Clinical trial NCT04342806: Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19
Official title: Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Worker (HCW)
COVID-19
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-04-13
Enrollment: 51466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The HERO Registry will include HCWs currently working across the United States, and their families and communities. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare. (Note: individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as housekeeping, food service, etc.)

Brief summary: The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their families and communities. The overall goal of the Registry is to develop the infrastructure necessary to create and engage a community of people who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment.

Detailed description: The HERO Registry provides a resource for collecting information on Healthcare Workers (HCWs) currently working in the United States, and their family members and communities. The overall goal of the Registry is to create and engage a community of HCWs and their families and communities who may be eligible for participation in future research studies, including those of COVID-19 prophylaxis and treatment. The HERO registry will create a repository of adults interested in COVID-19 research that can be eligible for future research studies. The main objectives of the study are 1) create a virtual community of adult HCWs in the United States, and their families and communities, 2) Identify adults interested in engaging in upcoming research studies, including those related to COVID-19, and 3) Create a dataset of health related measurements, risk factors, and outcomes for future analysis. The population of interest is adult healthcare workers in the United States, and their families and communities.

All analysis of the HERO Registry will be exploratory in nature. Analysis may include descriptive statistics of the cohort, statistical associations between variables of interest, and predictive modeling for health outcomes and behaviors. Analyses may be conducted on all participants in the HERO Registry or may be conducted on subpopulations defined based on clinical, demographic or other factors.

There is no direct benefit to the participants for their participation in this study, but the information obtained will be used in scientific research and may be helpful to the participant or others in the future. Participants may experience indirect benefits such as learning about their own health, access to health data, and opportunities to participate in future research.

Eligibility criteria: Inclusion Criteria:

* A member of one of the following three groups:

  * Individual currently works in a setting where individuals receive healthcare ("healthcare worker") (including emergency medical services), OR
  * A family member of a healthcare worker, OR
  * A member of a healthcare worker's community
* Age ≥ 18
* Able to speak and read English or Spanish

Exclusion Criteria:

\* There are no specific exclusion criteria for this study. Participants must meet inclusion criteria.

Primary outcomes:
measure: Number and percent of participants who enroll in the HERO Registry Study by geographic region, age, COVID-19 risk factors, and past COVID-19 diagnosis
timeFrame: Up to 79 years
measure: Distribution of COVID-19 risk factors by participant characteristics
timeFrame: Up to 79 years
measure: Proportion of participants undergoing changes in health status (e.g. new diagnosis of COVID-19, ER visits, hospitalization)
timeFrame: Up to 79 years
measure: Proportion of all participants enrolled in the HERO Registry who participate in an ancillary research study
timeFrame: Up to 79 years
measure: Proportion of participants who continue to supply information about their health to the HERO Registry at various time points after their enrollment
timeFrame: Up to 79 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Emily O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen-Lim ML, McCabe MA, Xu H, Thomas LE, Forrest CB, Birnbaum S, Webb LE, O'Brien EC. Experiences of U.S. Nurses Compared With Nonnurses in the First Year of COVID-19: Findings From a National Registry. Nurs Res. 2022 Nov-Dec 01;71(6):421-431. doi: 10.1097/NNR.0000000000000610. Epub 2022 Jul 23.
citation: Forrest CB, Xu H, Thomas LE, Webb LE, Cohen LW, Carey TS, Chuang CH, Daraiseh NM, Kaushal R, McClay JC, Modave F, Nauman E, Todd JV, Wallia A, Bruno C, Hernandez AF, O'Brien EC; HERO Registry Research Group. Impact of the Early Phase of the COVID-19 Pandemic on US Healthcare Workers: Results from the HERO Registry. J Gen Intern Med. 2021 May;36(5):1319-1326. doi: 10.1007/s11606-020-06529-z. Epub 2021 Mar 10.