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

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.

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism; Arterial Thromboembolism
• Intervention / Treatment: Other: IMPROVE DD VTE Tool

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.

• Study Type: Interventional
• Enrollment (Actual): 10699
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Manhasset, New York, United States, 11030
      • The Institute for Health Innovations and Outcomes Research
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Medical Care; As per standard of care
Experimental: "SMART on FHIR" application of the IMPROVE DD VTE CPR; 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; Universal "SMART on FHIR" platform-based EHR-embedded IMPROVE VTE CPR with electronic order entry incorporated into required admission and discharge EHR workflow.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Alex Spyropoulos, MD, Northwell Health

Publications and helpful links

General Publications

• Spyropoulos AC, Anderson FA Jr, FitzGerald G, Decousus H, Pini M, Chong BH, Zotz RB, Bergmann JF, Tapson V, Froehlich JB, Monreal M, Merli GJ, Pavanello R, Turpie AGG, Nakamura M, Piovella F, Kakkar AK, Spencer FA; IMPROVE Investigators. Predictive and associative models to identify hospitalized medical patients at risk for VTE. Chest. 2011 Sep;140(3):706-714. doi: 10.1378/chest.10-1944. Epub 2011 Mar 24.
• Spyropoulos AC, Raskob GE. New paradigms in venous thromboprophylaxis of medically ill patients. Thromb Haemost. 2017 Aug 30;117(9):1662-1670. doi: 10.1160/TH17-03-0168. Epub 2017 Jun 22.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 20-0752

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No