Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-term Care Facilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Number of all-cause hospitalizations in RAPID-LTCF vs. control LTCF during the 4-month influenza season
研究概览
简要总结
RAPID-LTCF is a stratified, block-randomized controlled trial to assess the effectiveness of a simple ARI case definition, rapid influenza diagnostic test (RIDT) with wireless transmission of results, and provision of infection control guidance when influenza is detected. Because of the nature of the intervention, blinding is not possible. Sites will be initially recruited for a study of "respiratory infections within LTCFs." After acceptance into the study, sites will be matched in terms of bed capacity, location, and other features prior to randomization.
详细描述
Project Overview: The primary goal of RAPID-LTCF is to conduct a randomized, controlled clinical trial (RCT) to assess the effect of on-site, rapid influenza detection at long-term care facilities (LTCFs) on influenza-related hospitalizations, deaths, and healthcare-associated costs.
The basic research question in PICO format is:
Population: for residents of LTCFs across Wisconsin
Intervention: does early detection of influenza coupled with infection control guidance
Comparator: compared to usual care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any resident of one of the 10 LTCF intervention facilities with two acute respiratory infection symptoms (rhinorrhea/runny nose, nasal congestion, sore throat, cough or fever).
排除标准
- 未提供
研究组 & 干预措施
LTCF with RIDT
Nasal swabs will be tested by nursing personnel at each intervention site using SOFIA Fluorescent Immunoassay Analyzer Influenza A+B (LTCF with RIDT). Anonymous results will be sent, via wireless transmission, for daily review by the study team and public health personnel. A positive influenza detection will trigger direct communication with LTCF personnel with advice on antiviral treatment, antiviral prophylaxis, and appropriate infection control practices. We will collect data from each site regarding the prescribing of influenza antivirals for treatment and prophylaxis, number of hospitalizations, number of deaths, and associated healthcare costs during annual, dynamic, 4-month risk windows, based on Wisconsin surveillance of influenza patterns.
干预措施: Sofia Fluorescent Immunoassay Analyzer Influenza A+B (Device)
LTCF Control
Usual care.
Data will be collected from each site regarding the prescribing of influenza antivirals for treatment and prophylaxis, number of hospitalizations, number of deaths, and associated healthcare costs during annual, dynamic, 4-month risk windows, based on Wisconsin surveillance of influenza patterns.
干预措施: Usual care (Other)
结局指标
主要结局
Number of all-cause hospitalizations in RAPID-LTCF vs. control LTCF during the 4-month influenza season
时间窗: 4 months
All transfers of patients to the hospital will be assessed.
Number of respiratory infection-related hospitalizations in RAPID-LTCF vs control LTCF during the 4-month influenza season
时间窗: 4 months
These will include all hospitalizations that include a discharge diagnosis for any respiratory infection.
Deaths during the 4-month influenza season in RAPID-LTCF vs. control LTCF
时间窗: 4 months
Number of influenza antiviral treatment courses provided during the 4-month influenza seasons in RAPID-LTCF vs. control LTCF
时间窗: 4 months
Oseltamivir is the most commonly used antiviral for influenza treatment. The usual dose is 75 mg twice a day for 5 days.
Number of influenza antiviral prophylaxis courses provided during the 4-month influenza season in RAPID-LTCF vs. control LTCF
时间窗: 4 months
Oseltamivir is the most commonly used antiviral for influenza prophylaxis. The usual dose is 75 mg daily for the duration of likely exposure
次要结局
未报告次要终点