- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665505
Resource Optimization in the Intensive Care Unit Setting
Resource Optimization in the Intensive Care Unit Setting: A Staff Education and Scheduling Pilot Study to Improve Treatment Decisions and Staff Satisfaction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kwadwo Kyeremanteng, MD, MHA
- Phone Number: 6137193742
- Email: kwadwo77@gmail.com
Study Contact Backup
- Name: Julia Hajjar, PhD (c)
- Phone Number: 6132228251
- Email: jhajjar@toh.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Employees aged 18 year and older who provide direct patient care in the ICU at the Civic Campus of the Ottawa Hospital or the Montfort Hospital as physicians, nurses, or allied health professionals (e.g., respiratory therapists, occupational therapists).
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ICU Staff
The study group is composed of ICU care providers at the Ottawa Hospital Civic campus and the Montfort Hospital, including intensivists, fellows, nurses and allied health professionals.
The study site participant breakdown is approximately 58 TOH staff respondents and 15 Montfort respondents.
|
The intervention consists of providing educational content for all ICU care providers concerning building staff knowledge surrounding methods to facilitate cost-effective and evidence-based decision-making about patient care (including tests, treatments, and procedures).
The first intervention is an educational workshop to increase staffs' awareness of the current Choosing Wisely Canada Critical Care strategies and recommendations to facilitate cost-effective and evidence-based decision-making about patient care (including tests, treatments, and procedures).
This initiative will focus solely on the nurse subgroup and concerns schedule optimization to ensure the presence of the appropriate number of nurses per shift, thereby reducing stress, burnout and limiting the need for overtime.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU Costs
Time Frame: 12 months
|
Case costing will be used to determine the costs associated with ICU care during the study period, including: a) ICU total costs; b) ICU direct costs (i.e., all expenses to the hospital with fee codes linked to patient chart); c) ICU indirect costs (i.e., any overhead operational fees associated with service provided to patient); d) ICU cost/patient.
|
12 months
|
|
ICU Quality Metric 1: Ventilator Associated Pneumonia
Time Frame: 12 months
|
This outcome will be included to evaluate the quality of ICU patient care during the study period.
The number of patients who develop ventilator associated pneumonia will be collected from the TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 months
|
|
ICU Quality Metric 2: Central Line Infections
Time Frame: 12 Months
|
This outcome will be included to evaluate the quality of ICU patient care during the study period.
The number of patients who develop central line infections will be collected from the TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Quality Metric 3: C. difficile
Time Frame: 12 Months
|
This outcome will be included to evaluate the quality of ICU patient care during the study period.
The number of patients who develop C. difficile infections will be collected from the TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Quality Metric 4: Early Mobilization
Time Frame: 12 Months
|
This outcome will be included to evaluate the quality of ICU patient care during the study period.
The number of patients who receive early mobilization will be collected from the TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU Patient Outcomes 1: Length of Stay
Time Frame: 12 Months
|
Metrics for evaluation concerning patient outcomes include measurement of length of stay within the ICU in days, or LOS.
Patient data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Patient Outcomes 2: Patient Deaths
Time Frame: 12 Months
|
Metrics for evaluation concerning patient outcomes include measurement of the number of patients who die within the ICU.
Patient data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Patient Outcomes 3: Perceived Quality of Care
Time Frame: 12 Months
|
Metrics for evaluation concerning patient outcomes include measurement of the quality of care perceived by patients and their families.
Data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Medical Procedures 1: Albumin Use
Time Frame: 12 Months
|
Metrics for evaluation concerning ICU medical procedures specifically targeted in the educational intervention component include the rate of albumin used per ICU admission (bags of albumin used/admission).
Patient data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Medical Procedures 2: Mechanical Ventilation
Time Frame: 12 Months
|
Metrics for evaluation concerning ICU medical procedures specifically targeted in the educational intervention component include the number of patients mechanically ventilated, and the duration of their ventilation in days.
Patient data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Medical Procedures 3: Chest Radiographs
Time Frame: 12 Months
|
Metrics for evaluation concerning ICU medical procedures specifically targeted in the educational intervention component include the number of ICU patient chest radiographs completed per day.
Patient data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
ICU Medical Procedures 4: Red Blood Cell Transfusions
Time Frame: 12 Months
|
Metrics for evaluation concerning ICU medical procedures specifically targeted in the educational intervention component include the rate of red blood cell transfusions per admission.
