What types of hospitals are you looking to join?
Enrollment is open to any hospital who would like to participate and has capacity to enter all COVID-19 patients sequentially. The registry is capturing clinical data, vitals and cardiac biomarkers in COVID-19 patients, therefore hospitals that routinely collect serial cardiac labs will be able to upload and track more patient outcomes in this quality improvement program. If your site has a strong interest, please reach out as soon as possible to email@example.com.
What is the patient population for the registry?
- All patients ≥18 years old who are hospitalized with an active COVID-19 infection (for example ICD-10-CM code U07.1 among discharge diagnosis).
- The infection should be confirmed with an RT-PCR test, either prior to or during the hospitalization, a positive IgM antibody test, or a clinical diagnosis using hospital specific criteria.
- Active infection encompasses:
- Patients who are diagnosed prior to hospitalization, but still symptomatic during the hospitalization.
- Patients with a positive test or diagnosis during hospital admission
- Patients who are symptomatic during the hospitalization and have a confirmed test available only after hospital discharge
- Patients < 18 years of age
- Patients who do not have a COVID-19 diagnosis
- Patients who previously tested positive or have been diagnosed with COVID-19, but without active infection as determined by COVID-19 related symptoms. This may include pts with positive IgG antibody tests without positive IgM antibody test.
Does my site need IRB approval to participate?
Similar to the American Heart Association’s existing suite of Get With The Guidelines® (GWTG) programs, the COVID-19 CVD registry is a Quality Improvement program and data are collected and submitted as part of standard healthcare operations.
Most hospitals participating in the other GWTG registries as well as this patient data registry do not require institutional review board (IRB) review. Your hospital IRB will determine whether participation is subject to or exempt from IRB oversight.
The U.S. Department of Health & Human Services offers a resource of Quality Improvement Activities FAQs that may help answer your specific IRB questions.
Can the registry be customized for states and regions?
The ability to customize data elements will vary depending on the extent of desired customizations and demands of the core product development. The AHA platform does offer sites the ability to configure elements for custom data capture. If AHA is not able to accommodate a customization to the core form, these custom elements may be an option for your region. For more information, contact firstname.lastname@example.org.
Joining the Registry
When will the registry launch?
The registry will launch in early May. However, paper case report forms (CRFs) along with detailed coding instructions will be provided to enrolled sites, so they can collect data in advance of the online registry go live date.
Is there a cost for the registry?
The registry is free.
How long will the registry be enrolling patients?
The registry plans to enroll patients through 12/31/2020. We will consider extending enrollment as needed.
How do hospitals enroll in the COVID-19 CVD Registry?
NON-Get With The Guidelines Hospitals:
Hospitals not already contracted for one of our GWTG programs will need to execute an online unified participation agreement (UPA).
Get With The Guidelines Hospitals:
Hospitals already contracted for GWTG through the AHA UPA may:
- sign a paper amendment to the UPA; or
- complete an online UPA solely for enrollment in the COVID-19 CVD Registry.
Hospitals who have Participating Hospital Agreements (PHA) with IQVIA may:
- execute an online UPA to bring all of their modules under the UPA; or
- complete an online UPA solely for enrollment in COVID-19 CVD Registry.
What data are you tracking in the registry?
The registry will capture patient clinical characteristics, medications, treatments, labs, vitals, biomarkers and outcomes in patients hospitalized with COVID-19. Below is a high-level summary of the types of data captured.
|Demographics||Sex, race/ethnicity, age|
|Medical history||Cardiac risk factors, COPD, autoimmune disorders|
|Medical therapy (prior to admission)||ACE inhibitor, steroids|
|Admission vital signs||Height, weight, blood pressure, heart rate, oxygen saturation|
|Laboratory values (admission)||Creatinine, AST, ALT|
|Medical therapy (inpatient)||Hydroxychloroquine, lopinavir/ritonavir, Remdesivir|
|Inpatient interventions||Mechanical ventilation, mechanical circulatory support|
Mortality, stroke, heart attack, arrhythmia, DVT/PE
How much time does it take to abstract a patient record?
Abstraction times range from 30 – 45 minutes per record, which is in-line with abstraction time in our other GWTG programs. The CRF was designed to collect minimum necessary data to understand quality of care and outcomes in hospitalized COVID-19 patients. Abstraction time may vary depending on the individual case and how accessible the information is in your EMR.
My hospital does not run all of the labs listed in the case report form (CRF). Can I still enroll?
The registry will not turn hospitals away. Your data will be a valuable contribution to our understanding of this new disease.
However, there are some data elements and laboratory tests that are required. These required elements are noted in bold font on the CRF.
If you are not able to complete all required data elements, you may not be able to save your form as complete and may not receive full reporting and feedback due to missing data elements.
