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Recruiting NCT06587360

fertiShare Evaluation

Trial Parameters

Condition Infertility Assisted Reproductive Technology
Sponsor Cardiff University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 420
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-08
Completion 2025-09-30
Interventions
fertiShare intervention - sharing bad news eLearning coursefertiShare control - basic communication skills eLearning course

Brief Summary

Sharing bad news (SBN) is a daily challenge for fertility staff and patients. Bad news happens at all stages of fertility care and includes e.g., diagnosing infertility, reporting unexpected, repeated, or definitive treatment failure. Extensive evidence shows that SBN triggers stress in staff due to anticipation of negative emotions and evaluations or, in extreme cases, even complaints and lawsuits. Inability to manage bad news can increase negative emotions in patients and fuel distrust, potentially leading to treatment discontinuation. Efficient SBN training exists but does not address challenges of SBN in fertility care, does not meet fertility staff training and patient care preferences, and its impact on patients is unclear. fertiShare is a brief, evidence-based, e-Learning SBN course bespoke for fertility care. The aim of the study is to evaluate the feasibility of implementing fertiShare at fertility clinics and of implementing an online multi-centre RCT to determine fertiShare's efficacy. This will allow to conclude if fertiShare should proceed to efficacy evaluation. An international interdisciplinary stakeholder group (patients, consultants, embryologists, nurses, psychologists, digital educators) will inform all aspects of the proposed project.

Eligibility Criteria

Fertility Healthcare Professionals' inclusion criteria are: * working at participating clinics; and * whose role involves a minimum of 10% of week time (half a day) SBN or being a non-clinical decision-maker (e.g., clinic/line managers). Patients' inclusion criteria are • adult individuals or couples attending participating clinics to discuss or undergo (in)fertility diagnosis or treatment with participating FHPs. Exclusion criteria are: * not being able to read, speak or understand English; * not being able to provide consent. * for FHPs only, being unable to undergo the fertiShare training (e.g., visual impairments). We will not be targeting groups or individuals deemed vulnerable. Potential participants are explicitly informed in the information sheet that, if they are worried about their mental health or psychological wellbeing they may chose not to participate at all. They are also advised to inform their fertility team and contact their GP in the usual way or the NHS Mental Healt

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