A Universal Electronic Health Record-based IMPROVE DD VTE Risk Assessment Model for the Prevention of Thromboembolism in Hospitalized Medically Ill Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Venous Thromboembolism, Arterial Thromboembolism

Intervention / Treatment
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* Other: IMPROVE DD VTE Tool


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Medical Care<br>As per standard of care | |
| Experimental: SMART on FHIR application of the IMPROVE DD VTE CPR<br>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 VTE CPR 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. Health outcomes and health resource utilization will be assessed for the duration of patient hospitalization until 90 days post-discharge by review of health records. 2 hospitals will be randomized to the experimental arm and 2 hospitals will be randomized to the No Intervention arm. | Other: IMPROVE DD VTE Tool<br>* Universal SMART on FHIR platform-based EHR-embedded IMPROVE VTE CPR with electronic order entry incorporated into required admission and discharge EHR workflow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE | 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). | 90 days | 
| Number of participants with VTE-related readmissions | The combined total number of VTE-related readmissions of patients at up to 90 days. | 90 days | 
| Number of participants with all cause readmissions | The combined total of the number of patients with all cause hospital readmissions. | 90 days | 
| Change in diagnosis-related group | Change in diagnosis-related group of patients from baseline up to 90 days. | 90 days | 
| Change in type of insurance | Change in type of insurance for patients from baseline up to 90 days. | 90 days | 
| Change in drug cost | Change in drug cost for patients from baseline up to 90 days. | 90 days | 
| Change in prescriber patterns of LMWH (low molecular weight heparin) | Change in prescriber patterns for patient use of LMWH, enoxaparin, compared to standard of 40mg SQ QD. | 90 days | 
| Change in prescriber patterns of UFH (unfractionated heparin) | Change in prescriber patterns of patient use of UFH, as compared to standard of 5000U SQ BID or TID. | 90 days | 
| Change in prescriber patterns of fondaparinux | Change in prescriber patterns of patient use of fondaparinux, as compared to standard of 2.5mg SQ QD. | 90 days | 
| Change in prescriber patterns of rivaroxaban | Change in prescriber patterns of patient use of direct oral anticoagulant, rivaroxaban, as compared to a standard of 10mg PO QD. | 90 days | 
| Arterial thromboembolism (ATE) | including stroke, transient ischemic attack (TIA), myocardial infarction (MI) | 90 days | 
| Total thromboembolism (VTE and ATE) | Including stroke, transient ischemic attack (TIA), myocardial infarction (MI) systemic embolism, acute limb ischemia, lower extremity deep vein thrombosis (DVT). | 90 days |