ThrombocytopeniaNCT04155775
Effects of a Platelet Transfusion Best Practices Alert
A study testing Computer electronic health record alert (Best Practice Alert - BPA) in people with Thrombocytopenia, run by Stanford University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Computer electronic health record alert (Best Practice Alert - BPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 4 Feb 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recent platelet count >50k/uL
- Platelet transfusion ordered
Who cannot join
- Neurosurgery
- Procedure area (OR, catheterization lab, interventional radiology suite)
- Documented history of antiplatelet agent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Healthcare
Stanford, California, 94305-5626
About this study
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).
Read the 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.
- Conditions
- Thrombocytopenia
- Being tested
- Computer electronic health record alert (Best Practice Alert - BPA)
- Keywords
- Electronic Health Records, Best Practice Alerts
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer electronic health record alert (Best Practice Alert - BPA)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Best Practice Alert | Experimental | 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. Receives: Other: Computer electronic health record alert (Best Practice Alert - BPA) |
| No Best Practice Alert | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Platelet transfusions above threshold
Number of platelet transfusions occurring in patients with recent platelet counts above 50k/uL
Measured: Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start
Secondary outcomes (1)
Total platelet transfusions
Total number of platelet transfusions occurring during study period.
Measured: Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start9 May 2019
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
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 ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin H Murphy, MD, Principal investigator, Stanford UniversityNeil Shah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155775
- Sponsor's protocol ID
- IRB-47797
- Status last verified
- Feb 2023
- First submitted
- 15 May 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy C, Mou E, Pang E, Shieh L, Hom J, Shah N. A randomized study of a best practice alert for platelet transfusions. Vox Sang. 2022 Jan;117(1):87-93. doi: 10.1111/vox.13132. Epub 2021 Jun 3.
PubMed 34081800
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Platelet Transfusion Best Practices Alert
- ClinicalTrials.gov ID
- NCT04155775
- Acronym / sponsor ID
- IRB-47797
- Conditions
- Thrombocytopenia
- Keywords
- Electronic Health Records, Best Practice Alerts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 7 Nov 2019 (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.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Practice Alert | Experimental | Other: Computer electronic health record alert (Best Practice Alert - BPA)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. |
| No Best Practice Alert | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Recent platelet count >50k/uL
- Platelet transfusion ordered
Key exclusion criteria (3 listed)
- Neurosurgery
- Procedure area (OR, catheterization lab, interventional radiology suite)
- Documented history of antiplatelet agent
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 |
|---|---|---|
| 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. | Other | Best Practice Alert |
Primary outcome
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
1 secondary outcome
Total platelet transfusions
Time frame: Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start
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 9 Feb 2023.
- Results publication: PubMed 34081800Murphy C, Mou E, Pang E, Shieh L, Hom J, Shah N. A randomized study of a best practice alert for platelet transfusions. Vox Sang. 2022 Jan;117(1):87-93. doi: 10.1111/vox.13132. Epub 2021 Jun 3.
- 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.
Colin H Murphy, MD principal investigator
Stanford University
Neil Shah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer electronic health record alert (Best Practice Alert - BPA) in people with Thrombocytopenia, run by Stanford University 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 3 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 9 Feb 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?
Platelet transfusions above threshold (time frame: Data will be initially reviewed before 6 months from start with anticipated completion 1 year from start). 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 NCT04155775, 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 9 Feb 2023.