Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

Determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a randomized study design to reduce risk of bias. Alerts will be visible to the experimental ordering provider group, while they will not be visible to the control. Both groups still have access to information about best practices: local clinical transfusion guidelines are available and education on blood transfusion best practices will continue regardless of randomization assignment.

Study Overview

• Status: Completed
• Conditions: Anemia; Thrombocytopenia; Coagulopathy, Mild; Hypofibrinogenemia
• Intervention / Treatment: Behavioral: Clinical Decision Support

• Study Type: Interventional
• Enrollment (Actual): 1543
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Ordering providers that order at least one blood product in the electronic health record

Exclusion Criteria:

• Any individual without privileges to place an initial order for blood product(s)

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ordering Providers Assigned to Visible Clinical Decision Support Alerts; Clinical decision support alert will fire and become visible to the ordering provider in the electronic health record if blood product(s) are ordered out of accordance with guidelines. Information about transfusion guidelines and best practices will be sent to providers prior to starting the study and will be available on an internal website.	Behavioral: Clinical Decision Support; In blood product order entry within the electronic health record, the ordering provider is required to select an indication for the blood product order. If the patient's laboratory values are not in line with the guideline indication selected, a clinical decision support alert will fire and be shown to the ordering provider. This alert will inform the provider that the order is outside institutional guidelines and the provider has the option to cancel the order (or bypass the order and select a reason for proceeding with the order).; Other Names: Best Practice Advisory
No Intervention: Ordering Providers Assigned to No Visible Clinical Decision Support Alerts; Clinical decision support alert will not be visible to the ordering provider in the electronic health record if blood product(s) are ordered out of accordance with guidelines. Information about transfusion guidelines and best practices will be sent to providers prior to starting the study and will be available on an internal website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of blood components transfused that met clinical decision support alert criteria	Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of red blood cell components transfused that met clinical decision support alert criteria	Number of red blood cell components transfused that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of platelet components transfused that met clinical decision support alert criteria	Number of platelet components transfused that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of plasma components transfused that met clinical decision support alert criteria	Number of plasma components transfused that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of cryoprecipitate component pools transfused that met clinical decision support alert criteria	Number of cryoprecipitate component pools transfused that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood component cost difference between clinical decision support eligible transfusions by study arm	Blood component acquisition cost difference of completed alert eligible transfusions between study arms	Through study completion, an average of 12 months
Number of blood components ordered that met clinical decision support alert criteria	Number of blood components ordered (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of red blood cell components ordered that met clinical decision support alert criteria	Number of red blood cell components ordered that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of platelet components ordered that met clinical decision support alert criteria	Number of platelet components ordered that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of plasma components ordered that met clinical decision support alert criteria	Number of plasma components ordered that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of cryoprecipitate component pools ordered that met clinical decision support alert criteria	Number of cryoprecipitate component pools ordered that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of blood components transfused	Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire	Through study completion, an average of 12 months
Number of red blood cell components transfused	Number of red blood cell components transfused	Through study completion, an average of 12 months
Number of platelet components transfused	Number of platelet components transfused	Through study completion, an average of 12 months
Number of plasma components transfused	Number of plasma components transfused	Through study completion, an average of 12 months
Number of cryoprecipitate component pools transfused	Number of cryoprecipitate component pools transfused	Through study completion, an average of 12 months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Ryan Metcalf, MD, University of Utah

Publications and helpful links

General Publications

• Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Transfusion
• Additional Relevant MeSH Terms: Cytopenia; Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: IRB_00156498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No