Clinical trial NCT06587360: FertiShare Evaluation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility Assisted Reproductive Technology
Keywords: sharing bad news
healthcare communication
assisted reproduction
infertility
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK
name: Dept of Health Sciences, Milan University, Milan, Italy
First posted: 2024-09-19
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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\&#39; 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)
timeFrame: Within one week of enrolment in the study
Secondary outcomes:
measure: Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome)
timeFrame: Within two weeks after exposure (fertiShare, control), which happens 5 months from enrollment
measure: Limited Efficacy Testing: changes from baseline in patients trust in their Fertility Healthcare Professional (secondary outcome)
timeFrame: Within one week of enrolment in the study
measure: Limited Efficacy Testing: changes from baseline in patients decisional conflict about continuing fertility treatment (secondary outcome)
timeFrame: Within one week of enrolment in the study
measure: Limited Efficacy Testing: changes from baseline in patients satisfaction with care at the clinic (secondary outcome)
timeFrame: Within one week of enrolment in the study
Other outcomes:
measure: Implementation of intervention: Fertility Healthcare Professionals experience of technical issues preventing implementation
timeFrame: Within two weeks after exposure (fertiShare, control), which happens at 5 months from enrollment
measure: Demand of intervention: Fertility Healthcare Professionals demand for intervention
timeFrame: Within two weeks after exposure (fertiShare, control), which happens 5 months from enrollment
measure: Feasibility of intervention: Fertility Healthcare Professionals use of intervention
timeFrame: Within two weeks after exposure (fertiShare, control), which happens at 5 months from enrollment
measure: Implementation of study protocol
timeFrame: Fertility Healthcare Professionals: from enrollment until end of participation (seven months from enrollment). Patients: from enrollment until end of participation (within 2 weeks of enrollment).
measure: Practicality of study protocol - Patients
timeFrame: At enrollment, within two weeks of enrollment, and within two months of enrollment.
measure: Demand of study protocol - Patients
timeFrame: Participation assessed at enrollment, retention within 2 weeks of of enrollment.
measure: Demand of study protocol - Patients
timeFrame: Within 2 weeks of enrollment
measure: Acceptability of study protocol - Patients
timeFrame: Within two weeks of enrollment
measure: Demand of study protocol - Fertility Healthcare Professionals
timeFrame: At baseline (within 2 weeks pre-exposure) and follow-up (within 2 weeks after exposure, which happens 5 months from enrollment)
measure: Practicality of study protocol - Fertility Healthcare Professionals
timeFrame: Enrollment, baseline (within two weeks of exposure), follow-up (within two weeks after exposure, which happens 5 months from enrollment), and within 7 months from enrollment.
measure: Demand of study protocol - Fertility Healthcare Professionals
timeFrame: Participation assessed at enrollment, retention at baseline (within 2 weeks pre-exposure) and follow-up (within 2 weeks after exposure, which happens 5 months from enrollment).
measure: Acceptability of study protocol - Fertility Healthcare Professionals
timeFrame: At baseline (within two weeks pre-exposure) and follow-up (within two weeks after exposure, which happens 5 months from enrollment).
measure: Acceptability of intervention: Fertility Healthcare Professionals experience of doing intervention
timeFrame: Within two weeks after exposure (fertiShare, control), which happens at 5 months from enrollment
measure: Acceptability of intervention: patients evaluation of how bad news was shared with them
timeFrame: Within one week of enrolment in the study
measure: Acceptability of intervention: Fertility Healthcare Professionals evaluation of intervention
timeFrame: Within two weeks after exposure (fertiShare, control), which happens at 5 months from enrollment
Locations:
city: Newcastle
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
state: Newcastle upon Tyne
city: Aberdeen
country: United Kingdom
facility: Aberdeen Fertility Centre
city: London
country: United Kingdom
facility: King's Fertility
city: Manchester
country: United Kingdom
facility: Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust
city: Port Talbot
country: United Kingdom
facility: Wales Fertility Institute
Study officials:
affiliation: Cardiff University
name: Sofia Gameiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Helen Falconer
role: STUDY_CHAIR
References:
citation: 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.
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citation: 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.
citation: 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.