The U.S. Embryologist Fatigue Study

Cardiovascular Diseases Clinical Trial

— FUSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326802
• Other study ID #: Pro00062375
• Status: Completed
• Start date: April 7, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2023
• Source: TMRW Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: May 30, 2022
• Est. primary completion date: April 25, 2022
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• complete surveys from embryologists;

Exclusion Criteria:

• incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.

Related Conditions & MeSH terms

• Back Pain
• Burnout, Professional
• Burnout, Psychological
• Cardiovascular Diseases
• Chest Pain
• Digestive System Diseases
• Dizziness
• Dyspnea
• Fatigue
• Gastrointestinal Diseases
• Headache
• Musculoskeletal Pain
• Neck Pain
• Shortness of Breath
• Sleep Disturbance
• Stress
• Syncope

Locations

Country	Name	City	State
United States	TMRW Life Sciences	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
TMRW Life Sciences	Dudley Associates Healthcare Marketing & Communications

Country where clinical trial is conducted

United States, 

References & Publications (14)

Caruso CC, Baldwin CM, Berger A, Chasens ER, Edmonson JC, Gobel BH, Landis CA, Patrician PA, Redeker NS, Scott LD, Todero C, Trinkoff A, Tucker S. Policy brief: Nurse fatigue, sleep, and health, and ensuring patient and public safety. Nurs Outlook. 2019 Sep-Oct;67(5):615-619. doi: 10.1016/j.outlook.2019.08.004. No abstract available. — View Citation

Dyrbye et al. 2018. A Pragmatic Approach for Organizations to Measure Health Care Professional Well-Being. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/201810b

Dyrbye LN, Shanafelt TD, Johnson PO, Johnson LA, Satele D, West CP. A cross-sectional study exploring the relationship between burnout, absenteeism, and job performance among American nurses. BMC Nurs. 2019 Nov 21;18:57. doi: 10.1186/s12912-019-0382-7. eCollection 2019. — View Citation

Frone MR, Tidwell MO. The meaning and measurement of work fatigue: Development and evaluation of the Three-Dimensional Work Fatigue Inventory (3D-WFI). J Occup Health Psychol. 2015 Jul;20(3):273-288. doi: 10.1037/a0038700. Epub 2015 Jan 19. — View Citation

Letterie G, Fox D. Lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period. F S Rep. 2020 Jul 9;1(2):78-82. doi: 10.1016/j.xfre.2020.06.007. eCollection 2020 Sep. — View Citation

Lopez-Leria B, Jimena P, Clavero A, Gonzalvo MC, Carrillo S, Serrano M, Lopez-Regalado ML, Olvera C, Martinez L, Castilla JA. Embryologists' health: a nationwide online questionnaire. J Assist Reprod Genet. 2014 Dec;31(12):1587-97. doi: 10.1007/s10815-014-0352-7. Epub 2014 Oct 5. — View Citation

Moutos CP, Lahham R, Phelps JY. Cryostorage failures: a medicolegal review. J Assist Reprod Genet. 2019 Jun;36(6):1041-1048. doi: 10.1007/s10815-019-01478-x. Epub 2019 May 24. — View Citation

Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology, and Practice Committee of the Society of Reproductive Biologists and Technologists. Electronic address: asrm@asrm.org. Minimum standards for practices offering assisted reproductive technologies: a committee opinion. Fertil Steril. 2021 Mar;115(3):578-582. doi: 10.1016/j.fertnstert.2020.12.036. Epub 2021 Feb 7. — View Citation

Practice Committee of the American Society for Reproductive Medicine; Practice Committee of the Society for Assisted Reproductive Technology; Practice Committee of the Society of Reproductive Biologists and Technologists. Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion. Fertil Steril. 2014 Oct;102(4):960-3. doi: 10.1016/j.fertnstert.2014.06.036. Epub 2014 Jul 23. — View Citation

Priddle H, Pickup S, Hayes C; Association of Reproductive and Clinical Scientists (ARCS). Occupational health issues experienced by UK embryologists: informing improvements in clinical reproductive science practice. Hum Fertil (Camb). 2022 Oct;25(4):608-617. doi: 10.1080/14647273.2021.1871782. Epub 2021 Jan 18. — View Citation

Shanafelt TD, West CP, Sinsky C, Trockel M, Tutty M, Satele DV, Carlasare LE, Dyrbye LN. Changes in Burnout and Satisfaction With Work-Life Integration in Physicians and the General US Working Population Between 2011 and 2017. Mayo Clin Proc. 2019 Sep;94(9):1681-1694. doi: 10.1016/j.mayocp.2018.10.023. Epub 2019 Feb 22. — View Citation

Tawfik DS, Profit J, Morgenthaler TI, Satele DV, Sinsky CA, Dyrbye LN, Tutty MA, West CP, Shanafelt TD. Physician Burnout, Well-being, and Work Unit Safety Grades in Relationship to Reported Medical Errors. Mayo Clin Proc. 2018 Nov;93(11):1571-1580. doi: 10.1016/j.mayocp.2018.05.014. Epub 2018 Jul 9. — View Citation

Trockel MT, Menon NK, Rowe SG, Stewart MT, Smith R, Lu M, Kim PK, Quinn MA, Lawrence E, Marchalik D, Farley H, Normand P, Felder M, Dudley JC, Shanafelt TD. Assessment of Physician Sleep and Wellness, Burnout, and Clinically Significant Medical Errors. JAMA Netw Open. 2020 Dec 1;3(12):e2028111. doi: 10.1001/jamanetworkopen.2020.28111. — View Citation

West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018 Jun;283(6):516-529. doi: 10.1111/joim.12752. Epub 2018 Mar 24. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sociodemographic characteristics of U.S. embryologists	The sociodemographic characteristics of U.S. embryologists whose routine work duties include IVF procedures and freezing and cryomanagement of embryos and gametes.	4-6 weeks
Primary	The work-related health status of U.S. embryologists	The overall health status of U.S. embryologists and associated health issues related to their professional duties.	4-6 weeks
Primary	The work-related stress and fatigue among U.S. embryologists	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.	4-6 weeks
Primary	The work-related burnout amount U.S. embryologists	The burnout experienced by U.S. embryologists because of their stress and fatigue.	4-6 weeks
Primary	Potential strategies to reduce stress, fatigue, and burnout in U.S. Embryologists	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.	4-6 weeks
Secondary	The underlying causes of work-related physical and mental health issues in U.S. Embryologists	The underlying causes of physical strain, stress, fatigue, and burnout in U.S. embryologists related to their occupational characteristics	4-6 weeks
Secondary	The correlation between negative health outcomes, manual workload, and error among U.S. embryologists	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.	4-6 weeks