FertiShare Evaluation
- Conditions
- Infertility Assisted Reproductive Technology
- Interventions
- Other: fertiShare intervention - sharing bad news eLearning courseOther: fertiShare control - basic communication skills eLearning course
- Registration Number
- NCT06587360
- Lead Sponsor
- Cardiff University
- 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\' 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%.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fertiShare intervention fertiShare intervention - sharing bad news eLearning course sharing bad news eLearning course fertiShare control fertiShare control - basic communication skills eLearning course basic communication training skills eLearning course
- Primary Outcome Measures
Name Time Method Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome) Within one week of enrolment in the study Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient perceived FHPs' sharing bad news performance (primary outcome) between patients in the baseline and follow-up cohort. Patient perceived FHPs' sharing bad news performance will be assessed with an adapted version of the Breaking Bad News Assessment Scale. The scale is composed of 23 items that list evidence-based best practice behaviours on how to share bad news (e.g., warn you they would be sharing bad news). Patients are asked to rate the degree to which the FHP did each behaviour on a Likert scale from 1- not at all to 5 - completely. A global average score is calculated that ranges from 1 to 5, with higher values indicating better sharing bad news performance.
- Secondary Outcome Measures
Name Time Method Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome) Within two weeks after exposure (fertiShare, control), which happens 5 months from enrollment Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of changes in confidence in SBN (secondary outcomes) from pre to post exposure to fertiShare or control eLearning. Confidence in sharing bad news will be assessed with an adapted version of the Breaking Bad News Assessment Scale. The scale is composed of 23 items that list evidence-based best practice behaviours on how to share bad news (e.g., warn patients you will be sharing bad news). FHPs are asked to rate how confident they feel doing each behaviour listed on a Likert scale from 1- not at all to 5 - completely. A global average score is calculated that ranges from 1 to 5, with higher values indicating higher confidence in sharing bad news.
Limited Efficacy Testing: changes from baseline in patients trust in their Fertility Healthcare Professional (secondary outcome) Within one week of enrolment in the study Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient trust in their Fertility Healthcare Professional (secondary outcome) between patients in the baseline and follow-up cohort. Trust will be assessed with the Wake Forest Physician Trust Scale. The scale is composed of ten statements describing care provided (e.g., They will do whatever it takes to get you all the care you need.). Patients are asked to rate their level of agreement with each statement on a Likert scale from 1- strongly disagree to 5-strongly agree. Trust is measured by the sum of the 10 item scores (reverse-scored for negative items), ranging from 10 to 50, with a higher score indicating more trust.
Limited Efficacy Testing: changes from baseline in patients decisional conflict about continuing fertility treatment (secondary outcome) Within one week of enrolment in the study Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient decisional conflict about continuing fertility treatment (secondary outcome) between patients in the baseline and follow-up cohort. Assessed with the Decisional Conflict Scale. Patients are asked to select which treatment option they prefer (doing another treatment cycle at clinic, doing another treatment cycle at a different clinic, stopping fertility treatment, other). After, patients are asked to rate the degree to which they agree with a list of 16 statements related to their decision (e.g., I know which options are available to me) on a Likert scale from 0-strongly agree to 4-strongly disagree. Total decisional conflict and sub-dimension scores (uncertainty, informed, values clarity, support) are calculated and linearly transformed to range from 0 to 100, with higher scores indicating more of the construct.
Limited Efficacy Testing: changes from baseline in patients satisfaction with care at the clinic (secondary outcome) Within one week of enrolment in the study Modified intention-to-treat (mITT, all FHPs randomized) and per protocol (PP, only FHPs who completed a sufficient dose) analyses of mean differences in patient satisfaction with care at the clinic (secondary outcome) between patients in the baseline and follow-up cohort. Assessed with five questions used by the Human Fertility and Embryology Authority for patients to rate their satisfaction with care provided at UK based fertility clinics (e.g., To what extent did you feel you were treated with privacy and dignity?). Patients answer on a Likert scale from 1-never to 5-always (answer scale anchors vary with question), with higher values indicating higher satisfaction with care.
Trial Locations
- Locations (5)
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
🇬🇧Newcastle, Newcastle upon Tyne, United Kingdom
Aberdeen Fertility Centre
🇬🇧Aberdeen, United Kingdom
King's Fertility
🇬🇧London, United Kingdom
Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Wales Fertility Institute
🇬🇧Port Talbot, United Kingdom