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

backgroundEarly 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.

objectiveThe 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.

methodsThe 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.

resultsThe 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.

conclusionsThe 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 registrationClinicalTrials.gov NCT04370821; https://clinicaltrials.gov/ct2/show/NCT04370821. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30757.