Second Victim PhenomenonNCT06888297
RESCUE: European Certification for Second Victim Support
An observational study of Second Victim Phenomenon and Occupational Stress, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Second Victim Phenomenon, Occupational Stress, Healthcare Workforce Well-Being
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jul 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: From the start of the pilot phase (July 2024) to the end of study (October 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start31 Jul 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Second Victim PhenomenonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Joaquín Mira Solves, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888297
- Sponsor's protocol ID
- RESCUE - IG19113
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37525127Mira 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.
PubMed 38589877Harkanen 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.
PubMed 37443003Guerra-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.
PubMed 38151271Guerra-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.
PubMed 39280904Gil-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.
PubMed 37365924Mira 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.
PubMed 39360222Carrillo 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
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.
PubMed 41310735
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Certification of Interventions in Support of Second Victims (RESCUE)
- ClinicalTrials.gov ID
- NCT06888297
- Acronym / sponsor ID
- RESCUE - IG19113
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 37525127Seys 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.
- Background: PubMed 38589877Mira 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.
- Background: PubMed 37443003Harkanen 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.
- Background: PubMed 38151271Guerra-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.
- Background: PubMed 39280904Guerra-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.
- Background: PubMed 37365924Gil-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.
- Background: PubMed 39360222Mira 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.
- BackgroundCarrillo 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
- Derived from this study: PubMed 41310735Mira 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.
- Official website of the RESCUE project, providing information on the study protocol, objectives, and implementation of second victim support interventionsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Second Victim Phenomenon and Occupational Stress, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888297, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.