- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519205
Measuring Fatigue in Triage: A Pilot Study
Study Overview
Detailed Description
This will be a prospective descriptive pilot study. The demographic data forms and the adapted reaction questionnaires will be administered to subjects via pen and paper after obtaining informed consent at the conclusion of the staff meetings. They will be collected by administrative assistants and placed into a secure drop box, located in the study coordinator's office. Only the assigned unique subject ID will be used on all data forms.
During the ED triage data collection phase, administrative assistants will be on-site to give triage nurses the fatigue questionnaire. It will be completed using pen and paper every two hours, with subjects cued to complete the questionnaire by administrative assistants.
After the subject completes the survey, he/she will place it in an envelope and hand it to the administrative assistant who will place it into a secured drop box, located in a study coordinator's office. No PHI or identifying data will be on the completed surveys. Each participant will only use the previously assigned unique subject ID, known only to the study coordinator & Co-PIs, & PI. The key to the unique ID will be kept in a locked secure file accessible only by the study coordinator and Co-PI.
Data will be collected over a total of six 24-hour periods. The first 24-hour data collection period will take place on a high volume day (Monday) in which triage nurses will be assigned to 12-hour triage shifts. The second 24-hour data collection period will take place on a low volume day (Sunday) in which triages nurses will again be assigned to 12-hour triage shifts. The third 24-hour data collection period will take place on a high volume day (Monday) in which nurses will be assigned to 8-hour triage shifts. The fourth 24-hour data collection period will take place on a low volume day (Sunday) in which nurses will again be assigned to 8-hour triage shifts. The fifth 24-hour data collection period will take place on a high volume day (Monday) in which nurses will be assigned to 4-hour triage shifts. The sixth 24-hour data collection period will take place on a low volume day (Sunday) in which nurses will again be assigned to 4-hour triage shifts.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States
- Duke Regional Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-Eligible nurses include those who:
- are regularly assigned to triage
- have demonstrated competency by passing the ESI Triage class. (Nurses in both emergency departments are required to attend a course in Emergency Severity Index (ESI), as well as demonstrate competency through ESI testing prior to being assigned to work in the triage area. Before taking the course, a nurse is required to have one year of nursing experience.)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ED Nurses
ED triage nurses from Duke University Hospital (DUH) and Duke Regional Hospitals (DRH).
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fatigue level, as measured by questionnaire
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00065707
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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