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

Overview

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

• Behavioral Theory 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.
• Behavioral Theory 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).

Primary outcome measures

• 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]
• Number and intensity of the barriers detected that hinder the implementation of Just Culture in the organizations [Time frame: 11 months]
• Cost-effectiveness of psychoeducational interventions A and B [Time frame: 18 months]
• Existence of a guide of recommendations for implementing Just Culture that complies with AGREE II criteria [Time frame: 8 months]

Secondary outcome measures (3)

• Behavioral Intention [Time frame: 18 months]
• Cognitive Dissonance [Time frame: 18 months]
• Effects of the Intervention [Time frame: 18 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Spain · 1 center

• Centro de Salud Hospital Plá — Alicante

Publications

• Mira JJ, Lorenzo S, Aranaz-Andres JM, Macias-Maroto M, Cobos-Vargas A, Moreno Campoy EE, Perez-Perez P, Trillo-Lopez P, Corpas-Nogales E, Gea Velazquez de Castro MT, Arencibia-Jimenez M, Asencio A, Diez Herrero D, Molina-Ribera J, Calderon E, Lozano-Gago P, Libano Beristain A, Navarro Macia C, San Jose Saras D, Gil-Hernandez E, Carrillo I. Understanding and reframing clinical errors through just c PMID 41120161

Identifiers

NCT: NCT06835517 · UGP-24-005 · PI24/00243 · PI24/00376 · PI24/00901

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