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Completed

NCT Number: NCT04881279

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

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Key information

Conditions

Trauma Electronic Health Record Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Erie County Medical Center

Buffalo, New York, 14215, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Event

Other

Ransomware attack

Primary outcomes

  1. Hospital and ICU length of stay (LOS), and in-hospital mortality

    Time frame: 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 outcomes

  1. Disposition at discharge and AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 11, 2021
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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