DECIDE Just Culture: Conceptualization of Clinical Error

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

Status: Active, not recruiting

Conditions: Error Disclosure

Treatments: Behavioral: Theory of Dissonance; Behavioral: Theory of Reasoned Action

Study type: Interventional

Funder types: Other

Identifiers

NCT06835517

UGP-24-005

PI24/00376 (Other Grant/Funding Number)

PI24/00243 (Other Grant/Funding Number)

PI24/00901 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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).

Enrollment: 1,255 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,255 participants in 3 patient groups

Control group

No Intervention group

Description:

Subjects in the control group will participate in a lecture (40 minutes and 15 minutes of discussion) on patient safety, causes of clinical errors and measures to reduce them in healthcare centers.

Theory of Dissonance

Experimental group

Description:

This theory describes psychological discomfort when people have thoughts or beliefs that conflict with each other, or when their actions are not aligned with their beliefs or values. In these cases, the intervention seeks this discrepancy by presenting dissonant information, which leads to an adjustment of one's beliefs and attitudes, and thus of one's behaviours.

Treatment:

Behavioral: Theory of Dissonance

Theory of Reasoned Action

Experimental group

Description:

This theory provides a conceptual framework for understanding how social norms influence the formation of intentions, and how these intentions predict behaviour. It is especially useful for changing behaviour by modifying the beliefs and norms that underlie attitudes based on the social influence exerted by peers.

Treatment:

Behavioral: Theory of Reasoned Action