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Workplace ViolenceVIA-HNCT05419687

Violence Against Health Care Workers in Fragile Settings

A study testing Training in de-escalating violence and Code of conduct delivered via a warning board in people with Workplace Violence, run by Swiss Tropical & Public Health Institute at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Workplace Violence
What is being tested?
Training in de-escalating violence and Code of conduct delivered via a warning board
Could I receive a placebo?
No, everyone receives an active treatment
How many people
798 participants
Where
2 sitesin 2 countries
Study dates
1 Nov 2022to 31 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • 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

Who cannot join

  • Age <18 years; cognitive impairment

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Democratic Republic of the Congo1 site
  • Catholic University of Bukavu, School of Public Health

    Bukavu

Other trials in Democratic Republic of the Congo

Iraq1 site
  • Al-Mustansiriya University

    Baghdad

Other trials in Iraq

About this study

Official title: 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

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.

Read the 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.

Being tested
Training in de-escalating violence, Code of conduct delivered via a warning board
Keywords
de-escalating, violence prevention, behavioral symptoms, code of conduct
Medical subject headings
Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in de-escalating violenceBehavioural

    • 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
  • Code of conduct delivered via a warning boardBehavioural

    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

Study groups in NCT05419687
Study groupRoleWhat they receive
Arm 1 De-escalating violence trainingExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence
Arm 2 De-escalating violence trainingExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence
Arm 3 De-escalating violence trainingExperimentalThe de-escalating violence training intervention will be introduced before the third observation period at month 18.
Receives: Behavioral: Training in de-escalating violence
Arm 4 De-escalating violence training + Code of conductExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board
Arm 5 De-escalating violence training + Code of conductExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board
Arm 6 Code of conduct + De-escalating violence trainingExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board
Arm 7 De-escalating violence training + Code of conductExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board
Arm 8 De-escalating violence training + Code of conductExperimentalThe 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.
Receives: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board
Arm 9 De-escalating violence training + Code of conductExperimentalThe code of conduct via a warning board and the violence de-escalating training will be simultaneously introduced at month 18.
Receives: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board
Arm 10 Code of conductExperimentalThe code of conduct via a warning board will be introduced at month 11.
Receives: Behavioral: Code of conduct delivered via a warning board
Arm 11 Code of conductExperimentalThe code of conduct via a warning board will be introduced at month 18.
Receives: Behavioral: Code of conduct delivered via a warning board

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (9)
  1. Level of confidence in coping with patient aggression

    Instrument "Clinicians confidence in coping with patient aggression (CCPAI) (Thackreys, 1987)"

    Measured: 0, 6, 12, 18 months

  2. 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)"

    Measured: 0, 6, 12, 18 months

  3. 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.

    Measured: 0, 6, 12, 18 months

  4. Psychological empathy among HCWs

    Instrument "Jefferson scale of physician empathy (Hojat M et al. 2007)"

    Measured: 0, 6, 12, 18 months

  5. Absenteeism

    Number of sick leave spells taken by the HCWs during the study period

    Measured: 0, 6, 12, 18 months

  6. 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.

    Measured: 0, 6, 12, 18 months

  7. 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).

    Measured: 18 months

  8. 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).

    Measured: 18 months

  9. 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).

    Measured: 0, 6, 12, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
798 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05419687
Sponsor's protocol ID
70198
Acronym
VIA-H
Status last verified
Sep 2024
First submitted
10 Jun 2022
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Elrha, International Committee of the Red Cross (ICRC), RAND Europe. Researching Violence Against Health Care: Gaps and Priorities. 2020

  • Leach, Brandi, Emily Ryen Gloinson, Alex Sutherland, and Michael Whitmore, Reviewing the Evidence Base for De-escalation Training: A Rapid Evidence Assessment. Santa Monica, CA: RAND Corporation, 2019.

  • Geoffrion S, Hills DJ, Ross HM, Pich J, Hill AT, Dalsbo TK, Riahi S, Martinez-Jarreta B, Guay S. Education and training for preventing and minimizing workplace aggression directed toward healthcare workers. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD011860. doi: 10.1002/14651858.CD011860.pub2.

    PubMed 32898304
  • Ferrari G, Lwamushi SM, Balaluka GB, Lafta RK, Schindler C, Bugugu D, Lurhangire E, Tediosi F, Mendoza JR, Merten S. Understanding context of violence against healthcare through citizen science and evaluating the effectiveness of a co-designed code of conduct and of a tailored de-escalation of violence training in Eastern Democratic Republic of Congo and Iraq: a study protocol for a stepped wedge randomized controlled trial. Trials. 2023 Dec 19;24(1):814. doi: 10.1186/s13063-023-07839-3.

    PubMed 38110997

Questions about this trial

What is this clinical trial studying?

A study testing Training in de-escalating violence and Code of conduct delivered via a warning board in people with Workplace Violence, run by Swiss Tropical & Public Health Institute at 2 sites in 2 countries.

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 3 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Democratic Republic of the Congo, Iraq. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence and severity of self-reported non-physical aggression (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05419687, which also lists 4 linked publications.

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 22 Jan 2025.

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