FatigueNCT00983008
Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
A study testing Protected time and Dedicated time in people with Fatigue and Sleep Deprivation, run by Providence Health & Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fatigue, Sleep Deprivation, Depression
- What is being tested?
- Protected time and Dedicated time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2010
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Interns in the Providence St. Vincent Medical Center Internal Medicine Residency Program who are rotating through the medical intensive care unit.
Who cannot join
- Refusal to consent to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St. Vincent Medical Center
Portland, Oregon, 97225
About this study
Official title: A Prospective Cohort Study on the Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
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.
Read the 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).
- Conditions
- Fatigue, Sleep Deprivation, Depression
- Being tested
- Protected time and Dedicated time
- 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
- Medical subject headings
- Fatigue, Sleep Deprivation, Depression, Signs and Symptoms, Burnout, Professional, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protected time and Dedicated timeBehavioural
Also called Nap
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Protected time and Dedicated time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue as measured by daytime multiple sleep latency test.
Measured: Once, during last week of intervention.
Secondary outcomes (3)
Hours slept during protected time
Measured: Once, during last week of intervention
Depression
Measured: Once, during last week of intervention
Burnout
Measured: Once, during last week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Too few interns willing to consent to wear the actigraph watches.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Schoepflin Sanders, Providence Health & Services
- Investigators
- Gerald Dunlap, M.D., Principal investigator, Internal Medicine Resident Program, Providence St. Vincent Medical CenterMichelle Sanders, M.D., Study director, Internal Medicine Resident Program, Providence St. Vincent Medical CenterJay B Ham, M.D., Principal investigator, Internal Medicine Resident Program, Providence St. Vincent Medical CenterJeffrely Bluhm, M.D., Study director, Oregon Pulmonology Associates, Portland, Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983008
- Sponsor's protocol ID
- 09-085B
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2009
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19052119Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA; New Collective Author. 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.
PubMed 15509817Parthasarathy 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.
PubMed 17400688Barger 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.
PubMed 15647575Fisman 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.
PubMed 17230382Fahrenkopf 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.
PubMed 18258931Lockley 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.
PubMed 18173162Resident 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.
PubMed 15700727Pizza 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.
PubMed 18329412Reddy 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.
PubMed 19017897Volpp 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.
PubMed 17785643Volpp 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.
PubMed 17785642Shetty 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.
PubMed 17548403
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts
- ClinicalTrials.gov ID
- NCT00983008
- Acronym / sponsor ID
- 09-085B
- Conditions
- Fatigue, Sleep Deprivation, Depression
- Keywords
- Signs and Symptoms, Internship and Residency, Fatigue, Medical Errors, Burnout, Professional, Actigraphy, Personnel Staffing and Scheduling, Workload
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too few interns willing to consent to wear the actigraph watches.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Sep 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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protected Time Group | Experimental | Behavioral: Protected time and Dedicated timeInterns working 30 hour shifts every 3rd night and an average of 80 hours per week in a medical intensive care unit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Interns in the Providence St. Vincent Medical Center Internal Medicine Residency Program who are rotating through the medical intensive care unit.
Key exclusion criteria (1 listed)
- Refusal to consent to participate
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 |
|---|---|---|
| Protected time and Dedicated timeAlso: NapOn 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. | Behavioural | Protected Time Group |
Primary outcome
Fatigue as measured by daytime multiple sleep latency test.
Time frame: Once, during last week of intervention.
3 secondary outcomes
Hours slept during protected time
Time frame: Once, during last week of intervention
Depression
Time frame: Once, during last week of intervention
Burnout
Time frame: Once, during last week of intervention
Results and safety
The study was stopped early (reason given: Too few interns willing to consent to wear the actigraph watches.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 19052119Iglehart 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.
- Background: PubMed 15509817Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA; New Collective Author. 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.
- Background: PubMed 17400688Parthasarathy 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.
- Background: PubMed 15647575Barger 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.
- Background: PubMed 17230382Fisman 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.
- Background: PubMed 18258931Fahrenkopf 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.
- Background: PubMed 18173162Lockley 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.
- BackgroundResident 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: PubMed 15700727Littner 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.
- Background: PubMed 18329412Pizza 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.
- Background: PubMed 19017897Reddy 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.
- Background: PubMed 17785643Volpp 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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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.
Gerald Dunlap, M.D. principal investigator
Internal Medicine Resident Program, Providence St. Vincent Medical Center
Michelle Sanders, M.D. study director
Internal Medicine Resident Program, Providence St. Vincent Medical Center
Jay B Ham, M.D. principal investigator
Internal Medicine Resident Program, 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 Protected time and Dedicated time in people with Fatigue and Sleep Deprivation, 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: stopped early, as of the sponsor's last update on 26 Sep 2019. 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 was stopped early (reason given: Too few interns willing to consent to wear the actigraph watches.). Results are not available in the source record.
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?
Fatigue as measured by daytime multiple sleep latency test. (time frame: Once, during last week of intervention.). 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 NCT00983008, which also lists 14 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 26 Sep 2019.