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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881279
• Other study ID #: STUDY00002779
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2021
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 846
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Electronic Health Record
• Trauma
• Wounds and Injuries

Intervention

Other:
• Event
Ransomware attack

Locations

Country	Name	City	State
United States	Erie County Medical Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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