Actively Recruiting

Phase Not Applicable
Age: 18Years - 110Years
All Genders
ID06232551

eVTE: A Cluster, Randomized, Step-Wedge Study of an Alert for Extended Duration Thromboprophylaxis in At-Risk Hospital Discharge Patients to Prevent Venous Thromboembolism

Led by Scott C. Woller, MD · Updated on 2024-07-17

152000

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

Sponsors

S

Scott C. Woller, MD

Lead Sponsor

J

Janssen Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an alert system designed to help doctors identify hospital patients at high risk for blood clots but low risk for bleeding. This study aims to see if this alert increases the prescription of rivaroxaban, a blood thinner, to prevent venous thromboembolism after discharge. The study also monitors the impact of the alert on patient outcomes such as blood clots, stroke, heart attack, death, and major bleeding. The study compares two periods: a baseline phase with no alert to clinicians and an intervention phase where a pop-up alert appears during patient discharge if certain risk criteria are met. This alert informs the clinician that the patient may benefit from extended duration thromboprophylaxis with rivaroxaban 10 mg daily for 30 days. Hospitals are introduced to the alert in groups over time in a randomized sequence. Participants include medical patients being discharged who meet specific risk criteria for clotting and bleeding. Researchers will track prescription rates of rivaroxaban from discharge to 7 days after, and clinical outcomes up to 90 days after enrollment. Safety outcomes such as major bleeding will be monitored for 30 days post-enrollment. The study runs until September 2025 and measures both how the alert affects prescribing behavior and patient health outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Discharging clinician must be a hospitalist, internal medicine physician, or family medicine physician, nurse practitioner, or physician assistant using the iCentra electronic health record
  • Patient age 18 years or older
  • Patient must be inpatient with a signed hospital discharge order
  • Patient meets increased venous thromboembolism risk and low bleeding risk criteria as assessed by eVTE
Not Eligible

You will not qualify if you...

  • Patient is pregnant during the hospital encounter
  • Discharge order completed by an ineligible clinician type
  • Patient is currently prescribed and intended to be discharged on anticoagulant medications such as apixaban, dabigatran, dalteparin, enoxaparin, edoxaban, betrixaban, fondaparinux, rivaroxaban, or warfarin
  • Patient has creatinine clearance less than 30 milliliters per minute based on the last eligible serum creatinine value before discharge

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or electronic health record review)

Monitoring

Duration - From discharge until 90 days after enrollment

Participants who meet risk criteria are monitored to assess the impact of an electronic alert on prescribing extended duration thromboprophylaxis after hospital discharge.

Follow-up assessments during the 90-day period post-discharge

Trial Site Locations

Total: 1 location

1

Intermountain Medical Center

Murray, Utah, United States, 84107

Actively Recruiting

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Research Team

V

Valerie Aston, MBA

C

Carlos Barbagelata, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Predicting post-discharge venous thromboembolism and bleeding among medical patients: External validation of a novel risk score utilizing ubiquitous biomarkers.

S Nabeel Hyder, Henry B Han, Scott Ash...

https://pubmed.ncbi.nlm.nih.gov/37235947

Biomarker derived risk scores predict venous thromboembolism and major bleeding among patients with COVID-19.

Scott C Woller, Scott M Stevens, Joseph R Bledsoe...

https://pubmed.ncbi.nlm.nih.gov/35873221

Post-discharge thrombosis and bleeding in medical patients: A novel risk score derived from ubiquitous biomarkers.

Scott C Woller, Scott M Stevens, Masarret Fazili...

https://pubmed.ncbi.nlm.nih.gov/34263106