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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cardiff University
- Enrollment
- 420
- Locations
- 5
- Primary Endpoint
- Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Fertility Healthcare Provides (FHPs) will be randomised on a 1:1 ratio via computer-generated randomisation to have access to the fertiShare eLearning or a control condition eLearning (basic communication training), via a URL. Only the creative company responsible for the technical development of fertiShare know which URL (URL a or b) provide access to fertiShare and the control eLearnings. No trial participant (FHPs, patients), clinic managers and/or gatekeepers will be informed of the randomisation result. The trial management team (SG, JB) will know if participants were allocated to URL a or b. The data analyst will not know any randomisation result.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
- •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.
Arms & Interventions
fertiShare intervention
sharing bad news eLearning course
Intervention: fertiShare intervention - sharing bad news eLearning course (Other)
fertiShare control
basic communication training skills eLearning course
Intervention: fertiShare control - basic communication skills eLearning course (Other)
Outcomes
Primary Outcomes
Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)
Time Frame: 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 reported FHPs' sharing bad news performance (primary outcome) between patients in the baseline (pre FHPs training) and follow-up (post FHPs training) cohort. Patient reported FHPs' sharing bad news performance will be assessed with an adapted version of the Sharing Bad News Behavioural 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 (or 6 - does not apply). A global average score is calculated that ranges from 1 to 5, with higher values indicating better sharing bad news performance.
Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)
Time Frame: 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 reported FHPs' sharing bad news performance (primary outcome) between patients in the baseline (pre FHPs training) and follow-up (post FHPs training) cohort. Patient reported FHPs' sharing bad news performance will be assessed with an adapted version of the Sharing Bad News Behavioural 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 (or 6 - does not apply). A global average score is calculated that ranges from 1 to 5, with higher values indicating better sharing bad news performance.
Secondary Outcomes
- Limited Efficacy Testing: mean difference in patient trust in their Fertility Healthcare Professional (FHP) between the baseline and follow-up patient cohorts (secondary outcome)(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)(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)(6 months and 2 weeks after enrolment)
- Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome)(From two weeks after enrolment to two weeks after training (fertiShare, control), which happens 5 months from enrolment)
- Limited Efficacy Testing: mean difference in patients' satisfaction with care at the clinic (secondary outcome) between the baseline and follow-up patient cohorts(Within one week of enrolment in the study)
Investigators
Sofia Gameiro
Principal Investigator
Cardiff University