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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorScott C. Woller, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physician, nurse practitioner, or physician assistant hospitalist

Physician internal medicine

Physician family medicine

Patient age ≥ 18 years.

Disqualifiers

Pregnant during encounter

Discharge order completed by ineligible clinician type

Apixaban

Dabigatran

Trial design

Design model

Sequential

Treatments tested in this trial

  • EHR (electronic health record) alert

    Other intervention

    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

    Other intervention

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

Treatment groups

152,000 Participants
are divided into 2 treatment groups
Group A: At-risk patients for which an alert is sent during the intervention phaseExperimental treatment 1 intervention
Group B: At-risk patients during the baseline phaseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome (implementation)

Proportion of rivaroxaban prescriptions sent during the intervention phase, compared to the baseline phase

Time frame
From discharge to 7 days after discharge
2

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

Time frame
From enrollment until 90 days after enrollment
3

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

Time frame
From enrollment until 30 days after enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scott C. Woller, MD

Lead sponsor

Intermountain Health Care, Inc.

Sponsor institution

Janssen Pharmaceuticals

Collaborator