Blood Transfusion Reduction - QI Project

Blood Transfusion Reduction Quality Improvement Project

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.

Study Overview

• Status: Completed
• Conditions: Blood Transfusion
• Intervention / Treatment: Behavioral: General improvement; Behavioral: In-line help text; Behavioral: Interruptive alert

• Study Type: Interventional
• Enrollment (Actual): 1640
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General improvement; Using the expertise of the study personnel, electronic-health record system architects working for UCHealth, and incorporating feedback from the users who participated in the user-centered design sessions we made changes to the blood transfusion order-set as well as the "prepare" and "transfuse" orders. The intention of the changes to the interface are to be more intuitive for ordering clinicians.	Behavioral: General improvement; Changes to interface to be more intuitive.
Experimental: In-line help text; In addition to general improvement changes, subjects exposed to the in-line help text arm receive text detailing evidence-based transfusion recommendations that appear if the most recent hemoglobin level is above 7.0 g/dL. This text appears within the transfusion order but is non-interruptive as it does not require users to acknowledge the text nor does is require any additional keystrokes or clicks.	Behavioral: In-line help text; General improvement + in-line help text
Experimental: Interruptive alert; In addition to general improvement changes, subjects exposed to the interruptive alert arm receive text detailing evidence-based transfusion recommendations that appear if the most recent hemoglobin level is above 7.0 g/dL. In contrast to the in-line help text arm, this arm includes an interruptive alert that appears when the user selects the transfusion order. This alert offers users the option to remove the order which results in no-blood product ordered. Alternatively, users may continue to order blood and are asked to select the reason for proceeding with the intended order.	Behavioral: Interruptive alert; General improvement + interruptive alert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Transfusion Orders	Number of patients who received blood transfusions during the study by arm.	78 weeks
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Study Director: Michael Ho, MD, PhD, University of Colorado Denver Anschutz Medical Campus; Principal Investigator: Tyler Anstett, DO, University of Colorado Denver Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: blood transfusion; user-centered design; EHR interventions; high-value care
• Other Study ID Numbers: 19-0918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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