Use of a REDCap-based Clinical Registry for Clinical Care & Translational Research - Lindsey Helvaty

Filmed during IU REDCap Day 2023 - https://go.iu.edu/iu-redcap-day

Introduction: Indiana University Health (IUH) runs multidisciplinary cardiovascular (CV) genetic clinics that specialize in the evaluation, diagnosis, and treatment of cardiovascular conditions with a genetic etiology such as connective tissue disorders, thoracic aortic aneurysms, cardiomyopathies, arrhythmias, lipid disorders, and pulmonary arterial hypertension. Depending on the individual patient’s presentation and family history, they are seen by a genetic counselor, clinical geneticist, and/or cardiologist. Clinical procedures include collection of a 3-generation pedigree, cardiac diagnostic imaging, physical exam, and genetic testing, when applicable.
Cardiac imaging reports and genetic testing results are generated outside of Cerner and imported as a pdf. In order to visualize and use the data in a longitudinal fashion for individual patients and as diagnostic cohorts, an external database was needed.

Methods: Our team was granted permission through IUH in 2018 to create the CV Genetics Patient Clinical Registry in REDCap and begin capturing data outside of Cerner. The project is monitored by three IUH REDCap administrators with full access privileges. Additional user access is limited to CV genetics personnel.
The registry utilizes 12 repeating instruments to store longitudinal data on eight cardiac imaging modalities, cardiac phenotyping, clinical genetic testing results, clinical visits, and medications. Non-repeating instruments include demographic data, family history, surgical history, and disease specific forms to capture more granular phenotype data.

Live filters are used to visualize longitudinal clinical data within the REDCap environment. Custom record status dashboards assist data entry and REDCap reports are created on a regular basis to observe trends in specific disease groups, complete variant analyses, and generate research questions for additional study.
Results: Data entry began in August 2019 and to date we have entered 3872 CV genetics patients into the CV Genetics Patient Clinical Registry. Clinical genetic testing was ordered on 2842 of these patients and pathogenic or likely pathogenic variants were found in 979 patients and variants of uncertain significance were identified in an additional 585 patients. Granular phenotyping has occurred on 742 patients with connective tissue disorders/thoracic aortic aneurysm and dissection as well as 611 patients with cardiomyopathy. After submission to the Indiana University Institutional Review Board, two exempt studies were created using these datasets. Abstracts were submitted to two conferences and accepted for poster presentations in 2022. One abstract is being drafted into a manuscript and submission is slated for summer of 2023.

Additionally, the clinical genetic testing results instrument has been shared with multiple genetic counselors throughout IUH for use in capturing their patient populations genetic testing data.
Conclusion: Creating and utilizing a clinical registry within REDCap can be a powerful tool for clinical care and translational research.

Limitations: Usage of data from repeating instruments does require more advanced knowledge of data manipulation, therefore a data engineer was hired on the CV Genetics clinical research team in March 2023.

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Filmed May 18, 2023