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临床试验/NCT06888297
NCT06888297已完成不适用

European Certification of Interventions in Support of Second Victims (RESCUE)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Development of Two Certification Systems for Second Victim Support Interventions and Peer Supporters

研究概览

简要总结

The "second victim" phenomenon affects healthcare professionals who experience highly stressful events in their daily practice, potentially compromising their well-being and patient safety. Despite the need for structured support interventions, many European institutions lack formal programs to address this issue.

The RESCUE project responds to this need, building on the previous work of the ERNST Consortium (COST Action 19113). Its objective is to develop and validate two certification systems: one for second victim support interventions and another for training healthcare professionals as peer supporters. A mixed-methods approach will be used, incorporating expert consensus techniques (e.g., Delphi study and consensus conferences) and pilot studies in healthcare institutions across multiple European countries.

The study aims to establish European certification standards for second victim support interventions, improving support for healthcare professionals, increasing resilience, and reducing the impact of adverse events on clinical performance.

详细描述

The RESCUE project (European Certification of Interventions in Support of Second Victims) aims to develop and validate two certification systems to improve support for healthcare professionals who experience the second victim phenomenon. This phenomenon occurs when healthcare workers are involved in stressful or traumatic clinical events, potentially affecting their well-being and patient safety. Despite its significant impact, many European institutions lack structured support interventions to address this issue.

Background and Rationale:

The ERNST Consortium (COST Action 19113) identified a critical gap in support interventions for second victims. Over four years of research, the consortium developed an intervention model structured into five stages: prevention, self-care, peer support, structured professional support, and structured clinical support. The RESCUE project builds upon this work to create a European-wide certification system for second victim support interventions and peer supporter training.

Study Objectives:

The primary objective of the study is to implement and validate two complementary certification systems:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Healthcare professionals (e.g., physicians, nurses, midwives, clinical managers, patient safety officers).
  • A minimum of 5 years of experience in healthcare-related fields such as clinical management, patient safety, quality assurance, or second victim support interventions.
  • Employed in a healthcare institution or involved in second victim support initiatives at the time of the study.
  • Willing to participate in peer support training, intervention certification, or evaluation processes related to the RESCUE project.
  • Able to provide informed consent to participate in the study.

排除标准

  • Non-healthcare professionals or individuals without experience in patient safety, clinical management, or second victim support.
  • Less than 5 years of professional experience in relevant fields.
  • Not affiliated with a healthcare institution or not involved in second victim support activities.
  • Unable to provide informed consent.

研究组 & 干预措施

RESCUE-Peer Supporters

Healthcare professionals receiving certification as peer supporters to assist colleagues experiencing the second victim phenomenon.

RESCUE-Support Interventions

Healthcare institutions participating in the certification process for structured second victim support interventions.

结局指标

主要结局

Development of Two Certification Systems for Second Victim Support Interventions and Peer Supporters

时间窗: From study start (January 2025) to certification system finalization (May 2025).

The study will assess the successful development and definition of certification standards for second victim support interventions (RESCUE-Interventions) and for healthcare professionals trained as peer supporters (RESCUE-Peer Supporters). The certification standards for second victim support interventions (RESCUE-Interventions) and peer supporters (RESCUE-Peer Supporters) will be developed using expert consensus methodologies, including Delphi studies and consensus conferences. Metric: Successful definition and agreement on certification criteria, with at least 85% consensus among experts in Delphi rounds and consensus meetings.

Relevance of the RESCUE Certification System

时间窗: From the start of pilot studies (July 2025) to the end of data collection (October 2025).

This measure will assess the perceived relevance of the RESCUE certification system for second victim support interventions and peer supporter training. The evaluation will be conducted through an ad hoc survey completed by healthcare professionals from the institutions participating in the field study. Metric: Percentage of healthcare professionals rating the certification system as "fairly relevant" or "highly relevant" on a 5-point Likert scale, based on responses to the relevant items in the 20-item survey. A minimum of 85% of positive responses ("fairly relevant" or "highly relevant") is required for the certification system to be considered relevant.

Feasibility of the RESCUE Certification System

时间窗: From the start of the pilot studies (July 2025) to the end of data collection (October 2025).

This measure will assess the perceived feasibility of implementing the RESCUE certification system in healthcare institutions. The evaluation will be conducted through an ad hoc survey completed by healthcare professionals from the institutions participating in the field study. Metric: Percentage of healthcare professionals rating the implementation of the certification system as "fairly feasible" or "highly feasible" on a 5-point Likert scale, based on responses to the relevant items in the 20-item survey. A minimum of 85% of positive responses ("fairly feasible" or "highly feasible") is required for the certification system to be considered feasible.

Acceptability of the RESCUE Certification System

时间窗: From the start of pilot studies (July 2025) to the end of data collection (October 2025).

This measure will assess the perceived acceptability of the RESCUE certification system among healthcare professionals. The evaluation will be conducted hrough an ad hoc survey completed by staff from the institutions participating in the field study. Metric: Percentage of healthcare professionals rating the certification system as "fairly acceptable" or "highly acceptable" on a 5-point Likert scale, based on responses to the relevant items in the 20-item survey. A minimum of 85% of positive responses ("fairly acceptable" or "highly acceptable") is required for the certification system to be considered acceptable.

次要结局

  • Perceived Scalability of the RESCUE Certification System in European Healthcare Institutions(From the start of the pilot phase (July 2024) to the end of study (October 2025).)

研究者

发起方
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Joaquín Mira Solves

Principal Investigator

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

研究点 (2)

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