The amount of red blood cell transfusions administered (measured in bags/admission) will be monitored throughout ICU admission.
Patient data used for this analysis will be collected from TOH Data Warehouse and Montfort's Department of Archives and Decision Support.
|
12 Months
|
|
Rate of ICU Staff Absenteeism
Time Frame: 12 Months
|
We will collect data on ICU full-time staff absenteeism during the study period from the Data Warehouse and Montfort Archives.
|
12 Months
|
|
Stakeholder perceptions
Time Frame: 12 Months
|
8-15 ICU stakeholder staff with special knowledge of ICU activities will be recruited for post-interventional interviews.
The semi-structured interviews will be conducted by trained research staff and will use the Post-Intervention Semi-Structured Interview Guide to assess the stakeholders' perceptions of intervention outcomes.
Stakeholders will be asked open-ended questions about their knowledge of the interventions implemented during the study period, their perceptions of the outcomes of these interventions, and any perceived changes in ICU care delivery in time period that corresponds to the post-intervention phase of the study.
The interview will last approximately 30 minutes and will be digitally recorded and transcribed.
Specific topics of discussion include introduction, participant's definition/perception of their field, quality of care, team morale/staff satisfaction and final thoughts/comments.
|
12 Months
|
|
Staff Demographic Variable Collection 1
Time Frame: 12 months
|
A 15-20 minute self-administered online questionnaire will be used to obtain demographic information. It will include 9 questions, 6 of which are qualitative such as ICU role, part time or full time status, types of shifts worked, age group, gender identity (optional), and staff turnover. The 3 quantitative questions are measured from 0-5, where 0 is strongly disagree/very dissatisfied and 5 is strongly agree/very satisfied. Satisfaction relates to both job satisfaction and perceptions on whether staffing is efficient and promotes quality of care. Perceptions on quality of care will be measured based on agreement with the statement "there are adequate support services to allow sufficient patient interactions". Team morale has 3 sub questions: whether ICU physicians, nurses and allied health professional have good working relations, whether supervisory staff is supportive of ICU staff and whether there is sufficient teamwork between health care professionals. |
12 months
|
|
Staff Demographic Variable Collection 2
Time Frame: 12 months
|
The Education Evaluation Survey will be administered at the end of the workshop and emailed the day after to obtain post-intervention data. Participants will identify their job position and any prior knowledge relating to test/treatment/procedure misuse in Canadian hospitals. They will detail their comfort prior to the workshop in engaging in conversations with patients about reducing unnecessary standard tests/treatments. Questions 4-8 can be answered by agree, neutral, disagree, don't know/non-applicable. I enjoyed the workshop, topic and lecture. I enjoyed the discussion among my peers. I have an increased awareness of what standard tests, treatments and procedures may be unnecessary or even harmful to my patients. I feel more comfortable about sharing knowledge with my peers and patients about what standard tests, treatments and procedures may be unnecessary or even harmful to my patients. I am more likely to engage in reflexive practices related to my healthcare practice. |
12 months
|
|
Staff Stress Levels and Burnout 1
Time Frame: 12 months
|
The short self-administered online questionnaire will evaluate ICU staff stress and burnout, as well as demographic variables discussed above. It will contain questions from the Perceived Stress Scale (PSS). The PSS consists of 10 questions, answered on a scale of 0-4 depending on the frequency of which the behavior is observed, with 0 indicating "never" and 4 indicating "very often". Overall, a score of 0 indicates low stress, while a score of 40 indicates an individual with high perceived stress levels. |
12 months
|
|
Staff Stress Levels and Burnout 2
Time Frame: 12 months
|
The short self-administered online questionnaire will evaluate ICU staff stress and burnout, as well as demographic variables discussed above. It will contain questions from the Maslach Burnout Inventory (MBI). The MBI is a 22 question survey which evaluates 3 subscales; emotional exhaustion, depersonalization and reduced personal accomplishment. Each question is rated from 1 to 5, where 1 is strongly disagree and 5 is strongly agree. A high score on the emotional exhaustion subscale (27+) coupled with a high score on the depersonalization scale (10+) indicates that the individual may be experiencing 1+ symptoms of burnout. |
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200060-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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