An interventional study of Theory of Dissonance and Theory of Reasoned Action in Error Disclosure, sponsored by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Not applicable, Interventional, and Health services research
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:
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).
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Phase 1
Phase 2
Phase 3
Phase 4
- Inclusion criteria: Male/female balance, minimum 10 years of experience. Recruitment, among members of SEDISA, SEMERGEN, SEMFyC, FAECAP and other scientific societies.
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.
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
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
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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 months
Behavioral Intention
Measured with an instrument based on the Error-Oriented Motivation Scale and the Safety Attitudes Questionnaire. The best performing items will be selected and their cross-cultural validity and metric properties (according to COSMIN guidelines) will be guaranteed. Assessments at three points in time: before the intervention, at the end of the intervention period and 6 months after.
Time frame: 18 months
Cognitive Dissonance
Measured through linguistic indicators of cognitive conflict. Assessments at three points in time: before the intervention, at the end of the intervention period and 6 months later.
Time frame: 18 months
Effects of the Intervention
Independently analysed by group using a linear mixed effects model (LMM) for repeated measures. Consideration of data matching and stratification by gender, age, participant profile and intervention arm.
Time frame: 18 months
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana