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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

⁃ • adult individuals or couples attending participating clinics to discuss or undergo (in)fertility diagnosis or treatment with participating FHPs.

Locations
Other Locations
United Kingdom
Aberdeen Fertility Centre
NOT_YET_RECRUITING
Aberdeen
King's Fertility
RECRUITING
London
Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust
RECRUITING
Manchester
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
RECRUITING
Newcastle
Wales Fertility Institute
NOT_YET_RECRUITING
Port Talbot
Contact Information
Primary
Sofia Gameiro, PhD
gameiros@cardiff.ac.uk
+44 (0)29 2087 5376
Backup
Jacky Boivin, PhD
boivin@cardiff.ac.uk
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 420
Treatments
Experimental: fertiShare intervention
sharing bad news eLearning course
Active_comparator: fertiShare control
basic communication training skills eLearning course
Related Therapeutic Areas
Sponsors
Leads: Cardiff University
Collaborators: Dept of Health Sciences, Milan University, Milan, Italy, Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK

This content was sourced from clinicaltrials.gov