The Hackensack Meridian Health Universal Observational COVID-19, a descriptive observational database, is a multi-center initiative collecting data throughout the Hackensack Meridian Health Network (HMH). HMH utilizes the EPIC system at most of the facilities, which will serve as the primary data source. The database will be designed within the REDCap system. A de-identified dataset will be sent to COTA for primary statistical analysis as requested by the research teams.
The principle objective of this observational database is to build research-grade real world
data that will serve as platform to advance the scientific understanding and clinical care of
patients with COVID-19.
1. Demographic, diagnostic, treatment and outcome data from centers throughout the Hackensack
Meridian Health Network will be abstracted from the electronic health records of patients
with confirmed or suspected COVID-19. This will be purely observational and no direction as
to the care of the patient will be performed as part of this effort.
1a. Data points to be collected will include, but are not limited to: age, gender, zip code,
prior evaluation for COVID-19, tobacco history, race, site of care, healthcare worker,
nursing home care, visits to ER, presenting features of fever/ cough/ dyspnea/
gastrointestinal/ mental status changes, days of symptoms, comorbidities, uses of
antihypertensives, duration of hospitalization/ icu care, presenting laboratory functions,
presenting vital signs, need for oxygen support, dialysis/ ecmo use, treatment with
hydroxychloroquine/ azithromycin/ remdesevir/ tociluzimab/ anti-inflammatory agents,
arrhythmias/ QTc prolongation, enrollment on clinical trial, positive cultures, survival and
cause of death. Additional data points will be added as needed.
2. The data will be entered into a central "Universal" database hosted within the REDCap
system (HIPAA compliant, secure, access only per HMH research approval)
3. A de-identified dataset will be sent to COTA for primary statistical analysis as requested
by the research teams. COTA will also make available a data/analytic visualization tool
(hosted on Tableau) for analysis by primary investigators.
4. Additional data points and analysis may be added to the Universal database as requested by
HMH investigators with IRB approval. De-identified data may also be sent directly to HMH
investigators for their own analysis with IRB approval of their projects 5. Data will be made
available to governmental agencies as requested.
Inclusion Criteria:
- Confirmed or suspected COVID-19
- Data available via the EPIC system
- NO age restriction
- NO pregnancy restrictions
Exclusion Criteria:
- Patients on a clinical trial in which the treatment is blinded may be included in the
database, however the study medication or treatment will be noted as "experimental"
and not reported individually. NO efforts to "break" randomization or blinding will be
permitted
- Patients may refuse to be tracked in the database and/or participate in this
observational study. Given the lack of active "study" procedures in this observational
database, formal informed consent is not required
Hackensack Meridian Health - John Theurer Cancer Center
Hackensack, New Jersey, United States
Andrew Ip, MD, Principal Investigator
Hackensack Meridian Health