An interventional study of Training in de-escalating violence and Code of conduct delivered via a warning board in Workplace Violence, sponsored by Swiss Tropical & Public Health Institute. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Swiss Tropical & Public Health Institute · Not applicable, Interventional, and Health services research
The general objective of the project is to assess whether a violence de-escalating training for health professionals and of a publicly displayed Code of Conduct (a set of rules developed through a citizen science and co-design approach) for both health professionals and clients at the level of the health facility, can reduce the incidence and severity of episodes of violence, and to identify the most cost-effective way to implement these interventions in rural Democratic Republic of Congo (DRC) and in the mega city of Baghdad, Iraq.
The study will adopt a stepped-wedge cluster-randomized intervention trial (SW-CRT) design to assess the two intervention components, a violence de-escalating training and the implementation of the code of conduct co-developed during the formative qualitative phase. The study will adopt a closed cohort with repeated measurements on the same participants (nurses in DRC and junior doctors in Baghdad) and will involve the unidirectional transition of each enrolled cluster (health facilities in DRC and secondary hospitals in Baghdad) from the control (no intervention) to the intervention sequence in a randomized sequential manner according to a predefined roll out process.
135 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.
This study's enrollment of 798 is above the median of 93 across 114 interventional studies indexed under Behavioral Symptoms.
Browse Behavioral Symptoms studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The de-escalating violence training intervention will be introduced after a pre-interventional period of 3 months. A refreshment training will be introduced at month 11.
Behavioral: Training in de-escalating violence
The de-escalating violence training intervention will be introduced before the second observation period at month 11. A refreshment training will be introduced at month 18.
Behavioral: Training in de-escalating violence
The de-escalating violence training intervention will be introduced before the third observation period at month 18.
Behavioral: Training in de-escalating violence
The de-escalating violence training intervention will be introduced after a pre-interventional period of 3 months. The code of conduct via a warning board will be introduced at month 11. A refreshment training will be introduced at month 18.
Behavioral: Training in de-escalating violence · Behavioral: Code of conduct delivered via a warning board
The de-escalating violence training intervention and the code of conduct via a warning board will be simultaneously introduced at month 11. A refreshment training will be introduced at month 18.
Behavioral: Training in de-escalating violence · Behavioral: Code of conduct delivered via a warning board
The code of conduct via a warning board will be introduced at month 11. The de-escalating violence training intervention will be introduced at month 18.
Behavioral: Training in de-escalating violence · Behavioral: Code of conduct delivered via a warning board
The de-escalating violence training intervention is introduced after a pre-interventional period of 3 months. The code of conduct via a warning board and a refreshment training will be simultaneously introduced at month 18.
Behavioral: Training in de-escalating violence · Behavioral: Code of conduct delivered via a warning board
The de-escalating violence training intervention will be introduced before the second observation period at month 11. The code of conduct via a warning board and a refreshment training will be simultaneously introduced at month 18.
Behavioral: Training in de-escalating violence · Behavioral: Code of conduct delivered via a warning board
The code of conduct via a warning board and the violence de-escalating training will be simultaneously introduced at month 18.
Behavioral: Training in de-escalating violence · Behavioral: Code of conduct delivered via a warning board
The code of conduct via a warning board will be introduced at month 11.
Behavioral: Code of conduct delivered via a warning board
The code of conduct via a warning board will be introduced at month 18.
Behavioral: Code of conduct delivered via a warning board
* Individual educational component through a de-escalating violence training for health care workers (verbal and non-verbal de-escalating techniques) * Refreshment training in the form of collaborative learning
A publicly displayed code of conduct (a co-designed set of rules) for both HCWs and clients, delivered via a warning board at the level of the health facilities and secondary hospitals
Incidence and severity of self-reported non-physical aggression
Number of self-reported non-physical aggression (verbal abuse, threats, ironic language, provocative or aggressive body language etc.) during the fulfillment of a professional activity in the last 6 months
Time frame: 6 months
Incidence and severity of self-reported physical aggression
Number of self-reported physical aggression during the fulfillment of a professional activity in the last 6 months
Time frame: 6 months
Level of confidence in coping with patient aggression
Instrument "Clinicians confidence in coping with patient aggression (CCPAI) (Thackreys, 1987)"
Time frame: 0, 6, 12, 18 months
Level of post-traumatic stress disorders (PTSD) among HCWs
Instrument "Post-traumatic stress disorder PTSD Checklist for DSM-5 (PCL-5)) (Weathers, F.W. et al. 2013)"
Time frame: 0, 6, 12, 18 months
Level of burnout among HCWs
Instrument "Level of burnout" (Malach 2005), burnout measure short version (BMS). The ten-item version of the BMS are evaluated on 7-point frequency scales, with a score of 4 or above indicating burnout.
Time frame: 0, 6, 12, 18 months
Psychological empathy among HCWs
Instrument "Jefferson scale of physician empathy (Hojat M et al. 2007)"
Time frame: 0, 6, 12, 18 months
Absenteeism
Number of sick leave spells taken by the HCWs during the study period
Time frame: 0, 6, 12, 18 months
Intent to leave among HCWs
The shortened, six-item version of the turnover intention scale (TIS-6) (Bothma \& Roodt 2013), will be used to assess turnover intentions and as well as to predict actual turnover among HCWs. The TIS-6 scale is scored on a five-point Likert-type scale with scores ranging from 1 (never) to 5 ( always). A high score indicates stronger turnover intention.
Time frame: 0, 6, 12, 18 months
Economic cost of the intervention
Two types of costs will be considered: 1) direct costs of the intervention (e.g training costs, space or rent costs, costs to develop the code of conduct) and 2) direct costs due to health system disruption (e.g. health care services foregone or postponed, material etc.), cost incurred by the HCWs as a consequence of violent episodes including direct medical costs (e.g. hospital stay cost, consultation costs, laboratory costs), non-medical costs (e.g. transportation, meals etc.), and indirect costs (e.g. absenteeism, presenteeism).
Time frame: 18 months
Productivity loss (presenteeism)
Work Limitation questionnaire (WLQ) (Lerner D. et al. 2002). The WLQ consists of eight items investigating four domains (time management, physical tasks, mental-interpersonal tasks, and output tasks), which are calculated into scores ranging from 0 (no limitations) to 100 (highest limitations).
Time frame: 18 months
Health care workers health-related quality of life
European Quality of Life-5 Dimensions (EuroQol EQ-5D-5L) (Devlin NJ et al. 2017). The EQ-5D-5L questionnaire is self-assessed and it measures health outcomes on five dimensions (mobility, self-care, daily activities, pain/discomfort, and depression/anxiety) with five levels ranging from none to major complaints. Scores range from 0 (death) to 1 (full health).
Time frame: 0, 6, 12, 18 months
Ran from Nov 2022 to primary completion in Oct 2024, 23 months.
Of 68 non-industry interventional studies with no phase under Behavioral Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 23 months is below that.
Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 16 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Swiss Tropical & Public Health Institute