Recruiting

Rivaroxaban

Sponsor:

Scott C. Woller, MD

Code:

NCT06232551

Conditions

Venous Thromboembolic Disease

Pulmonary Embolism and Thrombosis

Deep Vein Thrombosis

Hospitalism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EHR (electronic health record) alert

No EHR (electronic health record) alert

Study Details

Brief 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.

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.

Conditions

Venous Thromboembolic Disease

Pulmonary Embolism and Thrombosis

Deep Vein Thrombosis

Hospitalism

Study ID

NCT06232551

Start date

Jun 1, 2024

Status verified date

Jul, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Jan 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

152000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: At-risk patients for which an alert is sent during the intervention phase

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

active comparator: At-risk patients during the baseline phase

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

Interventions

EHR (electronic health record) alert

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) alert

During the baseline phase while risk is assessed and stored, no alerting occurs

Primary outcome measure

  • Primary outcome (implementation) [ Time Frame: From discharge to 7 days after discharge ]
  • Primary clinical efficacy outcome (effectiveness) [ Time Frame: From enrollment until 90 days after enrollment ]
  • Primary clinical safety outcome [ Time Frame: From enrollment until 30 days after enrollment ]

Central Contacts and Locations

Central contacts

Valerie Aston, MBA

801-507-4606valerie.aston@imail.org

Carlos Barbagelata, MS

801-507-4607carlos.barbagelata@imail.org

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Scott C. Woller, MD

801-507-3376scott.woller@imail.org

More Information

Sponsor

Scott C. Woller, MD

Last update posted

Jul 17, 2024

Last verified

Jul, 2024

Keywords

  • post-discharge
  • extended duration thromboprophylaxis
  • rivaroxaban
  • direct oral anticoagulant
  • medical patient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Scott C. Woller, MD on 2024-07-17.