Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

NCT05634005 | Completed

• 1 other identifier: IRB_00156498
• Study Type: interventional
• Target: 1,543
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Thrombocytopenia; Coagulopathy, Mild; Hypofibrinogenemia

Keywords

Transfusion; Clinical Decision Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of red blood cell components transfused that met clinical decision support alert criteria

  Through study completion, an average of 12 months

• Number of platelet components transfused that met clinical decision support alert criteria

  Through study completion, an average of 12 months

• Number of plasma components transfused that met clinical decision support alert criteria

  Through study completion, an average of 12 months

• Number of cryoprecipitate component pools transfused that met clinical decision support alert criteria

  Through study completion, an average of 12 months

Other Outcomes (11)

• Number of blood components ordered that met clinical decision support alert criteria

  Through study completion, an average of 12 months

• Number of red blood cell components ordered that met clinical decision support alert criteria

  Through study completion, an average of 12 months

• Number of platelet components ordered that met clinical decision support alert criteria

  Through study completion, an average of 12 months

Study Arms (2)

Ordering Providers Assigned to Visible Clinical Decision Support Alerts

EXPERIMENTAL

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

Ordering Providers Assigned to No Visible Clinical Decision Support Alerts

NO INTERVENTION

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.

Interventions

Clinical Decision Support BEHAVIORAL

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).

Also known as: Best Practice Advisory

Ordering Providers Assigned to Visible Clinical Decision Support Alerts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 30860564 BACKGROUND

MeSH Terms

Conditions

Anemia; Thrombocytopenia; Hemostatic Disorders; Lymphoma, Follicular; Afibrinogenemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Cytopenia; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ryan Metcalf, MD

  University of Utah

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pathology

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: December 1, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)