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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Michael Smith Foundation
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01398878
First received: July 11, 2011
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Patient Safety
Resident Work Hours
Behavioral: Intervention work shift

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Preventable adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Quantity of scheduled and unscheduled learning activities residents participate in [ Time Frame: End of each 28 day rotation ] [ Designated as safety issue: No ]
    Assessed by review of sleep/activity log

  • Resident leisure time, sleep, and time spent in the hospital [ Time Frame: End of each 28 day rotation ] [ Designated as safety issue: No ]
    Assessed by review of sleep/activity log

  • Professionalism [ Time Frame: End of each 28 day rotation ] [ Designated as safety issue: No ]
    In order to further explore this qualitative outcome measure, during structured interviews of residents, attending physicians, nurses and patients and their families, specific questions will be used to probe the perceived level of resident professionalism. For example, degree of commitment and professional investment in individual patients, and degree of commitment to the profession of medicine.

  • Nursing impact [ Time Frame: Over course of study (12 months) ] [ Designated as safety issue: No ]
    In order to further explore this qualitative outcome measure, during focus groups with nurses specific questions will be used to probe the perceived level of impact on nursing.

  • Attending physician workload [ Time Frame: Over course of study (12 months) ] [ Designated as safety issue: No ]
    In order to further explore this qualitative outcome measure, during structured interviews of attending physicians specific questions will be used to probe the perceived level of physician workload. For example, the difference in level of direct involvement in patient care activities (writing notes, performing procedures, etc) between the two schedules.

  • Perceived continuity of care [ Time Frame: Over course of study (12 months) ] [ Designated as safety issue: No ]
    In order to further explore this qualitative outcome measure, during structured interviews of residents, attending physicians, nurses and patients and their families, specific questions will be used to probe the perceived level of continuity of care.

  • Quality of life [ Time Frame: End of each 28 day rotation ] [ Designated as safety issue: No ]
    In order to further explore this qualitative outcome measure, during structured interviews of residents specific questions will be used to probe the perceived level of quality of life for the different call schedules.

  • Resident knowledge acquisition and retention [ Time Frame: End of each 28 day rotation ] [ Designated as safety issue: No ]
    Scores on validated multiple choice question exams

  • Patient satisfaction [ Time Frame: Within two weeks of ICU discharge ] [ Designated as safety issue: No ]
    Given the multitude of potential variables that impact patient satisfaction, during the interviews of patients and their families, the following questions will be used to inform the outcome measure: a global assessment of the patient's experience, their satisfaction with the overall care provided by the healthcare team and their satisfaction with their experiences with resident physicians in particular.

  • Job satisfaction/Stress [ Time Frame: End of each 28 day rotation ] [ Designated as safety issue: No ]
    In order to further explore this qualitative outcome measure, during structured interviews of residents specific questions will be used to probe the perceived level of job satisfaction and stress for the different call schedules.


Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Traditional work schedule
Residents in the intensive care unit perform overnight shifts in excess of 24 hrs every fourth night
Active Comparator: Intervention work schedule
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398878

Contacts
Contact: Najib Ayas, MD MPH 604-806-9429 NAyas@providencehealth.bc.ca

Locations
Canada, British Columbia
St Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Najib Ayas, MD MPH    604-806-9420    Nayas@providencehealth.bc.ca   
Principal Investigator: Najib Ayas, MD MPH         
Sub-Investigator: Adam Peets, MD MSc         
Sub-Investigator: Peter Dodek, MD MHSc         
Sub-Investigator: Natalie Henrich, PhD         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Michael Smith Foundation
Investigators
Principal Investigator: Najib Ayas, MD MPH University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Najib Ayas, University of British Columbia
ClinicalTrials.gov Identifier: NCT01398878     History of Changes
Other Study ID Numbers: H09-02007
Study First Received: July 11, 2011
Last Updated: July 22, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Medical education, graduate
Patient care
Outcome assessment (Health care)
Work schedule tolerance

ClinicalTrials.gov processed this record on November 25, 2014