Just-in-time Elastomeric Training and Fit Testing (JET FIT)

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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Other: Control fit test evaluation; Other: Reusable respirator fit test and competency evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Michigan
    • Detroit, Michigan, United States, 48021
      • Wayne State University
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: N95 Filtering Facepiece Respirator; control fit testing	Other: Control fit test evaluation; control comparator for fit testing time threshold
Experimental: Elastomeric Respirator; experimental rapid conversion fit testing and competency evaluations	Other: Reusable respirator fit test and competency evaluation; Feasibility of rapid conversion to reusable elastomeric respirator use during public health emergency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fit test pass and fail rates in healthcare	Participant subjective pass or fail result for sodium saccharin aerosol qualitative fit test	within 2 hours
Competency Evaluation	elastomeric half mask respirator participant "Competency Evaluation" determined by measuring competence based on tasks completed by participants using a numeric scale of 26-78 points possible. 6 competencies will be tested with subparts defined as tasks (5 competencies include 4 tasks and 1 competency includes 6 tasks). Each task is 1-3 points, with 3 points being the highest score and 1 point being the lowest possible score.	within 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User seal check predictive value	subjective pass or fail reported scores by subjects during user seal checks	within 2 hours
Bivariate Panel facial measurement accuracy for respirator size allocations	Bivariate Panel cell category allocation accuracy measured by pass or fail of fit test	within 60 days
Respirator fit test time threshold	Measurement of maximum time threshold for training required to convert subjects to disposable and reusable respirators	within 2 hours

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: The University of Texas Health Science Center, Houston; Wayne State University; Emory University
• Investigators: Principal Investigator: Lewis Radonovich, MD, Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: occupational health; personal protective equipment; healthcare workers; N95 filtering facepiece respirators; elastomeric respirators; public health emergency; respiratory protection program; airborne transmissible pathogens; reusable respirator
• Other Study ID Numbers: Elastomeric Base Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No