Clinical trial NCT05419687: Violence Against Health Care Workers in Fragile Settings
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Workplace Violence
Keywords: de-escalating
violence prevention
behavioral symptoms
code of conduct
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: International Committee of the Red Cross (ICRC)
name: Catholic University of Bukavu, Democratic Republic of Congo
name: Al-Mustansiriyah University
First posted: 2022-06-15
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of self-reported non-physical aggression
timeFrame: 6 months
measure: Incidence and severity of self-reported physical aggression
timeFrame: 6 months
Secondary outcomes:
measure: Level of confidence in coping with patient aggression
timeFrame: 0, 6, 12, 18 months
measure: Level of post-traumatic stress disorders (PTSD) among HCWs
timeFrame: 0, 6, 12, 18 months
measure: Level of burnout among HCWs
timeFrame: 0, 6, 12, 18 months
measure: Psychological empathy among HCWs
timeFrame: 0, 6, 12, 18 months
measure: Absenteeism
timeFrame: 0, 6, 12, 18 months
measure: Intent to leave among HCWs
timeFrame: 0, 6, 12, 18 months
measure: Economic cost of the intervention
timeFrame: 18 months
measure: Productivity loss (presenteeism)
timeFrame: 18 months
measure: Health care workers health-related quality of life
timeFrame: 0, 6, 12, 18 months
Other outcomes:
Locations:
city: Bukavu
country: Congo, The Democratic Republic of the
facility: Catholic University of Bukavu, School of Public Health
city: Baghdad
country: Iraq
facility: Al-Mustansiriya University
Study officials:
affiliation: Swiss Tropical and Public Health Institute (Swiss TPH)
name: Sonja Merten, MD MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elrha, International Committee of the Red Cross (ICRC), RAND Europe. Researching Violence Against Health Care: Gaps and Priorities. 2020
citation: 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.
citation: 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.