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Enrolling by Invitation

NCT Number: NCT06888297

RESCUE: European Certification for Second Victim Support

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FISABIO

San Juan, Alicante, 03110, Spain

About this study

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:

RESCUE-Interventions: Certification for structured support interventions in healthcare institutions.

RESCUE-Peer Supporters: Certification for healthcare professionals trained to provide peer support.

These certification systems will be developed through expert consensus techniques (Delphi study, consensus conferences) and validated through pilot studies in multiple European healthcare institutions.

Methodology:

This is an observational, descriptive study using a mixed-methods approach. The study will be conducted in four phases:

Phase 1: Definition of certification standards through expert consensus and literature review.

Phase 2: Pilot application of the certification system in selected European institutions (Austria, Belgium, Portugal, and Spain).

Phase 3: Evaluation of certification effectiveness through qualitative and quantitative assessments.

Phase 4: Finalization and dissemination of the certification framework.

Expected Impact:

By establishing a standardized certification system, RESCUE seeks to ensure that healthcare professionals receive appropriate training and institutional support when dealing with adverse events. The project aims to increase resilience, improve patient safety, and integrate second victim interventions into European healthcare systems.

Funding and Ethical Considerations:

The study is funded by COST Innovators Grants (CIG), European Cooperation in Science & Technology (Grant ID IG19113) and has received approval from the Comité de Ética de la Investigación del Hospital Universitario San Juan de Alicante.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

  2. Relevance of the RESCUE Certification System

    Time frame: 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.

  3. Feasibility of the RESCUE Certification System

    Time frame: 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.

  4. Acceptability of the RESCUE Certification System

    Time frame: 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.

Secondary outcomes

  1. Perceived Scalability of the RESCUE Certification System in European Healthcare Institutions

    Time frame: From the start of the pilot phase (July 2024) to the end of study (October 2025).

    The perceived scalability and sustainability of the RESCUE certification system for implementation in other institutions and European countries will be assessed.

    Metric: Opinions of key stakeholders (institutional leaders, policymakers, and healthcare professionals) regarding the feasibility of the system, measured through structured interviews with qualitative analysis.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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