The Respiratory Protection Effectiveness Clinical Trial (ResPECT)
Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.
Respiratory Syncytial Viruses
Device: N95 Respirator
Device: Medical/surgical mask
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Incidence of Respiratory Illness in Outpatient Healthcare Workers Who Wear Respirators or Medical Masks While Caring for Patients|
- Protective Effects of N95 Respirators vs Medical Masks [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]To determine and analyze the magnitude of the change, if any, in incidence of laboratory confirmed influenza in healthcare practitioners wearing N95 respirators (2009 CDC guidelines) compared to medical masks (2007 guidelines).
- Incidence Determination of Influenza and Viral Respiratory Illness [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]To improve understanding about the burden of influenza and other viral respiratory illnesses among HCPs stationed in outpatient settings by evaluating the incidence of laboratory-confirmed influenza.
- Protective Effects [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]
- To determine and analyze the magnitude of the change, if any, in incidence of acute respiratory illness, influenza-like illness, and lab-confirmed respiratory illness in HCPs wearing N95 respirators compared to medical masks.
- To examine the relationship between incidence and possible risk factors, including compliance, attitudes and opinions of HCPs and workplace exposures.
- Incidence determination [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]- To measure the incidence of acute respiratory illness, influenza-like illness, and lab-confirmed respiratory illness in selected outpatient settings.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: N95 Respirator
The investigators are comparing the 3M 1860 N95 respirator against the Precept 15320 medical mask.
Device: N95 Respirator
Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period.
Active Comparator: Medical/surgical mask
The investigators are comparing the Precept 15320 medical/surgical mask against the 3M 1860 N95 respirator.
Device: Medical/surgical mask
Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period.
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Prevention strategies are key in limiting the transmission of respiratory viruses such as influenza. Among non-pharmacologic interventions, there is intense interest in the use of facial protective equipment (FPE) - surgical masks or N95 respirators - as a key component of personal protective equipment (PPE) when faced with seasonal influenza or other respiratory illness. However, their relative protective effect is unknown, especially in the outpatient setting. To plan for future epidemics and best manage limited supplies of FPE, evidence is needed to guide planning activities and policy makers. This project aims to answer a key question about PPE use: How do respirators (N95s) protect HCWs in the outpatient setting against influenza, influenza-like illness (ILI), acute respiratory illness (ARI) and other respiratory illnesses, as compared to surgical masks? This study will have the following outcomes:
- An analysis to determine the most effective facial protective equipment to use to prevent disease transmission in the outpatient setting during a seasonal influenza outbreak, epidemic or pandemic event.
- An analysis of the incidence of organism-specific rates of respiratory viral infections in the outpatient setting during influenza season.
- An assessment of the incidence rate of organism-specific respiratory viral infections in the outpatient setting.
This is an approximately 16-18 week study. The investigators will initiate the study when viral surveillance data indicates that influenza season has begun. Recruitment will be accomplished through informational meetings with clinic staff. Participants will have blood drawn before week 1 and after the end of the active portion of the study to assess seroconversion over the study period; this will also allow us to capture the incidence of non-symptomatic influenza. All participants will fill out a pre-study survey on knowledge, attitudes and beliefs regarding influenza, influenza vaccinations, and appropriate PPE. All participants, regardless of study arm, will be fit-tested for an N95 respirator.
During the first week, participants will fill out a form with basic demographic and workplace information. Clinics (or their functional partitions) will be placed into either the N95 respirator or surgical/medical mask arm using a stratified randomization scheme to ensure comparability between the two arms. Participants will be asked to wear their appropriate FPE when in close contact with patients with suspected or confirmed influenza or respiratory disease for the next 12-16 weeks. Participants will be asked to fill out a daily form assessing exposure to influenza-like-illness and FPE use, and weekly forms assessing influenza-like symptoms and medication use. The investigators will collect nasal and throat swabs twice during the study for all participants, and also when participants report that they have an influenza-like illness. Study staff will make unannounced visits to the clinics to observe FPE and hand hygiene compliance rates. At the end of the study, participants will be asked to fill out a post-study survey on knowledge, attitudes, and opinions about FPE.
