- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00983008
Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
A Prospective Cohort Study on the Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The Institute of Medicine has proposed 5 hour naps for residents on extended overnight call-duty shifts citing resident and patient safety. Concerns raised about this recommendation include increased handoffs, truncated continuity, and if residents would be able to effectively use the protected time for sleep.
Objectives: The purpose of this study is to test if protected time for sleep during extended duty overnight shifts improves resident fatigue and if they actually utilize the time for sleep.
Methods: All interns rotating through the medical intensive care unit from October 2009 through October 2010 will work extended shifts every 3rd night. On Sunday through Thursday nights they will have a 5 hour protected period from 2 AM to 7 AM. During this time they will relinquish their pager and cell phone to the Night Float PGY2 or PGY3 who is already responsible for the ICU patients. The four hours between 2 and 6 am are entirely protected. From 6 AM to 7 AM, interns will be expected to start computer rounding on the ICU patients and to begin progress notes for the remaining members of the ICU team but still have no pager, cell phone, or cross coverage duties. On Friday and Saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shift.
Results from the October 2009 to October 2010 protected time cohort of interns will be compared with two comparison groups from the same institution and the same medical intensive care unit during the academic year June 2008 to June 2009. The first comparison group is interns working 30 hour shifts every 3rd night without any protected time and an average of 80 hours per week. The second comparison group is interns working a maximum shift length of 16 hours and an average of 60 hours per week.
The primary outcome will be measurement of fatigue (daytime multiple sleep latency tests). Secondary outcomes include the amount slept as measured by actigraphy, assessment of burnout (Maslach Burnout Inventory) and depression (Beck Depression Inventory-II).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97225
- Providence St. Vincent Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Interns in the Providence St. Vincent Medical Center Internal Medicine Residency Program who are rotating through the medical intensive care unit.
Exclusion Criteria:
- Refusal to consent to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protected Time Group
Interns working 30 hour shifts every 3rd night and an average of 80 hours per week in a medical intensive care unit.
|
On Sunday through Thursday nights medical intensive care unit interns will have a 5 hour protected period from 2 to 7 am.
During this time they will relinquish their pager and cell phone to the Night Float PGY2 or PGY3 who is already responsible for the ICU patients.
The four hours between 2 and 6 am are entirely protected.
6 AM to 7 AM is dedicated time during which the interns will be expected to start pre-rounding on the ICU patients and to begin progress notes for the remaining members of the ICU team but still have no pager, cell phone, or cross coverage duties.
On Friday and Saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shifts.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fatigue as measured by daytime multiple sleep latency test.
Time Frame: Once, during last week of intervention.
|
Once, during last week of intervention.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hours slept during protected time
Time Frame: Once, during last week of intervention
|
Once, during last week of intervention
|
Depression
Time Frame: Once, during last week of intervention
|
Once, during last week of intervention
|
Burnout
Time Frame: Once, during last week of intervention
|
Once, during last week of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerald Dunlap, M.D., Internal Medicine Resident Program, Providence St. Vincent Medical Center
- Study Director: Michelle Sanders, M.D., Internal Medicine Resident Program, Providence St. Vincent Medical Center
- Principal Investigator: Jay B Ham, M.D., Internal Medicine Resident Program, Providence St. Vincent Medical Center
- Study Director: Jeffrely Bluhm, M.D., Oregon Pulmonology Associates, Portland, Oregon
Publications and helpful links
General Publications
- Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005 Jan 13;352(2):125-34. doi: 10.1056/NEJMoa041401.
- Iglehart JK. Revisiting duty-hour limits--IOM recommendations for patient safety and resident education. N Engl J Med. 2008 Dec 18;359(25):2633-5. doi: 10.1056/NEJMp0808736. Epub 2008 Dec 3. No abstract available.
- Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA. Effect of reducing interns' work hours on serious medical errors in intensive care units. N Engl J Med. 2004 Oct 28;351(18):1838-48. doi: 10.1056/NEJMoa041406.
- Parthasarathy S, Hettiger K, Budhiraja R, Sullivan B. Sleep and well-being of ICU housestaff. Chest. 2007 Jun;131(6):1685-93. doi: 10.1378/chest.06-1398. Epub 2007 Mar 30.
