Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
Phase: NA
Conditions: Cardiac Arrest
Sponsor: Intermountain Health Care, Inc.

COPILOT Simulation Study Protocol 
 
July 10, 2017 
 
1
 
Protocol 
 
Title:  
Code Blue Outcomes & Process Improvement through Leadership 
Optimization using Teleintensivists-Simulation (COPILOT-Simulation) 
 
ClinicalTrials.gov ID: 
NCT03000829 
 
Study sites: 
Alta View Medical Center, American Fork Hospital, Heber Valley Medical Center, 
Intermountain Medical Center, LDS Hospital, McKay-Dee Hospital, Park City 
Medical Center, Riverton Hospital, The Orthopedic Specialty Hospital 
 
Principle investigator:  Ithan Peltan, MD, MSc 
 
Sponsor:  
 
Intermountain Research and Medical Foundation 
 
 
 
 

COPILOT Simulation Study Protocol 
 
July 10, 2017 
 
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PROTOCOL 
 
Code Blue Outcomes & Process Improvement through 
Leadership Optimization using Teleintensivists-Simulation  
(COPILOT-Simulation) 
 
Principle Investigator: Ithan Peltan, MD, MSc 
 
Purpose of the Study: Our long-term goal is to improve patient outcomes after in-hospital cardiac arrest 
(IHCA), an event often referred to as a “Code Blue.” The current project will evaluate the effect of 
telemedical consultation by an intensive care physician to assist local IHCA teams.  
 
Research Questions: Does remote consultation by experienced intensivists “copilots” improve the 
quality of resuscitation delivered by IHCA teams? 
 
Study summary: We will conduct a multicenter randomized trial using in-situ cardiac arrest simulations 
(“mock codes”) to test the effect of adding a telemedical intensivist “copilot” to IHCA teams on chest 
compression quality, ACLS protocol adherence, team function, and provider experience. 
 
Hypothesis: Intensivist support of the IHCA team during mock codes improves chest compression quality. 
 
Background and Significance: Only 15-30% of patients who suffer in-hospital cardiac arrest (IHCA) 
survive to hospital discharge.1,2 Factors associated with lower mortality and improved function include 
provision of high-quality, minimally-interrupted chest compressions, prompt administration of 
epinephrine, and swift defibrillation of eligible arrhythmias.3-6 Unfortunately, resuscitation teams 
provide suboptimal care to 25-40% of IHCA victims, with significant variation in IHCA outcomes and 
process adherence documented between hospitals.3,7 Resource limitations and less-experienced 
providers may explain lower IHCA at small hospitals and on nights and weekends.8,9 Although 
educational and technological interventions may improve patient outcomes, the gap between optimal 
and actual resuscitation practice remains large.1,10 Barriers to effective IHCA resuscitation countered by 
effective leadership include response teams’ ad hoc formation and variable structure and member 
expertise.11-13 Explicit leadership training improves processes of care and outcomes for IHCA 
resuscitation, but standard Advanced Cardiac Life Support (ACLS) training provides little instruction non-
technical skills critical for high-functioning IHCA teams.12,14,15 A dedicated, leadership-trained “copilot” 
on cardiac arrest resuscitation teams may improve IHCA outcomes by performing the same functions — 
parallel analysis, situational awareness augmentation, action checking, protocol verification, and error 
correction — for the resuscitation team leader that an airplane copilot provides the pilot during an in-
flight emergency. Employing telemedical technology to involve the “copilot” physician will allow this role 
to be filled by an intensivist physician with particular expertise in care of critical illness and will provide 
long-term cost and resource efficiencies, particularly in smaller hospitals with fewer available physicians. 
 
Research subjects: We will conduct mock codes at Intermountain Healthcare hospitals, specifically 
Intermountain Medical Center, LDS Hospital, Riverton Hospital, The Orthopedic Specialty Hospital, 
McKay-Dee Hospital, Park City Medical Center, and American Fork Hospital. 
 
• 
Local IHCA team: Intermountain Healthcare employees, resident physicians, and affiliated care 
providers who are either designated members of each participating hospital’s IHCA response 

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teams or act as voluntary responders to announced mock codes will be eligible to participate. 
The number of on-site participants for each simulated IHCA event is expected to average 15-25.  
• 
Telemedical intensivist IHCA copilot: Board-certified or board-eligible critical care medicine 
physicians on the staff of the Intermountain Healthcare Telecritical Care Center will act as IHCA 
team copilot. The total number of expected participants is up to 30.  
 
