RESCUE: European Certification for Second Victim Support

NCT06888297 | Enrolling By Invitation

• 1 other identifier: RESCUE - IG19113
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Second Victim Phenomenon; Occupational Stress; Healthcare Workforce Well-Being; Patient Safety; Healthcare Quality; Support Interventions

Keywords

Second Victim Phenomenon; Healthcare Professionals; Occupational Stress; Peer Support Programs; Psychological Support in Healthcare; Patient Safety; Healthcare Workforce Well-Being; Certification of Support Interventions

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  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

  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 Outcomes (1)

• 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).

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

FISABIO

San Juan, Alicante, 03110, Spain

Location

Related Publications (9)

• Seys D, Panella M, Russotto S, Strametz R, Joaquin Mira J, Van Wilder A, Godderis L, Vanhaecht K. In search of an international multidimensional action plan for second victim support: a narrative review. BMC Health Serv Res. 2023 Jul 31;23(1):816. doi: 10.1186/s12913-023-09637-8.

  PMID: 37525127 BACKGROUND

• Mira JJ, Matarredona V, Tella S, Sousa P, Ribeiro Neves V, Strametz R, Lopez-Pineda A. Unveiling the hidden struggle of healthcare students as second victims through a systematic review. BMC Med Educ. 2024 Apr 8;24(1):378. doi: 10.1186/s12909-024-05336-y.

  PMID: 38589877 BACKGROUND

• Harkanen M, Pineda AL, Tella S, Mahat S, Panella M, Ratti M, Vanhaecht K, Strametz R, Carrillo I, Rafferty AM, Wu AW, Anttila VJ, Mira JJ. The impact of emotional support on healthcare workers and students coping with COVID-19, and other SARS-CoV pandemics - a mixed-methods systematic review. BMC Health Serv Res. 2023 Jul 13;23(1):751. doi: 10.1186/s12913-023-09744-6.

  PMID: 37443003 BACKGROUND

• Guerra-Paiva S, Lobao MJ, Simoes DG, Fernandes J, Donato H, Carrillo I, Mira JJ, Sousa P. Key factors for effective implementation of healthcare workers support interventions after patient safety incidents in health organisations: a scoping review. BMJ Open. 2023 Dec 27;13(12):e078118. doi: 10.1136/bmjopen-2023-078118.

  PMID: 38151271 BACKGROUND

• Guerra-Paiva S, Carrillo I, Mira J, Fernandes J, Strametz R, Gil-Hernandez E, Sousa P. Developing Core Indicators for Evaluating Second Victim Programs: An International Consensus Approach. Int J Public Health. 2024 Aug 30;69:1607428. doi: 10.3389/ijph.2024.1607428. eCollection 2024.

  PMID: 39280904 BACKGROUND

• Gil-Hernandez E, Carrillo I, Tumelty ME, Srulovici E, Vanhaecht K, Wallis KA, Giraldo P, Astier-Pena MP, Panella M, Guerra-Paiva S, Buttigieg S, Seys D, Strametz R, Mora AU, Mira JJ. How different countries respond to adverse events whilst patients' rights are protected. Med Sci Law. 2024 Apr;64(2):96-112. doi: 10.1177/00258024231182369. Epub 2023 Jun 27.

  PMID: 37365924 BACKGROUND

• Mira J, Carillo I, Tella S, Vanhaecht K, Panella M, Seys D, Ungureanu MI, Sousa P, Buttigieg SC, Vella-Bonanno P, Popovici G, Srulovici E, Guerra-Paiva S, Knezevic B, Lorenzo S, Lachman P, Ushiro S, Scott SD, Wu A, Strametz R. The European Researchers' Network Working on Second Victim (ERNST) Policy Statement on the Second Victim Phenomenon for Increasing Patient Safety. Public Health Rev. 2024 Sep 18;45:1607175. doi: 10.3389/phrs.2024.1607175. eCollection 2024.

  PMID: 39360222 BACKGROUND

• Carrillo I, Tella S, Strametz R, Vanhaecht K, Panella M, Guerra-Paiva S, et al. Studies on the second victim phenomenon and other related topics in the pan-European environment: The experience of ERNST Consortium members. J Patient Saf Risk Manag. 2022;27(2):59-65. doi: 10.1177/25160435221076985

  BACKGROUND

• Mira JJ, Potura E, Schroder K, Panella M, Sousa P, Knezevic B, Tella S, Strametz R; RESCUE. Standardizing second victim support: development of the RESCUE certification framework for health care institutions. BMC Health Serv Res. 2025 Nov 27;25(1):1539. doi: 10.1186/s12913-025-13741-2.

  PMID: 41310735 DERIVED

Related Links

• Official website of the RESCUE project, providing information on the study protocol, objectives, and implementation of second victim support interventions

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 21, 2025
• Study Start: July 31, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Supporting information may be available after study completion and publication of primary results, expected in Q1 2026
• 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.

Locations

ES (1)