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Not yet recruitingNCT07909096Updated Nov 3, 2026

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

An interventional study of ED-HIKRS and Usual Care in Emergency Department and Revisit, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention

Updated Nov 3, 2026Start date movedEligibility revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
4,010
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Emergency Department
  • Revisit

Browse trials for

03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- ED patients aged 18 years at recruitment.

Exclusion criteria

Exclusion Criteria:

  • Inability to sign ;
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
4,010 participants (estimated)

Study arms

  • Experimental
    ED-HIKRS

    Other: ED-HIKRS

  • Active comparator
    Usual Care

    Other: Usual Care

Interventions

  • OtherED-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)

  • OtherUsual Care

    Care as usual

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During the stay in the emergency department (a median length of 3 hours) or within 24 hours of revisit hospitalization

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartEst.
Nov 2026was Oct 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 2026→Nov 2026
Nov 3, 2026
Eligibility
1 inclusion criterion edited; 1 exclusion criterion edited, 3 added; 1 criterion removed
What changed in the criteria
  • Removed-
Inclusion criteria
  • EditedInclusion Criteria:- ED patients aged 18 years at recruitment. -
Exclusion criteria
  • AddedInability to sign informed consent;
  • EditedExclusion Criteria:1) Inability to sign informed consent; 2) Diagnosis of sychiatricpsychiatric disorders that would limit the ability to comply with the study protocol e.g., wearing a wristband for 7 days); 3) Intending to leave ED against medical advice; 4) Already enrolled or planning to enroll in a research study that would conflict with full participation in the study.
  • AddedIntending to leave ED against medical advice;
  • AddedAlready enrolled or planning to enroll in a research study that would conflict with full participation in the study.
Nov 3, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 3, 2026
    Start date Oct 2026→Nov 2026
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion edited, 3 added; 1 criterion removed
    What changed in the criteria
    • Removed-
    Inclusion criteria
    • EditedInclusion Criteria:- ED patients aged 18 years at recruitment. -
    Exclusion criteria
    • AddedInability to sign informed consent;
    • EditedExclusion Criteria:1) Inability to sign informed consent; 2) Diagnosis of sychiatricpsychiatric disorders that would limit the ability to comply with the study protocol e.g., wearing a wristband for 7 days); 3) Intending to leave ED against medical advice; 4) Already enrolled or planning to enroll in a research study that would conflict with full participation in the study.
    • AddedIntending to leave ED against medical advice;
    • AddedAlready enrolled or planning to enroll in a research study that would conflict with full participation in the study.
    + 2 other changes: description and conditions
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07909096
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Chu-Lin Tsai MD
Contact
chulintsai@ntu.edu.tw
+886-2-2312-3456 Ext. 262831

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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