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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    11000
  • sponsor
    Northwell Health
Updated on 6 March 2021

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.

Details
Condition Venous Thromboembolism, Thromboembolism, arterial thromboembolism
Treatment IMPROVE DD VTE Tool
Clinical Study IdentifierNCT04768036
SponsorNorthwell Health
Last Modified on6 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 60 yrs?
Gender: Male or Female
Do you have any of these conditions: Thromboembolism or arterial thromboembolism or Venous Thromboembolism?
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
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