Centro de Salud Hospital Plá
Alicante, 03013, Spain
Location status: Recruiting
Location contact
José J Mira
CONTACT
NCT Number: NCT06835517
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Alicante, 03013, Spain
Location status: Recruiting
José J Mira
CONTACT
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Phase 1
Phase 2
Phase 3
Phase 4
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.
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).
Time frame: 8 months
The Focus Group technique (face-to-face) will be used to describe the participants' vision of human fallibility. The following will be considered: consistency between contributions (triangulation within and between groups), spontaneity (number of different original contributions); intensity, weighting assigned to each of the ideas (on a scale of 1 to 5 points); and relevance (considering the agreement they arouse by means of the coefficient of variation). Discussions will be held until the information is saturated. In addition, the data collected from the different groups will be triangulated to present joint results.
Time frame: 11 months
The Just Culture Assessment Tool (Petschonek et al. J Patient Saf. 2013;9:190-7) and Safety Culture Stack approach (Kirwan et al. Safety and Reliability 2018;38(3):200-217) will be used after cross-cultural adaptation. ANOVA will be used to analyze the relationships between care levels and professional profiles. The t-test statistic will be used to determine differences between men and women. Multiple linear regression will be used taking as dependent variable: scale score and as factors: years of experience, sex, professional profile, autonomous community.
Time frame: 18 months
Cost-effectiveness will be assessed using a cost-effectiveness analysis, comparing the direct and indirect costs of each intervention with their impact on attitudes, behavioral intention, and cognitive dissonance.
Time frame: 8 months
The Consensus Conference technique will be used to obtain a guide that complies with the AGREE II (Appraisal of Guidelines for Research and Evaluation) principles and that includes recommendations for implementing Just Culture in the different healthcare institutions, adapted to the context.
Time frame: 18 months
Measured with an instrument based on the Error-Oriented Motivation Scale and the Safety Attitudes Questionnaire. The best performing items will be selected and their cross-cultural validity and metric properties (according to COSMIN guidelines) will be guaranteed. Assessments at three points in time: before the intervention, at the end of the intervention period and 6 months after.
Time frame: 18 months
Measured through linguistic indicators of cognitive conflict. Assessments at three points in time: before the intervention, at the end of the intervention period and 6 months later.
Time frame: 18 months
Independently analysed by group using a linear mixed effects model (LMM) for repeated measures. Consideration of data matching and stratification by gender, age, participant profile and intervention arm.
Contact information is provided by the study sponsor or research team.
Irene Carrillo Murcia
CONTACT
Jose J Mira
CONTACT
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Other
Design of Tools to Transform the Conceptualization of Clinical Error Within and Outside Healthcare Centers, Social-health Centers, Hospitals and Healthcare Management
Acronym: DECIDE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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