Clinical trial NCT06780540: Testing and Evaluating a Psychoeducation Tool and Guidelines for Victims of Violence in Belgian Hospitals.
Official title: Testing and Evaluating a Psychoeducational Toolkit and Clinical Screening Guidelines for Victims of Domestic and Sexual Violence in Belgian Hospitals.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enhance Care to Victims of Violence
Keywords: violence
abuse
psycho-education
guideline
training
pilot study
clinical trial
evaluation
Belgium
hospitals
victims
healthcare providers
mixed methods research
multi-method design
sexual violence
domestic violence
older adults
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: AZ Delta
name: Centre Hospitalier Universitaire de Liege
name: Centre Hospitalier Universitaire Saint Pierre
name: Vertrouwenscentrum Kindermishandeling
name: Aditi ASBL/vzw
name: SOS enfants asbl
First posted: 2025-01-17
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The "Operation Alert/Operatie Alert/Opération Alerte" project, developed by UGent-ICRH and UZGent with funding from the Belgian Federal Public Service for Health, focuses on strengthening basic competencies to better and more quickly identify signs of violence. It also aims to provide victim-centered care and refer to specialized services when necessary. This initiative combines training for healthcare providers with practical tools, such as a psycho-education tool and clinical guidelines, to enhance care delivery. Below is an overview of the project's main components:

Sub-Study 1: Psycho-education Tool

* Objective: Develop and evaluate a tool to support healthcare providers and patients in understanding and addressing sexual and domestic violence, trauma, and their impacts on well-being.
* Tool Description: A set of cards presented in a calendar format, featuring illustrations on one side and explanatory text on the other.

Target Groups: Healthcare providers and victims/patients.

* Development process: The tool was developed based on literature and input from experts and stakeholders during regular meetings.
* Testing Phase: The tool will undergo a pilot study in selected hospitals and non-profit organizations (NGOs) working with victims of violence.
* Evaluation: The tool's acceptability, usability, and relevance to the recovery process will be assessed through feedback collected via questionnaires from both healthcare providers and victims/patients.

Sub-Study 2: Guidelines Older Adults

* Objective: Develop and implement guidelines for screening violence among older adults and providing appropriate care for victims of various forms of violence (psychological, physical, (socio-)economic, and sexual).
* Tool Description: A guideline that includes a screening protocol, care and referral pathways, and theoretical background on the topic.
* Target Group: Older adults with sufficient cognitive abilities.
* Development Process: The guidelines are informed by a literature review, expert, and stakeholder input through regular meetings and focus groups, and a pilot study involving cognitively capable older adults in the geriatric departments of four hospitals.
* Testing Phase: The screening protocol is integrated into standard care procedures, such as intake interviews or geriatric assessments. It is implemented by multidisciplinary professionals, including physicians, nurses, psychologists, occupational therapists, and social workers.
* Evaluation: Feedback on the guidelines is collected from healthcare providers via questionnaires. Older adults themselves are not directly involved in the evaluation, as the screening protocol is intentionally embedded discreetly within standard care procedures.

Training and Support The project includes a robust training component delivered through educational online modules designed to equip healthcare providers with the knowledge and skills necessary to effectively use the tools and guidelines developed.

Languages and Application The study materials and procedures are conducted in both French and Dutch, reflecting Belgium's bilingual context.

Significance This project highlights the importance of tailored support for victims of violence and a systematic approach to care within clinical settings.


Eligibility criteria: Inclusion Criteria:

Substudy 1: Psycho-education Tool

* Healthcare Providers: In-hospital healthcare providers who used the psycho-education tool during the pilot phase with a victim of violence.
* Victims/Patients: Victims of violence aged 16 years or older who received psycho-education from an in-hospital healthcare provider during the pilot phase.

Substudy 2: Guideline

* Healthcare Providers: In-hospital healthcare providers who used the guideline during the pilot phase with an older adult.
* Older Adults/Patients: Older adults with sufficient cognitive abilities who were admitted to the geriatric department (either for a day clinic or a longer stay).

Exclusion Criteria:

Substudy 1: Psycho-education tool

* Victims under the age of 16. Substudy 2: Guideline
* Older adults with cognitive impairments.

Primary outcomes:
measure: Enhanced identification, care, and referral processes for victims of violence.
timeFrame: Conducting the psycho-education tool or guideline will not take more than 30 minutes in total.
Secondary outcomes:
measure: Evaluating the feasibility and acceptability of the psycho-education tool and guideline in clinical practice.
timeFrame: An evaluation is completed after testing the psycho-education tool or guideline and takes approximately 10 minutes.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Aditi ASBL/vzw
city: Antwerp
country: Belgium
facility: Vertrouwenscentrum Kindermishandeling Antwerpen
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint-Pierre
city: Brussels
country: Belgium
facility: Vertrouwenscentrum Kindermishandeling Brussel
city: Brussels
country: Belgium
facility: SOSEnfants Bruxelles ASBL
city: Charleroi
country: Belgium
facility: SOSEnfants Charleroi ASBL
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Roeselare
country: Belgium
facility: AZ Delta
city: Saint-Servais
country: Belgium
facility: SOSEnfants Namur ASBL
Study officials:
affiliation: Ghent University Hospital and Ghent University (VIORESC)
name: Ines Keygnaert, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: