Blood Transfusion Reduction - QI Project

NCT04823273 | Completed

• 1 other identifier: 19-0918
• Study Type: interventional
• Target: 1,640
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Transfusion

Keywords

blood transfusion; EHR interventions; user-centered design; high-value care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Historical Blood Transfusion Orders

  Baseline

• Historical Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion

  Baseline

• Guideline Concordance Measured by Number of Units Ordered Per Transfusion

  Baseline

Study Arms (3)

General improvement

EXPERIMENTAL

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

In-line help text

EXPERIMENTAL

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

Interruptive alert

EXPERIMENTAL

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

Interventions

General improvement BEHAVIORAL

Changes to interface to be more intuitive.

General improvement

In-line help text BEHAVIORAL

General improvement + in-line help text

In-line help text

Interruptive alert BEHAVIORAL

General improvement + interruptive alert

Interruptive alert

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• All physicians and nurses ordering blood transfusion ordering blood in the OR
• Blood ordered through massive transfusion protocol

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Mistry N, Richardson V, Carey E, Porter S, Pincus S, Novins-Montague S, Elmer M, Lin CT, Ho PM, Anstett T. General improvements versus interruptive or non-interruptive alerts in the blood order set: study protocol for a randomized control trial to improve packed red blood cell utilization. Trials. 2023 May 8;24(1):314. doi: 10.1186/s13063-023-07319-8.

  PMID: 37158929 DERIVED

Study Officials

• Michael Ho, MD, PhD

  University of Colorado Denver Anschutz Medical Campus

  STUDY DIRECTOR

• Tyler Anstett, DO

  University of Colorado Denver Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: April 6, 2021
• Primary Completion: April 5, 2022
• Study Completion: October 15, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)