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Development, Validation, and Clinical Trial of a Prediction Tool for High-Risk Emergency Department Revisits

1. november 2026 opdateret af: National Taiwan University Hospital

Development, Validation, and Prospective Clinical Trial of a Tool for Predicting Serious Adverse Events in Return Emergency Department Visits

Emergency department (ED) visits have grown tremendously in Taiwan over the past few years, reaching approximately 7 million visits in 2019. This growth in ED visits has led to unprecedented levels of ED crowding, resulting in delays in care and increased morbidity and mortality in the ED. One of the complications of ED crowding is unsafe ED discharge leading to return ED visits. About 5-10% of the patients return to the ED within 3 days of the initial ED visit. Return visits are not only burdensome but also costly. Some return ED visits are even potentially dangerous, such as intensive care unit (ICU) admission, receiving emergency surgery or cardiac catheterization, and in-hospital cardiac arrest (IHCA) during the revisit to the ED. These "high-risk" return ED visits are important in that they may reflect suboptimal initial ED care. Early identification of these high-risk events and appropriate interventions are critical for clinicians and patients. The investigators previously estimated that about 0.1% of the ED visits would become these high-risk ED visits.

High-risk revisits are relatively rare events, which require a large sample size for investigation. To this end, the increasing use of electronic health records (EHR) has opened the door to research rare events using big data. With the gradual adoption of EHR in major sections of the NTUH (outpatient in 2006; inpatient in 2007; and emergency department [ED] in 2009), investigators are now able to conduct clinical research using a wealth of data components in the EHR. For example, from 2013 to 2022, there have been >1 million ED visits to the NTUH. The large sample size also enables studies of rare but important events, such as serious adverse events in return ED visits.

In this proposal, the investigators aim to develop and validate a vital-sign trajectory model (GBTM) and a machine learning/artificial intelligence (ML/AI) based prediction model for the high-risk ED revisits. The investigators will develop and validate these predictive tools using the NTUH data from 2013 to 2022, totaling approximately 1 million ED visits. In phase 2 (prospective validation), the investigators will prospectively collect data, fine tune our model, and optimize the system structure. In phase 3 (intervention), the investigators will embed the model into our hospital information system (HIS) in real-time to identify high-risk patients on ED discharge. If a patient is classified as high-risk, the computer user interface will recommend re-evaluating the patient and observing. At the discretion of the treating physician, wearable smart wristbands will be distributed to borderline high-risk patients who are still sent home to augment vital signs monitoring for 7 days. A dedicated case manager will review the records daily and consult the treating physician if red flags occur. A telemedicine session will be initiated if needed. The detection and intervention components together form the response system, the Emergency Department High-risk Revisits Prevention System (ED-HIKRS). In the intervention phase, the investigators will enroll and randomize 10 attending physicians into the ED-HIKRS or the usual care arm for 5 months, with each of them treating 200 patients (patients clustered within physicians). The pragmatic 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 200 patients for another 5 months. A total of 4,000 adult patients will be enrolled. The primary outcome is the rate of high-risk revisits (ICU admission, receiving emergency surgery, and IHCA within 7 days of ED discharge) or same outcomes within 24 hours of hospitalization through the ED revisit. The secondary outcomes include general ED revisit rates, revisit admission rates, and ED mortality during the revisit.

The proposed study is highly significant because it addresses high-risk ED revisits, an understudied yet increasingly important area. The two state-of-the-art models, if successful, can be readily implemented in the EHR system for real-time prediction. The intervention of ED-HIKRS, if successful, may possibly intercept unsafe ED discharges and prevent subsequent serious adverse events. Our long-term goal is to deploy our system in existing clinical workflows to assist clinicians. This model may be generalizable to other health care systems countrywide.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

4010

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

- ED patients aged 18 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 for 7 days;
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sædvanlig pleje

Care as usual

Eksperimentel: ED-HIKRS

In phase 3 (intervention), we will embed the model into our hospital information system (HIS) in real-time to identify high-risk patients on ED discharge. If a patient is classified as high-risk, the computer user interface will recommend re-evaluating the patient and observing. At the discretion of the treating physician, wearable smart wristbands will be distributed to borderline high-risk patients who are still sent home to augment vital signs monitoring for 7 days. A dedicated case manager will review the records daily and consult the treating physician if red flags occur. A telemedicine session will be initiated if needed. The detection and intervention components together form the response system, the Emergency Department High-risk Revisits Prevention System (ED-HIKRS)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary outcome is the rate of high-risk revisits (ICU admission, receiving emergency surgery, and IHCA within 7 days of ED discharge) or same outcomes within 24 hours of revisit hospitalization
Tidsramme: During the stay in the emergency department (a median length of 3 hours) or within 24 hours of revisit hospitalization
During the stay in the emergency department (a median length of 3 hours) or within 24 hours of revisit hospitalization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

26. oktober 2026

Først indsendt, der opfyldte QC-kriterier

26. oktober 2026

Først opslået (Faktiske)

2. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 202206008RINA

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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