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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patient Safety, Resident Work Hours

Intervention / Treatment
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* Behavioral: Intervention work shift


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional work schedule<br>Residents in the intensive care unit perform overnight shifts in excess of 24 hrs every fourth night | |
| Active Comparator: Intervention work schedule<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of scheduled and unscheduled learning activities residents participate in | Assessed by review of sleep/activity log | End of each 28 day rotation | 
| Resident leisure time, sleep, and time spent in the hospital | Assessed by review of sleep/activity log | End of each 28 day rotation | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| Resident knowledge acquisition and retention | Scores on validated multiple choice question exams | End of each 28 day rotation | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical education, graduate, Patient care, Outcome assessment (Health care), Work schedule tolerance