Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-term Care Facilities
Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-term Care Facilities
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.
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

 Outcomes: result in:

 1. increase early detection and reporting of influenza outbreaks?

 2. increased early antiviral treatment of influenza?

 3. increased use of antiviral prophylaxis for other at-risk residents?

 4. fewer hospitalizations during the influenza season?

 5. reduced mortality during the influenza season?

 6. lower healthcare associated costs during the influenza season?

 Building on two highly successful pilot QI projects-undertaken during the last two influenza
 seasons-that confirmed the feasibility and desirability of this approach, existing,
 CLIA-waived, low-complexity rapid influenza diagnostic test (RIDT) with high sensitivity and
 high specificity in this population as the diagnostic platform will be used. RIDT analyzers
 will be configured for wireless transmission of anonymous test results to a cloud-based
 server for real-time access by public health. Detection of influenza at a LTCF and its
 transmission to public health in real time will trigger communication and advice on
 appropriate infection control measures to reduce in-facility transmission. This approach has
 high potential for limiting influenza's effect at LTCFs.

 Residents of LTCFs are at high risk for influenza infection due to reduced efficacy of
 influenza vaccines in elders, close quartering, presence of co-morbid medical conditions, and
 delayed response times. Consequently, outbreaks of influenza and other significant
 respiratory viruses easily spread within LTCFs and cause substantial morbidity and mortality
 in these populations. Results from this RCT will provide highly generalizable approaches
 using low-cost, low-complexity and easily-adapted tools and protocols for extremely early
 influenza detection and response. It is anticipated that early outbreak recognition and
 control in LTCFs will substantially reduce morbidity, mortality and healthcare associated
 costs in this vulnerable population.

 Background: At present, 1.8 million individuals live in this nation's 16,000 nursing homes
 and an additional 900,000 live in assisted living facilities. Significant healthcare
 disparities exist for these individuals; a recent study found that the largest for-profit
 nursing homes delivered significantly lower quality of care. Part of this disparity is
 reflected in the fate of those infected with influenza. Influenza and pneumonia combine to
 form the 8th leading cause of death in the United States. Outbreaks of influenza and other
 respiratory viruses are common in LTCFs and result in significant morbidity and mortality
 among residents. This increased morbidity and mortality is due to a combination of close
 quartering, residents with co-morbid medical conditions, and delays in medical response.
 Because of this high risk, influenza vaccination has long been recommended for all residents
 and health care workers in these settings. Influenza vaccines, however, can have very low
 efficacy in older individuals; vaccine efficacy for protection from the predominant influenza
 strain in 2014-2015 was estimated to be only 14% for individuals aged 50 years and older.
 Accordingly, elders (aged 65+) accounted for 72.4% of Wisconsin's influenza-related
 hospitalizations during the 2014-2015 influenza season and 63% of influenza-related ICU
 admissions. Moreover, across the country, the rate of attributable influenza hospitalization
 was 313 per 100,000 for individuals aged 65 year and older.

 The current practice for identifying and responding to influenza outbreaks in LTCFs is
 reactive and delayed. Of 41 known influenza outbreaks in LTCFs during the 2010-2011 season in
 New York, most were identified retrospectively through reporting of influenza
 hospitalizations and well before the LTCFs submitted reports to the Department of Health. The
 availability of CLIA-waived, low-complexity, sensitive and specific rapid influenza detection
 tests (RIDTs) can facilitate on-site diagnosis and early detection of an outbreak. Coupling
 RIDTs with wireless transmission of anonymous results directly to public health officials
 provides the means for extremely early and proactive outbreak recognition and intervention.

 Program Goal: A randomized, controlled clinical trial to assess the effect of on-site RIDTs
 at LTCFs on subsequent influenza-related hospitalizations, deaths, and healthcare-associated
 costs is proposed. LTCF nursing staff will use RIDT technology to screen residents with acute
 respiratory infections (ARI). The proposed RIDT is a CLIA-waved, low-complexity test that
 uses a benign nasal swab specimen. It is configured to send test results via wireless
 transmission to a cloud platform. From there, data can be accessed in real-time by public
 health partners.

 Methods: Starting in January 2013, extensive experience with the Quidel SOFIA Influenza A+B
 system at 20 clinical sites and 7 LCTFs where the testing platform transmits influenza test
 results immediately to a cloud-based system with public health access has been acquired. True
 "real-time" availability of surveillance results are achievable. Since initiation, this
 highly innovative system has been working flawlessly. A plan to conduct RAPID-LTCF over three
 sequential influenza seasons to adapt to the uncertainties of influenza epidemiology has been
 proposed. Twenty LTCFs across Wisconsin will be recruited for participation and randomized,
 following stratification, to intervention (RIDT) or control (usual care) arms. Waived consent
 for on-site specimen collection from residents at the RIDT sites with acute respiratory
 infections has been approved by the IRB. Nasal swabs will be tested by nursing personnel at
 each intervention site using SOFIA. 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. Data
 will be collected from each site regarding the number of courses of influenza antiviral
 medication provided for influenza treatment and for influenza 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. An independent
 data monitoring and safety board will continuously review outcomes and halt the study should
 significant differences between the two arms emerge. Outcomes will be assessed using standard
 statistical methods.

 Significance: This program reflects the full intent of the Wisconsin Partnership Program and
 the Wisconsin Idea by identifying high-risk populations, and combining research, education
 and public health practice to reduce the disparities of care experienced by these
 populations. The application of cutting-edge, inexpensive, high-performing and reliable
 technology into a population of traditionally under-served, high-risk individuals would
 provide a translatable model for very early and proactive detection of, and response to
 influenza in LTCFs, thus allowing for appropriate medical (antiviral) and public health
 (in-room quarantining, enhanced personal protection equipment, prophylaxis of other
 residents) interventions.
Inclusion Criteria:

 -  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).

 Exclusion Criteria:

 -  None