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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04665505
Other study ID # 20200060-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date September 2025

Study information

Verified date December 2023
Source Ottawa Hospital Research Institute
Contact Kwadwo Kyeremanteng, MD, MHA
Phone 6137193742
Email kwadwo77@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 73
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Workshop
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 Scheduling
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Hopital Montfort, The Ottawa Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Primary 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. 12 months
Primary 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. 12 Months
Primary 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. 12 Months
Primary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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. 12 Months
Secondary 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.
12 months
Secondary 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.
12 months
Secondary 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.
12 months
Secondary 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.
12 months
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