DECIDE Just Culture: Conceptualization of Clinical Error

NCT ID: NCT06835517

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-23
• Study Completion Date: 2027-12-31

Brief Summary

The main objective of this project is to extend the principles of Just Culture in primary care, hospitals and social-health centers, providing new information on key elements in the social and professional conceptualization of the human factor (fallibility) in safety incidents.

A mixed design combining cross-sectional observational studies based on qualitative (focus groups and consensus conference) and quantitative (survey) methodology with an experimental study or randomized clinical trial with three arms will be used.

The methodology is deployed in four stages or phases of the study:

1. Focus Group technique (qualitative research) with 70 primary care health professionals, 80 hospital health professionals, 70 health professionals from socio-health centers, 72 health managers and 80 social leaders to identify key elements of the subjective norms and social influence processes that define the conceptualization of a clinical error, including impact of gender bias and other stereotypes in relation to blame.

2. Online survey of a stratified random sample of 1,255 managers, middle managers and professionals from primary care, hospitals and social-health centers to analyze the barriers and facilitating factors for the implementation of Just Culture.

3. Randomized experimental study with three arms (84 subjects in each) and control group to determine the effectiveness of two interventions aimed at modifying attitudes, beliefs and behaviors in relation to honest mistakes, based on the Theory of Dissonance and Reasoned Action, both in social leaders and professionals.

4. Application of AGREE II and Consensus Conference technique (33 experts) to elaborate a guide of recommendations in order to implement Just Culture in primary care, with the involvement of all actors (social and professional level) that will be transferred to practice.

Detailed Description

Researchers will compare with a control group the effectiveness of two interventions to modify attitudes, beliefs and behaviors in relation to honest mistakes, based on the theory of dissonance and reasoned action, in both social and professional leaders.

The design of intervention A will consist of presenting information that generates dissonance with subjects' attitudes and beliefs about clinical errors. The dissonance will be intensified by experiential experiences through simulations that provide convincing information that supports the idea of accepting honest errors as learning opportunities within the framework of a Just Culture.

The psychoeducational intervention B based will consist of the presentation of testimonials, narratives, statements and analysis of everyday clinical practice situations that promote a change in so-called "subjective norms" (a person's beliefs about whether significant people in their life approve or disapprove of a specific behavior) in relation to the acceptance of honest errors (including learning and improving healthcare from error).

Conditions

Error Disclosure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control group

Subjects in the control group will participate in a lecture (40 minutes and 15 minutes of discussion) on patient safety, causes of clinical errors and measures to reduce them in healthcare centers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Theory of Dissonance

This theory describes psychological discomfort when people have thoughts or beliefs that conflict with each other, or when their actions are not aligned with their beliefs or values. In these cases, the intervention seeks this discrepancy by presenting dissonant information, which leads to an adjustment of one's beliefs and attitudes, and thus of one's behaviours.

Group Type: EXPERIMENTAL

Theory of Dissonance

Intervention Type: BEHAVIORAL

The design of this intervention will consist of presenting information that generates dissonance with the subjects' attitudes and beliefs about clinical errors. Dissonance will be intensified by experiential experiences through simulations that provide compelling information that supports the idea of accepting honest errors as learning opportunities within the framework of a Just Culture.

Theory of Reasoned Action

This theory provides a conceptual framework for understanding how social norms influence the formation of intentions, and how these intentions predict behaviour. It is especially useful for changing behaviour by modifying the beliefs and norms that underlie attitudes based on the social influence exerted by peers.

Group Type: EXPERIMENTAL

Theory of Reasoned Action

Intervention Type: BEHAVIORAL

The intervention will consist of the presentation, to the different groups, of testimonies, narratives, statements and analysis of everyday clinical practice situations that promote a change in the so-called "subjective norms" (a person's beliefs about whether significant people in his or her life approve or disapprove of a specific behavior) in relation to the acceptance of honest mistakes (including learning and improving health care from error).

Interventions

Theory of Dissonance

The design of this intervention will consist of presenting information that generates dissonance with the subjects' attitudes and beliefs about clinical errors. Dissonance will be intensified by experiential experiences through simulations that provide compelling information that supports the idea of accepting honest errors as learning opportunities within the framework of a Just Culture.

Intervention Type: BEHAVIORAL

Theory of Reasoned Action

The intervention will consist of the presentation, to the different groups, of testimonies, narratives, statements and analysis of everyday clinical practice situations that promote a change in the so-called "subjective norms" (a person's beliefs about whether significant people in his or her life approve or disapprove of a specific behavior) in relation to the acceptance of honest mistakes (including learning and improving health care from error).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

Phase 2

Phase 3

Phase 4

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

José Joaquín Mira Solves

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose J Mira

Role: PRINCIPAL_INVESTIGATOR

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

Susana Lorenzo Martínez

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Fundación Alcorcón

Jesús M Aranaz Andrés

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Locations

Centro de Salud Hospital Plá

Alicante, , Spain

Countries

Spain

References

Mira JJ, Lorenzo S, Aranaz-Andres JM, Macias-Maroto M, Cobos-Vargas A, Moreno Campoy EE, Perez-Perez P, Trillo-Lopez P, Corpas-Nogales E, Gea Velazquez de Castro MT, Arencibia-Jimenez M, Asencio A, Diez Herrero D, Molina-Ribera J, Calderon E, Lozano-Gago P, Libano Beristain A, Navarro Macia C, San Jose Saras D, Gil-Hernandez E, Carrillo I. Understanding and reframing clinical errors through just culture: protocol for the DECIDE mixed-methods study in Spanish healthcare and community contexts. BMJ Open. 2025 Oct 20;15(10):e101421. doi: 10.1136/bmjopen-2025-101421.

Reference Type: DERIVED

PMID: 41120161 (View on PubMed)

Other Identifiers

PI24/00243

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI24/00376

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI24/00901

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UGP-24-005

Identifier Type: -

Identifier Source: org_study_id