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NCT Number: NCT06835517

DECIDE Just Culture: Conceptualization of Clinical Error

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Hospital Plá

Alicante, 03013, Spain

Location status: Recruiting

Location contact

José J Mira

CONTACT

About this 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Exclusion criteria:Litigation or claim in the last 15 years.

Phase 3

  • Inclusion criteria: Same as in phase 1, who voluntarily agree to participate and commit to a dedication of 90 minutes.
  • Exclusion criteria: Same as in phase 1. Who have participated in phase 1.

Phase 4

  • Inclusion criteria: Male/female balance, minimum 10 years of experience. Recruitment, among members of SEDISA, SEMERGEN, SEMFyC, FAECAP and other scientific societies.

Treatment and study plan

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 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).

Primary outcomes

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

    Time frame: 8 months

    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.

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

    Time frame: 11 months

    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.

  3. Cost-effectiveness of psychoeducational interventions A and B

    Time frame: 18 months

    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.

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

    Time frame: 8 months

    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.

Secondary outcomes

  1. Behavioral Intention

    Time frame: 18 months

    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.

  2. Cognitive Dissonance

    Time frame: 18 months

    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.

  3. Effects of the Intervention

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Carrillo Murcia

CONTACT

[email protected]

+34 96 665 8350

Jose J Mira

CONTACT

[email protected]

+34 96 665 8984

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Hospital Universitario Fundación Alcorcón
  • Hospital Universitario Ramon y Cajal

Registry information

Official study title

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

Acronym: DECIDE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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