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DECIDE Just Culture: Conceptualization of Clinical Error

Design of Tools to Transform the Conceptualization of Clinical Error Within and Outside Healthcare Centers, Social-health Centers, Hospitals and Healthcare Management

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06835517
Acronym
DECIDE
Enrollment
1255
Registered
2025-02-19
Start date
2025-01-23
Completion date
2027-12-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Error Disclosure

Keywords

Just Culture, clinical error, honest mistake

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).

Interventions

BEHAVIORALTheory 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.

BEHAVIORALTheory 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).

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Lead SponsorOTHER
Hospital Universitario Ramon y Cajal
CollaboratorOTHER
Hospital Universitario Fundación Alcorcón
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Phase 1 * Inclusion criteria: Over 18 years of age, health professionals in primary care, hospitals or social-health centers with more than 5 years of experience. Healthcare managers. People who exercise social leadership in associations, media, blogs, etc. Subjects who voluntarily agree to participate after informed consent and who commit to a dedication of 5 hours. *

Exclusion criteria

Experience in patient safety groups/committees. Ongoing or serious adverse event claims or litigation with institutions. Phase 2 * Inclusion criteria: Managers of health centers, hospitals or socio-health centers in Andalusia, Aragon, Valencia and Madrid, with a minimum of 7 years of experience, who agree to participate. *

Design outcomes

Primary

MeasureTime frameDescription
Percentage of attitudes classified as honest mistakes, risky behaviour and reckless behaviour identified in the different video scenarios during the group sessions8 monthsThe 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.
Number and intensity of the barriers detected that hinder the implementation of Just Culture in the organizations11 monthsThe 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.
Cost-effectiveness of psychoeducational interventions A and B18 monthsCost-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.
Existence of a guide of recommendations for implementing Just Culture that complies with AGREE II criteria8 monthsThe 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.

Secondary

MeasureTime frameDescription
Behavioral Intention18 monthsMeasured 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.
Cognitive Dissonance18 monthsMeasured 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.
Effects of the Intervention18 monthsIndependently 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.

Countries

Spain

Contacts

CONTACTJose J Mira
jose.mira@umh.es+34 96 665 8984
CONTACTIrene Carrillo Murcia
icarrillo@umh.es+34 96 665 8350
PRINCIPAL_INVESTIGATORJose J Mira

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

PRINCIPAL_INVESTIGATORSusana Lorenzo Martínez

Hospital Universitario Fundación Alcorcón

PRINCIPAL_INVESTIGATORJesús M Aranaz Andrés

Hospital Universitario Ramón y Cajal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026