A Multicenter Randomized Study of a Universal Electronic Health Record-based IMPROVE-DD VTE Risk Assessment Model Implementation as a Quality Improvement Project for the Prevention of Thromboembolism in Hospitalized Medically Ill Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,699
- 试验地点
- 9
- 主要终点
- To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent
研究概览
简要总结
This study will be a multicenter clustered randomized trial of patients in hospitals in which a universal "SMART on FHIR" platform-based EHR-embedded IMPROVE DD VTE clinical prediction rules (CPRs) with electronic order entry has been incorporated into required admission and discharge EHR workflow versus hospitals following UMC for VTE risk assessment of medically ill patients. The patient population will consist of hospitalized, medically ill (non-surgical, non-obstetrical) individuals aged > 60 years.
详细描述
Investigators, plan to do a study using a pragmatic, randomized design as part of a Quality Improvement (QI) project as a substudy within the existing NIH R18 proposal of creating a universal "SMART on FHIR" platform of the IMPROVE VTE CPR for key Northwell Health hospitals. Investigators, aim is to assess whether an EHR-embedded CPR for VTE prevention - the IMPROVE VTE CPR - ultimately tied to electronic order entry will increase the proportion of hospitalized medical patients at risk of VTE who receive appropriate thromboprophylaxis, both at hospital admission AND at hospital discharge, compared to UMC. Investigators, secondary aims are to assess whether key adverse outcomes such as symptomatic VTE and hospital readmission for VTE are reduced and whether health -resource utilization metrics are improved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an acute medical illness and ONE of the following risk factors:
- •Age > 60 years
- •Presence of known thrombophilia
- •Intensive care unit (ICU)/coronary care unit (CCU) stay
- •Lower extremity paralysis
- •Immobilization
- •Previous VTE history
- •D-dimer (>2X ULN)
排除标准
- •Patients with the following factors:
- •Therapeutic anticoagulation
- •History of recent bleeding.
- •Active gastroduodenal ulcer
- •Thrombocytopenia (admission platelet count< 75x 109 cells/L )
- •Coagulopathy (baseline INR > 1.5)
- •Severe renal insufficiency (baseline)CrCl < 30ml/min)
- •Dual antiplatelet therapy
- •Bronchiectasis/pulmonary cavitation
- •Active cancer, and recent major surgery within 30 days of their index hospitalization bleeding.
结局指标
主要结局
To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent
时间窗: 90 days
Specifically, our pilot study will determine if this QI intervention will result in a greater increase in the proportion of at-VTE or high-VTE risk medical patients that are treated with an appropriate thromboprophylactic agent, both during hospitalization and in the post-hospital discharge period using a 5-point score where 0-1 constitutes low VTE risk, 2-3 constitutes moderate VTE risk, and 4 constitutes high VTE risk.
次要结局
- Total thromboembolism (VTE and ATE)(90 days)
- Number of participants with VTE-related readmissions(90 days)
- Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE(90 days)
- Number of participants with all cause readmissions(90 days)
- Change in drug cost(90 days)
- Change in prescriber patterns of LMWH (low molecular weight heparin)(90 days)
- Change in prescriber patterns of UFH (unfractionated heparin)(90 days)
- Change in prescriber patterns of fondaparinux(90 days)
- Change in prescriber patterns of rivaroxaban(90 days)
- Arterial thromboembolism (ATE)(90 days)
- Change in diagnosis-related group(90 days)
- Change in type of insurance(90 days)
研究者
Alex Spyropoulos
Principal Investigator
Northwell Health