Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit

April 15, 2025 updated by: University Hospital, Basel, Switzerland

A Retrospective Analysis of Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit

This study aims to investigate the occurrence of workplace violence, both physical, verbal, and sexual assaults, from patients and their relatives towards intensive care unit staff members.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Workplace violence, as defined by the International Labor Organization, includes any action, incident, or behavior that assaults, threatens, harms, or injures a person during their work. Healthcare workers face the highest risk of workplace violence among all professions. Violence can take many forms, including verbal abuse, physical offenses to sexual harassment. While most research focuses on psychiatric and emergency departments, workplace violence in intensive care units (ICUs) is understudied and often underreported.

As a result, little is known about its prevalence and risk factors, leading to a lack of awareness and effective prevention strategies. The aim of this retrospective single-center cohort study is to investigate the occurrence of workplace violence, both physical, verbal, and sexual assaults, from patients and their relatives towards ICU staff members. The study will assess the frequency, characteristics, and circumstances of these events in an intensive care setting. Additionally, the consequences of such incidents and the measures taken afterward will be examined. This analysis aims to identify potential risk factors and possible targets for intervention, ultimately contributing to the development and implementation of protocols that enhance the safety of both healthcare professionals and patients.

Study Type

Observational

Enrollment (Actual)

865

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • University Hospital Base, Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All consecutive adult patients (i.e.≥ 18 years of age) with a reported incident of physical, verbal or sexual violence in the intensive care unit at the University Hospital Basel from January 1st 2011 until end of June 2024 as documented in the digital medical records.

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Reported incident of physical, verbal or sexual violence in the intensive care unit at the University Hospital Basel

Exclusion Criteria:

None defined.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic information
Time Frame: 2011-06/2024
Demographic information of persons involved in the assault (e.g., age, sex, function) is collected.
2011-06/2024
Acute prehospital management data
Time Frame: 2011-06/2024
Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected. The collected data elements are aggregated to describe the overall EMS response.
2011-06/2024
Duration of intensive care unit stay
Time Frame: 2011-06/2024
The length of intensive care unit (ICU) stay is recorded.
2011-06/2024
Duration of hospital stay
Time Frame: 2011-06/2024
The length of the total hospital stay is recorded.
2011-06/2024
Discharge destination
Time Frame: 2011-06/2024
The destination at discharge (e.g., other hospital, nursing home, hospice, rehabilitation, or home) is recorded .
2011-06/2024
Date of assault
Time Frame: 2011-06/2024
The specific date of reported workplace violence is documented.
2011-06/2024
Characteristics of assault
Time Frame: 2011-06/2024
Details on the assault incident as documented in nurses' and physicians' progress notes (e.g. wording) to characterize the event.
2011-06/2024
Type of assault
Time Frame: 2011-06/2024
The type of workplace violence (e.g. verbal, physical, emotional) is recorded.
2011-06/2024
Additional features of the assault
Time Frame: 2011-06/2024
Assessment of additional features related to workplace violence, including involved staff members, shift type, and environment. These features are aggregated to characterize the context in which the assault occurred.
2011-06/2024
Patient characteristics
Time Frame: 2011-06/2024
Information on the patient (e.g., main diagnosis, comorbidities, medication) is documented.
2011-06/2024
Consequences of the assault
Time Frame: 2011-06/2024
Evaluation of the consequences, including staff changes, safety measures, and debriefing following workplace violence incidents.
2011-06/2024
Neurological status based on validated clinical assessment
Time Frame: 2011-06/2024
Neurological status during ICU stay is assessed using available data in the patient register from validated neurological assessments. These may include the Richmond Agitation-Sedation Scale (RASS), Sedation-Agitation Scale (SAS), Glasgow Coma Scale (GCS), Intensive Care Delirium Screening Checklist (ICDSC), or Status Epilepticus Severity Score (STESS). The specific tool used, as well as the scale of the score and meaning behind the score, depends on routine clinical practice and available documentation in the register. If multiple scores are available for a patient, they will be aggregated to provide a comprehensive assessment of neurological status.
2011-06/2024
Critical illness severity score
Time Frame: 2011-06/2024
Disease severity is assessed using standardized scoring systems, such as Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score II (SAPS II), and Sequential Organ Failure Assessment (SOFA) scores. The scale of the score and meaning behind the score depends on the severity assessment that is applied.
2011-06/2024
Charlson Comorbidity Index
Time Frame: 2011-06/2024
The Charlson Comorbidity Index (CCI) is calculated based on pre-existing comorbidities and additional diagnoses. The CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. It assigns weighted scores (from 0 to maximal 6) to 17 comorbid conditions (e.g., heart disease, diabetes, cancer), resulting in a total score ranging from 0 to 33, if the patient had the most severe form of each of the 17 conditions.
2011-06/2024
Laboratory parameters
Time Frame: 2011-06/2024
Routine laboratory value for e.g. C-Reactive Protein (CRP), albumin, Lactate Dehydrogenase (LDH), Creatine Kinase (CK), procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, and metabolic data, is collected. The specific parameters recorded may vary depending on the laboratory assessments documented in the patient register. All values will be reported using their respective units of measurement.
2011-06/2024
Glasgow Outcome Score
Time Frame: 2011-06/2024

The Glasgow Outcome Score (GOS) is calculated based on the assessment of key clinical outcomes such as in-hospital mortality, survival, survival with neurofunctional alteration, return to premorbid neurological function, and hospital readmission to determine the patient outcome.

The GOS ranges from 1 (death) to 5 (good recovery).

2011-06/2024
Therapeutic intervention
Time Frame: 2011-06/2024
The therapeutic intervention is document, including information on duration, dosage and number of treatment medication, number of neuroleptic, sedative and analgesic drugs, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, nutrition, etc.
2011-06/2024
Vital signs
Time Frame: 2011-06/2024
Vital signs are analyzed based on the data available in the patient register. These may include blood pressure, heart rate, respiratory rate, oxygen saturation, body temperature, and level of consciousness. The specific parameters recorded depend on the clinical documentation available. All values will be reported using their respective units of measurement. The collected parameters are aggregated to provide an overall assessment of the patient's clinical condition.
2011-06/2024
Fluid balance data
Time Frame: 2011-06/2024
Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented. These components are aggregated to represent overall fluid input for each patient.
2011-06/2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Raoul Sutter, Prof. Dr. med., University Hospital Basel, Department of Acute Medicine, Intensive Care Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Req-2024-00927; am25Sutter

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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