About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

fertiShare intervention - sharing bad news eLearning course
Other intervention
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. Each module offers video content-based lessons, case studies that illustrate guidance and brief quizzes for self-reflection and assessment. Case studies show learners optimal and suboptimal approaches to SBN.
fertiShare control - basic communication skills eLearning course
Other intervention
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, non-verbal communication, active listening and remote consultations, and communicating the likelihood of positive or negative treatment outcomes. Each module offers video content-based lessons, case studies, and brief quizzes. All teaching elements remain at the basic level (remembering and understanding instead of analysing and applying).

Treatment groups

420 Participants

are divided into 2 treatment groups

Group A: fertiShare interventionExperimental treatment 1 intervention

Group B: fertiShare controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Limited Efficacy Testing: changes from baseline in patients perceived FHPs' sharing bad news performance (primary outcome)

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.

Time frame

Within one week of enrolment in the study

Secondary outcomes

1

Limited Efficacy Testing: changes from baseline in staff confidence in sharing bad news (secondary outcome)

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 outcome) from pre to post training with 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 (or 6 - does not apply). A global average score is calculated that ranges from 1 to 5, with higher values indicating higher confidence in sharing bad news.

Time frame

From two weeks after enrolment to two weeks after training (fertiShare, control), which happens 5 months from enrolment

2

Limited Efficacy Testing: mean difference in patient trust in their Fertility Healthcare Professional (FHP) between the baseline and follow-up patient cohorts (secondary outcome)

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 FHP (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.

Time frame

Within one week of enrolment in the study

3

Limited Efficacy Testing: mean difference in patients' satisfaction with care at the clinic (secondary outcome) between the baseline and follow-up patient cohorts

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.

Time frame

Within one week of enrolment in the study

4

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)

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 shared decision-making support 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) and 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.

Time frame

Within one week of enrolment in the study

Other outcomes

1

Demand of intervention: Fertility Healthcare Professionals demand for intervention

Number of Fertility Healthcare Professionals who registered with the eLearning and completed each lesson. module, and quiz

Time frame

Within two weeks after exposure (fertiShare, control training), which happens 5 months from enrolment

2

Demand for intervention: Profile of Fertility Healthcare Processionals who registered and completed the intervention

Demographic and professional profile of FHPs who registered and completed the intervention (fertiShare, control training)

Time frame

Within two weeks after exposure (fertiShare, control training), which happens 5 months from enrolment

3

Acceptability of intervention: Fertility Healthcare Professionals experience of doing intervention

Quantitative ratings regarding 5 items describing the experience of doing the eLearning (e.g., I benefited, I learned). FHPs answer on a Likert-type scale ranging from 1 (not at all) to 5 (an extreme amount), presented in the eLearning evaluation form. Higher scores indicate higher acceptability of intervention.

Time frame

Within two weeks after exposure (fertiShare, control training), which happens at 5 months from enrolment

4

Acceptability of intervention: Proportion of Fertility Healthcare Professionals recommending the intervention to colleagues

Proportion of staff reporting they recommend fertiShare to other colleagues in their situation, fertiShare improved their preparation to have difficult conversations with their patients, and fertiShare reduced their anxiety when having difficult conversations with their patients: post-exposure (fertiShare, control training) staff assessment

Time frame

Within two weeks after exposure (fertiShare, control training), which happens at 5 months from enrolment

fertiShare Evaluation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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