- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359587
Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia (RePORT-BC)
Re-Purposing the Ordering of Routine Laboratory Testing in Hospitalized Medical Patients in British Columbia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to reduce unnecessary laboratory test use in hospitals using a stepped-wedge cluster randomized trial design. Over-use of laboratory testing in hospitals leads to patient discomfort, disruption of sleep patterns, and is associated with hospital-acquired anemia. The specific tests that the investigators focus on are complete blood count, electrolytes, creatinine, urea, international normalized ratio and partial thromboplastin time. After the initial control period, the investigators will begin with a pilot-phase for a feasibility assessment of the intervention tools. The intervention bundle will then be rolled out sequentially, one cluster (each cluster containing 2-3 hospitals) at a time in 12-week implementation steps.
The intervention bundle will contain tools to promote education around appropriate use of laboratory testing in hospitals (using an online module, clinical decision support tool), will share data on laboratory test utilization patterns locally, and include patient engagement materials (infographic and video).
Local champions in hospitals will form multidisciplinary implementation teams to facilitate adaptation and delivery of implementation tools within local context. A pragmatic stepped-wedge design will be used to implement the intervention bundle in 16 hospitals grouped into 8 clusters.
The first 4 weeks of implementation will be a pre-intervention period, trialing and adapting tools to the local context. Readiness assessments and workflow observations will be conducted to understand organizational readiness for implementation. Clusters will enter the intervention period during the latter 8 weeks of the implementation period where intervention tools will be deployed.
Data will be collected for at least 24 weeks post-implementation, evaluating the impact of tools without dedicated personnel support. Access to educational resources will continue, and laboratory utilization reports will be sent.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anshula Ambasta
- Phone Number: 4036184586
- Email: anshula.ambasta@ubc.ca
Study Locations
-
-
British Columbia
-
Prince George, British Columbia, Canada, V2M 1S2
- Recruiting
- University Hospital of Northern British Columbia
-
Contact:
- Anurag Singh
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Recruiting
- St. Paul's Hospital
-
Contact:
- Anshula Ambasta
-
Vancouver, British Columbia, Canada, V5T3N4
- Recruiting
- Mount St. Joseph's Hospital
-
Contact:
- Alyssa Shariff
-
Vancouver, British Columbia, Canada, V5Z1N1
- Recruiting
- Vancouver General Hospital
-
Contact:
- Penny Tam
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Participants involved in this study include the following groups: patients and healthcare providers (including learners, physicians and allied health staff)
Inclusion Criteria:
- Patients: The study will include all adult general medical patients that are admitted to the selected hospital during the study period under general internal medicine or family medicine (hospitalist) provider groups.
- Attending Physicians: All physicians who provide patient care in the general internal medicine or family medicine (hospitalist) provider groups in selected hospitals
- Learners and allied health staff (Medical Students/Resident physicians/Clinical Assistants/ Nurse Practitioners, etc.): All those who help take care of patients and can order labs during the study period in the under general internal medicine or family medicine (hospitalist) provider groups in selected hospitals The date range for both groups will extend from May 2024 until study completion in October 2026.
Exclusion Criteria:
- Patients: all patients in specialized medical units (e.g., coronary care, dialysis units, bone marrow transplants units etc.), in critical care, pediatric, obstetrical, surgical, and psychiatric units.
- Patients and Health Care Providers (HCPs) who are not in the internal medicine or family medicine groups
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm (Intervention Bundle Implementation)
This arm involves the time periods of the hospital units where the LTO bundle, including healthcare provider and patient engagement tools, is actively implemented.
|
Key Components of the LTO Bundle: Educational materials, including an online module, clinical decision support tool, provision of lab utilization (Audit and Feedback) reports for healthcare providers. Patient engagement tools, such as videos and educational infographics. System level implementation tools adapted to the local context, including EMR-based tools and order set changes, etc. |
|
No Intervention: Control Arm (No LTO Bundle Implementation)
This arm represents the time period of hospital units where the LTO bundle is not implemented.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle
Time Frame: 3 years
|
The change in the number of the six target laboratory tests with the LTO bundle
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of total laboratory tests ordered per patient-day with the LTO bundle
Time Frame: 3 years
|
Change in the number of all common laboratory tests ordered during the study with the LTO bundle
|
3 years
|
|
Rate of hospital re-admissions and mortality
Time Frame: 3 years
|
Rate of hospital re-admission and mortality rates over study period with LTO intervention bundle
|
3 years
|
|
Change in costs associated with routine laboratory testing
Time Frame: 3 years
|
Change in costs associated with routine laboratory testing
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anshula Ambasta, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-03005 (University of British Columbia)
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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