Physician FatigueROSTERSNCT02134847
Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
A study testing SCS intervention schedule in people with Physician Fatigue, run by Brigham and Women's Hospital at 6 sites in United States.
Trial summary
In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physician Fatigue
- What is being tested?
- SCS intervention schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jul 2013to 5 Mar 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a second or third year resident of pediatrics or a combined pediatrics program
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Childrens Hospital of Colorado
Aurora, Colorado, 80045
Childrens Hospital Boston
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22911
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229-3026
University of Iowa Hospital
Iowa City, Iowa, 52242
Seattle Children's Hospital
Seattle, Washington
About this study
In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:
- To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)
- To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)
- To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)
- Conditions
- Physician Fatigue
- Being tested
- SCS intervention schedule
- Keywords
- Resident, Fatigue, Sleep deprivation, medical errors
- Medical subject headings
- Fatigue, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCS intervention scheduleOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention cohort | Experimental | This cohort will work on the SCS intervention schedule Receives: Other: SCS intervention schedule |
| Control cohort | No intervention | This group will work on a traditional schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
resident-related preventable adverse events and near misses.
PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule;(primary endpoints: resident-related preventable adverse events and near misses)
Measured: Each resident (subject) will be observed for 1 month.
Secondary outcomes (3)
ICU-wide preventable adverse events and near misses
Rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule.
Measured: Each participating PICU will be studied for 8 months on each of the schedules (16 months total).
resident neurobehavioral performance.
Resident physicians' risk of neurobehavioral performance failures as assessed through simple visual reaction time tasks [Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule.
Measured: Subjects will be tested 3-5 times per week for 1 month.
Risk of resident motor vehicle crashes (MVC)
Fatigue during the commute to and from work, as assessed by the John's drowsiness scale (JDS), will be lower on the SCS schedule than the traditional schedule, making MVC's less likely during the time on the SCS schedule.
Measured: Subjects will be monitored while they drive to/from work for 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study start1 Jul 2013
- Primary completion5 Mar 2017
- Study completion5 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physician FatigueStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher P. Landrigan, MD, MPH, Brigham and Women's Hospital
- Investigators
- Christopher Landrigan, MD, MPH, Principal investigator, Brigham and Women's HospitalCharles A Czeisler, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134847
- Sponsor's protocol ID
- 2010P001346
- Acronym
- ROSTERS
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2013
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rahman SA, Sullivan JP, Barger LK, St Hilaire MA, O'Brien CS, Stone KL, Phillips AJK, Klerman EB, Qadri S, Wright KP Jr, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Sanderson AL, Zee PC, Landrigan CP, Czeisler CA, Lockley SW; ROSTERS STUDY GROUP. Extended Work Shifts and Neurobehavioral Performance in Resident-Physicians. Pediatrics. 2021 Mar;147(3):e2020009936. doi: 10.1542/peds.2020-009936. Epub 2021 Feb 22.
PubMed 33619044Landrigan CP, Rahman SA, Sullivan JP, Vittinghoff E, Barger LK, Sanderson AL, Wright KP Jr, O'Brien CS, Qadri S, St Hilaire MA, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee PC, Lockley SW, Stone KL, Czeisler CA; ROSTERS Study Group. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts. N Engl J Med. 2020 Jun 25;382(26):2514-2523. doi: 10.1056/NEJMoa1900669.
PubMed 32579812Barger LK, Sullivan JP, Blackwell T, O'Brien CS, St Hilaire MA, Rahman SA, Phillips AJK, Qadri S, Wright KP, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee P, Sanderson AL, Halbower AC, Lockley SW, Landrigan CP, Stone KL, Czeisler CA; ROSTERS Study Group. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS). Sleep. 2019 Aug 1;42(8):zsz110. doi: 10.1093/sleep/zsz110.
PubMed 31106381Blackwell T, Kriesel DR, Vittinghoff E, O'Brien CS, Sullivan JP, Viyaran NC, Rahman SA, Lockley SW, Barger LK, Halbower AC, Poynter SE, Wright KP Jr, Yu PL, Zee PC, Landrigan CP, Czeisler CA, Stone KL; ROSTERS Study Group. Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study. Contemp Clin Trials. 2019 May;80:22-33. doi: 10.1016/j.cct.2019.03.005. Epub 2019 Mar 15.