Recruitment: 
• 
Local IHCA team: IHCA team activation will employ the participating hospital’s standard 
mechanism. A sign posted outside the room used for the mock code will indicate that a video-
recorded simulation is taking place. After completion of the simulation, participants will receive 
an information sheet about the study.  
• 
Telemedical intensivist IHCA copilot: Eligible telemedical intensivists will be invited to participate 
by email and in person. 
 
Methods/Procedures:  
• 
Study design: Randomized, multicenter, simulation-based clinical trial  
• 
Intervention: Standardized consultation to IHCA team by off-site intensivist via two-way 
audiovisual link using a mobile telemedicine cart 
• 
Control: Display of 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. 
• 
Randomization: Each event will be randomly assigned to intervention or control using block 
randomization by hospital. 
• 
Procedures:  
o All event will be randomly pre-assigned to intervention (participation via telemedicine 
link by a remote critical care physician) or control (prerecorded video of telemedicine 
physician displayed on mobile telemedicine cart). 
o A research coordinator will arrange a time for mock code with local hospital clinical 
leadership and Code Blue leadership. The remainder of the IHCA team will not be 
informed that the announced event is a simulation prior to team activation. 
o The research coordinator and an experienced simulation technician will set up 
simulation equipment in an unused patient care room on the general medical or surgical 
ward at the hospital, including video recording device and mobile telemedicine cart. 
o Research coordinator will obtain final confirmation with the on duty clinical leadership 
that simulation will not interfere with patient care. 
o The hospital’s on duty IHCA resuscitation team will then be activated via the hospital’s 
standard mechanism. 
o Upon arrival to the room, members of the designated IHCA team and other care 
providers will be informed via a posted sign that the event is a videorecorded research 
simulation. They will then begin participate in the simulation at their discretion. 
o We will adapt existing, tested cardiac arrest simulation scenarios for use in this study.  
While the provided case histories will describe patients of different ages, genders, and 
presenting complaints, all scenarios will feature cardiac rhythms demanding 
substantively identical resuscitative actions (Figure 1).  
o The telemedical link (or a control video) will be activated by the research coordinator 
after the arrival of the team lead or after five minutes have elapsed, whichever occurs 
first. At this time, the coordinator will also provide simple, brief, and scripted “just-in-

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time” training to the mobile telemedicine cart and, for intervention events, the 
telemedical intensivist copilot.  
o For mock codes randomized to intervention, critical care physicians with experience in 
telecritical care who consent to participate in this study will provide standardized 
consultation to the on-site team. 
These IHCA team “copilots” will 
advice and assistance to the on-
site team leader including help 
with ensuring high-quality, 
minimally-interrupted chest 
compressions and prompt 
defibrillation, assisting 
situational awareness, 
encouraging etiologic evaluation, 
and promoting leadership 
behaviors. 
o The event will be terminated when team performs an action that was pre-determined 
for the scenario to result in return of spontaneous circulation. The simulation will be 
terminated no later than 25 minutes after initiation if team fails to perform this pre-
determined action. Most simulations are expected to last 10-12 minutes.  
o After simulation termination, participants will complete a brief, anonymous questionnaire.  
o Local code team leadership and/or the on-site code team leader will lead a debrief of 
the event. As needed, the research coordinator or simulation specialist will facilitate 
discussion of the simulation. 
o In progress mock code simulations may be terminated by on-duty hospital clinical 
leadership or physician code team members if clinical care of patients requires.  
• 
Mock codes terminated in progress due to competing clinical priorities prior to simulated return 
of spontaneous circulation will be excluded from the final analysis. If this occurs, the simulation 
event may be rescheduled at the same hospital for a later date, with the rescheduled mock code 
assigned to the same study arm as the aborted mock code. 
• 
If systematic problems interfering with study implementation, data collection, or interpretation 
are identified after study initiation, the study may be halted temporarily while the systematic 
issues are addressed. Affected events where data is invalid will be considered part of a roll-in 
phase of the study and will be excluded from data analysis. For each assigned to roll-in event 
status, we will schedule a make-up event at the affected hospital. Make-up events will be 
assigned to the same study arm as the roll-in event being replaced and will be interposed 
randomly with other events at the affected study site. 
• 
Data collection: A research coordinator will be present at all mock codes. Besides study 
implementation duties, the coordinator will record team composition and function, processes of 
care, and leadership behaviors. Additional data will be obtained from (1) the simulator device, (2) 
the defibrillator device, (3) videotaped recording obtained via the mobile telemedicine carts, and 
(4) a brief questionnaire completed by IHCA team members upon completion of the mock code. 
• 
The primary outcome for the study will be the fraction of time between activation of the 
telemedicine cart and beginning of the pulse check following the subsequent second full cycle of 
CPR that the IHCA team does not deliver chest compressions (“no-flow fraction”). Secondary 
outcomes are shown in Table 1.  
 On-site IHCA team members will complete a brief questionnaire (attached) to measure 
the subjective experience of individual and team function and — when applicable, 
Figure 1. Unified structure for mock code scenarios. (ROSC: 
return of spontaneous circulation.)  

