A Prospective "Universal" Observational Database for COVID-19
Status:
Recruiting
Sponsors
Hackensack Meridian Health
Abstract:
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.
Description:
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.
Last Verified:March/31/2020
First Submitted:April/12/2020
Estimated Enrollment Submitted:April/13/2020
First Posted:April/14/2020
Last Update Submitted:April/20/2020
Last Update Posted:April/23/2020
Actual Study Start Date:March/26/2020
Estimated Primary Completion Date:March/31/2021
Estimated Study Completion Date:March/31/2021
Condition or disease:COVID-19
Phase:-
Study design:
Study Type:Observational [Patient Registry]
Observational Model:Case-Only
Time Perspective:Prospective
Eligibility Criteria:
Sexes Eligible for Study:All
Sampling method:Non-Probability Sample
Accepts Healthy Volunteers:Yes
Criteria:

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

Outcome:
Primary Outcome Measures
1. Need for hospitalization [1 Year]
Rate of Hospitalization
2. Duration of hospitalization [1 Year]
The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
3. Need for ICU/Ventilator Support [1 Year]
Rate of ICU/Ventilator Support
4. Duration of ICU/Ventilator Support [1 Year]
The duration of ICU/Ventilator Support is defined as the time in days from the first day of using mechanical ventilation/ICU admission to the last day of using mechanical ventilation/ICU discharge. All evaluable patients will be included and no censoring for this analysis.
5. Overall Survival [1 Year]
Overall survival will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
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