An interventional study of Operation Alert: Support prgram in Enhance Care to Victims of Violence, sponsored by University Hospital, Ghent. Recruiting at 10 sites in Belgium. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Supportive care
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
Target Groups: Healthcare providers and victims/patients.
Sub-Study 2: Guidelines Older Adults
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.
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Substudy 1: Psycho-education Tool
Substudy 2: Guideline
Exclusion Criteria:
Substudy 1: Psycho-education tool
Substudy 1: Testing of a newly developed psycho-education tool will occur across four partner hospitals and participating nonprofit organizations (NGOs). Victims of violence seeking care at these sites will receive immediate support, with the pilot study integrated into standard care practices. The psycho-education toolkit enhances the foundational care already provided. The tool supports healthcare providers in offering psycho-education about e.g. violence and (the effects) of trauma, ... Substudy 2: This pilot study evaluates the Operation Alert guidelines within the geriatrics departments of four hospitals. A geriatric assessment is standard care during admission to these departments. The pilot will be embedded into this existing practice to ensure alignment with routine care. Additional questions will be embedded in a geriatric assessment/intake focusing on older adults' well-being, relationships and social network, and potential life events (e.g. experiences of violence).
Other: Operation Alert: Support prgram
Substudy 1: Testing of a newly developed psycho-education tool will occur across four partner hospitals and participating nonprofit organizations (NGOs). Victims of violence seeking care at these sites will receive immediate support, with the pilot study integrated into standard care practices. The psycho-education toolkit enhances the foundational care already provided. The tool supports healthcare providers in offering psycho-education about e.g. violence and (the effects) of trauma, ... Substudy 2: This pilot study evaluates the Operation Alert guidelines within the geriatrics departments of four hospitals. A geriatric assessment is standard care during admission to these departments. The pilot will be embedded into this existing practice to ensure alignment with routine care. Additional questions will be embedded in a geriatric assessment/intake focusing on older adults' well-being, relationships and social network, and potential life events (e.g. experiences of violence).
Enhanced identification, care, and referral processes for victims of violence.
Conduct a pilot study to evaluate a recently developed psycho-education tool and guideline for healthcare providers (Operation Alert study). These tools aim to enhance the delivery of psycho-education to victims of violence and improve the identification of and care for older victims of violence. The tools are evaluated through a self-developed questionnaire based on the theoretical framework of acceptability by Sekhon (2022), assessing 7 constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. In substudy 1, healthcare providers complete 11 open-ended questions and demographics, while patients answer 9 closed questions (Likert 1-5) and 10 open-ended ones. In substudy 2, healthcare providers piloting the guideline have to complete 6 open questions, 11 closed questions (Likert 1-5), and demographics. There are also 11 open-ended questions with no obligation to complete.
Time frame: Conducting the psycho-education tool or guideline will not take more than 30 minutes in total.
Evaluating the feasibility and acceptability of the psycho-education tool and guideline in clinical practice.
Targeted adjustments and finalization of the psycho-education tool and guidelines can be made based on the feedback obtained from questionnaires of healthcare providers (substudy 1 and 2) and patients/victims (substudy 1). The tools are evaluated by using a self-developed questionnaire based on the theoretical framework of acceptability (TFA) by Sekhon (2022). The questions comprise seven component constructs: affective attitude, burden, ethicality intervention coherence, opportunity costs, perceived effectiveness and self-efficacy. The framework presents a generic TFA questionnaire to evaluate the acceptability of interventions from the perspectives of recipients. It can be adapted to assess acceptability of any healthcare intervention. Its development was guided by theory, previous research, and stakeholder input.
Time frame: An evaluation is completed after testing the psycho-education tool or guideline and takes approximately 10 minutes.
Plan to share: No — Individual patient data are anonymized and encrypted to ensure privacy and security. The research specifically addresses violence, with a focus on sexual and domestic violence among participants aged 16 and older. Sharing any individual patient data would breach the confidentiality of this sensitive group and violate European GDPR regulations.
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University Hospital, Ghent