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

Study Overview
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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 30 hospitals in Alberta and British Columbia.

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 USD annually in the USA. 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: To implement a multimodal intervention bundle containing healthcare provider and patient engagement tools for hospitalized medical inpatients in 30 hospitals across two provinces (Alberta and British Columbia) in Canada in Alberta using a cluster randomized stepped-wedge design To evaluate the impact of the LTO 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 and British Columbia starting January 2023 and evaluated until October 2026. The investigators anticipate recruitment to continue until December 2025.

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

Conditions
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Utilization, Health Care

Intervention / Treatment
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* Other: Multimodal Intervention- education, audit and feedback, system changes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all participants (patients and healthcare providers) within enrolled adult hospitals in Alberta and British Columbia of medical and hospitalist units during study period Exclusion Criteria: outside of the above-mentioned provinces hospitals not enrolled non-medical units (eg. ICU, surgical, pediatric, obstetrical units)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped-wedge cluster randomized trial, randomizing the sequence of entry into intervention at a cluster level.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unexposed to intervention (control period)<br>This is the time period of the study where hospital clusters are not receiving the intervention | |
| Experimental: Exposed to intervention (intervention period)<br>This is the time period of the study where hospital clusters are receiving the multimodal intervention. | Other: Multimodal Intervention- education, audit and feedback, system changes<br>* Education, audit and feedback, patient engagement and system-changes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs associated with routine and all common laboratory test ordered | Costs of test and associated costs with and without intervention | 4 years | 
| Proportion of hospital patient lab-free days | Number of hospital patient-days not associated with laboratory blood draws | 4 years | 
| Proportion of critically abnormal test results | As defined by lab standards, we will track the proportion of critically abnormal test results | 4 years | 
| Length of stay | Patient length of stay on the unit | 4 years | 
| Transfer to Intensive Care Unit | Transfer rate to Intensive Care Unit | 4 years | 
| In-patient and 30-day patient mortality | Mortality rate in hospital and at 30-days post discharge | 4 years | 
| 30-day post discharge readmission rate | Hospital re-admission within 30 days post discharge | 4 years | 
| Number of all common laboratory tests | Number of all common laboratory tests (tests that contribute to >80% of hospital laboratory test utilization during study period) per patient-day. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overutilization of lab test, Multimodal intervention, Lab test overuse, Laboratory, Hospital