Trial Outcomes & Findings for Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation (NCT NCT03000829)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1001 participants

Primary outcome timeframe

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

Results posted on

2024-05-31

Participant Flow

Unit of analysis: Simulation events

Participant milestones

Participant milestones
Measure	Tele-intensivist Consultation Cardiac Arrest Simulations Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control Cardiac Arrest Simulations 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. 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.	Telemedical Intensivist Consultants Critical care physicians serving as consultants during simulation events randomized to tele-intensivist consultation
Overall Study STARTED	521 45	466 37	14 0
Overall Study COMPLETED	521 45	466 37	14 0
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age of on-site simulation participants - not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tele-intensivist Consultation n=45 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=37 Simulation events 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. 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.	Total n=82 Simulation events Total of all reporting groups
Age, Customized Age	NA Simulation events n=45 Simulation events • Age of on-site simulation participants - not collected	NA Simulation events n=37 Simulation events • Age of on-site simulation participants - not collected	NA Simulation events n=82 Simulation events • Age of on-site simulation participants - not collected
Sex: Female, Male Female	NA Simulation events n=45 Simulation events	NA Simulation events n=37 Simulation events	NA Simulation events n=82 Simulation events
Sex: Female, Male Male	NA Simulation events n=45 Simulation events	NA Simulation events n=37 Simulation events	NA Simulation events n=82 Simulation events
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	521 participants n=521 Participants	466 participants n=466 Participants	987 participants n=987 Participants

PRIMARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction precluded measurement of compression quality were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=36 simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=35 simulation events 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. 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.
Fraction of Pulseless Time With no Chest Compressions	0.22 Fraction analysis time CPR not delivered Standard Deviation 0.13	0.19 Fraction analysis time CPR not delivered Standard Deviation 0.10

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available and resuscitation team delivered ≥1 shock to the mannequin during the simulation. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of protocol adherence were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=30 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=31 Simulation events 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. 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.
Time From Onset of Shockable Rhythm to Defibrillation	37 seconds Standard Deviation 33	36 seconds Standard Deviation 25

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of compression quality were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=36 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=35 Simulation events 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. 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.
Fraction of Chest Compressions With Complete Release	0.89 Fraction compression in analysis window Standard Deviation 0.14	0.89 Fraction compression in analysis window Standard Deviation 0.15

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of compression quality were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=35 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=36 Simulation events 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. 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.
Fraction of Chest Compressions at Target Rate	0.59 Fraction compression in analysis window Standard Deviation 0.23	0.58 Fraction compression in analysis window Standard Deviation 0.29

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available and epinephrine was administered. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of protocol adherence were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=33 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=31 Simulation events 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. 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.
Time to First Dose of Epinephrine	329 seconds Standard Deviation 130	344 seconds Standard Deviation 124

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of protocol adherence were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=34 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=32 Simulation events 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. 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.
Overall ACLS Protocol Adherence (Using Checklist Adapted From McEvoy ACLS Assessment Tool)	0.77 Fraction of eligible actions performed Standard Deviation 0.11	0.78 Fraction of eligible actions performed Standard Deviation 0.12

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of protocol adherence were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=34 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=32 Simulation events 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. 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.
ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool)	2.8 Number of protocol errors Standard Deviation 1.7	2.9 Number of protocol errors Standard Deviation 1.4

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of team performance were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

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).

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=34 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=32 Simulation events 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. 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.
Team Emergency Assessment Measure Score	3.2 score on composite TEAM scale Standard Deviation 0.6	3.3 score on composite TEAM scale Standard Deviation 0.6

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of telemedical intensivist input were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=32 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	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. 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.
Types of Input by Telemedical Intensivist Copilot Arrest etiology identification	27 Simulation events	—
Types of Input by Telemedical Intensivist Copilot Arrest etiology treatment	24 Simulation events	—
Types of Input by Telemedical Intensivist Copilot Medical record review	26 Simulation events	—
Types of Input by Telemedical Intensivist Copilot Role clarity for on-site team	19 Simulation events	—
Types of Input by Telemedical Intensivist Copilot CPR quality	10 Simulation events	—

SECONDARY outcome

Timeframe: Immediately after simulation

Population: Pre-specified analysis included complete surveys returned by on-site participants in completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction or simulation error precluded measurement of resuscitation quality were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

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

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=275 Participants Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	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. 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.
Opinions of Study Subjects About Experience Participating in Simulated Cardiac Arrest, Using a Locally-developed and Validated Survey Instrument Survey participant: "Telemedical intensivist consultation improved the resuscitation care quality."	174 Participants	—
Opinions of Study Subjects About Experience Participating in Simulated Cardiac Arrest, Using a Locally-developed and Validated Survey Instrument Survey participant: "Telemedical intensivist consultation helped team function more smoothly."	176 Participants	—

SECONDARY outcome

Timeframe: Immediately after simulation

Population: Pre-specified analysis included completed surveys by participants completed simulations for which complete compression quality data were available. Per protocol, participants in simulations for which equipment malfunction or simulation error precluded measurement of compression quality were excluded, as were participants in intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

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.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=259 Participants Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	Control n=275 Participants 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. 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.
Short-form State-Trait Anxiety Inventory Score	12.9 score on a scale Standard Deviation 2.1	12.9 score on a scale Standard Deviation 1.9

SECONDARY outcome

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

Population: Pre-specified analysis included completed simulations for which complete compression quality data were available. Per protocol, simulations for which equipment malfunction precluded measurement of compression quality were excluded, as were intervention-group simulations classified as "run-in" simulations because they occurred before optimization of the telemedicine audio equipment.

Outcome measures

Outcome measures
Measure	Tele-intensivist Consultation n=36 Simulation events Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart 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	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. 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.
Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event	14 Simulation events	—

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tele-intensivist Consultation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ithan Peltan

Intermountain Health

Phone: 801-507-6556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place