Cardiac Arrest
Conditions
Keywords
Code blue, Code team, Crisis team leadership, Cardiopulmonary resuscitation, Telemedicine, Simulation, Mock code, In-hospital cardiac arrest
Brief 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, 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).
Interventions
OTHERTele-intensivist consultation
Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
OTHERSimulated 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.
Sponsors
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of Pulseless Time With no Chest Compressions | From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of Chest Compressions With Complete Release | 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 | 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 | 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) | From initiation of simulation through termination of simulation, an average of 15 minutes | — |
| ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool) | From initiation of simulation through termination of simulation, an average of 15 minutes | — |
| Time From Onset of Shockable Rhythm to Defibrillation | From onset of simulated VF or VT until first defibrillation or end of simulation | — |
| Types of Input by Telemedical Intensivist Copilot | 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 | 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 |
| Short-form State-Trait Anxiety Inventory Score | 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. |
| Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event | From initiation of simulation through termination of simulation, an average of 15 minutes | — |
| Team Emergency Assessment Measure Score | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 521 |
| 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
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 | 45 |
| 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. | 466 |
| 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. | 37 |
| Total | 1,069 |
Baseline characteristics
| Characteristic | Control | Total | Tele-intensivist Consultation |
|---|---|---|---|
| Age, Customized Age | NA Simulation events | NA Simulation events | NA Simulation events |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 466 participants | 987 participants | 521 participants |
| Sex: Female, Male Female | NA Simulation events | NA Simulation events | NA Simulation events |
| Sex: Female, Male Male | NA Simulation events | NA Simulation events | NA Simulation events |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 466 | 0 / 521 |
| serious Total, serious adverse events | 0 / 466 | 0 / 521 |
Outcome results
Primary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Fraction of Pulseless Time With no Chest Compressions | 0.22 Fraction analysis time CPR not delivered | Standard Deviation 0.13 |
| Control | Fraction of Pulseless Time With no Chest Compressions | 0.19 Fraction analysis time CPR not delivered | Standard Deviation 0.1 |
p-value: 0.41t-test, 2 sided
Secondary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool) | 2.8 Number of protocol errors | Standard Deviation 1.7 |
| Control | ACLS Protocol Errors (Using Checklist Adapted From McEvoy ACLS Assessment Tool) | 2.9 Number of protocol errors | Standard Deviation 1.4 |
p-value: 0.84t-test, 2 sided
Secondary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Fraction of Chest Compressions at Target Rate | 0.59 Fraction compression in analysis window | Standard Deviation 0.23 |
| Control | Fraction of Chest Compressions at Target Rate | 0.58 Fraction compression in analysis window | Standard Deviation 0.29 |
p-value: 0.87t-test, 2 sided
Secondary
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Fraction of Chest Compressions With Complete Release | 0.89 Fraction compression in analysis window | Standard Deviation 0.14 |
| Control | Fraction of Chest Compressions With Complete Release | 0.89 Fraction compression in analysis window | Standard Deviation 0.15 |
p-value: 0.97t-test, 2 sided
Secondary
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
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tele-intensivist Consultation | 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 |
| Tele-intensivist Consultation | 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
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Overall ACLS Protocol Adherence (Using Checklist Adapted From McEvoy ACLS Assessment Tool) | 0.77 Fraction of eligible actions performed | Standard Deviation 0.11 |
| Control | Overall ACLS Protocol Adherence (Using Checklist Adapted From McEvoy ACLS Assessment Tool) | 0.78 Fraction of eligible actions performed | Standard Deviation 0.12 |
p-value: 0.62t-test, 2 sided
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Tele-intensivist Consultation | Presence of Telemedicine Audiovisual Connection Problems for Intervention Group Simulation Event | 14 Simulation events |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Short-form State-Trait Anxiety Inventory Score | 12.9 score on a scale | Standard Deviation 2.1 |
| Control | Short-form State-Trait Anxiety Inventory Score | 12.9 score on a scale | Standard Deviation 1.9 |
p-value: 0.92Mixed Models Analysis
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Team Emergency Assessment Measure Score | 3.2 score on composite TEAM scale | Standard Deviation 0.6 |
| Control | Team Emergency Assessment Measure Score | 3.3 score on composite TEAM scale | Standard Deviation 0.6 |
p-value: 0.4t-test, 2 sided
Secondary
Time From Onset of Shockable Rhythm to Defibrillation
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Time From Onset of Shockable Rhythm to Defibrillation | 37 seconds | Standard Deviation 33 |
| Control | Time From Onset of Shockable Rhythm to Defibrillation | 36 seconds | Standard Deviation 25 |
p-value: 0.86t-test, 2 sided
Secondary
Time to First Dose of Epinephrine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tele-intensivist Consultation | Time to First Dose of Epinephrine | 329 seconds | Standard Deviation 130 |
| Control | Time to First Dose of Epinephrine | 344 seconds | Standard Deviation 124 |
p-value: 0.63t-test, 2 sided
Secondary
Types of Input by Telemedical Intensivist Copilot
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tele-intensivist Consultation | Types of Input by Telemedical Intensivist Copilot | Arrest etiology identification | 27 Simulation events |
| Tele-intensivist Consultation | Types of Input by Telemedical Intensivist Copilot | Arrest etiology treatment | 24 Simulation events |
| Tele-intensivist Consultation | Types of Input by Telemedical Intensivist Copilot | Medical record review | 26 Simulation events |
| Tele-intensivist Consultation | Types of Input by Telemedical Intensivist Copilot | Role clarity for on-site team | 19 Simulation events |
| Tele-intensivist Consultation | Types of Input by Telemedical Intensivist Copilot | CPR quality | 10 Simulation events |