Primary outcome
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)
11 secondary outcomes
Time From Onset of Shockable Rhythm to Defibrillation
Time frame: 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)
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)
Time to First Dose of Epinephrine
Time frame: 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
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
Team Emergency Assessment Measure Score
Time frame: 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
Opinions of Study Subjects About Experience Participating in Simulated Cardiac Arrest, Using a Locally-developed and Validated Survey Instrument
Time frame: Immediately after simulation
Short-form State-Trait Anxiety Inventory Score
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSpielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
- Background: PubMed 1393159Marteau 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.
- Background: PubMed 22561464McKay 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.
- Background: PubMed 20117874Cooper 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.
- Results publication: PubMed 35063451Peltan 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.
- Derived from this study: PubMed 36214207Silva 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ithan Peltan, MD principal investigator
Intermountain Health Care, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-intensivist consultation and Simulated "observation" by ICU physician in people with Cardiac Arrest, run by Intermountain Health Care, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000829, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.