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

• ClinicalTrials.gov Identifier: NCT03888898
• Recruitment Status: Unknown
• First Posted: March 25, 2019
• Last Update Posted: March 20, 2020
• Sponsor: Centers for Disease Control and Prevention
• Collaborators: Emory University; The University of Texas Health Science Center, Houston; Wayne State University
• Information provided by (Responsible Party): Centers for Disease Control and Prevention

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infection	Other: Reusable respirator fit test and competency evaluation; Other: Control fit test evaluation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Just-in-time Elastomeric Training and Fit Testing (JET FIT)
• Actual Study Start Date: April 2, 2019
• Estimated Primary Completion Date: December 1, 2020
• Estimated Study Completion Date: February 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Fit test pass and fail rates in healthcare [ Time Frame: within 2 hours ]
   Participant subjective pass or fail result for sodium saccharin aerosol qualitative fit test
2. Competency Evaluation [ Time Frame: within 2 hours ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48021

United States, Texas

University of Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Centers for Disease Control and Prevention

Emory University

The University of Texas Health Science Center, Houston

Wayne State University

Investigators

• Principal Investigator: Lewis Radonovich, MD; Centers for Disease Control and Prevention

More Information

• Responsible Party: Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT03888898
• Other Study ID Numbers: Elastomeric Base Protocol
• First Posted: March 25, 2019
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centers for Disease Control and Prevention:

N95 filtering facepiece respirators; elastomeric respirators; public health emergency; healthcare workers; occupational health; respiratory protection program; personal protective equipment; airborne transmissible pathogens; reusable respirator