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.
