Evaluating the Clinical Outcomes of Abbott ID NOW Point-of-Care Testing for Respiratory Illnesses in Long-Term Care Facility Residents in Taiwan: Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Time From Specimen Collection to Availability of Influenza Test Result
研究概览
简要总结
With the rapid aging of the global population, long-term care facilities (LTCFs) have become an increasingly important component of modern public health systems. However, these settings are also at high risk for outbreaks of respiratory infectious diseases. Influenza virus transmission within LTCFs has distinct epidemiological characteristics, including high transmissibility and high risks of severe illness and mortality. In Taiwan, with the accelerated aging of the population, LTCF residents commonly have multiple chronic comorbidities (multimorbidity) and age-related immune dysfunction (immunosenescence). Influenza infection in this population may not only lead to acute respiratory failure but may also contribute to a "silent burden," including post-infection cardiovascular events, metabolic dysregulation, and long-term functional decline.
Under the current standard of care (SOC), influenza diagnosis relies on reverse transcription polymerase chain reaction (RT-PCR) testing performed by external laboratories, with a turnaround time (TAT) of approximately 24 to 48 hours. This time-to-result gap may delay clinical decision-making, potentially preventing timely initiation of antiviral treatment within the optimal 48-hour treatment window and leading facilities to adopt broad precautionary isolation measures, thereby increasing healthcare resource utilization and staffing burden.
The Abbott ID NOW system uses isothermal nucleic acid amplification technology (INAAT) and can provide molecular diagnostic results within approximately 15 minutes. Through a prospective cluster-randomized controlled design, this study aims to evaluate whether implementation of an ID NOW-based point-of-care testing (POCT) strategy can improve clinical outcomes among LTCF residents and reduce overall healthcare costs compared with the current standard diagnostic pathway.
详细描述
Long-term care facilities (LTCFs) play an increasingly important role in healthcare systems as populations age. However, LTCFs are also settings with a high risk of respiratory infectious disease transmission. Influenza outbreaks in these facilities are of particular concern because residents often have advanced age, multiple chronic comorbidities, and age-related immune dysfunction, all of which may increase the risks of severe disease, hospitalization, and mortality. In addition to acute respiratory complications, influenza infection in this population may also be associated with subsequent cardiovascular events, metabolic deterioration, and prolonged functional decline.
In current clinical practice, influenza diagnosis in LTCFs commonly relies on reverse transcription polymerase chain reaction (RT-PCR) testing performed by external laboratories. The interval between specimen collection and reporting of results may be approximately 24 to 48 hours. This delay may affect the timing of clinical decision-making, including initiation of antiviral therapy and implementation of infection prevention and control measures. During the period when diagnostic results are unavailable, LTCFs may also need to implement precautionary isolation or cohorting measures for residents with suspected influenza-like illness, which may increase healthcare resource utilization and staff workload.
The Abbott ID NOW system is a rapid molecular diagnostic platform based on isothermal nucleic acid amplification technology (INAAT) and can provide molecular test results within approximately 15 minutes. The availability of rapid molecular testing at the point of care may shorten the time between clinical suspicion, diagnostic testing, and subsequent management decisions.
This study is designed as a prospective, cluster-randomized, open-label, two-arm, active-controlled study to evaluate the impact of two different influenza diagnostic strategies in residents of LTCFs in Taiwan: an ID NOW-based point-of-care testing strategy and the current standard diagnostic pathway. The study aims to determine whether the implementation of rapid point-of-care molecular testing can improve clinical outcomes and healthcare resource utilization compared with the standard diagnostic approach.
The study is planned to be conducted in 8 to 10 legally registered residential LTCFs, including nursing homes and other long-term care institutions, located in northern, central, southern, and eastern Taiwan. Participating facilities are required to have at least 40 approved beds, sufficient healthcare personnel to follow the study procedures, the ability to perform on-site specimen collection and infection-control measures, and an established system of regular physician visits. Institutional management approval is required before a facility enters the randomization process.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 筛查
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Acute onset of illness with fever (tympanic temperature ≥38°C) persisting for at least 24 hours.
- Acute onset of illness accompanied by decreased oxygen saturation (e.g., SpO₂ decreased to 94% or deterioration in oxygenation), or influenza infection highly suspected by the treating physician.
- Residents aged 65 years or older with comorbidities (e.g., diabetes mellitus, dialysis, hypertension, heart disease, or use of immunosuppressive agents) who develop acute illness with fever (tympanic temperature ≥37.5°C) persisting for at least 24 hours.
- At least one respiratory symptom, such as cough, sore throat, or rhinorrhea, persisting for at least 24 hours.
排除标准
- A definite alternative diagnosis identified at the initial assessment that explains the influenza-like illness, such as bacterial pneumonia, non-respiratory infection, aspiration pneumonia following choking during feeding, definite urinary tract infection, or known exacerbation of heart failure without evidence of infection.
- Refusal by the resident or the resident's legally authorized representative to provide informed consent for data collection.
- Expected survival of less than 48 hours, as assessed by a physician.
- Participation in this study within the previous 14 days, to avoid duplicate enrollment for the same illness episode.
- Residence in a dedicated dementia care unit, because differences in disease characteristics, communication ability, and care practices may affect the internal validity of the study.
研究组 & 干预措施
ID NOW Point-of-Care Testing Strategy
Participants in this arm will receive point-of-care molecular testing for suspected influenza using the Abbott ID NOW system at the participating long-term care facility. Nasal or nasopharyngeal swab specimens will be collected on site, and the rapid test result will be used to support subsequent clinical management and infection prevention and control decisions.
干预措施: Abbott ID NOW Point-of-Care Testing (Device)
Standard Diagnostic Pathway
Participants in this arm will receive the current standard diagnostic pathway for suspected influenza, including laboratory-based reverse transcription polymerase chain reaction (RT-PCR) testing performed through the usual external laboratory process, together with routine clinical management and infection-control measures.
干预措施: Standard Laboratory-Based RT-PCR Diagnostic Pathway (Diagnostic Test)
结局指标
主要结局
Time From Specimen Collection to Availability of Influenza Test Result
时间窗: During the index influenza-like illness episode, from specimen collection to availability of the test result, up to 48 hours
Time elapsed between collection of the respiratory specimen and availability of the influenza test result for clinical decision-making, compared between the ID NOW point-of-care testing strategy and the standard laboratory-based RT-PCR diagnostic pathway.
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07846423
- 其他研究编号
- CMUH115-REC2-151
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否