Design of Tools to Transform the Conceptualization of Clinical Error Within and Outside Healthcare Centers, Social-health Centers, Hospitals and Healthcare Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,255
- 试验地点
- 2
- 主要终点
- Percentage of attitudes classified as honest mistakes, risky behaviour and reckless behaviour identified in the different video scenarios during the group sessions
研究概览
简要总结
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:
- 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.
- 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.
- 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.
- 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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Experience in patient safety groups/committees. Ongoing or serious adverse event claims or litigation with institutions.
- •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.
- •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
- •Who have participated in phase
- •Inclusion criteria: Male/female balance, minimum 10 years of experience. Recruitment, among members of SEDISA, SEMERGEN, SEMFyC, FAECAP and other scientific societies.
结局指标
主要结局
Percentage of attitudes classified as honest mistakes, risky behaviour and reckless behaviour identified in the different video scenarios during the group sessions
时间窗: 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.
Number and intensity of the barriers detected that hinder the implementation of Just Culture in the organizations
时间窗: 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.
Cost-effectiveness of psychoeducational interventions A and B
时间窗: 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.
Existence of a guide of recommendations for implementing Just Culture that complies with AGREE II criteria
时间窗: 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.
次要结局
- Behavioral Intention(18 months)
- Cognitive Dissonance(18 months)
- Effects of the Intervention(18 months)
研究者
José Joaquín Mira Solves
Dr.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana