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

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.

Study Overview

• Status: Recruiting
• Conditions: Utilization, Health Care
• Intervention / Treatment: Other: Multimodal Intervention: Education; Other: Multimodal Intervention: Audit and Feedback; Other: Multimodal Intervention: Patient Engagement; Other: Multimodal Intervention: System Changes

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 251817
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anshula Ambasta; Phone Number: 1-403-6184586; Email: aambasta@ucalgary.ca
• Study Contact Backup: Name: Surakshya Pokharel; Email: surakshya.pokharel@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary
      • Contact: Surakshya Pokharel; Phone Number: (403) 220-5110; Email: surakshya.pokharel@ucalgary.ca
      • Principal Investigator: Anshula Ambasta, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Unexposed to intervention (control period); This is the time period of the study where hospital clusters are not receiving the intervention
Experimental: Exposed to intervention (intervention period); This is the time period of the study where hospital clusters are receiving the multimodal intervention.	Other: Multimodal Intervention: Education; The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.; Other: Multimodal Intervention: Audit and Feedback; The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.; Other: Multimodal Intervention: Patient Engagement; The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.; Other: Multimodal Intervention: System Changes; The multimodal intervention bundle consists of education, audit and feedback, patient engagement, and system changes.

What is the study measuring?

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	7 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	7 years
Proportion of hospital patient lab-free days	Number of hospital patient-days not associated with laboratory blood draws	7 years
Proportion of critically abnormal test results	As defined by lab standards, we will track the proportion of critically abnormal test results	7 years
Length of stay	Patient length of stay on the unit	7 years
Transfer to Intensive Care Unit	Transfer rate to Intensive Care Unit	7 years
In-patient and 30-day patient mortality over a 7-year period	Mortality rate in hospital and at 30-days post discharge	7 years
30-day post discharge readmission rate	Hospital re-admission within 30 days post discharge	7 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.	7 years

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of British Columbia; Canadian Institutes of Health Research (CIHR); Alberta Health services
• Investigators: Principal Investigator: Anshula Ambasta, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): March 24, 2024
• Study Completion (Estimated): September 8, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hospital; Laboratory; Multimodal intervention; Overutilization of lab test; Lab test overuse
• Other Study ID Numbers: REB17-1215; H22-03005 (University of British Columbia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data and results will be available for sharing with other researchers who follow the ethical and institutional protocols required by hospitals and health systems involved to obtain the same data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No