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Violence Against Health Care Workers in Fragile Settings

Violence Against Health Care Workers: Understanding Context Through Citizen Science and Measuring a De-escalation Training Intervention Effectiveness in Eastern Democratic Republic of Congo and Iraq

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05419687
Acronym
VIA-H
Enrollment
798
Registered
2022-06-15
Start date
2022-11-01
Completion date
2024-10-31
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Workplace Violence

Keywords

de-escalating, violence prevention, behavioral symptoms, code of conduct

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALTraining in de-escalating violence

* 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

BEHAVIORALCode of conduct delivered via a warning board

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

Sponsors

International Committee of the Red Cross (ICRC)
CollaboratorUNKNOWN
Catholic University of Bukavu, Democratic Republic of Congo
CollaboratorUNKNOWN
Al-Mustansiriyah University
CollaboratorOTHER
Swiss Tropical & Public Health Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Only the statistician and the PI will be aware of the allocation order sequence, while the country co-investigators will be blinded to the allocation sequence and only the next health facility/secondary hospital randomized for roll out will be revealed at each crossover intervention implementation time point. The outcome assessors will also be blinded.

Intervention model description

The SW-RCTs will consist of 11 sequences (11 different possibilities of timing and sequencing the introduction of the intervention components), and a maximum of four intervention periods, combining an individual de-escalating training intervention followed by a refreshment training in the form of a collaborative learning and a code of conduct board level intervention with an overall study duration of 24 months.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HCWs from selected participating health facilities in DRC, junior doctors during their first year resident and permanent health care staff from participating secondary hospitals in Iraq * HCWs and junior medical doctors and permanent health care staff must have been employed/ or worked as HCW/ medical doctors or as permanent health care staff for at least 6 months * All above participants must have completed the written informed consent

Exclusion criteria

* Age \<18 years; cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Incidence and severity of self-reported non-physical aggression6 monthsNumber 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
Incidence and severity of self-reported physical aggression6 monthsNumber of self-reported physical aggression during the fulfillment of a professional activity in the last 6 months

Secondary

MeasureTime frameDescription
Level of burnout among HCWs0, 6, 12, 18 monthsInstrument 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.
Psychological empathy among HCWs0, 6, 12, 18 monthsInstrument Jefferson scale of physician empathy (Hojat M et al. 2007)
Absenteeism0, 6, 12, 18 monthsNumber of sick leave spells taken by the HCWs during the study period
Level of confidence in coping with patient aggression0, 6, 12, 18 monthsInstrument Clinicians confidence in coping with patient aggression (CCPAI) (Thackreys, 1987)
Economic cost of the intervention18 monthsTwo 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).
Productivity loss (presenteeism)18 monthsWork 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).
Health care workers health-related quality of life0, 6, 12, 18 monthsEuropean 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).
Intent to leave among HCWs0, 6, 12, 18 monthsThe 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.
Level of post-traumatic stress disorders (PTSD) among HCWs0, 6, 12, 18 monthsInstrument Post-traumatic stress disorder PTSD Checklist for DSM-5 (PCL-5)) (Weathers, F.W. et al. 2013)

Countries

Democratic Republic of the Congo, Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026