Arterial Thromboembolism, Venous Thromboembolism
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERIMPROVE DD VTE Tool
Universal SMART on FHIR platform-based EHR-embedded IMPROVE VTE CPR with electronic order entry incorporated into required admission and discharge EHR workflow.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Intervention model description
A multicenter clustered randomized study of a universal electronic health record-based IMPROVE VTE risk assessment model implementation as a quality improvement project for the prevention of venous thromboembolism in hospitalized medically ill patients.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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 * Cancer * Immobilization * Previous VTE history * D-dimer (\>2X ULN)
Exclusion criteria
• 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with VTE-related readmissions | 90 days | The combined total number of VTE-related readmissions of patients at up to 90 days. |
| Number of participants with all cause readmissions | 90 days | The combined total of the number of patients with all cause hospital readmissions. |
| Change in diagnosis-related group | 90 days | Change in diagnosis-related group of patients from baseline up to 90 days. |
| Change in type of insurance | 90 days | Change in type of insurance for patients from baseline up to 90 days. |
| Change in drug cost | 90 days | Change in drug cost for patients from baseline up to 90 days. |
| Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE | 90 days | Change in patient rates of VTE - lower extremity deep vein thrombosis (DVT) or PE using objective testing at up to 90 days and VTE-related death by autopsy or objective criteria (ICD codes and CPT diagnostic codes as per Appendix 2). |
| Change in prescriber patterns of UFH (unfractionated heparin) | 90 days | Change in prescriber patterns of patient use of UFH, as compared to standard of 5000U SQ BID or TID. |
| Change in prescriber patterns of fondaparinux | 90 days | Change in prescriber patterns of patient use of fondaparinux, as compared to standard of 2.5mg SQ QD. |
| Change in prescriber patterns of rivaroxaban | 90 days | Change in prescriber patterns of patient use of direct oral anticoagulant, rivaroxaban, as compared to a standard of 10mg PO QD. |
| Arterial thromboembolism (ATE) | 90 days | including stroke, transient ischemic attack (TIA), myocardial infarction (MI) |
| Total thromboembolism (VTE and ATE) | 90 days | Including stroke, transient ischemic attack (TIA), myocardial infarction (MI) systemic embolism, acute limb ischemia, lower extremity deep vein thrombosis (DVT). |
| Change in prescriber patterns of LMWH (low molecular weight heparin) | 90 days | Change in prescriber patterns for patient use of LMWH, enoxaparin, compared to standard of 40mg SQ QD. |
Countries
United States
Outcome results
None listed