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opinions about the simulated mock code. Some on-site study participants will also 
complete a short-form version of the State-Trait Anxiety Index (STAI)16 validated for 
measurement of state anxiety (i.e. anxiety/stress at the time the questions are 
answered).17 Some participants may complete the survey online using REDCap, a secure 
web application for building and managing online surveys and databases.18 
o Off-site IHCA team copilots will complete a brief questionnaire (attached). Most 
participants may complete the survey online using a version of this questionnaire 
implemented in REDCap.18 Opinions about the procedure will also be elicited through 
post-study qualitative interviews. 
 ACLS protocol adherence and violations using a checklist adapted from previously 
validated research tools.8,40  
o Leadership behaviors will be evaluated according to a previously published taxonomy.19  
o Overall function of the IHCA team will also be evaluated using a previously validated 
instrument.20,21 
• 
Number of simulation events and power analysis: Assuming a baseline no-flow percentage of 
0.285,10,22 a best-case no-flow fraction of 0.08 (protocol guidelines advise a single 10 second 
pause in chest compressions for a pulse and cardiac rhythm check every two minutes), and 
equipment malfunction or simulation termination precluding event analysis for 15% of mock 
codes, we will require 76 completed mock codes (38 in each arm) to achieve 80% power to 
detect a 31% relative decrease (9% absolute decrease) in the mean no-flow fraction.  
• 
Study duration: The 76 planned mock codes will be divided between the 7-8 participating 
institutions. We expect to complete 2-6 simulations at each participating hospital every 2 
months. Accounting for scheduling conflicts and expected intermissions during implementation 
of a new electronic medical record at some study hospitals, we expect study completion to 
require 18-24 months (and potentially up to 48 months) after simulations begin. 
 
Informed consent (“copilot” physicians): Members of the research team will approach the eligible 
subjects by email (see attached) or in person at their workplace. Interested subjects will be consented 
by research team member(s) according to the Intermountain Healthcare Informed Consent Policy.  
Table 1: Descriptive & outcome measures for randomized trial of telemedical intensivist IHCA team copilot 
Variable 
Data source 
Primary 
Secondary 
Response team characteristics 
 
 
Response team structure 
In-person observation 
Video recording 
Past experience of code team members 
Questionnaire 
 
 
 
 
Primary outcome 
 
 
Fraction of pulseless time with no chest compressions* 
Simulator mannequin 
 
 
 
 
Secondary outcomes 
 
 
Time from onset of shockable rhythm to defibrillation 
Simulator mannequin 
Defibrillator 
Fraction of chest compressions in target depth range 23* 
Simulator mannequin 
Defibrillator 
Fraction of chest compressions with incomplete release*  
Simulator mannequin 
Defibrillator 
Fraction of 30s segments with 8-12 breaths/minute23* 
Simulator mannequin 
Defibrillator 
Fraction chest compressions at target rate (100-120/minute)* 
Simulator mannequin 
Defibrillator 
Time to first dose of epinephrine 
In-person observation 
Video recording 
ACLS protocol adherence fraction (using validated instrument)
24 
In-person observation 
Video recording 

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Data analysis:  
The primary analysis will include completed simulation where CPR quality data is complete and 
non-corruprted. Simulations for which equipment malfunction preclude measurement of compression 
quality will be excluded from analysis. Simulation events where malfunction of audiovisual recording 
equipment or major deviations during simulation implementation prevent accurate evaluation of 
resuscitation team performance and protocol will be excluded from analyses addressing these topics. 
Prematurely terminated simulation events and simulation events classified as run-in events will be 
excluded from all analyses. 
Between-group comparisons for continuous variables will employ two-sided t-tests with 
unequal variance. Comparisons for binary or categorical variables will employ Fisher’s exact test or chi-
squared test as appropriate. Given clustering within simulations, between-group comparisons of of 
survey responses will employ multilevel logistic (for binary variables) or linear (for continuous variables) 
regression with a random effect for simulation event. Comparisons of Likert-style variables will use the 
rank-sum method described Datta/Satten.28 
 
Sample size/power analysis: Assuming a baseline no-flow percentage of 0.285, a best-case no-flow 
fraction of 0.08 (protocol guidelines advise a single 10 second pause in chest compressions for a pulse 
and cardiac rhythm check every two minutes), and equipment malfunction or simulation termination 
precluding event analysis for 15% of mock codes, we will require 76 mock codes (38 in each arm) to 
achieve 80% power to detect a 31% relative decrease (9% absolute decrease) in the mean no-flow 
fraction. We therefore expect to enroll 1900 on-site IHCA team members as study subjects (although 
some participants may participate in >1 mock code). 
 
