Protocol for a Realist Evaluation and Feasibility RCT of fertiShare
Research type
Research Study
Full title
Protocol for a Realist Evaluation and Feasibility RCT: Understanding and developing a SPIKES-based eLearning training course called fertiShare to support sharing bad news encounters between fertility healthcare professionals (FHPs) and patients.
IRAS ID
332326
Contact name
Sofia Gameiro
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Sharing bad news (SBN) is a daily challenge for fertility healthcare providers (FHPs) 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 FHPs 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 FHPs training and patient care preferences, and its impact on patients is unclear.
The aim of this project is to support best practice in SBN at fertility clinics via evaluating a brief, evidence-based e-Learning SBN course bespoke for fertility care: the FertiShare.
fertiShare (v.1) was funded by the Council of Wales and is based on SPIKES, an evidence-based framework to guide delivery of bad news. It was co-produced with fertility staff and patients via a series of workshops to develop its specification (content, features, activities) and inform its technical development.
This project aims to evaluate and refine fertiShare and is organised in two phases:
Phase 1 is a realistic evaluation of fertiShare (v.1), to understand how it is used in practice. Specifically, for whom does fertiShare work, under what circumstances, in what respects, how, and why. Findings will inform refinements to fertiShare, to produce a v.2 of the eLearning.
Phase 2 is a feasibility evaluation of fertiShare (v.2), to determine if it is feasible to implement it at fertility clinics and if it is feasible to implement a multicentre randomised controlled trial (RCT) to determine its efficacy.
We will work with our multidisciplinary stakeholder group to inform all aspects of the project.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0864
Date of REC Opinion
25 Oct 2023
REC opinion
Further Information Favourable Opinion