The COVID-19 Study of Healthcare and Support Personnel (CHAMPS): Protocol for a Longitudinal Observational Study.

Author(s)

Peter G. Kaufmann, Villanova UniversityFollow
Donna S. Havens, Villanova UniversityFollow
Janell L. Mensinger, Nova Southeastern UniversityFollow
Patricia K. Bradley, Villanova UniversityFollow
Heather M. Brom, Villanova UniversityFollow
Linda C. Copel, Villanova UniversityFollow
Alexander Costello, Villanova University
Christine D'Annunzio, Villanova University
Jennifer Dean Durning, Villanova University
Linda Maldonado, Villanova UniversityFollow
Ann Barrow McKenzie, Villanova UniversityFollow
Suzanne C. Smeltzer, Villanova UniversityFollow
Jennifer Yost, Villanova UniversityFollow
CHAMPS Study Investigators, Villanova University

ORCID

0000-0003-0459-2464, 0000-0003-2547-5777, 0000-0001-7675-8879, 0000-0002-3213-4957, 0000-0002-4295-6372, 0000-0003-1232-1867, 0000-0002-3875-3767, 0000-0001-7828-7089, 0000-0002-3210-4395, 0000-0002-9433-8592, 0000-0001-8722-125X, 0000-0002-1970-2243, 0000-0002-3170-1956,

Document Type

Article

Publication Title

JMIR Research Protocols

ISSN

1929-0748

Publication Date

10-7-2021

Abstract

BACKGROUND: Early in the development of the COVID-19 pandemic, it was evident that health care workers, first responders, and other essential workers would face significant stress and workplace demands related to equipment shortages and rapidly growing infections in the general population. Although the effects of other sources of stress on health have been documented, the effects of these unique conditions of the COVID-19 pandemic on the long-term health and well-being of the health care workforce are not known.

OBJECTIVE: The COVID-19 Study of Healthcare and Support Personnel (CHAMPS) was designed to document early and longitudinal effects of the pandemic on the mental and physical health of essential workers engaged in health care. We will investigate mediators and moderators of these effects and evaluate the influence of exposure to stress, including morbidity and mortality, over time. We will also examine the effect of protective factors and resilience on health outcomes.

METHODS: The study cohort is a convenience sample recruited nationally through communities, professional organizations, networks, social media, and snowball sampling. Recruitment took place for 13 months to obtain an estimated sample of 2762 adults who provided self-reported information administered on the web through structured questionnaires about their work environment, mental and physical health, and psychosocial factors. Follow-up questionnaires will be administered after 6 months and annually thereafter to ascertain changes in health, well-being, and lifestyle. Participants who consented to be recontacted form the longitudinal cohort and the CHAMPS Registry may be contacted to ascertain their interest in ancillary studies for which they may be eligible.

RESULTS: The study was approved by the Institutional Review Board and launched in May 2020, with grants from Travere Therapeutics Inc, McKesson Corporation, anonymous donors, and internal funding from the M. Louise Fitzpatrick College of Nursing at Villanova University. Recruitment ended in June 2021 after enrolling 2762 participants, 1534 of whom agreed to participate in the longitudinal study and the registry as well as to be contacted about eligibility for future studies.

CONCLUSIONS: The CHAMPS Study and Registry will enable the acquisition of detailed data on the effects of extended psychosocial and workplace stress on morbidity and mortality and serve as a platform for ancillary studies related to the COVID-19 pandemic.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04370821; https://clinicaltrials.gov/ct2/show/NCT04370821.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30757.

DOI

10.2196/30757

Volume

10

Issue

10

PubMed ID

34582354

NSUWorks Citation

Kaufmann, P. G., Havens, D. S., Mensinger, J. L., Bradley, P. K., Brom, H. M., Copel, L. C., Costello, A., D'Annunzio, C., Durning, J. D., Maldonado, L., McKenzie, A. B., Smeltzer, S. C., Yost, J., Study Investigators, C. (2021). The COVID-19 Study of Healthcare and Support Personnel (CHAMPS): Protocol for a Longitudinal Observational Study.. JMIR Research Protocols, 10(10).
Available at: https://nsuworks.nova.edu/cps_facarticles/1985