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

NCT ID: NCT04881279

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

846 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Trauma Electronic Health Record

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control

Trauma admissions in April-June 2016.

No interventions assigned to this group

Ransomware Group

Trauma admissions in April-June 2017.

Event

Intervention Type OTHER

Ransomware attack

Interventions

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Event

Ransomware attack

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Weidun Alan Guo, MD, PhD

Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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W. Alan Guo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Buffalo

Locations

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Erie County Medical Center

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00002779

Identifier Type: -

Identifier Source: org_study_id