Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Evaluation of the InterFACE-AR System for Cardiopulmonary Arrest A Multicenter Randomized Controlled Trial
Sponsor:
KidSIM Simulation Program
Organization:
KidSIM Simulation Program
Study Overview
Official Title:
Design Development and Evaluation of an Augmented Reality and Screen-based Decision Support System for Cardiopulmonary Arrest a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InterFACE-AR
Brief Summary:
Cognitive aids are decision support tools that present prompts to encourage recall of information thus freeing up mental resources to increase the likelihood of desired behaviors Cognitive aids have been trialed in different forms for use during resuscitation including pocket reference cards and digital apps Simulation-based studies of cognitive aid used during cardiac arrest events have shown improved adherence to guidelines improved time to completing critical tasks and reduced rate of critical errors Unfortunately existing pocket reference cards and mobile apps have significant flaws - they all require providers to search through content to identify relevant information
In the proposed study we will evaluate the impact of an enhanced system InterFACE-AR which provides role-specific decision support to the team leader and medication nurse through AR devices while concurrently optimizing team situational awareness by displaying a roadmap for patient care on the LCD screen Clinical data will be collected from the mobile app on a tablet used by the charting nurse The trial aims to assess the individual and combined effectiveness of InterFACE-AR components ie AR devices and LCD screen on adherence to AHA resuscitation guidelines during simulated cardiac arrest by conducting a randomized controlled trial with a factorial design
In the proposed study we will evaluate the impact of an enhanced system InterFACE-AR which provides role-specific decision support to the team leader and medication nurse through AR devices while concurrently optimizing team situational awareness by displaying a roadmap for patient care on the LCD screen Clinical data will be collected from the mobile app on a tablet used by the charting nurse The trial aims to assess the individual and combined effectiveness of InterFACE-AR components ie AR devices and LCD screen on adherence to AHA resuscitation guidelines during simulated cardiac arrest by conducting a randomized controlled trial with a factorial design
Detailed Description:
Introduction Cardiopulmonary resuscitation CPR is provided for thousands of patients suffering from cardiopulmonary arrests CPA each year in North America The provision of guideline-compliant basic life support BLS and advanced life support ALS improves patient outcomes following cardiac arrest Unfortunately healthcare providers struggle to consistently perform guideline-compliant BLS4 5 and ALSuring in-hospital cardiac arrest Deviations from American Heart Association AHA resuscitation guidelines are associated with decreased survival from in-hospital cardiac arrest signaling a pressing need to design evaluate and implement novel strategies to improve the delivery of BLS and ALS care
Delays in epinephrine administration delays in defibrillation medication dosing errors and errors in identification and treatment of the underlying condition represent common deviations from resuscitation guidelines associated with poor patient outcomes from cardiac arrest Prior studies point to high mental workload amongst resuscitation team members as a major contributor to protocol deviations The dynamic nature of resuscitation presents a significant challenge for team leaders who engage in complex cognitive process that result in extremely high mental workload leading to poor decision-making and errors Reducing mental workload of team members by providing decision support during resuscitation can potentially improve quality of care during cardiac arrest Our research team aims to address these issues by designing a novel system that integrates augmented reality AR and screen-based technology to provide decision support for resuscitation teams during cardiopulmonary arrest
Cognitive aids are decision support tools that present prompts to encourage recall of information thus freeing up mental resources to increase the likelihood of desired behavior Cognitive aids have been trialed in different forms for use during resuscitation including pocket reference cards and digital apps Simulation-based studies of cognitive aid used during cardiac arrest events have shown improved adherence to guidelines improved time to completing critical tasks and reduced rate of critical errors Unfortunately existing pocket reference cards and mobile apps have significant flaws - they all require providers to search through content to identify relevant information This presents a distraction and increases mental workload - resulting in impaired communication and poor situational awareness - both of which cause delays and errors in treatment
Augmented reality AR and display screens have the potential of addressing these gaps Augmented reality can present individualized role-specific guidance to potentially reduce mental workload while a display screen in the clinical environment can offer information to the entire team to improve communication and enhance situational awareness
