fertiShare Evaluation

NCT06587360 | Recruiting

• 1 other identifier: SPON1955-23
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 5

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.

Conditions

Infertility Assisted Reproductive Technology

Keywords

sharing bad news; healthcare communication; assisted reproduction; infertility

Outcome Measures

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.

  Within one week of enrolment in the study

Secondary Outcomes (5)

• 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 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 care at the clinic (secondary outcome) between the baseline and follow-up patient cohorts

  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

Other Outcomes (17)

• Demand of intervention: Fertility Healthcare Professionals demand for intervention

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

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

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

• Acceptability of intervention: Fertility Healthcare Professionals experience of doing intervention

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

Study Arms (2)

fertiShare intervention

EXPERIMENTAL

sharing bad news eLearning course

Other: fertiShare intervention - sharing bad news eLearning course

fertiShare control

ACTIVE COMPARATOR

basic communication training skills eLearning course

Other: fertiShare control - basic communication skills eLearning course

Interventions

fertiShare intervention - sharing bad news eLearning course OTHER

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 intervention

fertiShare control - basic communication skills eLearning course OTHER

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).

fertiShare control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• adult individuals or couples attending participating clinics to discuss or undergo (in)fertility diagnosis or treatment with participating FHPs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff University: lead
• Wales Fertility Institute, Swansea Bay University Healthboard, Wales, UK: collaborator
• Dept of Health Sciences, Milan University, Milan, Italy: collaborator

Study Sites (5)

Aberdeen Fertility Centre

Aberdeen, Aberdeen, AB25 2ZL, United Kingdom

NOT YET RECRUITING

King's Fertility

London, London, SE5 8BB, United Kingdom

RECRUITING

Saint Mary's Hospital Manchester, Manchester University NHS Foundation Trust

Manchester, Manchester, M13 9WU, United Kingdom

RECRUITING

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle, Newcastle upon Tyne, NE3 3HD, United Kingdom

RECRUITING

Wales Fertility Institute

Port Talbot, Port Talbot, SA12 7BR, United Kingdom

NOT YET RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Sofia Gameiro, PhD

  Cardiff University

  PRINCIPAL INVESTIGATOR

• Helen Falconer

  Cardiff University

  STUDY CHAIR

Central Study Contacts

Sofia Gameiro, PhD

CONTACT

+44 (0)29 2087 5376; gameiros@cardiff.ac.uk

Jacky Boivin, PhD

CONTACT

boivin@cardiff.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion: September 30, 2025
• Study Completion: February 28, 2026
• Last Updated: July 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start date: 01.01.2026, no end date.

Locations

GB (5)