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

Utilization, Health Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119464
• Other study ID #: REB17-1215
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: September 8, 2024

Study information

• Verified date: January 2024
• Source: University of Calgary
• Contact: Anshula Ambasta
• Phone: 1-403-6184586
• Email: aambasta[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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: 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 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 starting January 2023 and evaluated until September 2024. The investigators anticipate recruitment to continue until March 2024. Baseline data will be collected from March 2018.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 251817
• Est. completion date: September 8, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Utilization, Health Care

Intervention

Other:
• Multimodal Intervention: Education
The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.
• Multimodal Intervention: Audit and Feedback
The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.
• Multimodal Intervention: Patient Engagement
The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.
• Multimodal Intervention: System Changes
The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, Canadian Institutes of Health Research (CIHR), University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 years
Secondary	Costs associated with routine and all common laboratory test ordered	Costs of test and associated costs with and without intervention	7 years
Secondary	Proportion of hospital patient lab-free days	Number of hospital patient-days not associated with laboratory blood draws	7 years
Secondary	Proportion of critically abnormal test results	As defined by lab standards, we will track the proportion of critically abnormal test results	7 years
Secondary	Length of stay	Patient length of stay on the unit	7 years
Secondary	Transfer to Intensive Care Unit	Transfer rate to Intensive Care Unit	7 years
Secondary	In-patient and 30-day patient mortality over a 7-year period	Mortality rate in hospital and at 30-days post discharge	7 years
Secondary	30-day post discharge readmission rate	Hospital re-admission within 30 days post discharge	7 years
Secondary	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.	7 years