Blood Transfusion Reduction - QI Project

NCT ID: NCT04823273

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2022-10-15

Brief Summary

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Blood Banks of large medical centers have large annual budgets, typically millions of dollars. Blood product wastage results in not only in a loss of the product's cost, but also of the fees involved in transporting, handling, and administering these products. Optimal utilization of blood products requires a balance between maximizing patient clinical outcomes while avoiding unnecessary costs and risks associated with transfusions. This project will specifically focus on packed red blood cell transfusions (pRBCs). There are clear guidelines for transfusing pRBCs however these guidelines are not always followed. pRBC transfusions outside of recommended guidelines is associated with increased risk of harm to patients.

Our aim is to improve adherence to guideline indicated pRBC transfusions for patient in the UCHealth system thereby decreasing inappropriate (non-guideline indicated) pRBC transfusions. We will conduct a QI project seeking to improve pRBC transfusion guideline adherence. This project will involve data review to establish baseline rates, multimodal interventions to improve adherence to pRBC transfusion guidelines including provider education, modifications to the electronic ordering interface, and changing blood back policies at participating institutions.

Detailed Description

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Conditions

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Blood Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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General improvement

Using the expertise of the study personnel, electronic-health record system architects working for UCHealth, and incorporating feedback from the users who participated in the user-centered design sessions we made changes to the blood transfusion order-set as well as the "prepare" and "transfuse" orders. The intention of the changes to the interface are to be more intuitive for ordering clinicians.

Group Type EXPERIMENTAL

General improvement

Intervention Type BEHAVIORAL

Changes to interface to be more intuitive.

In-line help text

In addition to general improvement changes, subjects exposed to the in-line help text arm receive text detailing evidence-based transfusion recommendations that appear if the most recent hemoglobin level is above 7.0 g/dL. This text appears within the transfusion order but is non-interruptive as it does not require users to acknowledge the text nor does is require any additional keystrokes or clicks.

Group Type EXPERIMENTAL

In-line help text

Intervention Type BEHAVIORAL

General improvement + in-line help text

Interruptive alert

In addition to general improvement changes, subjects exposed to the interruptive alert arm receive text detailing evidence-based transfusion recommendations that appear if the most recent hemoglobin level is above 7.0 g/dL. In contrast to the in-line help text arm, this arm includes an interruptive alert that appears when the user selects the transfusion order. This alert offers users the option to remove the order which results in no-blood product ordered. Alternatively, users may continue to order blood and are asked to select the reason for proceeding with the intended order.

Group Type EXPERIMENTAL

Interruptive alert

Intervention Type BEHAVIORAL

General improvement + interruptive alert

Interventions

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General improvement

Changes to interface to be more intuitive.

Intervention Type BEHAVIORAL

In-line help text

General improvement + in-line help text

Intervention Type BEHAVIORAL

Interruptive alert

General improvement + interruptive alert

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All physicians and nurses with access to order inpatient blood transfusions through a hospital-based EMR.
* All physicians and nurses ordering blood for individuals over the age of 18.

Exclusion Criteria

* All physicians and nurses ordering blood transfusion ordering blood in the OR
* Blood ordered through massive transfusion protocol
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Ho, MD, PhD

Role: STUDY_DIRECTOR

University of Colorado Denver Anschutz Medical Campus

Tyler Anstett, DO

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver Anschutz Medical Campus

Locations

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UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Mistry N, Richardson V, Carey E, Porter S, Pincus S, Novins-Montague S, Elmer M, Lin CT, Ho PM, Anstett T. General improvements versus interruptive or non-interruptive alerts in the blood order set: study protocol for a randomized control trial to improve packed red blood cell utilization. Trials. 2023 May 8;24(1):314. doi: 10.1186/s13063-023-07319-8.

Reference Type DERIVED
PMID: 37158929 (View on PubMed)

Other Identifiers

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19-0918

Identifier Type: -

Identifier Source: org_study_id

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