Augmented reality using a head-mounted device allows for participant interaction with the real environment while displaying three-dimensional interactive images in a users field of view without disturbing normal vision AR-based cognitive aids enable fast decision making by providing clinically relevant prompts and supporting anticipatory behaviors by listing upcoming tasks Studies completed by our research team have shown that an AR device providing clinical guidance for the team leader improves compliance with pediatric and neonatal resuscitation guidelines but fell short on improving time to epinephrine or defibrillation In these studies the AR systems were entirely reliant upon data collected from the team leader through the AR device to determine the clinical guidance This amplified team leader workload which contributed to delays in task completionIn designing a new system our overarching goal is to reduce mental workload by providing role-specific and timely information to key team resuscitation team members To achieve this goal we developed a mobile app ie Guiding Pad app used by the charting nurse which provides guidance on pending tasks as the charting nurse enters completed tasks The Guiding Pad app interfaces with a large liquid crystal display LCD screen in the resuscitation room providing a collaborative platform used to support healthcare providers during management of cardiac arrest - called InterFACE Interconnected and Focused Mobile Applications in the Patient Care Environment Integration of the LCD screen allows for display of the cardiac arrest algorithm and a running list of tasks completed which we anticipate will promote communication and shared situational awareness When connected to AR devices the Guiding Pad app allows for role-specific decision support to be shared with the provider wearing the AR device
In the proposed study we will evaluate the impact of an enhanced system InterFACE-AR which provides role-specific decision support to the team leader and medication nurse through AR devices while concurrently optimizing team situational awareness by displaying a roadmap for patient care on the LCD screen Figure 1 Clinical data will be collected from the mobile app on a tablet used by the charting nurse The trial aims to assess the individual and combined effectiveness of InterFACE-AR components ie AR devices and LCD screen on adherence to AHA resuscitation guidelines during simulated cardiac arrest by conducting a randomized controlled trial with a factorial design
The primary aim is to determine amongst pediatric healthcare teams if the use of AR devices alone for the team leader and medication nurse the LCD screen alone or AR devices and LCD screen combined ie InterFACE-AR compared to groups using the AHA pocket reference card control improves adherence to AHA resuscitation guidelines Our secondary aims are to determine the impact of the AR devices LCD screen and the full InterFACE-AR system on provider workload cognitive load leadership and teamwork behaviors types and patterns of language used during resuscitation clinical performance eg number and types of pauses in CPR and to describe user experiences with the components of InterFACE-AR
METHODS We will conduct a prospective simulation-based randomized controlled trial with a factorial study design Simulation-based research confers the advantage of answering research questions without risk of harm to patients Ethics approval will be obtained at all sites Participants will be recruited to the study in teams of five comprised of a team leader charting nurse medication nurse and two bedside clinicians who will perform CPR Two research actors playing the scripted roles of airway provider and CPR Coach will join each group to comprise resuscitation team of seven healthcare providers Actors will be trained with methodology successfully used in prior multicenter trials Participant teams will manage one cardiopulmonary arrest simulation scenario using the specific trial intervention assigned during randomization
Our factorial study design will assess the individual and synergistic impact of two interventions designed to provide decision support a Augmented reality devices for the team leader and medication nurse and b LCD Screen
Intervention A Augmented Reality Devices - data collected from the Guiding-Pad app will be fed to two AR devices ie team leader and medication nurse which will provide role-specific decision support for these two providers
Intervention B LCD Screen - data collected from the Guiding-Pad app will be fed to the LCD screen which will be mounted on a wall in clear view for the entire resuscitation team to see
Intervention C InterFACE-AR System - data collected from the Guiding-Pad app will be fed to the two AR devices ie team leader and medication nurse to provide role-specific decision support and to the LCD screen in clear view for the entire resuscitation team to see
Control Group AHA Pocket Reference Card - all participants will have access to the AHA pocket reference card which is the mostly commonly used cognitive aid during resuscitation
