Venous Thromboembolic DiseaseeVTENCT06232551
Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism
A study testing EHR (electronic health record) alert and No EHR (electronic health record) alert in people with Venous Thromboembolic Disease and Pulmonary Embolism and Thrombosis, run by Scott C. Woller, MD at 1 site in United States.
Trial summary
A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Venous Thromboembolic Disease, Pulmonary Embolism and Thrombosis, Deep Vein Thrombosis
- What is being tested?
- EHR (electronic health record) alert and No EHR (electronic health record) alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 30 Sep 2025
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Discharging clinician must be in one of the following iCentra electronic health record (Cerner, Kansas City, MO) positions:
- Physician, nurse practitioner, or physician assistant hospitalist
- Physician internal medicine
- Physician family medicine
- Patient age ≥ 18 years.
- The encounter must be inpatient.
- A signed hospital discharge order must be present.
- eVTE target population criteria (increased venous thromboembolism risk, low bleeding risk) must be met
Who cannot join
- Pregnant during encounter
- Discharge order completed by ineligible clinician type
- Exclude all cases where the patient is being actively prescribed and intended to be discharged on the following qualifying anticoagulant medications, regardless of dose form or dosing regimen (i.e., they have an active prescription for one of these medications):
- Apixaban
- Dabigatran
- Dalteparin
Show all 15Show fewer
- Enoxaparin
- Edoxaban
- Betrixaban
- Fondaparinux
- Rivaroxaban
- Warfarin
- Creatinine clearance <30 milliliters/minute based on last-available eligible serum creatinine value preceding discharge
- Estimated creatine clearance based on actual body weight (preferred) ((140 - age years) * measured weight kilograms) / (72.0 * serum creatine milligrams/deciliter) (*0.85 if female)) = milliliters/minute
- If measured body weight not available, then based on ideal body weight ((140 - age years) * ideal body weight kilograms) / (72.0 * serum creatine milligrams/deciliter) (*0.85 if female)) = milliliters/minute
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Scott C. Woller, MD, 801-507-3376, scott.woller@imail.org
About this study
Official title: eVTE (Electronic Venous Thromboembolism): A Cluster, Randomized, Step-wedge Type II Hybrid Study of an Alert Recommending Extended Duration Thromboprophylaxis for At-risk Discharging Medical Patients to Prevent VTE.
A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal.
The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low.
The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.
Read the detailed description
The goal of this prospective, cluster, randomized, type II hybrid step wedge, implementation/effectiveness study is to compare the rates of rivaroxaban prescription for extended duration thromboprophylaxis (EDT) in discharging medical patients during the baseline period when no alert informs decision-making to guide EDT, versus EDT prescription during the intervention period when an alert to the discharging clinician is delivered.
Grouped sequential hospitals will be introduced to the intervention randomly in a step wedge fashion.
Aim 1 is to assess the implementation of the alert to discharging clinicians caring for eligible hospitalized medical patients. The primary outcome for Aim 1 is the comparative rate of prescription of EDT (rivaroxaban 10 mg daily for 30 days) during the baseline period versus the intervention period among eligible patients.
Secondary outcomes for Aim 1 will capture interactions with the alert.
Aim 2 is to assess the impact of the alert on important patient clinical outcomes.
The primary efficacy outcome for Aim 2 is the composite of 90-day venous thromboembolism, non-hemorrhagic stroke, myocardial infarction and death.
The primary safety outcome for Aim 2 is 30-day major bleeding. Secondary outcomes for Aim 2 will be the net clinical benefit, defined as the primary outcome + the primary safety outcome during the baseline phase versus the intervention phase among all at risk patients, and all patients for which an alert leads to the prescription of EDT.
Additional secondary outcomes will report components of the primary efficacy and safety outcomes in various groups.
