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

Venous Thromboembolism Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768036
• Other study ID #: 20-0752
• Status: Completed
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: January 21, 2022

Study information

• Verified date: July 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10699
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York
United States	The Institute for Health Innovations and Outcomes Research	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants with VTE-related readmissions	The combined total number of VTE-related readmissions of patients at up to 90 days.	90 days
Secondary	Number of participants with all cause readmissions	The combined total of the number of patients with all cause hospital readmissions.	90 days
Secondary	Change in diagnosis-related group	Change in diagnosis-related group of patients from baseline up to 90 days.	90 days
Secondary	Change in type of insurance	Change in type of insurance for patients from baseline up to 90 days.	90 days
Secondary	Change in drug cost	Change in drug cost for patients from baseline up to 90 days.	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Arterial thromboembolism (ATE)	including stroke, transient ischemic attack (TIA), myocardial infarction (MI)	90 days
Secondary	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