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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04823273
Other study ID # 19-0918
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 6, 2021
Est. completion date October 15, 2022

Study information

Verified date May 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Blood Banks of large medical centers have large annual budgets, typically millions of dollars. Blood product wastage results in not only in a loss of the product's cost, but also of the fees involved in transporting, handling, and administering these products. Optimal utilization of blood products requires a balance between maximizing patient clinical outcomes while avoiding unnecessary costs and risks associated with transfusions. This project will specifically focus on packed red blood cell transfusions (pRBCs). There are clear guidelines for transfusing pRBCs however these guidelines are not always followed. pRBC transfusions outside of recommended guidelines is associated with increased risk of harm to patients. Our aim is to improve adherence to guideline indicated pRBC transfusions for patient in the UCHealth system thereby decreasing inappropriate (non-guideline indicated) pRBC transfusions. We will conduct a QI project seeking to improve pRBC transfusion guideline adherence. This project will involve data review to establish baseline rates, multimodal interventions to improve adherence to pRBC transfusion guidelines including provider education, modifications to the electronic ordering interface, and changing blood back policies at participating institutions.


Recruitment information / eligibility

Status Completed
Enrollment 1640
Est. completion date October 15, 2022
Est. primary completion date April 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All physicians and nurses with access to order inpatient blood transfusions through a hospital-based EMR. - All physicians and nurses ordering blood for individuals over the age of 18. Exclusion Criteria: - All physicians and nurses ordering blood transfusion ordering blood in the OR - Blood ordered through massive transfusion protocol

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
General improvement
Changes to interface to be more intuitive.
In-line help text
General improvement + in-line help text
Interruptive alert
General improvement + interruptive alert

Locations

Country Name City State
United States UCHealth University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Historical Blood Transfusion Orders Number of patients who received blood transfusions during the 18 months prior to study start in the EHR at the same hospital. Baseline
Other Historical Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion The American Association of Blood Banks recommends a restrictive threshold of a pre-transfusion hemoglobin level of less than 7.0g/dL for the vast majority of inpatients. Historical data for 18 months prior to study start will be collected from EHR records for transfusions orders placed for patients with Hemoglobin levels above 7. Baseline
Other Guideline Concordance Measured by Number of Units Ordered Per Transfusion The American Association of Blood Banks recommends a restrictive threshold of a single unit pRBC transfusion for the vast majority of inpatients. Historical data for 18 months prior to study start will be collected from EHR records for the number of units transfused per blood transfusion order. Baseline
Primary Blood Transfusion Orders Number of patients who received blood transfusions during the study by arm. 78 weeks
Primary Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion The American Association of Blood Banks recommends a restrictive threshold of a pre-transfusion hemoglobin level of less than 7.0g/dL for the vast majority of inpatients. Transfusions with Hemoglobin levels above 7 will be compared in arm 1 vs 2 +3 combined; arm 2 vs arm 3. 78 weeks
Primary Guideline Concordance Measured by Number of Units Ordered Per Transfusion The American Association of Blood Banks recommends a restrictive threshold of a single unit pRBC transfusion for the vast majority of inpatients. This outcome will compare hemoglobin levels, units transfused in arm 1 verses arms 2 and 3 combined and arm 2 verses arm 3. 78 weeks
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