- Conditions
- Venous Thromboembolic Disease, Pulmonary Embolism and Thrombosis, Deep Vein Thrombosis, Hospitalism
- Being tested
- EHR (electronic health record) alert, No EHR (electronic health record) alert
- Keywords
- post-discharge, extended duration thromboprophylaxis, rivaroxaban, direct oral anticoagulant, medical patient
- Medical subject headings
- Pulmonary Embolism, Thrombosis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR (electronic health record) alertOther
Pop-up alert that informs the discharging clinician that the patient meets criteria to be considered for extended duration thromboprophylaxis
No EHR (electronic health record) alertOther
During the baseline phase while risk is assessed and stored, no alerting occurs
| Study group | Role | What they receive |
|---|---|---|
| At-risk patients for which an alert is sent during the intervention phase | Experimental | Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), thereby meeting criteria for alerting during the intervention phase Receives: Other: EHR (electronic health record) alert |
| At-risk patients during the baseline phase | Active comparator | Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), and who meet criteria for alerting, but for whom no alert is sent during the baseline phase Receives: Other: No EHR (electronic health record) alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome (implementation)
Proportion of rivaroxaban prescriptions sent during the intervention phase, compared to the baseline phase
Measured: From discharge to 7 days after discharge
Primary clinical efficacy outcome (effectiveness)
Composite of 90-day venous thromboembolism, myocardial infarction, non-hemorrhagic stroke, or death during the intervention phase for those patients for whom an alert was generated, compared to eligible at-risk patients during the baseline phase for whom no alert was generated
Measured: From enrollment until 90 days after enrollment
Primary clinical safety outcome
30 day major bleeding during the intervention phase for those patients for whom an alert was generated and a prescription was sent, compared to eligible at-risk patients during the baseline phase for whom no alert was generated
Measured: From enrollment until 30 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jun 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- Cluster-randomized, Type II hybrid implementation effectiveness study with step-wedge implementation
- Masking
- None (open label)
- Enrolment
- 152,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott C. Woller, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor-investigator, Scott C. Woller, MD, Intermountain Health Care, Inc.
- Investigators
- Scott C. Woller, MD, Principal investigator, Intermountain Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232551
- Sponsor's protocol ID
- 1052468
- Acronym
- eVTE
- Status last verified
- Jul 2024
- First submitted
- 18 Jan 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyder SN, Han HB, Ash S, Horne BD, Stevens SM, Woller SC, Barnes GD. Predicting post-discharge venous thromboembolism and bleeding among medical patients: External validation of a novel risk score utilizing ubiquitous biomarkers. Thromb Res. 2023 Jul;227:45-50. doi: 10.1016/j.thromres.2023.05.011. Epub 2023 May 19.
PubMed 37235947Woller SC, Stevens SM, Bledsoe JR, Fazili M, Lloyd JF, Snow GL, Horne BD. Biomarker derived risk scores predict venous thromboembolism and major bleeding among patients with COVID-19. Res Pract Thromb Haemost. 2022 Jul 21;6(5):e12765. doi: 10.1002/rth2.12765. eCollection 2022 Jul.
PubMed 35873221Woller SC, Stevens SM, Fazili M, Lloyd JF, Wilson EL, Snow GL, Bledsoe JR, Horne BD. Post-discharge thrombosis and bleeding in medical patients: A novel risk score derived from ubiquitous biomarkers. Res Pract Thromb Haemost. 2021 Jul 7;5(5):e12560. doi: 10.1002/rth2.12560. eCollection 2021 Jul.
PubMed 34263106
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eVTE (Electronic Venous Thromboembolism): A Cluster, Randomized, Step-wedge Type II Hybrid Study of an Alert Recommending Extended Duration Thromboprophylaxis for At-risk Discharging Medical Patients to Prevent VTE.
- ClinicalTrials.gov ID
- NCT06232551
- Acronym / sponsor ID
- eVTE / 1052468
- Conditions
- Venous Thromboembolic Disease, Pulmonary Embolism and Thrombosis, Deep Vein Thrombosis, Hospitalism
- Keywords
- post-discharge, extended duration thromboprophylaxis, rivaroxaban, direct oral anticoagulant, medical patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152,000 participants (estimated)
- Lead sponsor
- Scott C. Woller, MDUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Jan 2024 (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.
A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal.
The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low.
The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.
Detailed description
The goal of this prospective, cluster, randomized, type II hybrid step wedge, implementation/effectiveness study is to compare the rates of rivaroxaban prescription for extended duration thromboprophylaxis (EDT) in discharging medical patients during the baseline period when no alert informs decision-making to guide EDT, versus EDT prescription during the intervention period when an alert to the discharging clinician is delivered.
Grouped sequential hospitals will be introduced to the intervention randomly in a step wedge fashion.
Aim 1 is to assess the implementation of the alert to discharging clinicians caring for eligible hospitalized medical patients. The primary outcome for Aim 1 is the comparative rate of prescription of EDT (rivaroxaban 10 mg daily for 30 days) during the baseline period versus the intervention period among eligible patients.
Secondary outcomes for Aim 1 will capture interactions with the alert.
Aim 2 is to assess the impact of the alert on important patient clinical outcomes.
