Evaluation of the InterFACE-AR System for Cardiopulmonary Arrest: A Multicenter, Randomized Controlled Trial (InterFACE-AR)

Design, Development and Evaluation of an Augmented Reality and Screen-based Decision Support System for Cardiopulmonary Arrest: a Multicenter, Randomized Controlled Trial

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 (i.e. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Arrest; Cardiopulmonary Arrest
• Intervention / Treatment: Device: Augmented reality; Device: LCD Screen

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 user's 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 (i.e. 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 (i.e. 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 (i.e. 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 (e.g. 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 (i.e. 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 (i.e. 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 (e.g. www.sealedenvelope.com). Sequentially numbered recruitment packages provided for each site will contain sealed opaque envelopes (i.e. 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 < 0.025 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 0.8 and a significance level of 0.025 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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Cheng, MD; Phone Number: 4039552633; Email: Adam.Cheng@albertahealthservices.ca
• Study Contact Backup: Name: Nicola Peiris; Phone Number: 4039552432; Email: nicola.peiris@ahs.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants from pediatric inpatient units, intensive care units, operating rooms and emergency departments across all sites will be recruited. Inclusion criteria for the team leader include: attending physician, fellow, or senior resident in pediatric emergency medicine, adult emergency medicine, pediatric intensive care, pediatric anesthesia or general pediatrics. Inclusion criteria for the medication and charting nurse roles include: nurse in pediatric emergency medicine, pediatric intensive care, pediatric anesthesia, pediatric surgery or general pediatrics. Inclusion criteria for all other team members include: pediatric attending physician, resident, fellow, nurse or respiratory therapist. All participants must have prior basic life support training.

Exclusion Criteria:

• (1) Decline to provide informed consent; (2) previously enrolled; or (3) unable to perform tasks required of the role.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; 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.
Experimental: Augmented Reality Only; Augmented Reality Devices - data collected from the Guiding-Pad app will be fed to two AR devices (i.e. team leader and medication nurse), which will provide role-specific decision support for these two providers.	Device: Augmented reality; Augmented Reality Devices - data collected from the Guiding-Pad app will be fed to two AR devices (i.e. team leader and medication nurse), which will provide role-specific decision support for these two providers.; Other Names: AR
Experimental: LCD Screen Only; 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.	Device: LCD Screen; 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.; Other Names: LCD
Experimental: Augmented Reality + LCD Screen (Full InterFACE-AR System); InterFACE-AR System - data collected from the Guiding-Pad app will be fed to the two AR devices (i.e. 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.	Device: Augmented reality; Augmented Reality Devices - data collected from the Guiding-Pad app will be fed to two AR devices (i.e. team leader and medication nurse), which will provide role-specific decision support for these two providers.; Other Names: AR; Device: LCD Screen; 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.; Other Names: LCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to epinephrine	Time to epinephrine administration, in seconds	During event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to initiation of CPR	Time to initiation of CPR, in seconds	During event
Time to defibrillation	Time to defibrillation, in seconds	During event
Time to amiodarone administration	Time to amiodarone administration, in seconds	During event
Time to intubation	Time to intubation, in seconds	During event
Medication errors	Frequency of medication errors	During event
Pauses in CPR	Frequency and duration of pauses in CPR	During event
Percentage of overall excellent CPR	Percentage of overall excellent CPR	During event
Chest compression fraction	Chest compression fraction	During event
Percentage compliance for CPR depth	Percentage compliance within guidelines for for CPR depth	During event
Percentage compliance for CPR rate	Percentage compliance within guidelines for for CPR rate	During event
Peri-shock pause duration	Peri-shock pause duration, in seconds	During event
Provider workload	NASA-Task Load Index	Immediately after event
Provider cognitive load	PAAS scale	Immediately After event
Team leadership quality	Leadership quality via CALM tool	Immediately After event
Teamwork quality	Teamwork quality via TEAM tool	Immediately After event
User Experience	UEQ survey	Immediately After event
System Usability	SUS survey	Immediately After event
Technology Acceptance	TAM survey	Immediately After event
Provider anxiety	STAI survey	Immediately After event

Collaborators and Investigators

• Sponsor: KidSIM Simulation Program
• Collaborators: University of Alabama at Birmingham; Columbia University; University of Southern California; University of Alberta; University of Toronto; University of Padova; Laval University; University of Genova
• Investigators: Principal Investigator: Adam Cheng, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac arrest; Simulation; Cognitive aid; Cardiopulmonary arrest; Decision support
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: LevMax 232403355; 232403355 (Other Grant/Funding Number: LevMax Grant, Alberta Innovates)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No