Following randomization all participants will view a standardized orientation video describing the clinical environment equipment manikin functionality and participant roles Video content will be customized to include an orientation to the intervention assigned to each group followed by a 15-minute table-top practice simulation where participants have opportunity to use the assigned intervention in their provider roles by running through a cardiac arrest scenario while seated at a table For example participants in the InterFACE-AR group will do a table-top simulation with the medication nurse and team leader using the AR device charting nurse using the Guiding Pad app and the LCD screen visible to the entire team Participants assigned to the control group will participate in a table-top simulation using the AHA pocket reference card
An 18-minute cardiopulmonary arrest simulation scenario ventricular tachycardia to ventricular fibrillation to pulseless electrical activity will be run for all participants with CPR quality data collected by the Zoll R Series feedback defibrillator All recruitment sites will utilize the identical pediatric manikin SimJuniorTM Laerdal Corporation specifically designed and calibrated for CPR training All simulation scenarios will be tightly standardized by using a scenario template with highly scripted actor roles and patient progression Following completion of the scenario participants will complete the NASA-TLX survey User Experience Questionnaire System Usability Survey Technology Acceptance Model survey and STAI survey Scenarios will be videotaped from a birds-eye view angle at the foot of the bed and by high-definition action cameras worn hand-free by the leader and medication nurse After the session all participants will receive an educational debriefing to address performance issues using a blended-method approach to debriefing
Randomization will occur at the level of the team stratified by study site and sex of the team leader to ensure equal distribution of sex in both arms and conducted in blocks of 4 to ensure an even distribution of teams across study arms Randomization packages will be prepared at a central study site using a web-based random number generator eg wwwsealedenvelopecom Sequentially numbered recruitment packages provided for each site will contain sealed opaque envelopes ie one envelope per team with study arm assignments and unique identifier codes for participants
Sample size estimation is based on the primary outcome measure The sample size estimation assumes that the main effects of the 2 different interventions on the time to first dose of epinephrine would comprise the 2 primary comparisons Allowing for Bonferroni adjustments p 0025 was considered statistically significant Time to the first dose of epinephrine was previously reported to be approximately 165 sec with a standard deviation of 60 sec We aim to improve the time to first dose of epinephrine to 120 sec which is associated with improved clinical outcomes from pediatric cardiac arrest10 Assuming similar variability amongst teams receiving either intervention to detect a difference of 45 sec in time to administer first dose of epinephrine with a power of 08 and a significance level of 0025 for each of the comparison the required sample size will be 68 teams 17 teams per study arm Based on our prior experiences with simulation-based research we estimated 15 of missing data due to technical issues Accounting for missing data we aim to recruit a total of 80 teams 20 teams per study arm
STATISTICAL ANALYSIS Demographic characteristics of participants including sex gender profession and experience will be reported using descriptive statistics across all study arms The analyses will be conducted in the unit of teams We will use multivariable linear regression analysis to assess the effect of both interventions on the primary and secondary outcomes and include the interaction term in the model As the effects of the two interventions may be non-additive we will also report the effect of each intervention at each level of the other intervention All estimates of intervention effects will be reported as mean differences with 95 confidence intervals
Delays in epinephrine administration delays in defibrillation medication dosing errors and errors in identification and treatment of the underlying condition represent common deviations from resuscitation guidelines associated with poor patient outcomes from cardiac arrest Prior studies point to high mental workload amongst resuscitation team members as a major contributor to protocol deviations The dynamic nature of resuscitation presents a significant challenge for team leaders who engage in complex cognitive process that result in extremely high mental workload leading to poor decision-making and errors Reducing mental workload of team members by providing decision support during resuscitation can potentially improve quality of care during cardiac arrest Our research team aims to address these issues by designing a novel system that integrates augmented reality AR and screen-based technology to provide decision support for resuscitation teams during cardiopulmonary arrest
