Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts

NCT00983008 | Terminated DMC

• 1 other identifier: 09-085B
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the feasibility and effectiveness of protected time for physicians in training during 30 hour shifts in a medical intensive care unit. The primary outcome will be fatigue. Secondary outcomes include the amount slept while on call, depression, and burnout.

Conditions

Fatigue; Sleep Deprivation; Depression

Keywords

Signs and Symptoms; Internship and Residency; Fatigue; Medical Errors; Burnout, Professional; Actigraphy; Personnel Staffing and Scheduling; Workload; Adult; Intensive Care Units; Prospective Studies; Work Schedule Tolerance; Disorders of Excessive Somnolence; Guideline Adherence; Internal Medicine Education

Outcome Measures

Primary Outcomes (1)

• Fatigue as measured by daytime multiple sleep latency test.

  Once, during last week of intervention.

Secondary Outcomes (3)

• Hours slept during protected time

  Once, during last week of intervention

• Depression

  Once, during last week of intervention

• Burnout

  Once, during last week of intervention

Study Arms (1)

Protected Time Group

EXPERIMENTAL

Interns working 30 hour shifts every 3rd night and an average of 80 hours per week in a medical intensive care unit.

Behavioral: Protected time and Dedicated time

Interventions

Protected time and Dedicated time BEHAVIORAL

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.

Also known as: Nap

Protected Time Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Interns in the Providence St. Vincent Medical Center Internal Medicine Residency Program who are rotating through the medical intensive care unit.

You may not qualify if:

• Refusal to consent to participate

Sponsors & Collaborators

• Providence Health & Services: lead

Study Sites (1)

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Related Publications (14)

• 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.

  PMID: 19052119 BACKGROUND

• 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.

  PMID: 15509817 BACKGROUND

• 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.

  PMID: 17400688 BACKGROUND

• 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.

  PMID: 15647575 BACKGROUND

• 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.

  PMID: 17230382 BACKGROUND

• 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.

  PMID: 18258931 BACKGROUND

• 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.

  PMID: 18173162 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15700727 BACKGROUND

• 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.

  PMID: 18329412 BACKGROUND

• 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.

  PMID: 19017897 BACKGROUND

• 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.

  PMID: 17785643 BACKGROUND

• 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.

  PMID: 17785642 BACKGROUND

• 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.

  PMID: 17548403 BACKGROUND

MeSH Terms

Conditions

Fatigue; Sleep Deprivation; Depression; Signs and Symptoms; Burnout, Professional; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Sleep Disorders, Intrinsic

Study Officials

• Gerald Dunlap, M.D.

  Internal Medicine Resident Program, Providence St. Vincent Medical Center

  PRINCIPAL INVESTIGATOR

• Michelle Sanders, M.D.

  Internal Medicine Resident Program, Providence St. Vincent Medical Center

  STUDY DIRECTOR

• Jay B Ham, M.D.

  Internal Medicine Resident Program, Providence St. Vincent Medical Center

  PRINCIPAL INVESTIGATOR

• Jeffrely Bluhm, M.D.

  Oregon Pulmonology Associates, Portland, Oregon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)