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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10699 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2022-01-21

Brief Summary

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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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Detailed Description

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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.

Conditions

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Venous Thromboembolism Arterial Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multicenter clustered randomized study of a universal electronic health record-based IMPROVE VTE risk assessment model implementation as a quality improvement project for the prevention of venous thromboembolism in hospitalized medically ill patients.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Usual Medical Care

As per standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

"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.

Group Type EXPERIMENTAL

IMPROVE DD VTE Tool

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No