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

Sponsor
University of Calgary (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119464
Collaborator
Alberta Health services (Other), Canadian Institutes of Health Research (CIHR) (Other), University of British Columbia (Other)
503,633
2
2
44.9
251816.5
5602.8

Study Details

Study Description

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 30 hospitals in Alberta and British Columbia.

Condition or Disease Intervention/Treatment Phase
  • Other: Multimodal Intervention- education, audit and feedback, system changes
N/A

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 30 hospitals across two provinces (Alberta and British Columbia) in Canada in Alberta 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 and British Columbia starting January 2023 and evaluated until October 2026. The investigators anticipate recruitment to continue until December 2025.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
503633 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Stepped-wedge cluster randomized trial, randomizing the sequence of entry into intervention at a cluster level.Stepped-wedge cluster randomized trial, randomizing the sequence of entry into intervention at a cluster level.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)
Actual Study Start Date :
Jan 2, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

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, audit and feedback, system changes
Education, audit and feedback, patient engagement and system-changes

Outcome Measures

Primary Outcome Measures

  1. Number of the six target laboratory tests ordered per patient-day. [4 years]

    Number of the six target laboratory tests (complete blood count, electrolytes, creatinine, urea, international normalized ratio and partial thromboplastin time) ordered per patient-day

  2. Number of all common laboratory test ordered per patient-day [4 years]

    Number of all common laboratory tests (tests that contribute to >80% of hospital laboratory test utilization during study period) per patient-day.

Secondary Outcome Measures

  1. Costs associated with routine and all common laboratory test ordered [4 years]

    Costs of test and associated costs with and without intervention

  2. Proportion of hospital patient lab-free days [4 years]

    Number of hospital patient-days not associated with laboratory blood draws

  3. Proportion of critically abnormal test results [4 years]

    As defined by lab standards, we will track the proportion of critically abnormal test results

  4. Length of stay [4 years]

    Patient length of stay on the unit

  5. Transfer to Intensive Care Unit [4 years]

    Transfer rate to Intensive Care Unit

  6. In-patient and 30-day patient mortality [4 years]

    Mortality rate in hospital and at 30-days post discharge

  7. 30-day post discharge readmission rate [4 years]

    Hospital re-admission within 30 days post discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Calgary Alberta Canada T2N 1N4
2 University of British Columbia Vancouver British Columbia Canada

Sponsors and Collaborators

  • University of Calgary
  • Alberta Health services
  • Canadian Institutes of Health Research (CIHR)
  • University of British Columbia

Investigators

  • Principal Investigator: Anshula Ambasta, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anshula Ambasta, Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier:
NCT06119464
Other Study ID Numbers:
  • REB17-1215
  • H22-03005
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anshula Ambasta, Clinical Assistant Professor, University of Calgary

Study Results

No Results Posted as of Nov 7, 2023