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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yen-Pin Chen, PhD
- Número de telefone: +886 978732756
- E-mail: f06945029@g.ntuh.edu.tw
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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. |
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Comparador Ativo: 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. |
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Comparador de Placebo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Exact agreement with expert TTAS reference standard
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Active time to complete 50 case assessments
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Safety-Adjusted Efficiency Score
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sensitivity for high-acuity cases (TTAS Levels 1-2)
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Undertriage rate
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Overtriage rate
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Acceptance of incorrect suggestions in the sham condition
Prazo: During each of three approximately 60-minute study periods, separated by 7-14 days; up to approximately 4 weeks per participant.
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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.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Palavras-chave
Outros números de identificação do estudo
- 202608042RIND
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