Violence Against Health Care Workers in Fragile Settings

NCT ID: NCT05419687

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Workplace Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Arm 1 De-escalating violence training

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 2 De-escalating violence training

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 3 De-escalating violence training

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

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 4 De-escalating violence training + Code of conduct

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 board

Intervention Type BEHAVIORAL

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 5 De-escalating violence training + Code of conduct

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 board

Intervention Type BEHAVIORAL

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 6 Code of conduct + De-escalating violence training

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 board

Intervention Type BEHAVIORAL

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 7 De-escalating violence training + Code of conduct

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 board

Intervention Type BEHAVIORAL

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 8 De-escalating violence training + Code of conduct

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.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 board

Intervention Type BEHAVIORAL

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 9 De-escalating violence training + Code of conduct

The code of conduct via a warning board and the violence de-escalating training will be simultaneously introduced at month 18.

Group Type EXPERIMENTAL

Training in de-escalating violence

Intervention Type BEHAVIORAL

* 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 board

Intervention Type BEHAVIORAL

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 conduct

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

Group Type EXPERIMENTAL

Code of conduct delivered via a warning board

Intervention Type BEHAVIORAL

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 11 Code of conduct

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

Group Type EXPERIMENTAL

Code of conduct delivered via a warning board

Intervention Type BEHAVIORAL

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

Interventions

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Training 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

Intervention Type BEHAVIORAL

Code 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Committee of the Red Cross (ICRC)

UNKNOWN

Sponsor Role collaborator

Catholic University of Bukavu, Democratic Republic of Congo

UNKNOWN

Sponsor Role collaborator

Al-Mustansiriyah University

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonja Merten, MD MPH PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical and Public Health Institute (Swiss TPH)

Locations

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Catholic University of Bukavu, School of Public Health

Bukavu, , Democratic Republic of the Congo

Site Status

Al-Mustansiriya University

Baghdad, , Iraq

Site Status

Countries

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Democratic Republic of the Congo Iraq

References

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 32898304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38110997 (View on PubMed)

Other Identifiers

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70198

Identifier Type: -

Identifier Source: org_study_id

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