DECIDE Just Culture: Conceptualization of Clinical Error

NCT06835517 | Recruiting

• 4 other identifiers: UGP-24-005PI24/00243PI24/00376PI24/00901
• Study Type: interventional
• Target: 1,255
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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.

Conditions

Error Disclosure

Keywords

Just Culture; clinical error; honest mistake

Outcome Measures

Primary Outcomes (4)

• Percentage of attitudes classified as honest mistakes, risky behaviour and reckless behaviour identified in the different video scenarios during the group sessions

  The Focus Group technique (face-to-face) will be used to describe the participants' vision of human fallibility. The following will be considered: consistency between contributions (triangulation within and between groups), spontaneity (number of different original contributions); intensity, weighting assigned to each of the ideas (on a scale of 1 to 5 points); and relevance (considering the agreement they arouse by means of the coefficient of variation). Discussions will be held until the information is saturated. In addition, the data collected from the different groups will be triangulated to present joint results.

  8 months

• Number and intensity of the barriers detected that hinder the implementation of Just Culture in the organizations

  The Just Culture Assessment Tool (Petschonek et al. J Patient Saf. 2013;9:190-7) and Safety Culture Stack approach (Kirwan et al. Safety and Reliability 2018;38(3):200-217) will be used after cross-cultural adaptation. ANOVA will be used to analyze the relationships between care levels and professional profiles. The t-test statistic will be used to determine differences between men and women. Multiple linear regression will be used taking as dependent variable: scale score and as factors: years of experience, sex, professional profile, autonomous community.

  11 months

• Cost-effectiveness of psychoeducational interventions A and B

  Cost-effectiveness will be assessed using a cost-effectiveness analysis, comparing the direct and indirect costs of each intervention with their impact on attitudes, behavioral intention, and cognitive dissonance.

  18 months

• Existence of a guide of recommendations for implementing Just Culture that complies with AGREE II criteria

  The Consensus Conference technique will be used to obtain a guide that complies with the AGREE II (Appraisal of Guidelines for Research and Evaluation) principles and that includes recommendations for implementing Just Culture in the different healthcare institutions, adapted to the context.

  8 months

Secondary Outcomes (3)

• Behavioral Intention

  18 months

• Cognitive Dissonance

  18 months

• Effects of the Intervention

  18 months

Study Arms (3)

Control group

NO INTERVENTION

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.

Theory of Dissonance

EXPERIMENTAL

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.

Behavioral: Theory of Dissonance

Theory of Reasoned Action

EXPERIMENTAL

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.

Behavioral: Theory of Reasoned Action

Interventions

Theory of Dissonance 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 Dissonance

Theory of Reasoned Action 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).

Theory of Reasoned Action

Eligibility Criteria

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

You may not qualify if:

• Phase 2
• Phase 3
• Phase 4

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario Fundación Alcorcón: collaborator

Study Sites (1)

Centro de Salud Hospital Plá

Alicante, Alicante, 03013, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 41120161 DERIVED

MeSH Terms

Interventions

Theory of Planned Behavior

Intervention Hierarchy (Ancestors)

Models, Psychological; Models, Theoretical; Investigative Techniques

Study Officials

• Jose J Mira

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

  PRINCIPAL INVESTIGATOR

• Susana Lorenzo Martínez

  Hospital Universitario Fundación Alcorcón

  PRINCIPAL INVESTIGATOR

• Jesús M Aranaz Andrés

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose J Mira

CONTACT

+34 96 665 8984; jose.mira@umh.es

Irene Carrillo Murcia

CONTACT

+34 96 665 8350; icarrillo@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 19, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

ES (1)