PubMed 30885799
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
- ClinicalTrials.gov ID
- NCT02134847
- Acronym / sponsor ID
- ROSTERS / 2010P001346
- Conditions
- Physician Fatigue
- Keywords
- Resident, Fatigue, Sleep deprivation, medical errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 5 Mar 2017 (actual)
- Study completion
- 5 Mar 2017 (actual)
- First posted
- 9 May 2014 (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.
In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:
- To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)
- To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)
- To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | Experimental | Other: SCS intervention scheduleThis cohort will work on the SCS intervention schedule |
| Control cohort | No intervention | –This group will work on a traditional schedule |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a second or third year resident of pediatrics or a combined pediatrics program
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SCS intervention schedule | Other | Intervention cohort |
Primary outcome
resident-related preventable adverse events and near misses.
Time frame: Each resident (subject) will be observed for 1 month.
PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule;(primary endpoints: resident-related preventable adverse events and near misses)
3 secondary outcomes
ICU-wide preventable adverse events and near misses
Time frame: Each participating PICU will be studied for 8 months on each of the schedules (16 months total).
resident neurobehavioral performance.
Time frame: Subjects will be tested 3-5 times per week for 1 month.
Risk of resident motor vehicle crashes (MVC)
Time frame: Subjects will be monitored while they drive to/from work for 1 month.
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 30 Apr 2019.
- Derived from this study: PubMed 33619044Rahman SA, Sullivan JP, Barger LK, St Hilaire MA, O'Brien CS, Stone KL, Phillips AJK, Klerman EB, Qadri S, Wright KP Jr, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Sanderson AL, Zee PC, Landrigan CP, Czeisler CA, Lockley SW; ROSTERS STUDY GROUP. Extended Work Shifts and Neurobehavioral Performance in Resident-Physicians. Pediatrics. 2021 Mar;147(3):e2020009936. doi: 10.1542/peds.2020-009936. Epub 2021 Feb 22.
- Derived from this study: PubMed 32579812Landrigan CP, Rahman SA, Sullivan JP, Vittinghoff E, Barger LK, Sanderson AL, Wright KP Jr, O'Brien CS, Qadri S, St Hilaire MA, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee PC, Lockley SW, Stone KL, Czeisler CA; ROSTERS Study Group. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts. N Engl J Med. 2020 Jun 25;382(26):2514-2523. doi: 10.1056/NEJMoa1900669.
- Derived from this study: PubMed 31106381Barger LK, Sullivan JP, Blackwell T, O'Brien CS, St Hilaire MA, Rahman SA, Phillips AJK, Qadri S, Wright KP, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee P, Sanderson AL, Halbower AC, Lockley SW, Landrigan CP, Stone KL, Czeisler CA; ROSTERS Study Group. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS). Sleep. 2019 Aug 1;42(8):zsz110. doi: 10.1093/sleep/zsz110.
- Derived from this study: PubMed 30885799Blackwell T, Kriesel DR, Vittinghoff E, O'Brien CS, Sullivan JP, Viyaran NC, Rahman SA, Lockley SW, Barger LK, Halbower AC, Poynter SE, Wright KP Jr, Yu PL, Zee PC, Landrigan CP, Czeisler CA, Stone KL; ROSTERS Study Group. Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study. Contemp Clin Trials. 2019 May;80:22-33. doi: 10.1016/j.cct.2019.03.005. Epub 2019 Mar 15.
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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.
Christopher Landrigan, MD, MPH principal investigator
Brigham and Women's Hospital
Charles A Czeisler, MD, PhD principal investigator
Brigham and Women's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCS intervention schedule in people with Physician Fatigue, run by Brigham and Women's Hospital at 6 sites 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
resident-related preventable adverse events and near misses. (time frame: Each resident (subject) will be observed for 1 month.). 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 NCT02134847, which also lists 4 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 30 Apr 2019.