The primary efficacy outcome for Aim 2 is the composite of 90-day venous thromboembolism, non-hemorrhagic stroke, myocardial infarction and death.
The primary safety outcome for Aim 2 is 30-day major bleeding. Secondary outcomes for Aim 2 will be the net clinical benefit, defined as the primary outcome + the primary safety outcome during the baseline phase versus the intervention phase among all at risk patients, and all patients for which an alert leads to the prescription of EDT.
Additional secondary outcomes will report components of the primary efficacy and safety outcomes in various groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized, Type II hybrid implementation effectiveness study with step-wedge implementation
| Arm | Type | Receives |
|---|---|---|
| At-risk patients for which an alert is sent during the intervention phase | Experimental | Other: EHR (electronic health record) alertPatients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), thereby meeting criteria for alerting during the intervention phase |
| At-risk patients during the baseline phase | Active comparator | Other: No EHR (electronic health record) alertPatients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), and who meet criteria for alerting, but for whom no alert is sent during the baseline phase |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Discharging clinician must be in one of the following iCentra electronic health record (Cerner, Kansas City, MO) positions:
- Patient age ≥ 18 years.
- The encounter must be inpatient.
- A signed hospital discharge order must be present.
- eVTE target population criteria (increased venous thromboembolism risk, low bleeding risk) must be met
Key exclusion criteria (15 listed)
- Pregnant during encounter
- Discharge order completed by ineligible clinician type
- Exclude all cases where the patient is being actively prescribed and intended to be discharged on the following qualifying anticoagulant medications, regardless of dose form or dosing regimen (i.e., they have an active prescription for one of these medications):
- Creatinine clearance <30 milliliters/minute based on last-available eligible serum creatinine value preceding discharge
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 |
|---|---|---|
| EHR (electronic health record) alertPop-up alert that informs the discharging clinician that the patient meets criteria to be considered for extended duration thromboprophylaxis | Other | At-risk patients for which an alert is sent during the intervention phase |
| No EHR (electronic health record) alertDuring the baseline phase while risk is assessed and stored, no alerting occurs | Other | At-risk patients during the baseline phase |
Primary outcome
Primary outcome (implementation)
Time frame: From discharge to 7 days after discharge
Proportion of rivaroxaban prescriptions sent during the intervention phase, compared to the baseline phase
Primary clinical efficacy outcome (effectiveness)
Time frame: From enrollment until 90 days after enrollment
Composite of 90-day venous thromboembolism, myocardial infarction, non-hemorrhagic stroke, or death during the intervention phase for those patients for whom an alert was generated, compared to eligible at-risk patients during the baseline phase for whom no alert was generated
Primary clinical safety outcome
Time frame: From enrollment until 30 days after enrollment
30 day major bleeding during the intervention phase for those patients for whom an alert was generated and a prescription was sent, compared to eligible at-risk patients during the baseline phase for whom no alert was generated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 37235947Hyder SN, Han HB, Ash S, Horne BD, Stevens SM, Woller SC, Barnes GD. Predicting post-discharge venous thromboembolism and bleeding among medical patients: External validation of a novel risk score utilizing ubiquitous biomarkers. Thromb Res. 2023 Jul;227:45-50. doi: 10.1016/j.thromres.2023.05.011. Epub 2023 May 19.
- Background: PubMed 35873221Woller SC, Stevens SM, Bledsoe JR, Fazili M, Lloyd JF, Snow GL, Horne BD. Biomarker derived risk scores predict venous thromboembolism and major bleeding among patients with COVID-19. Res Pract Thromb Haemost. 2022 Jul 21;6(5):e12765. doi: 10.1002/rth2.12765. eCollection 2022 Jul.
- Background: PubMed 34263106Woller SC, Stevens SM, Fazili M, Lloyd JF, Wilson EL, Snow GL, Bledsoe JR, Horne BD. Post-discharge thrombosis and bleeding in medical patients: A novel risk score derived from ubiquitous biomarkers. Res Pract Thromb Haemost. 2021 Jul 7;5(5):e12560. doi: 10.1002/rth2.12560. eCollection 2021 Jul.
- 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.
Scott C. Woller, MD principal investigator
Intermountain Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR (electronic health record) alert and No EHR (electronic health record) alert in people with Venous Thromboembolic Disease and Pulmonary Embolism and Thrombosis, run by Scott C. Woller, MD 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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Aston, MBA (801-507-4606, valerie.aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (implementation) (time frame: From discharge to 7 days after discharge). 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 NCT06232551, which also lists 3 linked publications.
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 17 Jul 2024.