Sleep DeprivationNCT00996320
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
A study testing Reduced work hour schedule in people with Sleep Deprivation and Depression, run by Providence Health & Services at 1 site in United States.
Trial summary
The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Depression
- What is being tested?
- Reduced work hour schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2009
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Interns rotating at Providence St. Vincent Medical Center ICU
Who cannot join
- Diagnosis of narcolepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St. Vincent Medical Center Intensive Care Unit
Portland, Oregon, 97225
About this study
Official title: Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors
The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.
Read the detailed description
Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.
- Conditions
- Sleep Deprivation, Depression
- Being tested
- Reduced work hour schedule
- Keywords
- Internship and Residency, Medical Errors, Burnout, Professional, Burnout, Depression, Actigraphy, Personnel Staffing and Scheduling, Sleep Deprivation, Workload, Humans, Adult, Male, Female, Intensive Care Units, Prospective Studies, Crossover Studies, Work Schedule Tolerance, Disorders of Excessive Somnolence, Guideline Adherence, Internal Medicine Education
- Medical subject headings
- Sleep Deprivation, Depression, Burnout, Professional, Burnout, Psychological, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced work hour scheduleOther
Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Schedule | Experimental | Interns on the intervention schedule work the a modified ICU schedule averaging about 60 hours per week over 4 weeks, with maximum scheduled shift length 16 hours. Receives: Other: Reduced work hour schedule |
| Traditional Schedule | No intervention | Interns on the traditional schedule work the usual ICU schedule averaging about 80 hours per week over 4 weeks, with maximum shift length 30 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sleep Latency Test
Measured: Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle
Secondary outcomes (5)
Hours slept per night measured by actigraphy
Measured: Daily
Pharmaceutical order error rate
Measured: Daily
Burnout measured by Maslach Burnout Inventory
Measured: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation
Beck Depression Inventory, Second Edition (BDI-II)
Measured: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation
Hours worked per shift on the traditional and intervention schedules
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Providence St. Vincent Department of Medicine, Providence Center for Outcomes Research and Education
- Investigators
- Michelle L Schoepflin Sanders, MD, Principal investigator, Providence St. Vincent Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996320
- Sponsor's protocol ID
- IRB 08-74B
- Status last verified
- Oct 2009
- First submitted
- 28 Aug 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors
- ClinicalTrials.gov ID
- NCT00996320
- Acronym / sponsor ID
- IRB 08-74B
- Conditions
- Sleep Deprivation, Depression
- Keywords
- Internship and Residency, Medical Errors, Burnout, Professional, Burnout, Depression, Actigraphy, Personnel Staffing and Scheduling, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Providence St. Vincent Department of Medicine, Providence Center for Outcomes Research and Education
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Oct 2009 (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 whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.
Detailed description
Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Schedule | Experimental | Other: Reduced work hour scheduleInterns on the intervention schedule work the a modified ICU schedule averaging about 60 hours per week over 4 weeks, with maximum scheduled shift length 16 hours. |
| Traditional Schedule | No intervention | –Interns on the traditional schedule work the usual ICU schedule averaging about 80 hours per week over 4 weeks, with maximum shift length 30 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Interns rotating at Providence St. Vincent Medical Center ICU
Key exclusion criteria (1 listed)
- Diagnosis of narcolepsy
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 |
|---|---|---|
| Reduced work hour scheduleInterns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours. | Other | Intervention Schedule |
Primary outcome
Multiple Sleep Latency Test
Time frame: Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle
5 secondary outcomes
Hours slept per night measured by actigraphy
Time frame: Daily
Pharmaceutical order error rate
Time frame: Daily
Burnout measured by Maslach Burnout Inventory
Time frame: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation
Beck Depression Inventory, Second Edition (BDI-II)
Time frame: Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation
Hours worked per shift on the traditional and intervention schedules
Time frame: Daily
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 16 Oct 2009.
Related trials for Sleep Deprivation
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Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
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Effect of Sleep Extension in Prevention to Sleep Deprivation
Healthy
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
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Active, not recruiting
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
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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.
Michelle L Schoepflin Sanders, MD principal investigator
Providence St. Vincent Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced work hour schedule in people with Sleep Deprivation and Depression, run by Providence Health & Services 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 16 Oct 2009. 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?
Multiple Sleep Latency Test (time frame: Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle). 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 16 Oct 2009.