Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Calgary
- Enrollment
- 251,817
- Locations
- 1
- Primary Endpoint
- Number of routine laboratory tests ordered per patient-day in the intervention versus control periods
Study Overview
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.
Detailed Description
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:
- 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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Unexposed to intervention (control period)
This is the time period of the study where hospital clusters are not receiving the intervention
Exposed to intervention (intervention period)
This is the time period of the study where hospital clusters are receiving the multimodal intervention.
Intervention: Multimodal Intervention: Education (Other)
Exposed to intervention (intervention period)
This is the time period of the study where hospital clusters are receiving the multimodal intervention.
Intervention: Multimodal Intervention: Audit and Feedback (Other)
Exposed to intervention (intervention period)
This is the time period of the study where hospital clusters are receiving the multimodal intervention.
Intervention: Multimodal Intervention: Patient Engagement (Other)
Exposed to intervention (intervention period)
This is the time period of the study where hospital clusters are receiving the multimodal intervention.
Intervention: Multimodal Intervention: System Changes (Other)
Outcomes
Primary Outcomes
Number of routine laboratory tests ordered per patient-day in the intervention versus control periods
Time Frame: 1 year 9 months
Number of the six target laboratory tests (complete blood count, electrolytes, creatinine, urea, international normalized ratio and partial thromboplastin time) ordered per patient-day
Secondary Outcomes
- In-patient and 30-day patient mortality over study period(30 days post discharge)
- 30-day post discharge readmission rate(30 days post discharge)
- Length of stay(1 year 9 months)
- Proportion of critically abnormal test results(1 year 9 months)
- Transfer to Intensive Care Unit(1 year 9 months)
- 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)
- Number of all common laboratory tests(1 year 9 months)
Investigators
Anshula Ambasta
Clinical Assistant Professor
University of Calgary