NCT06119464

Brief Summary

Laboratory test overuse occurs when tests are ordered repetitively, without due consideration of impact on clinical status. Repetitive inpatient lab testing often provides limited value for patient outcomes while increasing healthcare costs, patient discomfort, and unnecessary transfusions and prolonging hospitalizations. The research study aims to reduce laboratory test overuse in hospitals through implementation of a comprehensive, multi-disciplinary, and multi-faceted intervention bundle that includes audit and feedback reports, clinician education, clinical decision support tool, and patient infographics across 14 hospitals in Alberta.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
251,817

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

January 2, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

October 26, 2023

Last Update Submit

December 16, 2024

Conditions

Keywords

Overutilization of lab testMultimodal interventionLab test overuseLaboratoryHospital

Outcome Measures

Primary Outcomes (1)

  • Number of routine laboratory tests ordered per patient-day in the intervention versus control periods

    Number of the six target laboratory tests (complete blood count, electrolytes, creatinine, urea, international normalized ratio and partial thromboplastin time) ordered per patient-day

    1 year 9 months

Secondary Outcomes (8)

  • Costs associated with routine and all common laboratory test ordered

    1 year 9 months

  • Proportion of hospital patient lab-free days

    1 year 9 months

  • Proportion of critically abnormal test results

    1 year 9 months

  • Length of stay

    1 year 9 months

  • Transfer to Intensive Care Unit

    1 year 9 months

  • +3 more secondary outcomes

Study Arms (2)

Unexposed to intervention (control period)

NO INTERVENTION

This is the time period of the study where hospital clusters are not receiving the intervention

Exposed to intervention (intervention period)

EXPERIMENTAL

This is the time period of the study where hospital clusters are receiving the multimodal intervention.

Other: Multimodal Intervention: EducationOther: Multimodal Intervention: Audit and FeedbackOther: Multimodal Intervention: Patient EngagementOther: Multimodal Intervention: System Changes

Interventions

The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.

Exposed to intervention (intervention period)

The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.

Exposed to intervention (intervention period)

The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.

Exposed to intervention (intervention period)

The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.

Exposed to intervention (intervention period)

Eligibility Criteria

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

You may qualify if:

  • all participants (patients and healthcare providers) within enrolled adult hospitals in Alberta of medical and hospitalist units during study period

You may not qualify if:

  • outside of the above-mentioned province
  • hospitals not enrolled
  • non-medical units (eg. ICU, surgical, pediatric, obstetrical units)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Anshula Ambasta

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped-wedge cluster randomized trial, randomizing the sequence of entry into intervention at a cluster level.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 7, 2023

Study Start

January 2, 2023

Primary Completion

October 31, 2024

Study Completion

October 1, 2025

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Study data and results will be available for sharing with other researchers who follow the ethical and institutional protocols required by hospitals and health systems involved to obtain the same data

Locations