NCT06359587

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700,000

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
May 2024Nov 2026

First Submitted

Initial submission to the registry

April 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

April 8, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in number of total laboratory tests ordered per patient-day with the LTO bundle

    3 years

  • Rate of hospital re-admissions and mortality

    3 years

  • Change in costs associated with routine laboratory testing

    3 years

Study Arms (2)

Intervention Arm (Intervention Bundle Implementation)

EXPERIMENTAL

This arm involves the time periods of the hospital units where the LTO bundle, including healthcare provider and patient engagement tools, is actively implemented.

Behavioral: Laboratory test overuse (LTO) Bundle

Control Arm (No LTO Bundle Implementation)

NO INTERVENTION

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

Interventions

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 Arm (Intervention Bundle Implementation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital of Northern British Columbia

Prince George, British Columbia, V2M 1S2, Canada

RECRUITING

Mount St. Joseph's Hospital

Vancouver, British Columbia, V5T3N4, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z1N1, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Iatrogenic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anshula Ambasta

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anshula Ambasta

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 11, 2024

Study Start

May 6, 2024

Primary Completion (Estimated)

November 16, 2026

Study Completion (Estimated)

November 16, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Locations