FatigueFUSENCT05326802
The U.S. Embryologist Fatigue Study
An observational study of Fatigue and Stress, run by TMRW Life Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Fatigue, Stress, Burnout, Professional
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Adult, Older adult
Study population: Embryologists are the ART/IVF/embryology laboratory personnel who provide fertility and embryology services, including but not limited to IVF procedures, pre-implantation genetic testing of embryos, freezing/vitrification of embryos and gametes, cryomanagement of frozen/vitrified embryos and gametes, and monitoring and maintenance of laboratory records and equipment. They range in age, gender, marital status, children, and relationship status, but they must have a minimum of B.A./B.S. degree, and ELS (AAB) or other professional certifications to work as an embryology laboratory technologist or supervisor, and a postgraduate degree, such as Ph.D., M.D., or D.O. to serve as the embryology laboratory director. Embryologists of all career levels work in a private, academic, government, or corporate IVF clinical/laboratory on a full-time, part-time, or per-diem basis, and with a permanent or a non-permanent contract.
Who may be able to join
- complete surveys from embryologists;
Who cannot join
- incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Physical and Mental Health Issues Experienced by U.S. Embryologists
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.
Read the 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.
- Conditions
- Fatigue, Stress, Burnout, Professional, Musculoskeletal Pain, Back Pain, Neck Pain
- Keywords
- embryologist, stress, fatigue, burnout, physical health, IVF
- Medical subject headings
- Fatigue, Burnout, Professional, Musculoskeletal Pain, Back Pain, Neck Pain, Headache, Dizziness, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 weeks
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.
Measured: 4-6 weeks
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.
Measured: 4-6 weeks
The work-related burnout amount U.S. embryologists
The burnout experienced by U.S. embryologists because of their stress and fatigue.
Measured: 4-6 weeks
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.
Measured: 4-6 weeks
Secondary outcomes (2)
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
Measured: 4-6 weeks
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.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start7 Apr 2022
- Primary completion25 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- TMRW Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dudley Associates Healthcare Marketing & Communications
- Responsible party
- Sponsor
- Investigators
- Anar Murphy, PhD, Principal investigator, TMRW Life SciencesMichael Collins, PhD, Principal investigator, TMRW Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326802
- Sponsor's protocol ID
- Pro00062375
- Acronym
- FUSE
- Status last verified
- Jan 2023
- First submitted
- 6 Apr 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: TMRW and Dudley Associates (DA) will keep a master list containing personal identifiers and responses separate from data forms (paper and electronic) that have only analyzed results. The master list will be on a separate computer at DA. This form of data is considered "coded" not de-identified. Since the data can be re-linked to identifiers, it is coded. Only after the key to the code or the Master List is destroyed are the data considered de-identified. External investigators will not have access to these files The password-protected data will be stored on TMRW's drives in addition to the PIs' computers that are backed up according to TMRW's company policies The coded data with personally identifiable information of the survey participants will be stored as described above. The participants' personal identifiers and other data will be destroyed, and data will hence be de-identified 5 years after study completion in compliance with TMRW Data Classification and Handling Policy
Publications
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.
PubMed 25284212Tawfik 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.
PubMed 30001832Priddle 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.
PubMed 33459106Practice 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.
PubMed 25064400Practice 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.
PubMed 33568271West 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.
PubMed 29505159Dyrbye 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
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.
PubMed 25602275Shanafelt 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.
PubMed 30803733Trockel 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.
PubMed 33284339Caruso 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.
PubMed 31582105Dyrbye 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.
PubMed 31768129Letterie 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.
PubMed 34223222Moutos 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.
PubMed 31127476Murphy A, Lapczynski MS, Proctor G Jr, Glynn TR, Domar AD, Gameiro S, Palmer GA, Collins MG. Comparison of embryologist stress, somatization, and burnout reported by embryologists working in UK HFEA-licensed ART/IVF clinics and USA ART/IVF clinics. Hum Reprod. 2024 Oct 1;39(10):2297-2304. doi: 10.1093/humrep/deae191.
PubMed 39198005
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Physical and Mental Health Issues Experienced by U.S. Embryologists
- ClinicalTrials.gov ID
- NCT05326802
- Acronym / sponsor ID
- FUSE / Pro00062375
- Conditions
- Fatigue, Stress, Burnout, Professional, Musculoskeletal Pain, Back Pain, Neck Pain
- Keywords
- embryologist, stress, fatigue, burnout, physical health, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- TMRW Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Dudley Associates Healthcare Marketing & Communications
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Embryologists are the ART/IVF/embryology laboratory personnel who provide fertility and embryology services, including but not limited to IVF procedures, pre-implantation genetic testing of embryos, freezing/vitrification of embryos and gametes, cryomanagement of frozen/vitrified embryos and gametes, and monitoring and maintenance of laboratory records and equipment. They range in age, gender, marital status, children, and relationship status, but they must have a minimum of B.A./B.S. degree, and ELS (AAB) or other professional certifications to work as an embryology laboratory technologist or supervisor, and a postgraduate degree, such as Ph.D., M.D., or D.O. to serve as the embryology laboratory director. Embryologists of all career levels work in a private, academic, government, or corporate IVF clinical/laboratory on a full-time, part-time, or per-diem basis, and with a permanent or a non-permanent contract.
Key inclusion criteria (1 listed)
- complete surveys from embryologists;
Key exclusion criteria (1 listed)
- incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sociodemographic characteristics of U.S. embryologists
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
The underlying causes of work-related physical and mental health issues in U.S. Embryologists
Time frame: 4-6 weeks
The correlation between negative health outcomes, manual workload, and error among U.S. embryologists
Time frame: 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 25284212Lopez-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.
- Background: PubMed 30001832Tawfik 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.
- Background: PubMed 33459106Priddle 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.
- Background: PubMed 25064400Practice 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.
- Background: PubMed 33568271Practice 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.
- Background: PubMed 29505159West 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.
- BackgroundDyrbye 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
- Background: PubMed 25602275Frone 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.
- Background: PubMed 30803733Shanafelt 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.
- Background: PubMed 33284339Trockel 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.
- Background: PubMed 31582105Caruso 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.
- Background: PubMed 31768129Dyrbye 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.
- Individual participant dataSharing planned: Yes. TMRW and Dudley Associates (DA) will keep a master list containing personal identifiers and responses separate from data forms (paper and electronic) that have only analyzed results. The master list will be on a separate computer at DA. This form of data is considered "coded" not de-identified. Since the data can be re-linked to identifiers, it is coded. Only after the key to the code or the Master List is destroyed are the data considered de-identified. External investigators will not have access to these files The password-protected data will be stored on TMRW's drives in addition to the PIs' computers that are backed up according to TMRW's company policies The coded data with personally identifiable information of the survey participants will be stored as described above. The participants' personal identifiers and other data will be destroyed, and data will hence be de-identified 5 years after study completion in compliance with TMRW Data Classification and Handling Policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anar Murphy, PhD principal investigator
TMRW Life Sciences
Michael Collins, PhD principal investigator
TMRW Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Stress, run by TMRW Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sociodemographic characteristics of U.S. embryologists (time frame: 4-6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326802, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.