Prospective Deployment of a Cardiac Arrest Response System (EDICARS) in the Emergency Department

Prospective Deployment of a Cardiac Arrest Response System (EDICARS) in the Emergency Department: A Cluster Randomized Controlled Trial

Based on data from the American Heart Association's (AHA) Get With the Guidelines-Resuscitation (GTWG-R) registry, the incidence of adult treated in-hospital cardiac arrest (IHCA) was about 10 per 1,000 bed-days (290,000 patients per year), and 15 to 20% of adult IHCA patients survived to hospital discharge (i.e., ~80% mortality). Despite the significant morbidity and mortality caused by IHCA, ED-based IHCA is surprisingly less studied. The investigators have utilized electronic medical record (EMR)'s big data (>700,000 visits) from our hospital to investigate, for the first time, the epidemiology and outcome of IHCA in the ED in Taiwan. The investigators also have developed and validated a simple prediction tool for ED-based IHCA, the Emergency Department In-hospital Cardiac Arrest Score (EDICAS). This tool has also been externally validated using Far Eastern Memorial Hospital's ED data. In addition, the investigators also have developed and validated a vital-sign trajectory-based longitudinal model (group-based trajectory modeling [GBTM]) to predict ED-based IHCA.

Based on these studies, the investigators now propose to (1) Embed the EDICAS into our hospital information system (HIS) in real-time at ED triage to identify high-risk patients (EDICAS 6+); and (2) Distribute wearable smart wristbands to high-risk patients to augment vital signs monitoring and send alerts based on GBTM results. The detection and intervention components together form the rapid response system, the Emergency Department In-hospital Cardiac Arrest Response System (EDICARS). In this study, the investigators will enroll and randomize 10 attending physicians into the EDICARS or the usual care arm for 3 months, with each of them treating 100 patients (patients clustered within physicians). The trial will stop for 2 months as a wash-out period, and an interim analysis will be performed. The physicians will then cross over, and each of them will treat 100 patients for another 3 months. A total of 2,000 adult patients will be enrolled. The primary outcome is a composite rate of ED-based IHCA and intensive care unit (ICU) admission. The secondary outcomes include time from ED triage to ED-based cardiac arrest, ICU and hospital length of stay, early ward-based IHCA, and early ICU transfer.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: EDICARS; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 2010
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chu-Lin Tsai, MD; Phone Number: 67684 +886-2-2312-3456; Email: chulintsai@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chu-Lin Tsai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ED patients aged 20 years at recruitment

Exclusion Criteria:

• Inability to sign informed consent;
• Diagnosis of psychiatric disorders that would limit the ability to comply with the study protocol (e.g., wearing a wristband);
• Intending to leave ED against medical advice;
• Already enrolled or planning to enroll in a research study that would conflict with full participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Other: Usual care; Usual care will be assigned to this arm. No additional interventions.
Experimental: EDICARS	Other: EDICARS; The investigators propose to (1) Embed the EDICAS into our hospital information system (HIS) in real-time at ED triage to identify high-risk patients (EDICAS 6+); and (2) Distribute wearable smart wristbands to high-risk patients to augment vital signs monitoring and send alerts based on GBTM results. The detection and intervention components together form the rapid response system, the Emergency Department In-hospital Cardiac Arrest Response System (EDICARS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED-based in-hospital cardiac arrest (IHCA) and intensive care unit (ICU) admission.	The primary outcome is a composite rate of ED-based IHCA and intensive care unit (ICU) admission.	During the stay in the emergency department, a median length of 3 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest
• Other Study ID Numbers: 202205061RINC

Drug and device information, study documents

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