Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit

NCT06933433 | Active Not Recruiting

• 1 other identifier: Req-2024-00927; am25Sutter
• Study Type: observational
• Target: 865
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Assault

Keywords

Workplace violence; Intensive care unit

Outcome Measures

Primary Outcomes (19)

• Demographic information

  Demographic information of persons involved in the assault (e.g., age, sex, function) is collected.

  2011-06/2024

• Acute prehospital management data

  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

  The length of intensive care unit (ICU) stay is recorded.

  2011-06/2024

• Duration of hospital stay

  The length of the total hospital stay is recorded.

  2011-06/2024

• Discharge destination

  The destination at discharge (e.g., other hospital, nursing home, hospice, rehabilitation, or home) is recorded .

  2011-06/2024

• Date of assault

  The specific date of reported workplace violence is documented.

  2011-06/2024

• Characteristics of assault

  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

  The type of workplace violence (e.g. verbal, physical, emotional) is recorded.

  2011-06/2024

• Additional features of the assault

  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

  Information on the patient (e.g., main diagnosis, comorbidities, medication) is documented.

  2011-06/2024

• Consequences of the assault

  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

  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

  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

  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

  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

  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

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None defined.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Base, Intensive Care Unit

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Raoul Sutter, Prof. Dr. med.

  University Hospital Basel, Department of Acute Medicine, Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 18, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

CH (1)