fertiShare Evaluation

Официальное название

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

Обзор

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.

Подробное описание

The aim of the feasibility study is to make a fully informed decision about whether fertiShare should proceed to efficacy evaluation. This aim will be achieved by resolving uncertainties about implementing fertiShare at fertility clinics and about running an online multi-centre efficacy RCT for fertiShare.

Design: Pre-registered, online, multi-centre, two-arm, triple-blinded (staff, patients, data analysts), feasibility RCT with 1:1 computer-generated randomized allocation to the intervention (fertiShare) or minimal SBN information control (20 mins SBN lecture emulating what most staff would receive as part of general training) groups.

The trial will include a process evaluation and adopt a pragmatic attitude to maximise the applicability of findings to fertility care practice (beyond the immediate trial setting). Examples of design choices that translate this pragmatic attitude are our choice of the control condition (emulating general SBN training that most staff will have), the inclusion of multiple staff and patient secondary trial outcomes (informed by stakeholders) and low standardisation of intervention delivery (staff will apply fertiShare as they think best). Criteria for progression to efficacy evaluation will be specified prior to implementation using a traffic-light system.

Setting: Six UK-based private and public fertility clinics.

Participants: Staff working at clinics whose role involves 10% of week time SBN. Exclusion criteria are being unable to undergo training.

Patient inclusion criteria are having received bad news from participating staff within last month. No exclusion criteria are applied.

Bad news is defined as any news meaning that patients\' first or second complete (fresh and frozen embryo transfers) initiated In Vitro Fertilization cycle did not result in a clinical pregnancy, as this is the most common challenging bad news shared by staff, and to ensure that patient outcome data (specifically continuation data) are comparable.

Guidance for feasibility studies to estimate participation rates, based on review of evidence from RCTs conducted within SBN training and fertility care, indicates 75% of staff will be eligible and participate, but a conservative estimate of 50% will be considered to decrease unknown risk. Recruiting 60 staff (10 per clinic) will allow to calculate a 50% participation rate to 95%CI of ±11%. 52% of patients will be eligible and participate. Recruiting 180 patients per cohort (30 per clinic) will allow to calculate a 60% participation rate to 95%CI of ±6%.

Вмешательства

• Другое 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.
• Другое 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

Первичные конечные точки

• Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome) [Срок оценки: Within one week of enrolment in the study]

Вторичные конечные точки (5)

• Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome) [Срок оценки: From two weeks after enrolment to two weeks after training (fertiShare, control), which happens 5 months from enrolment]
• Limited Efficacy Testing: mean difference in patient trust in their Fertility Healthcare Professional (FHP) between the baseline and follow-up patient cohorts (secondary outcome) [Срок оценки: Within one week of enrolment in the study]
• Limited Efficacy Testing: mean difference in patients' satisfaction with care at the clinic (secondary outcome) between the baseline and follow-up patient cohorts [Срок оценки: Within one week of enrolment in the study]
• Limited Efficacy Testing: mean difference in patients' satisfaction with shared decision-making support regarding continuing or stopping fertility treatment (secondary outcome) between the baseline and follow-up patient cohorts (secondary outcome) [Срок оценки: Within one week of enrolment in the study]
• Limited Efficacy Testing: mean difference in patients' uptake of and time to another stimulated In Vitro Fertilisation Cycle between the baseline and follow-up patients cohorts (secondary outcome) [Срок оценки: 6 months and 2 weeks after enrolment]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 5 центров

• Aberdeen Fertility Centre — Aberdeen
• King's Fertility — London
• Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust — Manchester
• The Newcastle Upon Tyne Hospitals Nhs Foundation Trust — Newcastle
• Wales Fertility Institute — Port Talbot

Публикации

• Gameiro S, Adcock E, Graterol Munoz C, O'Hanrahan M, D'Angelo A, Boivin J. What is bad news in fertility care? A qualitative analysis of staff and patients' accounts of bad and challenging news in fertility care. Hum Reprod. 2024 Jan 5;39(1):139-146. doi: 10.1093/humrep/dead231. PMID 37968233
• Yilmaz Y, Sarikaya O, Senol Y, Baykan Z, Karaca O, Demiral Yilmaz N, Altintas L, Onan A, Sayek I. RE-AIMing COVID-19 online learning for medical students: a massive open online course evaluation. BMC Med Educ. 2021 May 27;21(1):303. doi: 10.1186/s12909-021-02751-3. PMID 34039344
• Miller SJ, Hope T, Talbot DC. The development of a structured rating schedule (the BAS) to assess skills in breaking bad news. Br J Cancer. 1999 May;80(5-6):792-800. doi: 10.1038/sj.bjc.6690423. PMID 10360657
• Hall MA, Zheng B, Dugan E, Camacho F, Kidd KE, Mishra A, Balkrishnan R. Measuring patients' trust in their primary care providers. Med Care Res Rev. 2002 Sep;59(3):293-318. doi: 10.1177/1077558702059003004. PMID 12205830
• Axboe MK, Christensen KS, Kofoed PE, Ammentorp J. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals. BMC Med Educ. 2016 Oct 18;16(1):272. doi: 10.1186/s12909-016-0798-7. PMID 27756291
• Gameiro S, Leone D, D'Angelo A, Veleva Z, Morey R, Boivin J. Multicentre pragmatic randomised controlled feasibility trial of fertiShare, a brief eLearning course to increase fertility staff performance when sharing bad news with their patients - a protocol. BMJ Open. 2025 Aug 25;15(8):e101269. doi: 10.1136/bmjopen-2025-101269. PMID 40854842

Идентификаторы

NCT: NCT06587360 · SPON1955-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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