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

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

Study Overview

• Status: Completed
• Conditions: Trauma; Electronic Health Record
• Intervention / Treatment: Other: Event

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 Type: Observational
• Enrollment (Actual): 846

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Trauma patients being served by the level I trauma center catchment area in Western New York, Southern Ontario (Canada), and Northern Pennsylvania

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Trauma admissions in April-June 2016.
Ransomware Group; Trauma admissions in April-June 2017.	Other: Event; Ransomware attack

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disposition at discharge and AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection.	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	April to June 2016 and 2017

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: W. Alan Guo, MD, PhD, State University of Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: STUDY00002779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No