Gameiro Sofia, Leone Daniela, D'Angelo Arianna, Veleva Zdravka, Morey Richard, Boivin Jacky
School of Psychology, Women's Health Research Wales, Cardiff University, Cardiff, UK
Unit of Clinical Psychology, San Paolo University Hospital, Milan, Italy.
BMJ Open. 2025 Aug 25;15(8):e101269. doi: 10.1136/bmjopen-2025-101269.
Sharing bad news (SBN) is a recurring and stressful challenge for fertility staff and patients. Suboptimal SBN is associated with staff burnout, patient dissatisfaction with care and lack of trust in staff, potentially leading to patient discontinuation. Patients value staff having SBN skills, but staff feel unprepared to do this task. fertiShare is a 2-hour bespoke eLearning course to support fertility staff in SBN with their patients, organised into three modules, with each module offering video content-based lessons, simulated case studies showing optimal and suboptimal approaches to SBN and brief quizzes for self-reflection and assessment. This protocol aims to evaluate if it is feasible to implement fertiShare at UK-based fertility clinics and if it is acceptable to staff and patients.
Multicentre, two-arm, parallel-group, blinded, feasibility randomised controlled trial with 1:1 randomised staff allocation to fertiShare (intervention group) or general communication skills eLearning (control group). Six UK-based clinics, 60 staff spending a minimum of 10% week-time SBN and 360 patients having received bad news from participating staff within the last month will be recruited. Two cohorts of patients will be recruited, one after staff consent to the study and before fertiShare or control eLearning course (pretraining patient cohort) and another 1-month post staff training (post-training patient cohort). Outcome measures relate to demand, acceptability, implementation, practicality and limited efficacy testing, with the primary outcome being staff performance when SBN, reported by patients using an adapted version of the SBN Behavioural Assessment Scale. Recruitment and data collection will span from September 2025 to February 2026.
The study was approved by the National Health Service Research Ethics Committee (23/LO/0864) and the Cardiff University - School of Psychology Research Ethics Committee (EC.23.08.08.6827). Results will be disseminated via publications in peer-reviewed journals, conference presentations and public engagement, and will inform if fertiShare should proceed to efficacy evaluation. Insights from this study can inform the implementation of other SBN training in fertility or other healthcare domains and improve understanding of the impact SBN training has on patient experience and outcomes.
NCT06587360, https://www.
gov/.
对生殖医学工作人员和患者来说，传递坏消息（SBN）是一项反复出现且压力重重的挑战。传递坏消息的效果欠佳会导致工作人员倦怠、患者对护理不满意以及对工作人员缺乏信任，这可能会导致患者中断治疗。患者重视工作人员具备传递坏消息的技能，但工作人员觉得没有准备好承担这项任务。fertiShare是一个为时两小时的定制电子学习课程，旨在支持生殖医学工作人员与患者进行传递坏消息的沟通，该课程分为三个模块，每个模块都提供基于视频内容的课程、展示传递坏消息的最佳和欠佳方法的模拟案例研究以及用于自我反思和评估的简短测验。本方案旨在评估在英国的生殖医学诊所实施fertiShare是否可行，以及工作人员和患者是否能够接受。
多中心、双臂、平行组、盲法可行性随机对照试验，工作人员按1:1随机分配至fertiShare（干预组）或一般沟通技能电子学习课程（对照组）。将招募英国的六家诊所、60名每周至少花费10%时间进行传递坏消息沟通的工作人员以及360名在过去一个月内从参与研究的工作人员那里收到坏消息的患者。将招募两组患者，一组在工作人员同意参与研究后、fertiShare或对照电子学习课程之前（培训前患者队列），另一组在工作人员培训后1个月（培训后患者队列）。结果指标涉及需求、可接受性、实施情况、实用性和有限的疗效测试，主要结果是患者使用传递坏消息行为评估量表的改编版报告的工作人员在传递坏消息时的表现。招募和数据收集将从2025年9月持续到2026年2月。
该研究已获得英国国家医疗服务体系研究伦理委员会（23/LO/0864）和卡迪夫大学 - 心理学院研究伦理委员会（EC.23.08.08.6827）的批准。研究结果将通过在同行评审期刊上发表、会议报告和公众参与等方式进行传播，并将为是否应推进fertiShare的疗效评估提供依据。本研究的见解可为生殖医学或其他医疗领域实施其他传递坏消息培训提供参考，并增进对传递坏消息培训对患者体验和结果影响的理解。
NCT06587360，https://www.CLINICALTRIALS.gov/
