Burnout, ProfessionalNCT04665505
Resource Optimization in the Intensive Care Unit Setting
A study testing Educational Workshop and Optimizing Staff Scheduling in people with Burnout, Professional, run by Ottawa Hospital Research Institute.
Trial summary
The purpose of the study is to facilitate cost-effective, high quality care within the the ICUs of two Ottawa teaching hospitals through educational workshops and nurse scheduling optimization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Educational Workshop and Optimizing Staff Scheduling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- N/A
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Resource Optimization in the Intensive Care Unit Setting: A Staff Education and Scheduling Pilot Study to Improve Treatment Decisions and Staff Satisfaction
The purpose of the study is to facilitate cost-effective, high quality care within the the ICUs of two Ottawa teaching hospitals through educational workshops and nurse scheduling optimization.
Read the detailed description
This intervention pilot study has been developed for Intensive Care Unit (ICU) physicians and nurses by the Resource Optimization Network (RON) for implementation in The Ottawa Hospital (TOH) Civic Campus and the Montfort Hospital. The intervention targets ICU staff and is designed to reduce overall costs associated with ICU health care service delivery and improve staff satisfaction through reducing stress and associated burnout without sacrificing quality of care and patient outcomes. The intervention involves two components that (a) build ICU staffs' (i.e. physicians and nurses) knowledge to facilitate cost-effective and evidence-based decision making about patient care (including tests, treatments, and procedures); and (b) optimize nurse scheduling to ensure the presence of the appropriate number of nurses per shift, thereby reducing stress, burnout and limiting the need for overtime. To evaluate the impact of the intervention, a pre/post-intervention design will be employed, with a 3-month pre-intervention period, followed by a 6-month intervention period and a 3-month post-intervention period.
- Conditions
- Burnout, Professional
- Being tested
- Educational Workshop, Optimizing Staff Scheduling
- Keywords
- Resource Allocation, Personnel Staffing and Scheduling, Intensive Care Unit, Cost-Effectiveness, Burnout
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational WorkshopBehavioural
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).
Optimizing Staff SchedulingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ICU Staff | Experimental | 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. Receives: Behavioral: Educational Workshop; Behavioral: Optimizing Staff Scheduling |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Costs
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.
Measured: 12 months
ICU Quality Metric 1: Ventilator Associated Pneumonia
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.
Measured: 12 months
ICU Quality Metric 2: Central Line Infections
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.
Measured: 12 Months
ICU Quality Metric 3: C. difficile
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.
Measured: 12 Months
ICU Quality Metric 4: Early Mobilization
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.
Measured: 12 Months
Secondary outcomes (13)
ICU Patient Outcomes 1: Length of Stay
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.
Measured: 12 Months
ICU Patient Outcomes 2: Patient Deaths
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.
Measured: 12 Months
ICU Patient Outcomes 3: Perceived Quality of Care
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.
Measured: 12 Months
ICU Medical Procedures 1: Albumin Use
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.
Measured: 12 Months
ICU Medical Procedures 2: Mechanical Ventilation
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.
Measured: 12 Months
ICU Medical Procedures 3: Chest Radiographs
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.
Measured: 12 Months
ICU Medical Procedures 4: Red Blood Cell Transfusions
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.
Measured: 12 Months
Rate of ICU Staff Absenteeism
We will collect data on ICU full-time staff absenteeism during the study period from the Data Warehouse and Montfort Archives.
Measured: 12 Months
Stakeholder perceptions
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.
Measured: 12 Months
Staff Demographic Variable Collection 1
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.
Measured: 12 months
Staff Demographic Variable Collection 2
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.
Measured: 12 months
Staff Stress Levels and Burnout 1
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.
Measured: 12 months
Staff Stress Levels and Burnout 2
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group data from the 6-month interventional period will be compared to data from the 3-month pre and post interventional periods.
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Montfort, The Ottawa Hospital
- Responsible party
- Principal investigator, Kwadwo Kyeremanteng, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665505
- Sponsor's protocol ID
- 20200060-01
- Status last verified
- Dec 2023
- First submitted
- 10 Nov 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource Optimization in the Intensive Care Unit Setting: A Staff Education and Scheduling Pilot Study to Improve Treatment Decisions and Staff Satisfaction
- ClinicalTrials.gov ID
- NCT04665505
- Acronym / sponsor ID
- 20200060-01
- Conditions
- Burnout, Professional
- Keywords
- Resource Allocation, Personnel Staffing and Scheduling, Intensive Care Unit, Cost-Effectiveness, Burnout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Hopital Montfort, The Ottawa Hospital
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to facilitate cost-effective, high quality care within the the ICUs of two Ottawa teaching hospitals through educational workshops and nurse scheduling optimization.
Detailed description
This intervention pilot study has been developed for Intensive Care Unit (ICU) physicians and nurses by the Resource Optimization Network (RON) for implementation in The Ottawa Hospital (TOH) Civic Campus and the Montfort Hospital. The intervention targets ICU staff and is designed to reduce overall costs associated with ICU health care service delivery and improve staff satisfaction through reducing stress and associated burnout without sacrificing quality of care and patient outcomes. The intervention involves two components that (a) build ICU staffs' (i.e. physicians and nurses) knowledge to facilitate cost-effective and evidence-based decision making about patient care (including tests, treatments, and procedures); and (b) optimize nurse scheduling to ensure the presence of the appropriate number of nurses per shift, thereby reducing stress, burnout and limiting the need for overtime. To evaluate the impact of the intervention, a pre/post-intervention design will be employed, with a 3-month pre-intervention period, followed by a 6-month intervention period and a 3-month post-intervention period.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group data from the 6-month interventional period will be compared to data from the 3-month pre and post interventional periods.
| Arm | Type | Receives |
|---|---|---|
| ICU Staff | Experimental | Behavioral: Educational Workshop, Behavioral: Optimizing Staff SchedulingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational WorkshopThe 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). | Behavioural | ICU Staff |
| Optimizing Staff SchedulingThis 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. | Behavioural | ICU Staff |
Primary outcome
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.
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.
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.
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.
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.
13 secondary outcomes
ICU Patient Outcomes 1: Length of Stay
Time frame: 12 Months
ICU Patient Outcomes 2: Patient Deaths
Time frame: 12 Months
ICU Patient Outcomes 3: Perceived Quality of Care
Time frame: 12 Months
ICU Medical Procedures 1: Albumin Use
Time frame: 12 Months
ICU Medical Procedures 2: Mechanical Ventilation
Time frame: 12 Months
ICU Medical Procedures 3: Chest Radiographs
Time frame: 12 Months
ICU Medical Procedures 4: Red Blood Cell Transfusions
Time frame: 12 Months
Rate of ICU Staff Absenteeism
Time frame: 12 Months
Stakeholder perceptions
Time frame: 12 Months
Staff Demographic Variable Collection 1
Time frame: 12 months
Staff Demographic Variable Collection 2
Time frame: 12 months
Staff Stress Levels and Burnout 1
Time frame: 12 months
Staff Stress Levels and Burnout 2
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Workshop and Optimizing Staff Scheduling in people with Burnout, Professional, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwadwo Kyeremanteng, MD, MHA (6137193742, kwadwo77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Costs (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.