search
Back to results

Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

Primary Purpose

Anemia, Thrombocytopenia, Coagulopathy, Mild

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anemia focused on measuring Transfusion, Clinical Decision Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ordering Providers Assigned to Visible Clinical Decision Support Alerts

Ordering Providers Assigned to No Visible Clinical Decision Support Alerts

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
October 17, 2022
Last Updated
October 20, 2023
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT05634005
Brief Title
Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence
Official Title
Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Thrombocytopenia, Coagulopathy, Mild, Hypofibrinogenemia
Keywords
Transfusion, Clinical Decision Support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ordering Providers Assigned to Visible Clinical Decision Support Alerts
Arm Type
Experimental
Arm Description
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.
Arm Title
Ordering Providers Assigned to No Visible Clinical Decision Support Alerts
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Decision Support
Other Intervention Name(s)
Best Practice Advisory
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of blood components transfused that met clinical decision support alert criteria
Description
Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Secondary Outcome Measure Information:
Title
Number of red blood cell components transfused that met clinical decision support alert criteria
Description
Number of red blood cell components transfused that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of platelet components transfused that met clinical decision support alert criteria
Description
Number of platelet components transfused that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of plasma components transfused that met clinical decision support alert criteria
Description
Number of plasma components transfused that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of cryoprecipitate component pools transfused that met clinical decision support alert criteria
Description
Number of cryoprecipitate component pools transfused that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Other Pre-specified Outcome Measures:
Title
Number of blood components ordered that met clinical decision support alert criteria
Description
Number of blood components ordered (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of red blood cell components ordered that met clinical decision support alert criteria
Description
Number of red blood cell components ordered that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of platelet components ordered that met clinical decision support alert criteria
Description
Number of platelet components ordered that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of plasma components ordered that met clinical decision support alert criteria
Description
Number of plasma components ordered that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of cryoprecipitate component pools ordered that met clinical decision support alert criteria
Description
Number of cryoprecipitate component pools ordered that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of blood components transfused
Description
Number of blood components transfused (includes red blood cell, platelet, plasma, and cryoprecipitate pools) that met criteria for clinical decision support alerts to fire
Time Frame
Through study completion, an average of 12 months
Title
Number of red blood cell components transfused
Description
Number of red blood cell components transfused
Time Frame
Through study completion, an average of 12 months
Title
Number of platelet components transfused
Description
Number of platelet components transfused
Time Frame
Through study completion, an average of 12 months
Title
Number of plasma components transfused
Description
Number of plasma components transfused
Time Frame
Through study completion, an average of 12 months
Title
Number of cryoprecipitate component pools transfused
Description
Number of cryoprecipitate component pools transfused
Time Frame
Through study completion, an average of 12 months
Title
Blood component cost difference between clinical decision support eligible transfusions by study arm
Description
Blood component acquisition cost difference of completed alert eligible transfusions between study arms
Time Frame
Through study completion, an average of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Metcalf, MD
Phone
8015852010
Email
ryan.metcalf@path.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kensaku Kawamoto, MD
Email
kensaku.kawamoto@utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Metcalf, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Metcalf, MD
Phone
801-585-2010
Email
ryan.metcalf@path.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
30860564
Citation
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.
Results Reference
background

Learn more about this trial

Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence

We'll reach out to this number within 24 hrs