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

NCT04768036 | Completed

• 1 other identifier: 20-0752
• Study Type: interventional
• Target: 10,699
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Venous Thromboembolism; Arterial Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

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

  90 days

• Number of participants with VTE-related readmissions

  90 days

• Number of participants with all cause readmissions

  90 days

• Change in diagnosis-related group

  90 days

• Change in type of insurance

  90 days

Study Arms (2)

Usual Medical Care

NO INTERVENTION

As per standard of care

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

EXPERIMENTAL

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.

Other: IMPROVE DD VTE Tool

Interventions

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.

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (5)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

The Institute for Health Innovations and Outcomes Research

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Related 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.

  PMID: 21436241 BACKGROUND

• 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.

  PMID: 28640324 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alex Spyropoulos, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 24, 2021
• Study Start: December 21, 2020
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

US (5)