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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Yen-Pin Chen, PhD
- Telefonnummer: +886 978732756
- E-post: f06945029@g.ntuh.edu.tw
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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. |
|
|
Aktiv komparator: 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-jämförare: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exact agreement with expert TTAS reference standard
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sensitivity for high-acuity cases (TTAS Levels 1-2)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Nyckelord
Andra studie-ID-nummer
- 202608042RIND
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