Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06835517

DECIDE Just Culture: Conceptualization of Clinical Error

Led by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Updated on 2026-04-29

1255

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

Sponsors

F

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

Lead Sponsor

H

Hospital Universitario Ramon y Cajal

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

DECIDE Just Culture: Conceptualization of Clinical Error

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Voluntarily agree to participate after informed consent
  • Commit to a dedication of 5 hours (Phase 1)
  • Managers of health centers, hospitals, or socio-health centers in Andalusia, Aragon, Valencia, and Madrid with at least 7 years of experience who agree to participate (Phase 2)
  • Same as Phase 1, voluntarily agree to participate and commit to 90 minutes (Phase 3)
  • Male/female balance with minimum 10 years of experience among members of scientific societies (Phase 4)
Not Eligible

You will not qualify if you...

  • Experience in patient safety groups or committees (Phase 1 and 3)
  • Ongoing or serious adverse event claims or litigation with institutions (Phase 1 and 3)
  • Litigation or claim in the last 15 years (Phase 2)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centro de Salud Hospital Plá

Alicante, Alicante, Spain, 03013

Actively Recruiting

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Research Team

J

Jose J Mira

CONTACT

I

Irene Carrillo Murcia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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