Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit

Depression Clinical Trial

Official title:

Effect of Reducing ICU Interns' Work Hours on Sleep, Intern Well-Being, and Medical Errors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996320
• Other study ID #: IRB 08-74B
• Status: Completed
• Phase: N/A
• First received: August 28, 2009
• Last updated: October 15, 2009
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2009
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.

Description:

Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Interns rotating at Providence St. Vincent Medical Center ICU

Exclusion Criteria:

• Diagnosis of narcolepsy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Sleep Deprivation

Intervention

Other:
• Reduced work hour schedule
Interns on the intervention schedule work an average of 60 hours per week over 4 weeks, with maximum shift length 16 hours.

Locations

Country	Name	City	State
United States	Providence St. Vincent Medical Center Intensive Care Unit	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Providence Health & Services	Providence Center for Outcomes Research and Education, Providence St. Vincent Department of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple Sleep Latency Test		Measured once a month for each intern while on ICU rotation, at least 14 days into the scheduled 28 day cycle	No
Secondary	Hours slept per night measured by actigraphy		Daily	No
Secondary	Pharmaceutical order error rate		Daily	No
Secondary	Burnout measured by Maslach Burnout Inventory		Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation	No
Secondary	Beck Depression Inventory, Second Edition (BDI-II)		Measured once per month for each intern while on ICU rotation, at least 14 days into the 28 day rotation	No
Secondary	Hours worked per shift on the traditional and intervention schedules		Daily	No