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

Northwell Health

Status: Completed

Conditions: Venous Thromboembolism; Arterial Thromboembolism

Treatments: Other: IMPROVE DD VTE Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04768036

20-0752

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,699 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,699 participants in 2 patient groups

Usual Medical Care

No Intervention group

Description:

As per standard of care

"SMART on FHIR" application of the IMPROVE DD VTE CPR

Experimental group

Description:

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.

Treatment:

Other: IMPROVE DD VTE Tool