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临床试验/NCT05419687
NCT05419687已完成不适用

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

Swiss Tropical & Public Health Institute2 个研究点 分布在 2 个国家目标入组 798 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
798
试验地点
2
主要终点
Incidence and severity of self-reported non-physical aggression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Age <18 years; cognitive impairment

研究组 & 干预措施

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

Arm 3 De-escalating violence training

Experimental

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

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Code of conduct delivered via a warning board (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Code of conduct delivered via a warning board (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Code of conduct delivered via a warning board (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Code of conduct delivered via a warning board (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Code of conduct delivered via a warning board (Behavioral)

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.

干预措施: Training in de-escalating violence (Behavioral)

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.

干预措施: Code of conduct delivered via a warning board (Behavioral)

Arm 10 Code of conduct

Experimental

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

干预措施: Code of conduct delivered via a warning board (Behavioral)

Arm 11 Code of conduct

Experimental

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

干预措施: Code of conduct delivered via a warning board (Behavioral)

结局指标

主要结局

Incidence and severity of self-reported non-physical aggression

时间窗: 6 months

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

Incidence and severity of self-reported physical aggression

时间窗: 6 months

Number of self-reported physical aggression during the fulfillment of a professional activity in the last 6 months

次要结局

  • Level of post-traumatic stress disorders (PTSD) among HCWs(0, 6, 12, 18 months)
  • Level of confidence in coping with patient aggression(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)
  • Intent to leave among HCWs(0, 6, 12, 18 months)
  • Economic cost of the intervention(18 months)
  • Productivity loss (presenteeism)(18 months)
  • Health care workers health-related quality of life(0, 6, 12, 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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