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

NCT06232551 | Recruiting

• 1 other identifier: 1052468
• Study Type: interventional
• Target: 152,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Primary outcome (implementation)

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

  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

  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

  From enrollment until 30 days after enrollment

Study Arms (2)

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

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

Other: No EHR (electronic health record) alert

Interventions

EHR (electronic health record) alert OTHER

Pop-up alert that informs the discharging clinician that the patient meets criteria to be considered for extended duration thromboprophylaxis

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

No EHR (electronic health record) alert OTHER

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

At-risk patients during the baseline phase

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scott C. Woller, MD: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 37235947 BACKGROUND

• Woller 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.

  PMID: 35873221 BACKGROUND

• Woller 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.

  PMID: 34263106 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis; Venous Thrombosis

Interventions

Electronic Health Records; Caffeine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Scott C. Woller, MD

  Intermountain Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Aston, MBA

CONTACT

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

Carlos Barbagelata, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, thrombosis service, Intermountain Medical Center

Model Details: Cluster-randomized, Type II hybrid implementation effectiveness study with step-wedge implementation

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 30, 2024
• Study Start: June 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: September 30, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)