Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia

NCT ID: NCT06359587

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

700000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hospital Acquired Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Intervention Arm (Intervention Bundle Implementation):

This arm involves the time periods where hospital units are actively receiving the intervention bundle, including healthcare provider (HCP) and patient engagement tools.

Control Arm (No Intervention Bundle Implementation):

This arm represents the time periods when the hospital units do not receive the intervention bundle. This time period is the control period. Each hospital will contribute to intervention and control period data.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laboratory test overuse (LTO) Bundle

Intervention Type BEHAVIORAL

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.

Control Arm (No LTO Bundle Implementation)

This arm represents the time period of hospital units where the LTO bundle is not implemented.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Providence Health & Services

OTHER

Sponsor Role collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role collaborator

Fraser Health

OTHER

Sponsor Role collaborator

Interior Health

INDUSTRY

Sponsor Role collaborator

Northern Hospital, Australia

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Island Health

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Anshula Ambasta

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anshula Ambasta

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University Hospital of Northern British Columbia

Prince George, British Columbia, Canada

Site Status RECRUITING

Mount St. Joseph's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anshula Ambasta

Role: CONTACT

Phone: 4036184586

Email: [email protected]

Facility Contacts

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Anurag Singh

Role: primary

Alyssa Shariff

Role: primary

Penny Tam

Role: primary

Anshula Ambasta

Role: primary

References

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Ambasta A, Holroyd-Leduc JM, Pokharel S, Mathura P, Shih AW, Stelfox HT, Ma I, Harrison M, Manns B, Faris P, Williamson T, Shukalek C, Santana M, Omodon O, McCaughey D, Kassam N, Naugler C. Re-Purposing the Ordering of Routine Laboratory Tests in Hospitalized Medical Patients (RePORT): protocol for a multicenter stepped-wedge cluster randomised trial to evaluate the impact of a multicomponent intervention bundle to reduce laboratory test over-utilization. Implement Sci. 2024 Jul 2;19(1):45. doi: 10.1186/s13012-024-01376-6.

Reference Type DERIVED
PMID: 38956637 (View on PubMed)

Other Identifiers

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H22-03005

Identifier Type: -

Identifier Source: org_study_id