Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)

NCT ID: NCT06119464

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

251817 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Background: Laboratory and Pathology testing contributes to rising health care expenditure. A relatively large percentage (up to 42%) of laboratory testing can be considered wasteful. Redundant testing alone has been estimated to waste up to 5 billion dollars annually in the United States of America. Laboratory over-utilization leads to false positives that promotes further inappropriate testing and procedures, interruption of normal sleep pattern of inpatients, as well as iatrogenic anemia and pain. A Canadian study showed significant hemoglobin reductions as a result of phlebotomy. Studies support the safe reduction of repetitive laboratory testing without negative effects on adverse events, readmission rates, critical care utilization, or mortality.

The aim of this research study is the following:

1. To implement a multimodal intervention bundle containing healthcare provider and patient engagement tools for hospitalized medical inpatients in 14 hospitals across the province of Alberta in Canada using a cluster randomized stepped-wedge design
2. To evaluate the impact of the intervention bundle on laboratory test utilization of six target laboratory tests (complete blood count, electrolytes, creatinine, urea, partial thromboplastin time, and international normalized ratio), costs, and patient safety outcomes.

This intervention bundle will be implemented across all the adult hospital sites in Alberta starting January 2023 and evaluated until October 2024.

Conditions

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Utilization, Health Care

Keywords

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Overutilization of lab test Multimodal intervention Lab test overuse Laboratory Hospital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped-wedge cluster randomized trial, randomizing the sequence of entry into intervention at a cluster level.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Unexposed to intervention (control period)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Exposed to intervention (intervention period)

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

Group Type EXPERIMENTAL

Multimodal Intervention: Education

Intervention Type OTHER

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

Multimodal Intervention: Audit and Feedback

Intervention Type OTHER

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

Multimodal Intervention: Patient Engagement

Intervention Type OTHER

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

Multimodal Intervention: System Changes

Intervention Type OTHER

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

Interventions

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Multimodal Intervention: Education

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

Intervention Type OTHER

Multimodal Intervention: Audit and Feedback

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

Intervention Type OTHER

Multimodal Intervention: Patient Engagement

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

Intervention Type OTHER

Multimodal Intervention: System Changes

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alberta Health services

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Anshula Ambasta

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anshula Ambasta

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB17-1215

Identifier Type: -

Identifier Source: org_study_id