Clinical trial NCT06119464: Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)
Official title: Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Utilization, Health Care
Keywords: Overutilization of lab test
Multimodal intervention
Lab test overuse
Laboratory
Hospital
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: University of British Columbia
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-11-07
Enrollment: 251817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized trial, randomizing the sequence of entry into intervention at a cluster level.
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of routine laboratory tests ordered per patient-day in the intervention versus control periods
timeFrame: 1 year 9 months
Secondary outcomes:
measure: Costs associated with routine and all common laboratory test ordered
timeFrame: 1 year 9 months
measure: Proportion of hospital patient lab-free days
timeFrame: 1 year 9 months
measure: Proportion of critically abnormal test results
timeFrame: 1 year 9 months
measure: Length of stay
timeFrame: 1 year 9 months
measure: Transfer to Intensive Care Unit
timeFrame: 1 year 9 months
measure: In-patient and 30-day patient mortality over study period
timeFrame: 30 days post discharge
measure: 30-day post discharge readmission rate
timeFrame: 30 days post discharge
measure: Number of all common laboratory tests
timeFrame: 1 year 9 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Anshula Ambasta
role: PRINCIPAL_INVESTIGATOR
References: