University Hospital Base, Intensive Care Unit
Basel, Canton of Basel-City, 4031, Switzerland
Active, Not Recruiting
NCT Number: NCT06933433
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Demographic information
Time frame: 2011-06/2024
Demographic information of persons involved in the assault (e.g., age, sex, function) is collected.
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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.
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Duration of intensive care unit stay
Time frame: 2011-06/2024
The length of intensive care unit (ICU) stay is recorded.
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Duration of hospital stay
Time frame: 2011-06/2024
The length of the total hospital stay is recorded.
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Discharge destination
Time frame: 2011-06/2024
The destination at discharge (e.g., other hospital, nursing home, hospice, rehabilitation, or home) is recorded .
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Date of assault
Time frame: 2011-06/2024
The specific date of reported workplace violence is documented.
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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.
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Type of assault
Time frame: 2011-06/2024
The type of workplace violence (e.g. verbal, physical, emotional) is recorded.
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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.
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Patient characteristics
Time frame: 2011-06/2024
Information on the patient (e.g., main diagnosis, comorbidities, medication) is documented.
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Consequences of the assault
Time frame: 2011-06/2024
Evaluation of the consequences, including staff changes, safety measures, and debriefing following workplace violence incidents.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
Sponsors and collaborators
Lead sponsor
University Hospital, Basel, Switzerland
Other
Registry information
Official study title
A Retrospective Analysis of Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 18, 2025
- Registry last updated
- Jun 17, 2026
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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