FatigueNCT02519205
Measuring Fatigue in Triage: A Pilot Study
An observational study of Fatigue, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine how the length of a triage shift (i.e. 4 vs., 8 vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Survey
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ED Triage nurses
Who may be able to join
- -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.)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how the length of a triage shift (i.e. 4 vs., 8 vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED).
Read the 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.
- Conditions
- Fatigue
- Being tested
- Survey
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called Karolinska Sleepiness Scale, Samn-Perelli Seven Point Fatigue Scale
| Study group | Role | What they receive |
|---|---|---|
| ED Nurses | ED triage nurses from Duke University Hospital (DUH) and Duke Regional Hospitals (DRH). Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue level, as measured by questionnaire
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519205
- Sponsor's protocol ID
- Pro00065707
- Status last verified
- Feb 2016
- First submitted
- 5 Aug 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Fatigue in Triage: A Pilot Study
- ClinicalTrials.gov ID
- NCT02519205
- Acronym / sponsor ID
- Pro00065707
- Conditions
- Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Aug 2015 (estimated)
- 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 this study is to determine how the length of a triage shift (i.e. 4 vs., 8 vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED Nurses | – | Other: SurveyED triage nurses from Duke University Hospital (DUH) and Duke Regional Hospitals (DRH). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ED Triage nurses
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAlso: Karolinska Sleepiness Scale, Samn-Perelli Seven Point Fatigue Scale | Other | ED Nurses |
Primary outcome
Fatigue level, as measured by questionnaire
Time frame: 24 hours
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 20 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Duke University 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 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 20 Jul 2016. 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?
Fatigue level, as measured by questionnaire (time frame: 24 hours). 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 20 Jul 2016.