NCT05419687

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

January 22, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

June 10, 2022

Last Update Submit

January 20, 2025

Conditions

Keywords

de-escalatingviolence preventionbehavioral symptomscode of conduct

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    6 months

Secondary Outcomes (9)

  • Level of confidence in coping with patient aggression

    0, 6, 12, 18 months

  • Level of post-traumatic stress disorders (PTSD) among HCWs

    0, 6, 12, 18 months

  • Level of burnout among HCWs

    0, 6, 12, 18 months

  • Psychological empathy among HCWs

    0, 6, 12, 18 months

  • Absenteeism

    0, 6, 12, 18 months

  • +4 more secondary outcomes

Study Arms (11)

Arm 1 De-escalating violence training

EXPERIMENTAL

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

Arm 2 De-escalating violence training

EXPERIMENTAL

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

Arm 3 De-escalating violence training

EXPERIMENTAL

The de-escalating violence training intervention will be introduced before the third observation period at month 18.

Behavioral: Training in de-escalating violence

Arm 4 De-escalating violence training + Code of conduct

EXPERIMENTAL

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 violenceBehavioral: Code of conduct delivered via a warning board

Arm 5 De-escalating violence training + Code of conduct

EXPERIMENTAL

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 violenceBehavioral: Code of conduct delivered via a warning board

Arm 6 Code of conduct + De-escalating violence training

EXPERIMENTAL

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 violenceBehavioral: Code of conduct delivered via a warning board

Arm 7 De-escalating violence training + Code of conduct

EXPERIMENTAL

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 violenceBehavioral: Code of conduct delivered via a warning board

Arm 8 De-escalating violence training + Code of conduct

EXPERIMENTAL

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 violenceBehavioral: Code of conduct delivered via a warning board

Arm 9 De-escalating violence training + Code of conduct

EXPERIMENTAL

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 violenceBehavioral: Code of conduct delivered via a warning board

Arm 10 Code of conduct

EXPERIMENTAL

The code of conduct via a warning board will be introduced at month 11.

Behavioral: Code of conduct delivered via a warning board

Arm 11 Code of conduct

EXPERIMENTAL

The code of conduct via a warning board will be introduced at month 18.

Behavioral: Code of conduct delivered via a warning board

Interventions

* 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

Arm 1 De-escalating violence trainingArm 2 De-escalating violence trainingArm 3 De-escalating violence trainingArm 4 De-escalating violence training + Code of conductArm 5 De-escalating violence training + Code of conductArm 6 Code of conduct + De-escalating violence trainingArm 7 De-escalating violence training + Code of conductArm 8 De-escalating violence training + Code of conductArm 9 De-escalating violence training + Code of conduct

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

Arm 10 Code of conductArm 11 Code of conductArm 4 De-escalating violence training + Code of conductArm 5 De-escalating violence training + Code of conductArm 6 Code of conduct + De-escalating violence trainingArm 7 De-escalating violence training + Code of conductArm 8 De-escalating violence training + Code of conductArm 9 De-escalating violence training + Code of conduct

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years; cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic University of Bukavu, School of Public Health

Bukavu, Democratic Republic of the Congo

Location

Al-Mustansiriya University

Baghdad, Iraq

Location

Related Publications (4)

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32898304BACKGROUND
  • 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.

MeSH Terms

Conditions

Behavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sonja Merten, MD MPH PhD

    Swiss Tropical and Public Health Institute (Swiss TPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

November 1, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

January 22, 2025

Record last verified: 2024-09

Locations