Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587360
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
FertiShare Evaluation
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 fertiShares 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
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 fertiShares 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 11 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 patients39 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 95CI 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 95CI of 6
Design Pre-registered online multi-centre two-arm triple-blinded staff patients data analysts feasibility RCT with 11 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 patients39 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 95CI 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 95CI of 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None