RESCUE: European Certification for Second Victim Support

September 1, 2026 updated by: José Joaquín Mira Solves, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • San Juan, Alicante, Spain, 03110
        • FISABIO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of healthcare professionals from various disciplines, including physicians, nurses, midwives, clinical managers, patient safety officers, and other professionals involved in patient care and healthcare quality. Participants will be selected from European healthcare institutions implementing second victim support interventions.

The study will include experts with at least 5 years of experience in healthcare-related fields, particularly in clinical management, quality assurance, and second victim support programs. The population will be drawn from hospitals, primary care centers, and social care institutions in multiple European countries, including Austria, Belgium, Portugal, and Spain.

The study aims to develop and validate certification systems for second victim support interventions and peer supporter training, ensuring that healthcare institutions provide structured and evidence-based emotional support for affected professionals.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
RESCUE-Support Interventions
Healthcare institutions participating in the certification process for structured second victim support interventions.
RESCUE-Peer Supporters
Healthcare professionals receiving certification as peer supporters to assist colleagues experiencing the second victim phenomenon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From study start (January 2025) to certification system finalization (May 2025).
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.
From the start of pilot studies (July 2025) to the end of data collection (October 2025).
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.
From the start of the pilot studies (July 2025) to the end of data collection (October 2025).
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.
From the start of pilot studies (July 2025) to the end of data collection (October 2025).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of the pilot phase (July 2024) to the end of study (October 2025).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCUE - IG19113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers affiliated with academic or healthcare institutions may request access to the dataset by submitting a formal request to the principal investigator. Approval will be granted based on ethical guidelines and compliance with data protection regulations.

IPD Sharing Time Frame

Supporting information may be available after study completion and publication of primary results, expected in Q1 2026

IPD Sharing Access Criteria

Documents will be shared upon request with researchers affiliated with academic or healthcare institutions, subject to ethical approval and compliance with data protection regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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