Can I sample patients or upload a subset of COVID-19 patients to the registry?
Hospitals must commit to entering ALL patients hospitalized with a COVID-19 infection. This means complete consecutive case entry, not a sample. We recognize that this may be burdensome for some hospitals, however, allowing for sampling could introduce bias and confound later findings.
If you are not able to enter ALL patients hospitalized with COVID-19 for the duration of the pandemic, it is reasonable to commit to entering all cases for a select period of time (e.g. your hospital could choose to enter ALL consecutive COVID-19 cases for a 4 week period).
Is there a way to automate data from my hospital EMR, or other database to the registry?
The web-based registry form will launch in early May to facilitate data entry. The upload function, which allows you to upload an Excel file, will not be available in our initial release. However, it is a high priority for a subsequent release users will be notified once we have the date of availability.
The data will contain both the admission and hospitalization data as well as the serial lab data. It is important to note that the admission and hospitalization data will be in one tab of the file, while the serial lab data will be in a separate tab.
Your hospital may use the uploader for retrospective data as far back as you have patients who meet inclusion criteria. Once uploaded, you will have the ability to log-in and access uploaded records to update or complete data elements.
An overview of the Excel uploader workflow is listed below for your hospital.
- Uploader specifications provided to hospital
- IT Department or designated vendor creates an extract of data from your EHR or database (e.g., REDCap)
- IT Department converts that extract to an Excel file and format to match the uploader specifications.
- IT Department or abstractor follows 6 easy steps to upload the file on a pre-determined basis
Will cases I enter into other GWTG modules auto-populate overlapping fields in this registry?
At this time, cross module data population is not available in the COVID-19 CVD Registry. As we work to build out registry features and functions, we will explore cross module population and add it to the roadmap based on site feedback.
May I enter retrospective data?
Retrospective data may be added to the registry as long as all data are cases entered for the current time period.
Critically ill patients with COVID-19 may experience long hospitalizations which can affect interpretation of reported outcomes. What does this mean for a contributing site?
It is important that sites capture all COVID-19 discharges, even for patients with long lengths of stay. Sites should begin abstraction with basic information and admission date prior to patient discharge and complete the remainder of the information throughout the hospitalization and/or at the time of discharge. The registry platform will generate reports for contributing hospitals based on admission date, not discharge date. Therefore, we can report outcomes including a qualifier for how many patients are not yet discharged. This approach will better inform performance metrics.
Accessing the Registry Data for Research
Will I be able to analyze data at the state or regional level?
The COVID-19 CVD registry will have ‘super user’ functionality. Upon launch, super users (including states) will have the ability to download hospital data (from hospitals who have given permission) into a single file for analysis. Moving forward, as we add reports and comparison groups, states will be able to leverage reporting for the state aggregate as well as individual institutions. This functionality is similar to those that states and regions enjoy in our other GWTG modules.
How can researchers access the data?
Researchers, at hospitals participating in the COVID-19 CVD Registry, may request access to the COVID-19 CVD data, by submitting a research proposal with specific aims to email@example.com. Proposals will be accepted on a rolling basis and will be reviewed by the COVID-19 Steering Committee. Proposals will be blindly scored on the basis of priority, novel contribution to the scientific literature, feasibility with the data collected, and merit. Approved projects will be paired with a COVID-19 Steering Committee mentor for the duration of the study.
Researchers have two options to complete the statistical analysis for their approved proposal. They may conduct the statistical analysis using the data on the Precision Medicine Platform (PMP) using the data set available on the platform at the time. Alternatively, researchers may contract with the Duke Clinical Research Institute (DCRI) to conduct the statistical analysis. DCRI is the approved data analytics center for the COVID-19 CVD Registry.
No unauthorized data analyses may be conducted using the COVID-19 CVD registry without proposal review by the COVID-19 Steering Committee and written approval from the American Heart Association. All publications must follow AHA’s publication guidelines.
When will the data be available for research?
The COVID-19 CVD Registry will be available for hospitals and health systems to begin uploading data in early May 2020. Sites will be able to analyze and pull reports of their own real-time data. As more hospitals and health systems begin uploading data about their COVID-19 patients, the database will grow, and the American Heart Association can create a national dataset with benchmarks for individual data elements. These data will be available for preliminary research beginning in June 2020.
Additionally, hospitals and health systems that participate in AHA’s Get With The Guidelines® Quality Improvement programs will see the addition of COVID-19 specific data elements in each module in April 2020. Data from these condition areas (atrial fibrillation, coronary artery disease, heart failure, resuscitation, and stroke) may be available for preliminary analysis in July.
As more clinical records are entered, the databases will continue to grow. Researchers interested in querying the data for their research may do so by submitting a proposal to firstname.lastname@example.org.