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

Primary Purpose

Fatigue, Sleep Deprivation, Depression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protected time and Dedicated time
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fatigue focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence St. Vincent Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Protected Time Group

Arm Description

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

Outcomes

Primary Outcome Measures

Fatigue as measured by daytime multiple sleep latency test.

Secondary Outcome Measures

Hours slept during protected time
Depression
Burnout

Full Information

First Posted
September 22, 2009
Last Updated
September 24, 2019
Sponsor
Providence Health & Services
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1. Study Identification

Unique Protocol Identification Number
NCT00983008
Brief Title
Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
Official Title
A Prospective Cohort Study on the Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Too few interns willing to consent to wear the actigraph watches.
Study Start Date
October 2009 (Actual)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Providence Health & Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protected Time Group
Arm Type
Experimental
Arm Description
Interns working 30 hour shifts every 3rd night and an average of 80 hours per week in a medical intensive care unit.
Intervention Type
Behavioral
Intervention Name(s)
Protected time and Dedicated time
Other Intervention Name(s)
Nap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue as measured by daytime multiple sleep latency test.
Time Frame
Once, during last week of intervention.
Secondary Outcome Measure Information:
Title
Hours slept during protected time
Time Frame
Once, during last week of intervention
Title
Depression
Time Frame
Once, during last week of intervention
Title
Burnout
Time Frame
Once, during last week of intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Dunlap, M.D.
Organizational Affiliation
Internal Medicine Resident Program, Providence St. Vincent Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Sanders, M.D.
Organizational Affiliation
Internal Medicine Resident Program, Providence St. Vincent Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jay B Ham, M.D.
Organizational Affiliation
Internal Medicine Resident Program, Providence St. Vincent Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrely Bluhm, M.D.
Organizational Affiliation
Oregon Pulmonology Associates, Portland, Oregon
Official's Role
Study Director
Facility Information:
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19052119
Citation
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.
Results Reference
background
PubMed Identifier
15509817
Citation
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.
Results Reference
background
PubMed Identifier
17400688
Citation
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.
Results Reference
background
PubMed Identifier
15647575
Citation
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.
Results Reference
background
PubMed Identifier
17230382
Citation
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.
Results Reference
background
PubMed Identifier
18258931
Citation
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.
Results Reference
background
PubMed Identifier
18173162
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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PubMed Identifier
15700727
Citation
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.
Results Reference
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PubMed Identifier
18329412
Citation
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.
Results Reference
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PubMed Identifier
19017897
Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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Results Reference
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Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts

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