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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152,000
- 试验地点
- 1
- 主要终点
- Primary clinical efficacy outcome (effectiveness)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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):
- •Dabigatran
- •Dalteparin
- •Enoxaparin
- •Betrixaban
- •Fondaparinux
- •Rivaroxaban
- •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
研究组 & 干预措施
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
干预措施: EHR (electronic health record) alert (Other)
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
干预措施: No EHR (electronic health record) alert (Other)
结局指标
主要结局
Primary clinical efficacy outcome (effectiveness)
时间窗: 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
Primary outcome (implementation)
时间窗: From discharge to 7 days after discharge
Proportion of rivaroxaban prescriptions sent during the intervention phase, compared to the baseline phase
Primary clinical safety outcome
时间窗: 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
次要结局
未报告次要终点
研究者
Scott C. Woller, MD
Physician, thrombosis service, Intermountain Medical Center
Intermountain Health Care, Inc.