FUSE: The U.S. Embryologist Fatigue Study

Sponsor

TMRW Life Sciences (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05326802

Collaborator

Dudley Associates Healthcare Marketing & Communications (Other)

250

Enrollment

Location

1.7

Anticipated Duration (Months)

143.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine physical and mental health issues of U.S. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Stress Burnout, Professional Musculoskeletal Pain Back Pain Neck Pain Headache Dizziness Sleep Disturbance Chest Pain Syncope Cardiovascular Diseases Shortness of Breath Gastrointestinal Diseases

Detailed Description

Embryologist fatigue surveys conducted in Spain and the United Kingdom reported that embryologists experience work-related mental health issues similar to surgeons in the United States (36.3% in Spanish and 27.8% in U.K. embryologists v. 34% in U.S. surgeons), as well as high rates of self-reported, work-related MSDs despite taking better care of themselves than the average population. Among prevalent mental issues, they highlighted fatigue, stress, and burnout as contributing factors to decreased efficiency, cynicism, and emotional exhaustion, which, together with having to handle the increasing cycle volume using conventional, manual protocols of cryomanagement, can lead to human error and IVF incidents. The known IVF incidents resulted in lost, damaged, or misplaced embryos and gametes, lawsuits, and reputational damage to patients and providers. In the absence of a "better than" cryopreservation storage solution, many programs just turned to buying more tanks and alarms and/or added expensive staff. The more effective solutions should focus on optimizing workflows by adopting innovation like automation and a digital chain of custody, organizational changes that will lead to a more productive, collaborative, and rewarding work environment, allowing embryologists to focus on patient care, scientific research, innovation, and career planning, and fewer incidents and lawsuits.

The purpose of this cross-sectional study using a web-based survey is to determine physical and mental health issues of U.S. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Occupational Physical and Mental Health Issues Experienced by U.S. Embryologists

Anticipated Study Start Date :

Apr 7, 2022

Anticipated Primary Completion Date :

Apr 15, 2022

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
U.S. Embryologists U.S. embryologists of all ages, career levels, and other sociodemographic groups will be asked questions about their physical and mental health related to their occupational characteristics using the nationally validated surveys and questionnaires, and also about their working conditions in the ART/IVF laboratories using a custom occupational questionnaire and the single-item work unit grade (A-F).

Arm

Intervention/Treatment

U.S. Embryologists

U.S. embryologists of all ages, career levels, and other sociodemographic groups will be asked questions about their physical and mental health related to their occupational characteristics using the nationally validated surveys and questionnaires, and also about their working conditions in the ART/IVF laboratories using a custom occupational questionnaire and the single-item work unit grade (A-F).

Outcome Measures

Primary Outcome Measures

The sociodemographic characteristics of U.S. embryologists [4-6 weeks]
The sociodemographic characteristics of U.S. embryologists whose routine work duties include IVF procedures and freezing and cryomanagement of embryos and gametes.
The work-related health status of U.S. embryologists [4-6 weeks]
The overall health status of U.S. embryologists and associated health issues related to their professional duties.
The work-related stress and fatigue among U.S. embryologists [4-6 weeks]
The stress and fatigue experienced by U.S. embryologists because of their reliance on manual procedures, the need for a high degree of attention to avoid errors and litigation and depending on human intervention to respond to emergencies in the laboratory.
The work-related burnout amount U.S. embryologists [4-6 weeks]
The burnout experienced by U.S. embryologists because of their stress and fatigue.
Potential strategies to reduce stress, fatigue, and burnout in U.S. Embryologists [4-6 weeks]
The potential strategies, such as organizational changes and automation of cryomanagement protocols, to alleviate physical strain and stress, and to prevent fatigue and burnout that can reduce the embryologist's attention to detail and contribute to IVF errors.

Secondary Outcome Measures

The underlying causes of work-related physical and mental health issues in U.S. Embryologists [4-6 weeks]
The underlying causes of physical strain, stress, fatigue, and burnout in U.S. embryologists related to their occupational characteristics
The correlation between negative health outcomes, manual workload, and error among U.S. embryologists [4-6 weeks]
How we can correlate these negative health outcomes and potential for human error they can cause, and link them to the overreliance of embryologists on outdated technology that adds time and stress to their workload.