Violence Against Health Care Workers in Fragile Settings (VIA-H)

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.

Study Overview

• Status: Recruiting
• Conditions: Workplace Violence
• Intervention / Treatment: Behavioral: Training in de-escalating violence; Behavioral: Code of conduct delivered via a warning board

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.

• Study Type: Interventional
• Enrollment (Estimated): 798
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonja Merten, MD MPH PhD; Phone Number: +41 61 284 83 87; Email: sonja.merten@swisstph.ch
• Study Contact Backup: Name: Giovanfrancesco Ferrari, PhD; Phone Number: + 41 61 284 8209; Email: giovanfrancesco.ferrari@swisstph.ch

Study Locations

• Congo, The Democratic Republic of the
  • Bukavu, Congo, The Democratic Republic of the
    • Recruiting
    • Catholic University of Bukavu, School of Public Health
    • Contact: Ghislain Bisimwa Balaluka, MD PhD; Email: ghislainbiba@yahoo.fr
    • Contact: Samuel Makali, MD; Email: samuelmakali11@gmail.com
• Iraq
  • Baghdad, Iraq
    • Recruiting
    • Al-Mustansiriya University
    • Contact: Riyadh Lafta, MD PhD; Email: riyadhlafta@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Experimental: 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.	Behavioral: 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
Experimental: Arm 3 De-escalating violence training; The de-escalating violence training intervention will be introduced before the third observation period at month 18.	Behavioral: 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
Experimental: 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.	Behavioral: 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; 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
Experimental: 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.	Behavioral: 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; 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
Experimental: 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.	Behavioral: 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; 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
Experimental: 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.	Behavioral: 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; 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
Experimental: 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.	Behavioral: 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; 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
Experimental: 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.	Behavioral: 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; 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
Experimental: Arm 10 Code of conduct; The code of conduct via a warning board will be introduced at month 11.	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
Experimental: Arm 11 Code of conduct; The code of conduct via a warning board will be introduced at month 18.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of confidence in coping with patient aggression	Instrument "Clinicians confidence in coping with patient aggression (CCPAI) (Thackreys, 1987)"	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)"	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.	0, 6, 12, 18 months
Psychological empathy among HCWs	Instrument "Jefferson scale of physician empathy (Hojat M et al. 2007)"	0, 6, 12, 18 months
Absenteeism	Number of sick leave spells taken by the HCWs during the study period	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.	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).	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).	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).	0, 6, 12, 18 months

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Al-Mustansiriyah University; International Committee of the Red Cross (ICRC); Catholic University of Bukavu, Democratic Republic of Congo
• Investigators: Principal Investigator: Sonja Merten, MD MPH PhD, Swiss Tropical and Public Health Institute (Swiss TPH)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: behavioral symptoms; de-escalating; violence prevention; code of conduct
• Other Study ID Numbers: 70198

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No