- Fisman DN, Harris AD, Rubin M, Sorock GS, Mittleman MA. Fatigue increases the risk of injury from sharp devices in medical trainees: results from a case-crossover study. Infect Control Hosp Epidemiol. 2007 Jan;28(1):10-7. doi: 10.1086/510569. Epub 2006 Dec 28.
- Fahrenkopf AM, Sectish TC, Barger LK, Sharek PJ, Lewin D, Chiang VW, Edwards S, Wiedermann BL, Landrigan CP. Rates of medication errors among depressed and burnt out residents: prospective cohort study. BMJ. 2008 Mar 1;336(7642):488-91. doi: 10.1136/bmj.39469.763218.BE. Epub 2008 Feb 7.
- Lockley SW, Barger LK, Ayas NT, Rothschild JM, Czeisler CA, Landrigan CP; Harvard Work Hours, Health and Safety Group. Effects of health care provider work hours and sleep deprivation on safety and performance. Jt Comm J Qual Patient Saf. 2007 Nov;33(11 Suppl):7-18. doi: 10.1016/s1553-7250(07)33109-7.
- Resident duty hours: enhancing sleep, supervision, and safety: Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedules to Improve Patient Safety. Washington, DC: National Academies Press, 2008. Available online at http://www.nationalacademies.org/morenews/20081202.html . See also Attachment A for a comparison of the ACGME work hours requirements and the recommendations from the Institute of Medicine.
- Littner MR, Kushida C, Wise M, Davila DG, Morgenthaler T, Lee-Chiong T, Hirshkowitz M, Daniel LL, Bailey D, Berry RB, Kapen S, Kramer M; Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test. Sleep. 2005 Jan;28(1):113-21. doi: 10.1093/sleep/28.1.113.
- Pizza F, Contardi S, Ferlisi M, Mondini S, Cirignotta F. Daytime driving simulation performance and sleepiness in obstructive sleep apnoea patients. Accid Anal Prev. 2008 Mar;40(2):602-9. doi: 10.1016/j.aap.2007.08.014. Epub 2007 Sep 19.
- Reddy R, Guntupalli K, Alapat P, Surani S, Casturi L, Subramanian S. Sleepiness in medical ICU residents. Chest. 2009 Jan;135(1):81-85. doi: 10.1378/chest.08-0821. Epub 2008 Nov 18.
- Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Even-Shoshan O, Canamucio A, Bellini L, Behringer T, Silber JH. Mortality among patients in VA hospitals in the first 2 years following ACGME resident duty hour reform. JAMA. 2007 Sep 5;298(9):984-92. doi: 10.1001/jama.298.9.984.
- Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Even-Shoshan O, Wang Y, Bellini L, Behringer T, Silber JH. Mortality among hospitalized Medicare beneficiaries in the first 2 years following ACGME resident duty hour reform. JAMA. 2007 Sep 5;298(9):975-83. doi: 10.1001/jama.298.9.975.
- Shetty KD, Bhattacharya J. Changes in hospital mortality associated with residency work-hour regulations. Ann Intern Med. 2007 Jul 17;147(2):73-80. doi: 10.7326/0003-4819-147-2-200707170-00161. Epub 2007 Jun 4.
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-085B
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.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on Protected time and Dedicated time
-
Umeå UniversityUnknownNurse-Patient Relations | Mental Health Nursing
-
Mayo ClinicArizona State UniversityCompleted
-
University Hospital, ToulouseCompleted
-
Imperial College LondonUnknownEnd Stage Renal DiseaseUnited Kingdom
-
Theodore MacnowCompleted
-
Chung-Ang UniversityNational Research Foundation of KoreaCompletedNutritional and Metabolic Diseases | Body Weight MaintenanceKorea, Republic of
-
The First Affiliated Hospital of Dalian Medical...LanZhou University; Fudan University; Beijing Friendship Hospital; Chinese PLA... and other collaboratorsActive, not recruitingChronic Kidney DiseaseChina
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Universidad de GranadaUniversidad Pública de NavarraCompletedObesity, Abdominal | Time Restricted Feeding | Cardiometabolic SyndromeSpain