Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04542200
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2020-09-08
Brief Title:
Workforce Serosurveillance to Track Long-term Modifications to COVID-19 Exposure Due to Factors in the Built Environment
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Workforce Serosurveillance to Track Long-term Modifications to COVID-19 Exposure Due to Factors in the Built Environment
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal with this study is to leverage Northwell Health Systems diverse workforce and robust testing structures to contribute data-driven evidence-based strategies to better understand the sustained prevalence of antibodies and how conferred immunity may be modified by environmental factors The objective is to investigate the COVID-19SARS-CoV-2 disease prevalence and trajectory over time by conducting follow-up antibody testing on employees who consented to participate in research during the initial workforce offering From 70812 employees contacted 46117 were tested and received initial results Of those participants approximately 32000 agreed to be re-contacted and 34000 consented to research The investigators plan to conduct an additional five rounds of testing that would sample individuals over a two-year period This study is significant because it leverages Northwell Healths advanced laboratory systems to conduct serosurveillance of antibodies to COVID-19SARS-CoV-2 across a large and diverse workforce while taking into account the contextual environmental and occupational exposures that may modify continued immunity to the virus Northwell Healths employee health services EHS is poised to act quickly to adapt policies and practices where needed to protect the workforce The study is also innovative because it will be linking work environment and community measures with COVID-19 seropositive prevalence patterns over time to build a better understanding of the disease and its controls at the population level The expected outcomes include serial serology results as a measure of full or partial short-term 6 months and long-term 2 year immunity to re-infection and recognition of local environmental factors eg building ventilation rates zip code air quality indicators that could modify this immunity and assist with protecting the workforce and surrounding community These results could inform national and global policies
Detailed Description:
The objective of this study is to understand the COVID-19SARS-CoV-2 disease incidence prevalence and trajectory over time by conducting follow-up antibody testing on employees by first following up with the approximately 5600 team members who were positive and then extending the invitation to the remaining team members approximately 65212
Aim 1 Follow those who tested positive during prior institutional antibody testing to better understand whether IgG or total antibody measures confer continued immunity hypothesis 1 is that prior infection will be protective and that restricting testing to prior positives reduces impact of false positive results due to low prevalence populations Over a 15 year period testing will be repeated on seropositive individuals in January 2021 May 2021 September of 2021 January 2022 and May 2022
The results will be to document antibody seropositivity and continued presence of immunity over time The study investigators will invite those positive Northwell team members to participate in a research study that has the aim of testing for continued presence of antibodies to COVID-19 to understand trends over time
Aim 2 Continue to document seroconversion rates and distribution of exposure to COVID-19 across the entire remaining workforce hypothesis 2 is that employees will have lower rates than the general population even though false positive serology results will be highly dependent upon New York State positive prevalence rates Over the same 15 year period as in Aim 1 testing will be repeated for all workforce participants who previously tested negative and others interested in participating for the first time in May 2021 or September 2021 and May 2022
Aim 3 Track any associations between engineering administrative and personal protective equipment PPE policies across the health system and whether these continue to be protective and adapt to diseaseviral behavior over time hypothesis 3 is that Northwell Health policies are proactive and protective and that co-exposures to environmental factors in the workplace and community are measurable and remediable with respect to their effects on COVID-19 infection rates The investigators propose to complete three things First they will be linking job title department and industry codes from participant records with occupational indices of workplace exposure such as ONet This will create a job or task exposure matrix JEM for job groups in the Northwell Health system This JEM will reflect conventional understanding of job level exposure risk estimates to work stressors that may be physical eg heavy loads psychosocial eg job demandcontrol noise and chemical eg peracetic acid cleaners Second they will link departmental level policy information on personal protective equipment PPE for each jobtask administrative policies on work hours for the job and chemicals used for infection control at the unit level and engineering ventilation rates at the building and unit level eg air changes per hour and occupancy limits This institutional policy information will be gathered from January 2021 to each wave of data collection Any changes in policy will be documented and the most recent policy will be linked with the job title information Third the investigators will integrate community variable census information at the census tract or zip code level on neighborhood air quality poverty rates language predominance nativity US or other and household density The study will include travel distance to work and transportation mode
The investigators anticipate that findings from this work particularly from Aim 3 have implications that extend to communities across New York State Northwell Health is the largest employer in New York and its employee residences and work locations span every county They also believe that this work has broader national and international relevance as the world continues global efforts to navigate a built environment in which SARS-CoV-2 now exists in a pandemic The strengths of this study are that it accesses a large population sample of 70812 people that is diverse and also self-contained whereby multiple work home and environmental factors can be measured alongside trajectories in COVID-19 prevalence The population is economically and culturally diverse even by global standards and includes Queens County that has recorded some of the highest seropositivity rates to date
Aim 1 Follow those who tested positive during prior institutional antibody testing to better understand whether IgG or total antibody measures confer continued immunity hypothesis 1 is that prior infection will be protective and that restricting testing to prior positives reduces impact of false positive results due to low prevalence populations Over a 15 year period testing will be repeated on seropositive individuals in January 2021 May 2021 September of 2021 January 2022 and May 2022
The results will be to document antibody seropositivity and continued presence of immunity over time The study investigators will invite those positive Northwell team members to participate in a research study that has the aim of testing for continued presence of antibodies to COVID-19 to understand trends over time
Aim 2 Continue to document seroconversion rates and distribution of exposure to COVID-19 across the entire remaining workforce hypothesis 2 is that employees will have lower rates than the general population even though false positive serology results will be highly dependent upon New York State positive prevalence rates Over the same 15 year period as in Aim 1 testing will be repeated for all workforce participants who previously tested negative and others interested in participating for the first time in May 2021 or September 2021 and May 2022
Aim 3 Track any associations between engineering administrative and personal protective equipment PPE policies across the health system and whether these continue to be protective and adapt to diseaseviral behavior over time hypothesis 3 is that Northwell Health policies are proactive and protective and that co-exposures to environmental factors in the workplace and community are measurable and remediable with respect to their effects on COVID-19 infection rates The investigators propose to complete three things First they will be linking job title department and industry codes from participant records with occupational indices of workplace exposure such as ONet This will create a job or task exposure matrix JEM for job groups in the Northwell Health system This JEM will reflect conventional understanding of job level exposure risk estimates to work stressors that may be physical eg heavy loads psychosocial eg job demandcontrol noise and chemical eg peracetic acid cleaners Second they will link departmental level policy information on personal protective equipment PPE for each jobtask administrative policies on work hours for the job and chemicals used for infection control at the unit level and engineering ventilation rates at the building and unit level eg air changes per hour and occupancy limits This institutional policy information will be gathered from January 2021 to each wave of data collection Any changes in policy will be documented and the most recent policy will be linked with the job title information Third the investigators will integrate community variable census information at the census tract or zip code level on neighborhood air quality poverty rates language predominance nativity US or other and household density The study will include travel distance to work and transportation mode
The investigators anticipate that findings from this work particularly from Aim 3 have implications that extend to communities across New York State Northwell Health is the largest employer in New York and its employee residences and work locations span every county They also believe that this work has broader national and international relevance as the world continues global efforts to navigate a built environment in which SARS-CoV-2 now exists in a pandemic The strengths of this study are that it accesses a large population sample of 70812 people that is diverse and also self-contained whereby multiple work home and environmental factors can be measured alongside trajectories in COVID-19 prevalence The population is economically and culturally diverse even by global standards and includes Queens County that has recorded some of the highest seropositivity rates to date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None