Cognitive aids are decision support tools that present prompts to encourage recall of information thus freeing up mental resources to increase the likelihood of desired behavior Cognitive aids have been trialed in different forms for use during resuscitation including pocket reference cards and digital apps Simulation-based studies of cognitive aid used during cardiac arrest events have shown improved adherence to guidelines improved time to completing critical tasks and reduced rate of critical errors Unfortunately existing pocket reference cards and mobile apps have significant flaws - they all require providers to search through content to identify relevant information This presents a distraction and increases mental workload - resulting in impaired communication and poor situational awareness - both of which cause delays and errors in treatment
Augmented reality AR and display screens have the potential of addressing these gaps Augmented reality can present individualized role-specific guidance to potentially reduce mental workload while a display screen in the clinical environment can offer information to the entire team to improve communication and enhance situational awareness
Augmented reality using a head-mounted device allows for participant interaction with the real environment while displaying three-dimensional interactive images in a users field of view without disturbing normal vision AR-based cognitive aids enable fast decision making by providing clinically relevant prompts and supporting anticipatory behaviors by listing upcoming tasks Studies completed by our research team have shown that an AR device providing clinical guidance for the team leader improves compliance with pediatric and neonatal resuscitation guidelines but fell short on improving time to epinephrine or defibrillation In these studies the AR systems were entirely reliant upon data collected from the team leader through the AR device to determine the clinical guidance This amplified team leader workload which contributed to delays in task completionIn designing a new system our overarching goal is to reduce mental workload by providing role-specific and timely information to key team resuscitation team members To achieve this goal we developed a mobile app ie Guiding Pad app used by the charting nurse which provides guidance on pending tasks as the charting nurse enters completed tasks The Guiding Pad app interfaces with a large liquid crystal display LCD screen in the resuscitation room providing a collaborative platform used to support healthcare providers during management of cardiac arrest - called InterFACE Interconnected and Focused Mobile Applications in the Patient Care Environment Integration of the LCD screen allows for display of the cardiac arrest algorithm and a running list of tasks completed which we anticipate will promote communication and shared situational awareness When connected to AR devices the Guiding Pad app allows for role-specific decision support to be shared with the provider wearing the AR device
In the proposed study we will evaluate the impact of an enhanced system InterFACE-AR which provides role-specific decision support to the team leader and medication nurse through AR devices while concurrently optimizing team situational awareness by displaying a roadmap for patient care on the LCD screen Figure 1 Clinical data will be collected from the mobile app on a tablet used by the charting nurse The trial aims to assess the individual and combined effectiveness of InterFACE-AR components ie AR devices and LCD screen on adherence to AHA resuscitation guidelines during simulated cardiac arrest by conducting a randomized controlled trial with a factorial design
The primary aim is to determine amongst pediatric healthcare teams if the use of AR devices alone for the team leader and medication nurse the LCD screen alone or AR devices and LCD screen combined ie InterFACE-AR compared to groups using the AHA pocket reference card control improves adherence to AHA resuscitation guidelines Our secondary aims are to determine the impact of the AR devices LCD screen and the full InterFACE-AR system on provider workload cognitive load leadership and teamwork behaviors types and patterns of language used during resuscitation clinical performance eg number and types of pauses in CPR and to describe user experiences with the components of InterFACE-AR
METHODS We will conduct a prospective simulation-based randomized controlled trial with a factorial study design Simulation-based research confers the advantage of answering research questions without risk of harm to patients Ethics approval will be obtained at all sites Participants will be recruited to the study in teams of five comprised of a team leader charting nurse medication nurse and two bedside clinicians who will perform CPR Two research actors playing the scripted roles of airway provider and CPR Coach will join each group to comprise resuscitation team of seven healthcare providers Actors will be trained with methodology successfully used in prior multicenter trials Participant teams will manage one cardiopulmonary arrest simulation scenario using the specific trial intervention assigned during randomization
Our factorial study design will assess the individual and synergistic impact of two interventions designed to provide decision support a Augmented reality devices for the team leader and medication nurse and b LCD Screen
