Clinical trial NCT06835517: DECIDE Just Culture: Conceptualization of Clinical Error
Official title: Design of Tools to Transform the Conceptualization of Clinical Error Within and Outside Healthcare Centers, Social-health Centers, Hospitals and Healthcare Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Error Disclosure
Keywords: Just Culture
clinical error
honest mistake
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario Fundación Alcorcón
First posted: 2025-02-19
Enrollment: 1255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility 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.
* 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.

Primary outcomes:
measure: Percentage of attitudes classified as honest mistakes, risky behaviour and reckless behaviour identified in the different video scenarios during the group sessions
timeFrame: 8 months
measure: Number and intensity of the barriers detected that hinder the implementation of Just Culture in the organizations
timeFrame: 11 months
measure: Cost-effectiveness of psychoeducational interventions A and B
timeFrame: 18 months
measure: Existence of a guide of recommendations for implementing Just Culture that complies with AGREE II criteria
timeFrame: 8 months
Secondary outcomes:
measure: Behavioral Intention
timeFrame: 18 months
measure: Cognitive Dissonance
timeFrame: 18 months
measure: Effects of the Intervention
timeFrame: 18 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Centro de Salud Hospital Plá
Study officials:
affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
name: Jose J Mira
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Fundación Alcorcón
name: Susana Lorenzo Martínez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramón y Cajal
name: Jesús M Aranaz Andrés
role: PRINCIPAL_INVESTIGATOR
References: