Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study - Full Text View

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:

MedlinePlus related topics: Patient Safety

U.S. FDA Resources

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

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 May 22, 2013