Intervention A Augmented Reality Devices - data collected from the Guiding-Pad app will be fed to two AR devices ie team leader and medication nurse which will provide role-specific decision support for these two providers
Intervention B LCD Screen - data collected from the Guiding-Pad app will be fed to the LCD screen which will be mounted on a wall in clear view for the entire resuscitation team to see
Intervention C InterFACE-AR System - data collected from the Guiding-Pad app will be fed to the two AR devices ie team leader and medication nurse to provide role-specific decision support and to the LCD screen in clear view for the entire resuscitation team to see
Control Group AHA Pocket Reference Card - all participants will have access to the AHA pocket reference card which is the mostly commonly used cognitive aid during resuscitation
Following randomization all participants will view a standardized orientation video describing the clinical environment equipment manikin functionality and participant roles Video content will be customized to include an orientation to the intervention assigned to each group followed by a 15-minute table-top practice simulation where participants have opportunity to use the assigned intervention in their provider roles by running through a cardiac arrest scenario while seated at a table For example participants in the InterFACE-AR group will do a table-top simulation with the medication nurse and team leader using the AR device charting nurse using the Guiding Pad app and the LCD screen visible to the entire team Participants assigned to the control group will participate in a table-top simulation using the AHA pocket reference card
An 18-minute cardiopulmonary arrest simulation scenario ventricular tachycardia to ventricular fibrillation to pulseless electrical activity will be run for all participants with CPR quality data collected by the Zoll R Series feedback defibrillator All recruitment sites will utilize the identical pediatric manikin SimJuniorTM Laerdal Corporation specifically designed and calibrated for CPR training All simulation scenarios will be tightly standardized by using a scenario template with highly scripted actor roles and patient progression Following completion of the scenario participants will complete the NASA-TLX survey User Experience Questionnaire System Usability Survey Technology Acceptance Model survey and STAI survey Scenarios will be videotaped from a birds-eye view angle at the foot of the bed and by high-definition action cameras worn hand-free by the leader and medication nurse After the session all participants will receive an educational debriefing to address performance issues using a blended-method approach to debriefing
Randomization will occur at the level of the team stratified by study site and sex of the team leader to ensure equal distribution of sex in both arms and conducted in blocks of 4 to ensure an even distribution of teams across study arms Randomization packages will be prepared at a central study site using a web-based random number generator eg wwwsealedenvelopecom Sequentially numbered recruitment packages provided for each site will contain sealed opaque envelopes ie one envelope per team with study arm assignments and unique identifier codes for participants
Sample size estimation is based on the primary outcome measure The sample size estimation assumes that the main effects of the 2 different interventions on the time to first dose of epinephrine would comprise the 2 primary comparisons Allowing for Bonferroni adjustments p 0025 was considered statistically significant Time to the first dose of epinephrine was previously reported to be approximately 165 sec with a standard deviation of 60 sec We aim to improve the time to first dose of epinephrine to 120 sec which is associated with improved clinical outcomes from pediatric cardiac arrest10 Assuming similar variability amongst teams receiving either intervention to detect a difference of 45 sec in time to administer first dose of epinephrine with a power of 08 and a significance level of 0025 for each of the comparison the required sample size will be 68 teams 17 teams per study arm Based on our prior experiences with simulation-based research we estimated 15 of missing data due to technical issues Accounting for missing data we aim to recruit a total of 80 teams 20 teams per study arm
STATISTICAL ANALYSIS Demographic characteristics of participants including sex gender profession and experience will be reported using descriptive statistics across all study arms The analyses will be conducted in the unit of teams We will use multivariable linear regression analysis to assess the effect of both interventions on the primary and secondary outcomes and include the interaction term in the model As the effects of the two interventions may be non-additive we will also report the effect of each intervention at each level of the other intervention All estimates of intervention effects will be reported as mean differences with 95 confidence intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 232403355 | OTHER_GRANT | LevMax Grant Alberta Innovates | None |