Clinical trial NCT06888297: RESCUE: European Certification for Second Victim Support
Official title: European Certification of Interventions in Support of Second Victims (RESCUE)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of Two Certification Systems for Second Victim Support Interventions and Peer Supporters
timeFrame: From study start (January 2025) to certification system finalization (May 2025).
measure: Relevance of the RESCUE Certification System
timeFrame: From the start of pilot studies (July 2025) to the end of data collection (October 2025).
measure: Feasibility of the RESCUE Certification System
timeFrame: From the start of the pilot studies (July 2025) to the end of data collection (October 2025).
measure: Acceptability of the RESCUE Certification System
timeFrame: From the start of pilot studies (July 2025) to the end of data collection (October 2025).
Secondary outcomes:
measure: Perceived Scalability of the RESCUE Certification System in European Healthcare Institutions
timeFrame: From the start of the pilot phase (July 2024) to the end of study (October 2025).
Other outcomes:
Locations:
city: San Juan
country: Spain
facility: FISABIO
state: Alicante
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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