Alerting Providers to Consider Rivaroxaban for Blood Clot Prevention

This study is looking at how a special alert in a hospital's electronic health record (EHR) system can help doctors decide whether to prescribe rivaroxaban (a blood thinner) to patients when they leave the hospital. This alert pops up for patients who are at high risk for blood clots (like deep vein thrombosis or pulmonary embolism) but have a low risk of bleeding. The study wants to see if this alert increases the number of patients who receive rivaroxaban to prevent blood clots after discharge. We'll also be looking at important patient outcomes like new blood clots, stroke, heart attack, and major bleeding. This study plans to include a large number of patients, up to 152,000, and is currently unclear regarding its recruitment status.

Study design
This study is an interventional study involving a large number of participants (152,000 planned enrollment) where hospitals will be introduced to the alert system in a step-by-step, randomized way.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Patients will be followed for up to 90 days after enrollment to assess clinical efficacy outcomes, and for 30 days for safety outcomes.

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NCT06232551

Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism

UNKNOWN
NAAges 18+InterventionalHealth services
Scott C. Woller, MD
~152,000 participants
Updated 2024-07-17 on ClinicalTrials.gov
What's tested:EHR (electronic health record) alertNo EHR (electronic health record) alert

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary outcome (implementation)
Measured over From discharge to 7 days after discharge
+2 more outcomes measured
Venous Thromboembolic Disease
Pulmonary Embolism and Thrombosis
Deep Vein Thrombosis
Hospitalism
1 sites across 1 states
Utah1
  • Scott C. Woller, MD · PRINCIPAL_INVESTIGATOR · Intermountain Health

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Eligibility criteria

Inclusion

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

Exclusion

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
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
  • Primary outcome (implementation)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)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 outcomeFrom 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