Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19

• ClinicalTrials.gov Identifier: NCT04342806
• Recruitment Status: Completed
• First Posted: April 13, 2020
• Last Update Posted: October 27, 2022
• Sponsor: Duke University
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 13, 2020
• Last Update Posted Date: October 27, 2022
• Actual Study Start Date: April 10, 2020
• Actual Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2021)

• 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 [ Time Frame: Up to 79 years ]
• Distribution of COVID-19 risk factors by participant characteristics [ Time Frame: Up to 79 years ]
• Proportion of participants undergoing changes in health status (e.g. new diagnosis of COVID-19, ER visits, hospitalization) [ Time Frame: Up to 79 years ]
• Proportion of all participants enrolled in the HERO Registry who participate in an ancillary research study [ Time Frame: Up to 79 years ]
• Proportion of participants who continue to supply information about their health to the HERO Registry at various time points after their enrollment [ Time Frame: Up to 79 years ]

Original Primary Outcome Measures (submitted: April 10, 2020)

• 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 [ Time Frame: Up to 79 years ]
• Distribution of COVID-19 risk factors by participant characteristics [ Time Frame: Up to 79 years ]
• Proportion of participants undergoing changes in health status (e.g. new diagnosis of COVID-19, ER visits, hospitalization) [ Time Frame: Up to 79 years ]
• Proportion of all participants enrolled in the HERO Registry who participate in an ancillary research study [ Time Frame: Up to 79 years ]
• Proportion of participants who continue to supple information about their health to the HERO Registry at various time points after their enrollment [ Time Frame: Up to 79 years ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study, COVID-19
• Official Title: Healthcare Worker Exposure Response and Outcomes (HERO) Registry Study
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Biospecimen: Not Provided
• 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.)

Condition

• Health Care Worker (HCW)
• COVID-19

• Intervention: Not Provided

Study Groups/Cohorts

HCWs currently working in the US, and their families and communities

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.)

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2022): 51466
• Original Estimated Enrollment (submitted: April 10, 2020): 100000
• Actual Study Completion Date: September 30, 2022
• Actual Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 110 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04342806
• Other Study ID Numbers: Pro00105284
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Emily O'Brien, PhD; Duke University

• PRS Account: Duke University
• Verification Date: October 2022