Intermountain Medical Center
Murray, Utah, 84107, United States
Location status: Recruiting
NCT Number: NCT06232551
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.
Interested in participating?
Request Info18 year–110 year
All sexes
Interventional
Not applicable
Murray, Utah, 84107, United States
Location status: Recruiting
The goal of this prospective, cluster, randomized, type II hybrid step wedge, implementation/effectiveness study is to compare the rates of rivaroxaban prescription for extended duration thromboprophylaxis (EDT) in discharging medical patients during the baseline period when no alert informs decision-making to guide EDT, versus EDT prescription during the intervention period when an alert to the discharging clinician is delivered.
Grouped sequential hospitals will be introduced to the intervention randomly in a step wedge fashion.
Aim 1 is to assess the implementation of the alert to discharging clinicians caring for eligible hospitalized medical patients. The primary outcome for Aim 1 is the comparative rate of prescription of EDT (rivaroxaban 10 mg daily for 30 days) during the baseline period versus the intervention period among eligible patients.
Secondary outcomes for Aim 1 will capture interactions with the alert.
Aim 2 is to assess the impact of the alert on important patient clinical outcomes.
The primary efficacy outcome for Aim 2 is the composite of 90-day venous thromboembolism, non-hemorrhagic stroke, myocardial infarction and death.
The primary safety outcome for Aim 2 is 30-day major bleeding. Secondary outcomes for Aim 2 will be the net clinical benefit, defined as the primary outcome + the primary safety outcome during the baseline phase versus the intervention phase among all at risk patients, and all patients for which an alert leads to the prescription of EDT.
Additional secondary outcomes will report components of the primary efficacy and safety outcomes in various groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pop-up alert that informs the discharging clinician that the patient meets criteria to be considered for extended duration thromboprophylaxis
During the baseline phase while risk is assessed and stored, no alerting occurs
Time frame: From discharge to 7 days after discharge
Proportion of rivaroxaban prescriptions sent during the intervention phase, compared to the baseline phase
Time frame: From enrollment until 90 days after enrollment
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 30 days after enrollment
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
Contact information is provided by the study sponsor or research team.
Carlos Barbagelata, MS
CONTACT
Valerie Aston, MBA
CONTACT
Scott C. Woller, MD
Other
eVTE (Electronic Venous Thromboembolism): A Cluster, Randomized, Step-wedge Type II Hybrid Study of an Alert Recommending Extended Duration Thromboprophylaxis for At-risk Discharging Medical Patients to Prevent VTE.
Acronym: eVTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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