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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359587
Other study ID # H22-03005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 6, 2024
Est. completion date October 1, 2026

Study information

Verified date April 2024
Source University of British Columbia
Contact Anshula Ambasta
Phone 4036184586
Email anshula.ambasta@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this stepped-wedge cluster randomized trial is to assess the impact of a laboratory test overuse intervention bundle on laboratory test utilization in 6 health authorities (16 hospitals) in British Columbia. The main question it aims to answer is if the intervention bundle, inclusive of healthcare provider and patient engagement tools, can be effectively implemented for hospitalized medical inpatients in 16 hospitals across BC and reduce laboratory test over-use. Researchers will compare hospital clusters that receive the intervention at different (sequential) time points to see if there are significant changes in the measured outcomes after the intervention.


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. Historical data from March 2018 will be collected to understand trends, including the impact of electronic medical record (EMR) implementation and coronavirus disease (COVID-19) on laboratory test utilization. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 700000
Est. completion date October 1, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Laboratory test overuse (LTO) Bundle
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.

Locations

Country Name City State
n/a

Sponsors (8)

Lead Sponsor Collaborator
University of British Columbia Canadian Institutes of Health Research (CIHR), Fraser Health, Interior Health, Island Health, Northern Hospital, Australia, Providence Health & Services, Vancouver Coastal Health

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle The change in the number of the six target laboratory tests with the LTO bundle 3 years
Secondary Change in number of total laboratory tests ordered per patient-day with the LTO bundle Change in the number of all common laboratory tests ordered during the study with the LTO bundle 3 years
Secondary Rate of hospital re-admissions and mortality Rate of hospital re-admission and mortality rates over study period with LTO intervention bundle 3 years
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