- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07909096
Development, Validation, and Clinical Trial of a Prediction Tool for High-Risk Emergency Department Revisits
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Chu-Lin Tsai MD
- 전화번호: +886-2-2312-3456 Ext. 262831
- 이메일: chulintsai@ntu.edu.tw
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 평상시 관리
|
Care as usual |
|
실험적: 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) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202206008RINA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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