Virtually Enabled Biorepository in EHR Feasible, Cost Effective

Kimberley DeMerle, M.D.

A virtually enabled biorepository and electronic health record (EHR)-embedded, scalable cohort for precision medicine (VESPRE) demonstrated feasible digital screening, successful enrollment, biologic sampling, and lower costs compared with a traditional study design.

Study findings indicated VESPRE may be scalable across patients, centers, and laboratories at low incremental cost and burden.

Kimberley DeMerle, M.D., and a team of investigators developed VESPRE and compared the feasibility, enrollment, and costs compared with those of a traditional study design in acute care. The goals of VESPRE were to create a digital tool for patient screening and enrollment embedded in the EHR, to develop automated sample collection for a virtually enabled biorepository of waste tissue (remnant blood and urine specimens), and to develop a thin-client software that ensured adequate data integration, security, curation, and scalability across multiple hospitals. To do this, the team combined three components: existing tools of EHR sepsis screening, EHR data for clinical research, and remnant sample analyses.

A key design of the study was to seek a waiver of consent for VESPRE, reduce time and cost, and allow rapid enrollment with minimal patient risk. Patient screening, enrollment, and sample acquisition were done prospectively while daily screening alerts were created through a secure communication that reported potentially eligible encounters to the study team. Data collected from the EHR included patient demographics along with intensive care unit admission, hospital and intensive care unit length of stay, in-hospital mortality, and 90-day mortality.

Eligible patients were at least 18 years old who met criteria for sepsis within six hours of presenting at the emergency department. Sepsis was defined as sepsis-3. To identify sepsis-3, the team developed a digital alert to flag patients with location in the enrolling emergency department, at least 18 years old, blood cultures obtained in the first six hours after arrival, and antibiotics administered in the first six hours.

DeMerle and the team collected remnant blood and urine samples in the VESPRE biorepository to maximize the number of samples and minimize cost and time. The biorepository had embedded electronic alerts that triggered the research staff to collect samples.

The cost of VESPRE was compared with a prehospital cohort study and a hypothetical prospective cohort among hospitalized patients.

There was a total of 1,027 patients enrolled in the study and 549 were included in the proof-of-concept analysis (56% men; median age, 59 years old). VESPRE collected nearly 13,000 remnant blood and urine samples and showed adequate feasibility for clinical, biomarker, and microbiome analyses. The total cost was approximately $39 per enrolled patient compared to $239 per patient for a traditional cohort study.

To encourage precision medicine in acute care, an infrastructure embedded in the EHR that created a virtually enabled biorepository proved to be feasible and less costly for time-sensitive conditions.

The study, “Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine,” was published online in JAMA Network Open.