Effects of a Platelet Transfusion Best Practices Alert

February 7, 2023 updated by: Stanford University
This study is to determine the effectiveness of a computerized clinical decision support tool (Best Practice Alert - BPA) in reducing unnecessary platelet transfusions based on guidelines published by national transfusion societies such as the AABB (formerly American Association of Blood Banks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A computerized alert will be deployed through the electronic health record. The alert will trigger when a provider orders platelet transfusion above a threshold supported by current guidelines. The alert will provide information on current evidence and give the provider the option to cancel the order or proceed. The alert will not be triggered in procedural areas such as the operating room or as part of any emergency orders to prevent any delays to urgent patient care.

The proposed project will evaluate this alert by randomizing its implementation by patient chart. The investigators will observe the prevalence of this alert and its impact on ordering practices for the next 3 months. For patient charts randomized not to receive the intervention, the providers will not receive any alerts, but the analytics tool will record if the alert would have been triggered and the pertinent clinical information. After a period of three months, the investigators will review patient and provider information through analytics tools, assessing differences in platelet usage between the patients whose charts showed the alerts vs. those (control) patient charts not showing alerts.

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5626
        • Stanford Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent platelet count >50k/uL
  • Platelet transfusion ordered

Exclusion Criteria:

  • Neurosurgery
  • Procedure area (OR, catheterization lab, interventional radiology suite)
  • Documented history of antiplatelet agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Best Practice Alert
Platelet transfusion orders for patients with a recent platelet count exceeding 50,000 per microliter (50k/uL) will trigger an alert in the electronic health record that displays current guidelines for platelet transfusion. The alert will allow providers to bypass the recommendation and continue with platelet ordering by selecting a clinical acknowledgement / exception to recommendation.Exclusions will be built into the alert to avoid triggering in operative or procedural settings, for neurosurgery providers, or patients on anti-platelet medications.
Other: Computer electronic health record alert (Best Practice Alert - BPA)
Upon ordering platelets in patients with recent platelet count >50,000, a pop-up within the electronic health system will recommend to not continue with transfuse product order and provide clinical exceptions to continue. Importantly, the alert does not trigger in operating areas, emergency medicine treatment areas, for certain specialties like neurosurgery or for massive transfusion orders.
NO_INTERVENTION: No Best Practice Alert
For this group, no visible best practice alert will activate in the electronic health record for platelet transfusion orders and recent counts above 50k/uL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet transfusions above threshold
Time Frame: Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start
Number of platelet transfusions occurring in patients with recent platelet counts above 50k/uL
Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total platelet transfusions
Time Frame: Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start
Total number of platelet transfusions occurring during study period.
Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Colin H Murphy, MD, Stanford University
  • Principal Investigator: Neil Shah, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 9, 2019

Primary Completion (ACTUAL)

February 4, 2020

Study Completion (ACTUAL)

February 4, 2020

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (ACTUAL)

November 7, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-47797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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