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

Patient Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01398878
• Other study ID #: H09-02007
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2011
• Last updated: July 22, 2011
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2011
• Source: University of British Columbia
• Contact: Najib Ayas, MD MPH
• Phone: 604-806-9429
• Email: NAyas[@]providencehealth.bc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Patient Safety
• Resident Work Hours

Intervention

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

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Michael Smith Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Quantity of scheduled and unscheduled learning activities residents participate in	Assessed by review of sleep/activity log	End of each 28 day rotation	No
Secondary	Resident leisure time, sleep, and time spent in the hospital	Assessed by review of sleep/activity log	End of each 28 day rotation	No
Secondary	Professionalism	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.	End of each 28 day rotation	No
Secondary	Nursing impact	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.	Over course of study (12 months)	No
Secondary	Attending physician workload	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.	Over course of study (12 months)	No
Secondary	Perceived continuity of care	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.	Over course of study (12 months)	No
Secondary	Quality of life	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.	End of each 28 day rotation	No
Secondary	Resident knowledge acquisition and retention	Scores on validated multiple choice question exams	End of each 28 day rotation	No
Secondary	Patient satisfaction	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.	Within two weeks of ICU discharge	No
Secondary	Job satisfaction/Stress	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.	End of each 28 day rotation	No