Clinical trial NCT03888898: Just-in-time Elastomeric Training and Fit Testing (JET FIT)
Official title: Just-in-time Elastomeric Training and Fit Testing (JET FIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: N95 filtering facepiece respirators
elastomeric respirators
public health emergency
healthcare workers
occupational health
respiratory protection program
personal protective equipment
airborne transmissible pathogens
reusable respirator
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Emory University
name: The University of Texas Health Science Center, Houston
name: Wayne State University
First posted: 2019-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency.

Detailed description: This is a national multicenter pragmatic demonstrative clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency. This study will assess participant and institution ability to rapidly convert and demonstrate proficiency using reusable respirators in the healthcare field to provide a stopgap for respiratory protection program guidelines in times of disposable respirator supply shortages. This protocol is the first in a series of three studies included in the Assessment of Elastomeric Respirators in Healthcare Delivery Settings project sponsored by the National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention (CDC). This project is funded in kind by the National Personal Protective Technology Laboratory (NPPTL), the Office of Public Health Preparedness and Response (OPHPR), and the National Center for Immunization and Respiratory Diseases (NCIRD). The first of three protocols, this will be followed by laboratory and field studies assessing disinfection methods and routine use EHMR. Three (3) United States (US) healthcare delivery organizations (University of Texas Houston, Wayne State University, and Emory University) will be included as study sites in this base protocol, individually accruing a participant sample size up to 100 HCP, with a minimum of 50 evaluable participants per site. A total sample size of 150 to 300 evaluable participants are expected to be accrued nationally. The purpose of this Base protocol is to assess feasibility of reusable EHMRs in healthcare for a just in time adaptation during respiratory infectious disease outbreaks, epidemics, pandemics, and/or disposable respirator supply shortages.

Eligibility criteria: Inclusion Criteria:

* Ability to understand, the willingness to participate, and the completion of a written informed consent document
* Understands spoken and written English language as required for consent, demonstration videos, demonstration checklist, and evaluation measures
* Age \> 18 years old
* Medical Evaluation Form completed by the participant and reviewed/signed by a licensed medical professional such as a registered nurse, nurse practitioner, physician assistant, or physician
* If a subject reports "yes" to any medical condition listed on the Medical Evaluation Form in Part B Questions 2, 5, 6, and/or 7, a Physician must review the subject's current and past medical history and provide documented clearance for them to participate.
* Healthcare personnel requiring respiratory protection, included in the hospital's Respiratory Protection Program and able to provide estimated number of years using respirators
* Bivariate Panel facial measurements and completed data capture form
* Review of the General Photo Release Form. This allows photos and/or videos taken during study participation to be utilized in presentations and publications or the post study webinars contracted (photos/videos will not contain participant personal identifiers). Participants may decline completing this form (and if they decline, they may not be included in any photos or videos). Documented verification of agreement or decline must be addressed before registration to study
* Passed the Taste Threshold test with a score recorded of 10, 20, or 30, indicating participant can taste the sodium saccharin challenge agent for the qualitative fit test
* Eligibility Checklist

Exclusion Criteria:

* Inability to adhere to study and/or follow up procedures
* Facial hair or piercings, which may interfere with the facial seal region of the elastomeric respirator
* Individuals with facial deformities/injuries that may prevent seal and/or passing a fit test
* Known hypogeusia or ageusia (decreased ability to taste certain types of foods or the absence of taste entirely which precludes qualitative fit test)
* Inability to ensure availability for the study intervention date(s) selected by site personnel
* Chronic or current pulmonary or lung problems reported by subject (reports "yes" to any item in Part B. questions 3 or 4) on Medical Evaluation Form
* Prior problems using a respirator as reported in Part B. question 8 of the Medical Evaluation Form

Primary outcomes:
measure: Fit test pass and fail rates in healthcare
timeFrame: within 2 hours
measure: Competency Evaluation
timeFrame: within 2 hours
Secondary outcomes:
measure: User seal check predictive value
timeFrame: within 2 hours
measure: Bivariate Panel facial measurement accuracy for respirator size allocations
timeFrame: within 60 days
measure: Respirator fit test time threshold
timeFrame: within 2 hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Houston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Lewis Radonovich, MD
role: PRINCIPAL_INVESTIGATOR
References: