Gastroenterology & Work Related InjuriesNCT04216212
Gastroenterology & Work Related Injuries
An observational study of Gastroenterology & Work Related Injuries, run by Methodist Health System at 1 site in United States.
Trial summary
2.2.1. Primary Outcome(s) Percentage of gastroenterology fellows who have received any formal training in the ergonomics of endoscopy and how to prevent long term work related injuries. 2.2.2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroenterology & Work Related Injuries
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 2 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: It will be distributed to all gastroenterology fellowship coordinators through an email listserv maintained by programs nationwide for the purpose of communicating with their trainees.
Who may be able to join
- Gastroenterology fellows enrolled in an accredited program in the United States
- First, second and third year as well as advanced gastroenterology fellows
- Able and willing to provide consent
Who cannot join
- Advanced gastroenterology fellows
- Staff gastroenterologists
- Unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Is the Future of Gastroenterology Being Adequately Prepared to Prevent Work Related Injuries and Allow for a Long Healthy Career? Question Answered.
2.2.1. Primary Outcome(s)
- Percentage of gastroenterology fellows who have received any formal training in the ergonomics of endoscopy and how to prevent long term work related injuries.
2.2.2. Secondary Outcome(s)
- How much formal training given in multiple choice format fellows received in the ergonomics of endoscopy and how to prevent work related injuries.
- Number of perceived work related injuries fellows sustained.
- Types of perceived work related injuries fellows sustained.
- If fellow perceived work related injuries whether they felt it negatively affected their ability to perform their duties as a gastroenterology fellow.
Read the detailed description
This is a self-report survey utilizing a voluntary, non-probability sampling design. The survey instrument will be created in Google Survey© consisting of yes/no, multiple choice and free text response questions. This survey instrument questions have been developed empirically by the investigators.
It will be distributed to all gastroenterology fellowship coordinators through an email listserv maintained by programs nationwide for the purpose of communicating with their trainees. The email will include instructions to share the survey link (Appendix 2) with all first/second/third year as well as all advanced gastroenterology fellow s in their programs. The survey will be disseminated over a 2 week period. The fellowship coordinator will receive three separate emails. The first email (Appendix 2) will be on opening day of the survey requesting them to forward the link to their fellows. The second email (Appendix 3) will be sent on day 8 of the study period serving as a reminder to participate in the survey with link once again attached. The final email (Appendix 4) will be distributed on day 14 of the study period serving as a final reminder for fellows to complete the survey if they have not already and that the survey will close at midnight. The link will have both the informed consent form and the survey. Participants must press a key indicating agreement to get past the consent to the survey. The survey will take less than 2 minutes to complete electronically. This will be an anonymous survey and will be distributed via a secure online platform.
The results will be compiled using Google Survey© software. No personal identifying information will be included.
- Conditions
- Gastroenterology & Work Related Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Training on ergonomics of endoscopy
- Percentage of gastroenterology fellows who have received any formal training in the ergonomics of endoscopy and how to prevent long term work related injuries.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start2 Apr 2019
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenterology & Work Related InjuriesStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cassandra Craig, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216212
- Sponsor's protocol ID
- 058.GID.2018.D
- Status last verified
- Nov 2020
- First submitted
- 30 Dec 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Future of Gastroenterology Being Adequately Prepared to Prevent Work Related Injuries and Allow for a Long Healthy Career? Question Answered.
- ClinicalTrials.gov ID
- NCT04216212
- Acronym / sponsor ID
- 058.GID.2018.D
- Conditions
- Gastroenterology & Work Related Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 2 Jan 2020 (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.
2.2.1. Primary Outcome(s)
- Percentage of gastroenterology fellows who have received any formal training in the ergonomics of endoscopy and how to prevent long term work related injuries.
2.2.2. Secondary Outcome(s)
- How much formal training given in multiple choice format fellows received in the ergonomics of endoscopy and how to prevent work related injuries.
- Number of perceived work related injuries fellows sustained.
- Types of perceived work related injuries fellows sustained.
- If fellow perceived work related injuries whether they felt it negatively affected their ability to perform their duties as a gastroenterology fellow.
Detailed description
This is a self-report survey utilizing a voluntary, non-probability sampling design. The survey instrument will be created in Google Survey© consisting of yes/no, multiple choice and free text response questions. This survey instrument questions have been developed empirically by the investigators.
It will be distributed to all gastroenterology fellowship coordinators through an email listserv maintained by programs nationwide for the purpose of communicating with their trainees. The email will include instructions to share the survey link (Appendix 2) with all first/second/third year as well as all advanced gastroenterology fellow s in their programs. The survey will be disseminated over a 2 week period. The fellowship coordinator will receive three separate emails. The first email (Appendix 2) will be on opening day of the survey requesting them to forward the link to their fellows. The second email (Appendix 3) will be sent on day 8 of the study period serving as a reminder to participate in the survey with link once again attached. The final email (Appendix 4) will be distributed on day 14 of the study period serving as a final reminder for fellows to complete the survey if they have not already and that the survey will close at midnight. The link will have both the informed consent form and the survey. Participants must press a key indicating agreement to get past the consent to the survey. The survey will take less than 2 minutes to complete electronically. This will be an anonymous survey and will be distributed via a secure online platform.
The results will be compiled using Google Survey© software. No personal identifying information will be included.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It will be distributed to all gastroenterology fellowship coordinators through an email listserv maintained by programs nationwide for the purpose of communicating with their trainees.
Key inclusion criteria (3 listed)
- Gastroenterology fellows enrolled in an accredited program in the United States
- First, second and third year as well as advanced gastroenterology fellows
- Able and willing to provide consent
Key exclusion criteria (3 listed)
- Advanced gastroenterology fellows
- Staff gastroenterologists
- Unable or unwilling to provide consent
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
Training on ergonomics of endoscopy
Time frame: 14 days
• Percentage of gastroenterology fellows who have received any formal training in the ergonomics of endoscopy and how to prevent long term work related injuries.
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 19 Nov 2020.
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.
Cassandra Craig, M.D. principal investigator
The Methodist Hospital Research Institute
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 Gastroenterology & Work Related Injuries, run by Methodist Health System 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 3 inclusion and 3 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 19 Nov 2020. 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?
Training on ergonomics of endoscopy (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2020.