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Completed

NCT Number: NCT04768036

A Universal Electronic Health Record-based IMPROVE DD VTE Risk Assessment Model 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.

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Key information

Conditions

Venous Thromboembolism Arterial Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore University Hospital, Manhasset, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMPROVE DD VTE Tool

Other

Universal "SMART on FHIR" platform-based EHR-embedded IMPROVE VTE CPR with electronic order entry incorporated into required admission and discharge EHR workflow.

Primary outcomes

  1. To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent

    Time frame: 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 outcomes

  1. Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE

    Time frame: 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).

  2. Number of participants with VTE-related readmissions

    Time frame: 90 days

    The combined total number of VTE-related readmissions of patients at up to 90 days.

  3. Number of participants with all cause readmissions

    Time frame: 90 days

    The combined total of the number of patients with all cause hospital readmissions.

  4. Change in diagnosis-related group

    Time frame: 90 days

    Change in diagnosis-related group of patients from baseline up to 90 days.

  5. Change in type of insurance

    Time frame: 90 days

    Change in type of insurance for patients from baseline up to 90 days.

  6. Change in drug cost

    Time frame: 90 days

    Change in drug cost for patients from baseline up to 90 days.

  7. Change in prescriber patterns of LMWH (low molecular weight heparin)

    Time frame: 90 days

    Change in prescriber patterns for patient use of LMWH, enoxaparin, compared to standard of 40mg SQ QD.

  8. Change in prescriber patterns of UFH (unfractionated heparin)

    Time frame: 90 days

    Change in prescriber patterns of patient use of UFH, as compared to standard of 5000U SQ BID or TID.

  9. Change in prescriber patterns of fondaparinux

    Time frame: 90 days

    Change in prescriber patterns of patient use of fondaparinux, as compared to standard of 2.5mg SQ QD.

  10. Change in prescriber patterns of rivaroxaban

    Time frame: 90 days

    Change in prescriber patterns of patient use of direct oral anticoagulant, rivaroxaban, as compared to a standard of 10mg PO QD.

  11. Arterial thromboembolism (ATE)

    Time frame: 90 days

    including stroke, transient ischemic attack (TIA), myocardial infarction (MI)

  12. Total thromboembolism (VTE and ATE)

    Time frame: 90 days

    Including stroke, transient ischemic attack (TIA), myocardial infarction (MI) systemic embolism, acute limb ischemia, lower extremity deep vein thrombosis (DVT).

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2021
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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