Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

NCT ID: NCT05634005

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1543 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Clinical Decision Support

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Best Practice Advisory

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Ryan Metcalf

Associate Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Metcalf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30860564 (View on PubMed)

Other Identifiers

IRB_00156498

Identifier Type: -

Identifier Source: org_study_id