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RECRUITING
NCT06587360
NA

fertiShare Evaluation

Sponsor: Cardiff University

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2024-10-08

Completion Date

2026-02-28

Last Updated

2025-07-29

Healthy Volunteers

Yes

Interventions

OTHER

fertiShare intervention - sharing bad news eLearning course

two-hour self-led eLearning course to support fertility staff in sharing bad news (SBN) with their patients organised in three modules. Module 1 explores definitions of bad news, why it is challenging to FHPs and patients, and the benefits of training. Module 2 offers SPIKES-based step-by-step guidance to ease SBNs. Module 3 offers guidance to cope with common challenges FHPs face: sharing bad news remotely, managing anger and uncertainty, and using good news to lessen the impact of bad news. Each module offers video content-based lessons, case studies that illustrate guidance and brief quizzes for self-reflection and assessment. Case studies show learners optimal and suboptimal approaches to SBN.

OTHER

fertiShare control - basic communication skills eLearning course

self-led eLearning course branded as fertiShare but designed to emulate the basic communication training healthcare providers receive as they undergo their professional degrees. organised in three modules. Module 1 explores definitions of bad news, why it is challenging to FHPs and patients, and the benefits of training. Module 2 introduces the communication cycle and associated communication techniques. Module 3 offers guidance regarding other basic communication skills: empathic communication, non-verbal communication, active listening and remote consultations, and communicating the likelihood of positive or negative treatment outcomes. Each module offers video content-based lessons, case studies, and brief quizzes. All teaching elements remain at the basic level (remembering and understanding instead of analysing and applying).

Locations (5)

Aberdeen Fertility Centre

Aberdeen, Aberdeen, United Kingdom

King's Fertility

London, London, United Kingdom

Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust

Manchester, Manchester, United Kingdom

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle, Newcastle upon Tyne, United Kingdom

Wales Fertility Institute

Port Talbot, Port Talbot, United Kingdom