Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05634005

Collaborator

(none)

10,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Thrombocytopenia Coagulopathy, Mild Hypofibrinogenemia	Behavioral: Clinical Decision Support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of blood components transfused that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire per 1000 inpatient days

Secondary Outcome Measures

Number of red blood cell components transfused that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of red blood cell components transfused that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of platelet components transfused that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of platelet components transfused that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of plasma components transfused that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of plasma components transfused that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of cryoprecipitate component pools transfused that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of cryoprecipitate component pools transfused that met criteria for clinical decision support alerts to fire per 1000 inpatient days

Other Outcome Measures

Number of blood components ordered that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of blood components ordered (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of red blood cell components ordered that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of red blood cell components ordered that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of platelet components ordered that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of platelet components ordered that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of plasma components ordered that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of plasma components ordered that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of cryoprecipitate component pools ordered that met clinical decision support alert criteria per 1000 inpatient days [Through study completion, an average of 12 months]
Number of cryoprecipitate component pools ordered that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of blood components transfused per 1000 inpatient days [Through study completion, an average of 12 months]
Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire per 1000 inpatient days
Number of red blood cell components transfused per 1000 inpatient days [Through study completion, an average of 12 months]
Number of red blood cell components transfused per 1000 inpatient days
Number of platelet components transfused per 1000 inpatient days [Through study completion, an average of 12 months]
Number of platelet components transfused per 1000 inpatient days
Number of plasma components transfused per 1000 inpatient days [Through study completion, an average of 12 months]
Number of plasma components transfused per 1000 inpatient days
Number of cryoprecipitate component pools transfused per 1000 inpatient days [Through study completion, an average of 12 months]
Number of cryoprecipitate component pools transfused per 1000 inpatient days
Blood component cost difference between clinical decision support eligible transfusions by study arm [Through study completion, an average of 12 months]
Blood component acquisition cost difference of completed alert eligible transfusions between study arms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator: Ryan Metcalf, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Ryan Metcalf, Associate Professor of Pathology, University of Utah

ClinicalTrials.gov Identifier:

NCT05634005

Other Study ID Numbers:

IRB_00156498

First Posted:

Dec 1, 2022

Last Update Posted:

Dec 1, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ryan Metcalf, Associate Professor of Pathology, University of Utah

Transfusion

Clinical Decision Support

Additional relevant MeSH terms:

Thrombocytopenia

Study Results

No Results Posted as of Dec 1, 2022