Blood TransfusionNCT04823273
Blood Transfusion Reduction - QI Project
A study testing General improvement, In-line help text and Interruptive alert in people with Blood Transfusion, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Transfusion
- What is being tested?
- General improvement, In-line help text and Interruptive alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All physicians and nurses ordering blood transfusion ordering blood in the OR
- Blood ordered through massive transfusion protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Blood Transfusion Reduction Quality Improvement Project
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.
- Conditions
- Blood Transfusion
- Being tested
- General improvement, In-line help text, Interruptive alert
- Keywords
- blood transfusion, EHR interventions, user-centered design, high-value care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General improvementBehavioural
Changes to interface to be more intuitive.
In-line help textBehavioural
General improvement + in-line help text
Interruptive alertBehavioural
General improvement + interruptive alert
| Study group | Role | What they receive |
|---|---|---|
| General improvement | Experimental | 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. Receives: Behavioral: General improvement |
| In-line help text | Experimental | 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. Receives: Behavioral: In-line help text |
| Interruptive alert | Experimental | 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. Receives: Behavioral: Interruptive alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Transfusion Orders
Number of patients who received blood transfusions during the study by arm.
Measured: 78 weeks
Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion
The American Association of Blood Banks recommends a restrictive threshold of a pre-transfusion hemoglobin level of less than 7.0g/dL for the vast majority of inpatients. Transfusions with Hemoglobin levels above 7 will be compared in arm 1 vs 2 +3 combined; arm 2 vs arm 3.
Measured: 78 weeks
Guideline Concordance Measured by Number of Units Ordered Per Transfusion
The American Association of Blood Banks recommends a restrictive threshold of a single unit pRBC transfusion for the vast majority of inpatients. This outcome will compare hemoglobin levels, units transfused in arm 1 verses arms 2 and 3 combined and arm 2 verses arm 3.
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start6 Apr 2021
- Primary completion5 Apr 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Ho, MD, PhD, Study director, University of Colorado Denver Anschutz Medical CampusTyler Anstett, DO, Principal investigator, University of Colorado Denver Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823273
- Sponsor's protocol ID
- 19-0918
- Status last verified
- May 2023
- First submitted
- 23 Mar 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37158929
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Transfusion Reduction Quality Improvement Project
- ClinicalTrials.gov ID
- NCT04823273
- Acronym / sponsor ID
- 19-0918
- Conditions
- Blood Transfusion
- Keywords
- blood transfusion, EHR interventions, user-centered design, high-value care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,640 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General improvement | Experimental | Behavioral: General improvementUsing 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. |
| In-line help text | Experimental | Behavioral: In-line help textIn 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. |
| Interruptive alert | Experimental | Behavioral: Interruptive alertIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- All physicians and nurses ordering blood transfusion ordering blood in the OR
- Blood ordered through massive transfusion protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General improvementChanges to interface to be more intuitive. | Behavioural | General improvement |
| In-line help textGeneral improvement + in-line help text | Behavioural | In-line help text |
| Interruptive alertGeneral improvement + interruptive alert | Behavioural | Interruptive alert |
Primary outcome
Blood Transfusion Orders
Time frame: 78 weeks
Number of patients who received blood transfusions during the study by arm.
Guideline Concordance Measured by Pre-Transfusion Hemoglobin Values Per Transfusion
Time frame: 78 weeks
The American Association of Blood Banks recommends a restrictive threshold of a pre-transfusion hemoglobin level of less than 7.0g/dL for the vast majority of inpatients. Transfusions with Hemoglobin levels above 7 will be compared in arm 1 vs 2 +3 combined; arm 2 vs arm 3.
Guideline Concordance Measured by Number of Units Ordered Per Transfusion
Time frame: 78 weeks
The American Association of Blood Banks recommends a restrictive threshold of a single unit pRBC transfusion for the vast majority of inpatients. This outcome will compare hemoglobin levels, units transfused in arm 1 verses arms 2 and 3 combined and arm 2 verses arm 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 37158929Mistry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ho, MD, PhD study director
University of Colorado Denver Anschutz Medical Campus
Tyler Anstett, DO principal investigator
University of Colorado Denver Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General improvement, In-line help text and Interruptive alert in people with Blood Transfusion, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Transfusion Orders (time frame: 78 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.