- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07936864
Decision Support for Simulated Emergency Triage by Nurses: A Randomized Crossover Study
Development, Validation, and Human-AI Collaboration Evaluation of a Taiwan Triage and Acuity Scale Decision Support System
This randomized, three-period crossover study will evaluate a Taiwan Triage and Acuity Scale (TTAS) decision support system in a controlled simulation. Thirty nurses with emergency triage training or experience will each assess three different sets of 50 standardized, de-identified emergency cases. The three study conditions are unassisted triage, case-specific TTAS decision support, and a sham assistance interface. The order of conditions will be randomized, with 7 to 14 days between study periods. The main outcomes are agreement between nurses' final TTAS levels and an expert reference standard, active time needed to assess 50 cases, and a prespecified safety-adjusted efficiency score. Additional outcomes include undertriage, overtriage, workload, usability, and responses to misleading advice. The system will not be used for actual patient triage or entered into clinical records.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
The study will develop a traceable TTAS rule knowledge base and evaluate a decision support prototype in simulated emergency triage. A language-processing component identifies candidate complaints, vital signs, and modifiers from standardized case narratives. A deterministic rules engine generates a suggested TTAS level, matched rules, prompts for additional information, and a draft note. Nurses retain final decision authority. Three balanced case sets of 50 de-identified cases will be prepared from retrospective emergency data. At least two experienced emergency physicians or triage nursing experts will independently establish the reference TTAS level; disagreements will be adjudicated by a third blinded expert. Participants will be stratified by clinical experience and site and assigned to one of six condition sequences. Each participant completes all three conditions with different case sets and a 7- to 14-day interval between periods. The sham interface resembles the active interface but provides suggestions that are not based on the individual case, allowing assessment of automation bias. Analysis will account for study condition, period, sequence, case set, participant experience, case acuity, and repeated observations within participants and cases. This is a simulation study; no decision support output is used in care of real patients.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Yen-Pin Chen, PhD
- Puhelinnumero: +886 978732756
- Sähköposti: f06945029@g.ntuh.edu.tw
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Age 18 years or older.
- Able to read Chinese and use the study computer platform.
- Prior emergency triage training or practical emergency triage experience.
- Willing to provide written informed consent and complete the planned case assessments.
Exclusion Criteria:
- Unable to provide valid informed consent.
- Unable to perform basic operations on the study platform or to follow the study schedule.
- Involved in developing the study system or aware of details distinguishing active from sham assistance in a way that could compromise masking.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Ei väliintuloa: Sequence A[BC]
Period 1: unassisted triage (A); and then Period 2: active TTAS decision support (B); Period 3: sham assistance (C). Each period includes 50 different standardized cases. Period 2: sham assistance (C); Period 3: active TTAS decision support (B). Each period includes 50 different standardized cases. |
|
|
Active Comparator: Sequence B[AC]
Period 1: active TTAS decision support (B); and then Period 2: unassisted triage (A); Period 3: sham assistance (C). Each period includes 50 different standardized cases. Period 2: sham assistance (C); Period 3: unassisted triage (A). Each period includes 50 different standardized cases. |
During review of 50 standardized cases, a research-only interface displays candidate presenting complaints, matched TTAS rules, a suggested triage level, prompts for missing information, and a draft triage note. The nurse makes the final decision. |
|
Placebo Comparator: Sequence C[AB]
Period 1: sham assistance (C); and then Period 2: unassisted triage (A); Period 3: active TTAS decision support (B). Each period includes 50 different standardized cases. Period 2: active TTAS decision support (B); Period 3: unassisted triage (A). Each period includes 50 different standardized cases. |
During review of 50 standardized cases, an interface resembling the active system displays non-case-specific or distribution-matched suggestions. These suggestions are for simulation only and are not used in patient care. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Exact agreement with expert TTAS reference standard
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Percentage of completed case assessments for which the nurse's final five-level TTAS assignment exactly matches the adjudicated expert reference level, evaluated separately under each condition. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
|
Active time to complete 50 case assessments
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Total active time in minutes required to complete the 50-case set in each condition, excluding recorded breaks and system interruptions. The analysis of incomplete sets must be specified before enrollment. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
|
Safety-Adjusted Efficiency Score
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Prespecified score combining TTAS accuracy and speed. The approved protocol assigns 1.0 for exact agreement, 0.8 or 0.6 for overtriage by one or two levels, 0.4 for undertriage by one level, and 0 for undertriage by two or more levels, with additional penalties for undertriage of Level 1-2 cases. The exact high-acuity penalty, time component, aggregation, score range, and handling of missing cases require final specification before submission. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Sensitivity for high-acuity cases (TTAS Levels 1-2)
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Proportion of expert-reference Level 1-2 cases assigned Level 1 or 2 by the nurse under each condition. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
|
Undertriage rate
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Percentage of completed case assessments in which the nurse's final TTAS level indicates lower urgency than the expert reference standard; severe undertriage will be reported separately according to the prespecified threshold. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
|
Overtriage rate
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Percentage of completed case assessments in which the nurse's final TTAS level indicates higher urgency than the expert reference standard. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
|
Acceptance of incorrect suggestions in the sham condition
Aikaikkuna: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Percentage of sham-assisted cases in which an incorrect displayed recommendation is accepted in the nurse's final TTAS decision; denominator and incorrectness criteria to be prespecified. |
During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 202608042RIND
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .