Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study

NCT01398878 | Unknown

• 1 other identifier: H09-02007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of eliminating traditional resident work shifts (i.e. greater than 24 hours in length) on patient safety and resident educational outcomes. In addition, the investigators will explore with key stakeholders (patients and their families, nurses, resident physicians and attending physicians) their experiences when residents are undertaking shifts greater than 24 hours in length as compared to 16 hours or less.

Conditions

Patient Safety; Resident Work Hours

Keywords

Medical education, graduate; Patient care; Outcome assessment (Health care); Work schedule tolerance

Outcome Measures

Primary Outcomes (1)

• Preventable adverse events

  The primary outcome is the rate of preventable adverse events per 1000 patient days. An adverse event will be defined as any unplanned injury arising as a consequence of medical care that is associated with morbidity, requires treatment, prolongs hospital stay, or results in disability at discharge. Adverse events are not caused by the disease process itself, but do include any procedural or therapeutic complications. Preventable adverse events will be defined as those adverse events that could have been avoided given current knowledge and standards of care.

  Occurring during course of ICU admission and within first 72 hours of ICU discharge if event is attributable to process of care in the ICU

Secondary Outcomes (10)

• Quantity of scheduled and unscheduled learning activities residents participate in

  End of each 28 day rotation

• Resident leisure time, sleep, and time spent in the hospital

  End of each 28 day rotation

• Professionalism

  End of each 28 day rotation

• Nursing impact

  Over course of study (12 months)

• Attending physician workload

  Over course of study (12 months)

Study Arms (2)

Traditional work schedule

NO INTERVENTION

Residents in the intensive care unit perform overnight shifts in excess of 24 hrs every fourth night

Intervention work schedule

ACTIVE COMPARATOR

Residents in the Intensive Care Unit perform shifts less than 16 hours in length and have at least 8 hours off between shifts

Behavioral: Intervention work shift

Interventions

Intervention work shift BEHAVIORAL

Shiftwork schedule with elimination of shifts greater than 16 hours in length and at least 8 hours off between shifts for all residents in the Intensive Care Unit

Intervention work schedule

Eligibility Criteria

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

You may qualify if:

• Residents completing Intensive Care Unit rotations
• For focus groups and interviews, patients and families members admitted during the study period and nurses and attending physicians working during the study period

You may not qualify if:

• None

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Michael Smith Foundation: collaborator

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

Study Officials

• Najib Ayas, MD MPH

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Najib Ayas, MD MPH

CONTACT

604-806-9429; NAyas@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 21, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

CA (1)