DECIDE Just Culture: How clinical errors are understood and handled
Design of Tools to Transform the Conceptualization of Clinical Error Within and Outside Healthcare Centers, Social-health Centers, Hospitals and Healthcare Management
Tests two ways to help health professionals and leaders accept honest mistakes and promote a Just Culture for safer care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1255 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Alicante, Alicante) |
| Trial ID | NCT06835517 on ClinicalTrials.gov |
What this trial studies
This mixed-methods project combines focus groups, surveys, consensus conferences and a three-arm randomized experiment to study how clinical errors are conceptualized across primary care, hospitals and socio-health centers. Phase 1 gathers qualitative input from frontline professionals, managers and social leaders to identify norms and influences shaping views on human fallibility in safety incidents. The randomized component compares a dissonance-based experiential intervention, a psychoeducational narrative intervention, and a control to see which changes attitudes and intended behaviors about honest mistakes. Outcomes will include changes in beliefs, subjective norms, and self-reported willingness to treat honest errors as learning opportunities within a Just Culture framework.
Who should consider this trial
Good fit: Ideal participants are health professionals with more than five years' experience, healthcare managers, and social leaders who can commit to the study activities and consent to participate.
Not a fit: People with recent or ongoing litigation, those already active in patient safety committees, or those outside the targeted professional/leadership roles are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the interventions could increase open reporting and learning from honest errors, leading to safer care for patients.
How similar studies have performed: Related educational and culture-change approaches have shown mixed but promising results in improving error reporting and attitudes, while the specific combination of dissonance-based simulations and narrative interventions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Alicante, Alicante
- Centro de Salud Hospital Plá — Alicante, Alicante, Spain (Recruiting)
Study contacts
- Principal investigator: Jose J Mira — Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study coordinator: Jose J Mira
- Email: jose.mira@umh.es
- Phone: +34 96 665 8984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.