Waiver of Informed Consent and HIPAA Authorization (for on-site IHCA team members): 
We are requesting a waiver of informed consent and HIPAA authorization for on-site IHCA team 
study participants of this study. Participation in this study is similar to standard training for IHCA team 
members and involves no more than minimal risk to the subject. Individuals will be notified by means of 
a prominently displayed poster(s) that a simulation-based research project with video recording is in 
progress. Such notification will address individuals reasonable expectation of privacy. We will not use 
video recordings for any purposes except research, and digital video recordings will be stored securely 
and then transferred to a secure, approved server of the Intermountain network. We will not 
systematically collect individually identifiable information. The research therefore involves no more than 
minimal risk to the subjects; the only potential risk is a breach of confidentiality, and protections are in 
place to safeguard the data. Because risk is minimal, the waiver of consent and authorization will not 
adversely affect the rights or welfare of subjects. 
ACLS protocol errors of commission, timing and omission
24 
In-person observation 
Video recording 
Team Emergency Assessment Measure (TEAM) score20 
In-person observation 
Video recording 
Number and types of input by telemedical intensivist copilot 
Video recording 
In-person observation 
On-site provider experience during mock-code 
Questionnaire 
 
On-site provider satisfaction with telemedical intensivist copilot 
Questionnaire 
 
On-site provider short-form State-Trait Anxiety Inventory score 
16,17 
Questionnaire 
 
Off-site copilot experience during mock code 
Questionnaire 
Qualitative interview 
Audiovisual connection or equipment problems (logistic or technical) 
In-person observation 
Questionnaire 
* Outcome measured over (1) primary analysis window and from  (2) activation of telemedicine cart; (3) “Code Blue” 
activation; and (4) from arrival of first resuscitation team member until simulation termination 

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The research could not practicably be carried out without the waiver of consent and 
authorization. Most hospitals have dozens or even hundreds of staff eligible to participate formally in 
IHCA responses. We would estimate that more than 2000 individuals are eligible for study participation. 
Team membership is also flexible, and the list of eligible IHCA team members for each hospital is 
expected to vary significantly over the 24 months of this study as staffing changes. Finally, for hospitals 
announcing IHCA team activations via a public address system, additional ad hoc participation by other 
staff is to be expected. For all of these reasons, we are unable to identify and consent in advance 
individuals who will participate in simulations. Moreover, including on IHCA simulation teams only those 
subjects for whom advance consent could be obtained would compromise the scientific validity of the 
study and preclude useful conclusions, as a large proportion of the data would be eliminated if obtaining 
consent were a requirement. Informed consent would markedly increase the response burden for 
participants, thereby reducing response rates and compromising study validity.  
Similarly, obtaining consent after IHCA team activation and individual’s arrival to the simulation 
site but prior to an individual beginning participation in the simulation is also not feasible. This would 
preclude the necessarily rapid formation of a IHCA response team and abolish the simulation’s fidelity to 
actual cardiac arrest event, introducing significant bias into the results and compromising the scientific 
validity of the data obtained. 
On-site participants in code simulations will be provided an information sheet about study 
participation at the time the simulation concludes. 
Safeguards will be in place to protect subject identity. The data will be protected from improper 
use or disclosure.  The study data will be kept on encrypted, password-protected computers. The data 
will only be accessible to members of the research team, and all members of the research team with 
access to identifiable data have completed Human Subjects Protections training and understand the 
importance of protecting subject privacy and confidentiality. These computers are Intermountain 
Healthcare devices, which are routinely used for storage of patient data and research data including 
subject identifiers. No individual subject data will be presented in any presentation, publication, or 
report related to this research. Data will be presented only in aggregate or as results of statistical 
analyses and will not include any individual-level data that could be traced to a particular subject.  
 
Risks: Both the off-site copilot and on-site study participants may find participation in simulated IHCA 
events stressful. This expected stress related to the simulation is similar to the stress participants would 
experience during performance of their routine job duties or routine training related to these duties. 
On-site participants will have an opportunity to discuss their experience during the simulation during 
post-event debriefings. 
 
