AssaultNCT06933433
Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit
An observational study of Assault, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assault
- How many people
- 865 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 18 years of age
- Reported incident of physical, verbal or sexual violence in the intensive care unit at the University Hospital Basel
Who cannot join
- None defined.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Base, Intensive Care Unit
Basel, Canton of Basel-City, 4031
About this study
Official title: 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.
Read the 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.
- Conditions
- Assault
- Keywords
- Workplace violence, Intensive care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information
Demographic information of persons involved in the assault (e.g., age, sex, function) is collected.
Measured: 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.
Measured: 2011-06/2024
Duration of intensive care unit stay
The length of intensive care unit (ICU) stay is recorded.
Measured: 2011-06/2024
Duration of hospital stay
The length of the total hospital stay is recorded.
Measured: 2011-06/2024
Discharge destination
The destination at discharge (e.g., other hospital, nursing home, hospice, rehabilitation, or home) is recorded .
Measured: 2011-06/2024
Date of assault
The specific date of reported workplace violence is documented.
Measured: 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.
Measured: 2011-06/2024
Type of assault
The type of workplace violence (e.g. verbal, physical, emotional) is recorded.
Measured: 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.
Measured: 2011-06/2024
Patient characteristics
Information on the patient (e.g., main diagnosis, comorbidities, medication) is documented.
Measured: 2011-06/2024
Consequences of the assault
Evaluation of the consequences, including staff changes, safety measures, and debriefing following workplace violence incidents.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2011-06/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AssaultStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, Prof. Dr. med., Principal investigator, University Hospital Basel, Department of Acute Medicine, Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933433
- Sponsor's protocol ID
- Req-2024-00927; am25Sutter
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06933433
- Acronym / sponsor ID
- Req-2024-00927; am25Sutter
- Conditions
- Assault
- Keywords
- Workplace violence, Intensive care unit
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 865 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Reported incident of physical, verbal or sexual violence in the intensive care unit at the University Hospital Basel
Key exclusion criteria (1 listed)
- None defined.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic information
Time frame: 2011-06/2024
Demographic information of persons involved in the assault (e.g., age, sex, function) is collected.
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.
Duration of intensive care unit stay
Time frame: 2011-06/2024
The length of intensive care unit (ICU) stay is recorded.
Duration of hospital stay
Time frame: 2011-06/2024
The length of the total hospital stay is recorded.
Discharge destination
Time frame: 2011-06/2024
The destination at discharge (e.g., other hospital, nursing home, hospice, rehabilitation, or home) is recorded .
Date of assault
Time frame: 2011-06/2024
The specific date of reported workplace violence is documented.
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.
Type of assault
Time frame: 2011-06/2024
The type of workplace violence (e.g. verbal, physical, emotional) is recorded.
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.
Patient characteristics
Time frame: 2011-06/2024
Information on the patient (e.g., main diagnosis, comorbidities, medication) is documented.
Consequences of the assault
Time frame: 2011-06/2024
Evaluation of the consequences, including staff changes, safety measures, and debriefing following workplace violence incidents.
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.
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.
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.
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.
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).
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Related trials for Assault
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
Active, not recruiting
uSafeUS+ App Pilot Testing
Alcohol Consumption, Sexual Assault
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, Prof. Dr. med. principal investigator
University Hospital Basel, Department of Acute Medicine, Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assault, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic information (time frame: 2011-06/2024). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.