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

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT03888898

Collaborator

Emory University (Other), The University of Texas Health Science Center, Houston (Other), Wayne State University (Other)

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

100

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Apr 2, 2019

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Feb 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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Wayne State University	Detroit	Michigan	United States	48021
3	University of Texas	Houston	Texas	United States	77030