Protocol for a Realist Evaluation and Feasibility RCT: Developing and Evaluating the fertiShare eLearning Training Course Supporting Sharing Bad News Between Fertility Healthcare Professionals and Patients

What this Trial Is About

Researchers are evaluating fertiShare, a brief, evidence-based eLearning course designed to support fertility healthcare professionals in sharing bad news with their patients. The study aims to assess the feasibility of implementing fertiShare at fertility clinics and conducting a larger online randomized controlled trial to determine its effectiveness. This research addresses the challenges that fertility staff face when delivering difficult news, which can cause stress and impact patient trust and treatment continuation. The study is a pre-registered, online, multi-center, two-arm, triple-blinded feasibility randomized controlled trial. Participants are randomly assigned to either the fertiShare intervention group, which completes a two-hour self-led eLearning course organized into three modules focusing on sharing bad news and coping strategies, or to a control group receiving a basic communication skills eLearning course. The trial includes six UK-based fertility clinics and involves both fertility healthcare professionals and patients. Participants will be assessed through questionnaires measuring changes in patients' perceptions of how staff share bad news, staff confidence, patient trust, satisfaction with care and decision-making, and treatment continuation. Data will be collected at baseline and follow-up timepoints, with some outcomes measured within one week of enrollment and others up to six months later. The study includes process evaluations and safety monitoring, with the total participation period varying by participant.

fertiShare Evaluation