Clinical trial NCT04768036: A Universal Electronic Health Record-based IMPROVE DD VTE Risk Assessment Model for the Prevention of Thromboembolism in Hospitalized Medically Ill Patients
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Arterial Thromboembolism
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 10699
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent
timeFrame: 90 days
Secondary outcomes:
measure: Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE
timeFrame: 90 days
measure: Number of participants with VTE-related readmissions
timeFrame: 90 days
measure: Number of participants with all cause readmissions
timeFrame: 90 days
measure: Change in diagnosis-related group
timeFrame: 90 days
measure: Change in type of insurance
timeFrame: 90 days
measure: Change in drug cost
timeFrame: 90 days
measure: Change in prescriber patterns of LMWH (low molecular weight heparin)
timeFrame: 90 days
measure: Change in prescriber patterns of UFH (unfractionated heparin)
timeFrame: 90 days
measure: Change in prescriber patterns of fondaparinux
timeFrame: 90 days
measure: Change in prescriber patterns of rivaroxaban
timeFrame: 90 days
measure: Arterial thromboembolism (ATE)
timeFrame: 90 days
measure: Total thromboembolism (VTE and ATE)
timeFrame: 90 days
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: The Institute for Health Innovations and Outcomes Research
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Alex Spyropoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.