Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

Anemia Clinical Trial

Official title:

Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634005
• Other study ID #: IRB_00156498
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: Ryan Metcalf, MD
• Phone: 8015852010
• Email: ryan.metcalf[@]path.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Hypofibrinogenemia
• Thrombocytopenia

Intervention

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).

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Number of red blood cell components transfused	Number of red blood cell components transfused	Through study completion, an average of 12 months
Other	Number of platelet components transfused	Number of platelet components transfused	Through study completion, an average of 12 months
Other	Number of plasma components transfused	Number of plasma components transfused	Through study completion, an average of 12 months
Other	Number of cryoprecipitate component pools transfused	Number of cryoprecipitate component pools transfused	Through study completion, an average of 12 months
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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