RecruitingNot ApplicableNCT05480319

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


Sponsor

National Taiwan University Hospital

Enrollment

2,010 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria1

  • ED patients aged 20 years at recruitment

Exclusion Criteria4

  • 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.

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Interventions

OTHEREDICARS

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).

OTHERUsual care

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


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT05480319


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