Participants will be compensated for their participation (up to $599 total, as detailed below). Inclusion criteria are: (1) Clinical site leadership has agreed to have one or more staff participate in the trial (2) Subject meets the definition of "healthcare personnel" (3) Subject able to read and sign informed consent (4) Subject agrees to all requirements of the protocol, including fit testing and diary keeping (5) Subject's age is 18 or greater (6) Subject passes fit testing for one of the study supplied respirator models and agrees to use that model for the entire 16 week period of the study. Exclusion criteria are: (1) Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation (2) Known to not tolerate wearing respiratory protective equipment for any period (3) Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period (4) Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study (5) In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason (6) Self-identified as in, or will be in the third trimester of pregnancy, during the study period.
Participants will be compensated for their participation. Each participant who completes the requirements of the study will receive a total of $ 500 (12 weeks) or $599 (16 weeks). They will receive $55 for completing the pre-study package (pre-study survey, baseline survey, and initial blood draw). For each week the participant meets the study requirements, he will be paid $10.00 for completing the weekly & daily surveys. Each randomized swab set (nasal + throat) is worth $60. There is also a post-study package (post-study survey and final blood draw) worth $70. Following the study, a bonus of up to $135 will be given to participants who complete the entire study, pro-rated on number of completed weekly and work-shift exposure surveys.
During the study period, study staff will be making unannounced visits to the clinics to see if participants are washing their hands and wearing their FPE as discussed during the educational session. These observations are for study use only. The information collected will not be shared with the supervisors or administration of the clinics.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249625
|Contact: Trish M Perl, MD, MScfirstname.lastname@example.org|
|Contact: Jenna Losemail@example.com|
|United States, Colorado|
|Children's Hospital Colorado Infectious Disease||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Ann-Christine Nyquist, MD 720-777-6981 Chris.Nyquist@childrenscolorado.org|
|Contact: Megan Brocato Megan.Brocato@childrenscolorado.org|
|Principal Investigator: Ann-Christine Nyquist, MD|
|Denver Health Medical Center||Recruiting|
|Denver, Colorado, United States, 80204|
|Contact: Connie Price, MD 303-436-7481 Connie.Price@dhha.org|
|Contact: Amy Irwin, MS, RN 303-436-4843 Amy.Irwin@dhha.org|
|Principal Investigator: Connie Price, MD|
|Denver Veteran's Administration Medical Center||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Mary Bessesen, MD firstname.lastname@example.org|
|Contact: Jill Adams, RN 303-399-8020 ext 2392 Jill.Adams@va.gov|
|Principal Investigator: Mary Bessesen, MD|
|United States, District of Columbia|
|Veterans Affairs Medical Center, Washington, DC||Recruiting|
|Washington, District of Columbia, United States, 20422|
|Contact: Cynthia Gibert, MD Cynthia.Gibert@va.gov|
|Contact: Dana Silver Dana.Silver@va.gov|
|Principal Investigator: Cynthia Gibert, MD|
|United States, Maryland|
|Johns Hopkins Health Sytstem||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Trish M Perl, MD 410-955-8384 email@example.com|
|Contact: Jenna Los 410-614-3506 firstname.lastname@example.org|
|Principal Investigator: Trish M Perl, MD|
|United States, New York|
|VA New York Harbor Healthcare System||Recruiting|
|New York City, New York, United States, 10010|
|Contact: Michael Simbekoff, MD 212-263-6481 mike.simberkoffMD@va.gov|
|Contact: Christine Reel-Brander, RN 718-836-6600 Christine.Reel-Brander@va.gov|
|Principal Investigator: Simberkoff Michael, MD|
|United States, Texas|
|Houston VA Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maria Rodriguez-Barradas, MD Maria.Rodriguez-Barradas2@va.gov|
|Contact: Barbara Kertz 713-794-7224 email@example.com|
|Principal Investigator: Maria Rodriguez-Barradas, MD|
|Principal Investigator:||Trish M. Perl, MD||Johns Hopkins University School of Medicine/Johns Hopkins Hospital|
|Principal Investigator:||Lewis Radonovich, MD||North Georgia/South Florida VA|
|Study Director:||Derek Cummings, PhD||Johns Hopkins University|
|Study Director:||Michael Simberkoff, MD||New York Harbor Healthcare System VA|
|Study Director:||Connie S Price, MD||University of Colorado (Denver Health)|
|Study Director:||Charlotte Gaydos, PhD||Johns Hopkins University|
|Study Director:||Nicholas Reich, PhD||University of Massachusetts, Amherst|