Implementation of a commercial federated network of electronic health record data to enable sponsor-initiated clinical trials at an academic medical center.

BACKGROUND: A commercial federated network called TriNetX has connected electronic health record (EHR) data from academic medical centers (AMCs) with biopharmaceutical sponsors in a privacy-preserving manner to promote sponsor-initiated clinical trials. Little is known about how AMCs have implemented TriNetX to support clinical trials. FINDINGS: At our AMC over a six-year period, TriNetX integrated into existing institutional workflows enabled 402 requests for sponsor-initiated clinical trials, 14 % (n = 56) of which local investigators expressed interest in conducting. Although clinical trials administrators indicated TriNetX yielded unique study opportunities, measurement of impact of institutional participation in the network was challenging due to lack of a common trial identifier shared across TriNetX, sponsor, and our institution. CONCLUSION: To the best of our knowledge, this study is among the first to describe integration of a federated network of EHR data into institutional workflows for sponsor-initiated clinical trials. This case report may inform efforts at other institutions.

Implementation of the Surviving Sepsis Campaign one-hour bundle in a short stay unit: A quality improvement project.

OBJECTIVE: To improve timely sepsis care by implementing the 2018 Surviving Sepsis Campaign one-hour interventions. DESIGN: Ten-month prospective quality improvement project. SETTING: A 38-bed short stay unit within an 800-bed hospital in New York City. PARTICIPANTS: Patients admitted to the short stay unit who screened positive for sepsis. INTERVENTION: A sepsis implementation tool was created from the 2018 Surviving Sepsis Campaign guidelines. Sepsis champions delivered education on sepsis recognition, treatment, and management, and the sepsis implementation tool to the healthcare staff. PROCESS AND OUTCOME MEASURES: Time to first lactate, blood cultures × 2, antibiotic administration, length of stay and mortality were tracked weekly for five months. RESULTS: From May 6, 2019 to October 1, 2019, 32 patients were diagnosed with sepsis. Initial lactate and blood cultures were completed on every patient within 1one-hour of sepsis diagnosis. Administration of antibiotics within one-hour reached 100% after week four and was sustained. CONCLUSION: Use of a registered nurse-initiated sepsis implementation tool in a short stay unit led to the completion of blood cultures, initial lactate, and antibiotic administration within one-hour. Key factors to support this practice improvement were increasing registered nurse, physician and physician assistant sepsis knowledge, registered nurse and physician/physician assistant early collaboration, increased staffing and intravenous access equipment.