Maintaining Optimal Trauma Outcomes: Resilience in the Midst of a Ransomware Attack

Completed

• Conditions: Trauma; Electronic Health Record
• Interventions: Other: Event

• Registration Number: NCT04881279
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017 examining outcomes as affected by a ransomware attack in a level I trauma center

Detailed Description

On April 9, 2017, Erie County Medical Center, Western New York's sole level I trauma center was under cyberattack. The perpetrators utilized ransomware that gained access to the hospital's web server and encrypted hospital data, forcing a system-wide downtime for nearly 2 months. Electronic medical records, imaging, and interdepartmental communication were severely affected, forcing the hospital to temporarily return to pre-EMR era operations. We examined the impact of this cyber disaster on the outcomes of trauma care.

Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017, and 2018. Baseline characteristics of study cohort for each period will be examined using the chi-square test for categorical variables and the Student's t-test for continuous variables that are normally distributed.

This was an exempt study in our institution.

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2021-04-21
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 846

Inclusion Criteria

• All trauma patient admissions that were seen through the ECMC Trauma Center from April to June 2016 and April to June 2017
• Adult patients >13 years old

Exclusion Criteria

-Patients who came through the emergency department that were not categorized as trauma patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ransomware Group	Event	Trauma admissions in April-June 2017.

Primary Outcome Measures

Name	Time	Method
Hospital and ICU length of stay (LOS), and in-hospital mortality	April to June 2016 and 2017	Hospital and ICU length of stay (LOS) in days And in-hospital mortality between cohorts expressed as percentage of cohort

Secondary Outcome Measures

Name	Time	Method
Disposition at discharge and AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection.	April to June 2016 and 2017	Disposition at discharge defined as either discharged home, died, or sent to a rehabilitation facility, all expressed as the proportion of the cohort group with the above-mentioned findings reported in percentages; All AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection are indicated as the proportion of the cohort group with the above-mentioned findings reported in percentages

Trial Locations

Locations (1)

Erie County Medical Center; 🇺🇸 Buffalo, New York, United States