AI-enabled Emergency Clinical Research for Emerging and Re-emerging Infectious Diseases: Protocol for an International Consensus
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Response Time for Risk Assessment Report Generation and Submission
研究概览
简要总结
Emerging infectious diseases, such as COVID-19, mpox, and dengue fever, are characterized by rapid transmission, wide impact, and high uncertainty, posing ongoing threats to global public health. While China achieved significant success in COVID-19 control, the response also revealed key challenges, including fragmented information, delayed risk perception, experience-dependent assessment, and inefficiencies in complex decision-making. This study aims to establish a smart technology system covering the full chain of "risk perception-situational assessment-intelligent decision-making-comprehensive evaluation." Specific objectives include: Constructing a global disease burden database and knowledge graph for emerging infectious diseases; Developing early risk assessment models covering the full transmission spectrum (cross-species, imported, and local outbreak); Building an AI-driven collective intelligence decision-support tool for epidemic control; Developing precise intervention frameworks and comprehensive evaluation indicators for key populations (e.g., elderly, students); Integrating the above technologies into a multi-agent toolkit and evaluating its effectiveness through a cluster randomized controlled trial involving at least 36 district/county-level CDC clusters across five provinces/municipalities (Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai).
Three eligible CDC staff members will be enrolled from each participating cluster, including one CDC director or relevant leader responsible for infectious disease prevention and control and two professional staff members engaged in acute infectious disease surveillance, risk assessment, decision-making, or emergency response. Accordingly, at least 108 participants will be enrolled, and the final anticipated enrollment will be determined by the total number of participating clusters.
The intervention group will use the smart toolkit alongside routine practices, while the control group will follow routine practices only. The primary outcome is response time for epidemic assessment and decision-making (hours from risk perception to decision completion). Secondary outcomes include epidemic control effectiveness, user satisfaction, and socioeconomic benefits. The intervention period is 3 months, starting around July 2026 and ending in December 2027. This study has been approved by the Peking University Biomedical Ethics Committee. The study does not involve individual patient data; all data are aggregated at the district/county level from CDC sources or publicly available data. Anonymous questionnaires do not collect any personal identifiable information.
详细描述
This is a multicenter, cluster-randomized controlled trial (cRCT) with a single-blind design (blinding of statisticians). The study will be conducted across five provinces/municipalities: Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai. At least 36 district/county-level Centers for Disease Control and Prevention (CDCs) will be selected as study clusters and allocated in an approximately 1:1 ratio to either the intervention group or the control group. Three eligible CDC staff members will be enrolled from each participating cluster, including one CDC director or relevant leader responsible for infectious disease prevention and control and two professional staff members engaged in acute infectious disease surveillance, risk assessment, decision-making, or emergency response.
Randomization Procedure: For the four provinces (Zhejiang, Guangdong, Hubei, and Sichuan), participating district/county-level CDC clusters will be stratified within each province according to socioeconomic level (high, medium, and low), as applicable, and randomly allocated within strata to the intervention or control group. For Shanghai municipality, participating district-level CDC clusters will be stratified by urban functional zone (central urban vs. new/suburban districts) and randomly allocated within strata. Cluster allocation will be maintained in an approximately 1:1 ratio.
Intervention: The intervention group will use a multi-agent integrated toolkit (including data-knowledge agent, assessment agent, decision agent, and evaluation agent) to assist with epidemic risk perception, situational assessment, and emergency decision-making, in addition to routine practices. The control group will follow routine practices only.
Follow-up Plan: The intervention period is 3 months, timed to coincide with peak seasons for specific infectious diseases (winter/spring for respiratory infections; summer/autumn for vector-borne diseases like dengue). Follow-up assessments will occur every 3 months, with the endpoint defined as the conclusion of an emerging infectious disease event.
Sample Size: Using PASS software (two-sided α=0.05, Power=80%, ICC=0.05, CV=0.5, standard deviation=12 hours, and average cluster size m=3), and assuming a 30% reduction in response time in the intervention group, a minimum of 32 evaluable clusters, corresponding to 16 clusters per group and 96 evaluable participants, is required. Because only 3 participants will be enrolled from each cluster and an individual attrition rate of approximately 10% is anticipated, at least 36 clusters and at least 108 participants will be recruited. The final anticipated enrollment will equal three times the actual number of participating clusters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Working at a participating district/county-level CDC in one of the five provinces/municipalities (Zhejiang, Guangdong, Hubei, Sichuan, or Shanghai) where at least one emerging infectious disease (COVID-19, mpox, influenza, dengue, chikungunya, or avian influenza) has occurred.
- •Being one of the three designated participants from the participating CDC cluster: one CDC director or relevant leader responsible for infectious disease prevention and control, or one of two professional staff members engaged in acute infectious disease surveillance, risk assessment, decision-making, risk management, or emergency response.
- •Currently responsible for or involved in infectious disease epidemic prevention and control work, including information collection, risk perception, risk assessment, decision-making, risk management, and emergency response at the CDC.
- •Willing to voluntarily participate in this study and provide written informed consent.
排除标准
- •Under 18 years of age.
- •Diagnosed with severe mental illness or other conditions that impede normal communication.
- •Employed in the current CDC position for less than 1 year.
研究组 & 干预措施
Intervention Group
Participants in this arm will receive the multi-agent integrated smart toolkit, consisting of Data-Knowledge, Assessment, Decision, and Evaluation agents, in addition to routine infectious disease prevention and control practices. The toolkit is designed to assist CDC staff with epidemic risk perception, situational assessment, and emergency decision-making throughout the 3-month intervention period, alongside their routine CDC workflow.
干预措施: Multi-Agent Integrated Smart Toolkit for Emerging Infectious Diseases (Other)
Control Group
Participants in this arm will follow routine infectious disease prevention and control practices only, without access to the multi-agent integrated smart toolkit, including standard epidemic surveillance, information collection, risk assessment, and emergency response procedures currently implemented at their respective CDC, and will continue their regular workflow without any additional intervention during the 3-month study period.
干预措施: Routine Practices (Other)
结局指标
主要结局
Response Time for Risk Assessment Report Generation and Submission
时间窗: Measured at baseline (enrollment) and at the end of the 3-month intervention period
Response time consists of two components measured in hours: (1) Report generation time - time from the diagnosis of the index case in a cluster outbreak to the system's automatic generation of the first risk assessment report and decision-support recommendations; and (2) Report submission time - time from report generation to its official submission. Measured via electronic questionnaire and CDC reporting logs.
次要结局
- Consistency of Risk Assessment Results between Multi-Agent Toolkit and Expert Panel(Assessed at the end of the 3-month intervention period)
- Epidemic Control Effectiveness(Assessed continuously throughout the 3-month intervention period and summarized at the end of the intervention)
- User Experience and Satisfaction with the Smart Toolkit(Measured at the end of the 3-month intervention period)
- Healthcare Resource Consumption(Assessed at the end of the 3-month intervention period)
- Prevention and Control Resource Inputs(Assessed at the end of the 3-month intervention period)
- Reduction in Hospitalization Burden(Assessed at the end of the 3-month intervention period)
- Reduction in Severe Disease Burden(Assessed at the end of the 3-month intervention period)
- Cost-Effectiveness Ratio(Assessed at the end of the 3-month intervention period)
- Macroeconomic Impact(Assessed at the end of the 3-month intervention period)
研究者
Liu Jue
Professor
Peking University