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/37235947Actively Recruiting
Led by Scott C. Woller, MD · Updated on 2024-07-17
152000
Participants Needed
1
Research Sites
36 weeks
Total Duration
S
Scott C. Woller, MD
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
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
Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or electronic health record review)
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
Total: 1 location
1
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
V
Valerie Aston, MBA
C
Carlos Barbagelata, MS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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