The only other risk involved with this study is a potential breach of confidentiality. There is a minimal 
risk of a privacy and confidentiality breach. However, this risk is low given the secured databases and 
computers that will be employed for data storage. 
 
Benefits: It is unlikely that there will be any direct benefit to you as a result of participating in this study. 
Participation in simulated IHCA events may improve the skills used by both on-site IHCA team members 
and the telemedical copilot when managing actual patients suffering medical emergencies. Improved 
understanding of cardiac arrest resuscitation could improve outcomes for all patients suffering IHCA. 
 
Compensation:  
▪ 
On-site IHCA team member:  A small snack/drink or similar token of appreciation, valued at $1-2 
each, will be available for members of on-site code team after simulation completes 
▪ 
Telemedical physician copilot: Fleece jacket, valued at approximately $35-50 

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Data Collection: A research coordinator will be present at all mock codes. Besides study implementation 
duties, the coordinator will record team composition and function, processes of care, and leadership 
behaviors. Additional data will be obtained from (1) the simulator device, (2) the defibrillator device, (3) 
review of video recording of simulation event, (4) a brief questionnaire completed by IHCA team 
members upon completion of the mock code, and (5) a brief questionnaire completed by the 
telemedical physician copilot. 
 
Data elements for collection 
• 
Telemedical critical care physician (“copilot”) 
▪ 
Name 
▪ 
DOB 
▪ 
Email 
▪ 
Telephone 
▪ 
Race/ethnicity 
▪ 
Year completed medical school 
▪ 
Year completed post-graduate training 
▪ 
Date of first experience with telecritical care 
▪ 
Telecritical care shifts per year 
▪ 
Sex 
▪ 
Age 
▪ 
Credential type (MD vs DO) 
▪ 
Experience with in-person cardiac arrest events led 
▪ 
Date/time of each study simulation participation 
▪ 
Opinions about impact, utility, and feasibility of “copilot” interaction (survey) 
▪ 
Opinions about impact, utility, and feasibility of “copilot” interaction (post-participation 
qualitative interview) 
• 
On-site code team participants 
o Event ID 
o Profession 
o Specialty (if physician) 
o Role on IHCA team 
o IHCA team participation frequency 
o Experience participating in mock code 
o Opinions about code team function during mock code 
o Opinions about impact, utility, and feasibility of “copilot” interaction 
 Short form State-Trait Anxiety Inventory16,17 
• 
Simulation events (see also Table 1) 
o Location 
o Date/time of event 
o Participant numbers and professions 
o Simulation duration 
o Date/time of key response parameters (i.e. team leader arrival) 
o Date/time of key resuscitation events 
o CPR quality 
o Interventions by IHCA team 
o ACLS protocol adherence 
o ACLS protocol deviation & errors 

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o Etiology identification 
o IHCA team function 
o Debriefing (Y/N) and themes 
o Telemedicine interface function 
o Leadership behaviors by IHCA team leader 
 
Privacy, Confidentiality and Data Management 
Names, date of birth, email addresses, and telephone numbers of participating telemedicine 
critical care physicians will be maintained in a protected database on a protected computer and within 
the secure REDCap interface until completion of data collection and analysis. Individual identifiers will 
subsequently be deleted. We will not collect any individual identifiers for on-site IHCA team members. 
Paper questionnaires will be maintained securely in a locked office. All electronic subject and simulation 
data, including digital video recordings, will be kept in a protected database on a protected computer or 
server after transfer from collection devices. Video recordings will be viewed only be research staff and 
will be destroyed after completion of data collection and analysis. Information about physician and mid-
level remuneration (name/remuneration value) will be provided to Intermountain compliance officials 
to comply with requirements for imposed by the federal Stark Law requiring tracking of non-montary 
compensation given to clinicians. 
To comply with scientific journal data sharing requirements, deidentified and anonymized data 
from the proposed study may be shared with other researchers upon request. Deidentified and 
anonymized data may also be deposited to one or more research data repositories such as the Harvard 
Dataverse Network, the Dryad Digital Repository, or other data repository recommended by the specific 
journal in which study results are being published. 
 
Funding: This study is funded by a grant from the Intermountain Research and Medical Foundation. 
 
Appendix:  
• 
Post-simulation questionnaire for on-site IHCA team members 
• 
Post-simulation questionnaire for telecritical care physicians 
• 
State-Trait Anxiety inventory short form 
• 
Telemedical critical care physician recruitment emails 
• 
Informed consent for telemedical critical care physician 
• 
Poster for display outside simulation room 
• 
Information sheet for distribution to on-site IHCA team members after each simulation 
 
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