Evaluation of an e-Learning Course for Sharing Bad News in Fertility Care
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
This study is testing a new online course to help fertility staff communicate bad news to patients better, to see if it can be used in clinics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiff University Academic / other |
| Locations | 5 sites (Aberdeen, Aberdeen and 4 other locations) |
| Trial ID | NCT06587360 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of implementing an e-Learning course called fertiShare, designed to improve the communication of bad news by fertility staff to patients. It involves a pre-registered, online, multi-centre, two-arm, triple-blinded feasibility randomized controlled trial (RCT) comparing the fertiShare intervention with a minimal control group. The aim is to assess the practicality of the course in fertility clinics and to prepare for a larger efficacy evaluation. The study will include a process evaluation to ensure findings are applicable to real-world fertility care settings.
Who should consider this trial
Good fit: Ideal candidates include adult individuals or couples attending fertility clinics for diagnosis or treatment.
Not a fit: Patients who are unable to read, speak, or understand English may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance communication skills among fertility staff, leading to improved patient experiences and outcomes.
How similar studies have performed: While there is existing evidence on the importance of effective communication in healthcare, this specific approach using an e-Learning platform for fertility care is novel.
Eligibility criteria
Show full inclusion / exclusion 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 Health support service, www.nhs.yj/mental-health.
Where this trial is running
Aberdeen, Aberdeen and 4 other locations
- Aberdeen Fertility Centre — Aberdeen, Aberdeen, United Kingdom (Not_yet_recruiting)
- King's Fertility — London, London, United Kingdom (Recruiting)
- Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust — Manchester, Manchester, United Kingdom (Recruiting)
- The Newcastle Upon Tyne Hospitals Nhs Foundation Trust — Newcastle, Newcastle upon Tyne, United Kingdom (Recruiting)
- Wales Fertility Institute — Port Talbot, Port Talbot, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Sofia Gameiro, PhD — Cardiff University
- Study coordinator: Sofia Gameiro, PhD
- Email: gameiros@cardiff.ac.uk
- Phone: +44 (0)29 2087 5376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.