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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05480319

Collaborator

(none)

2,010

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: EDICARS Other: Usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2010 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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).
Active Comparator: Usual care	Other: Usual care Usual care will be assigned to this arm. No additional interventions.

Arm

Intervention/Treatment

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).

Active Comparator: Usual care

Other: Usual care

Usual care will be assigned to this arm. No additional interventions.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05480319

Other Study ID Numbers:

202205061RINC

First Posted:

Jul 29, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Arrest

Emergencies

Study Results

No Results Posted as of Aug 2, 2022