Venous ThromboembolismNCT04768036

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

A study testing IMPROVE DD VTE Tool in people with Venous Thromboembolism and Arterial Thromboembolism, run by Northwell Health at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Venous Thromboembolism, Arterial Thromboembolism
What is being tested?: IMPROVE DD VTE Tool
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10,699 participants
Where: 5 sitesUnited States
Study dates: 21 Dec 2020to 21 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Immobilization
Previous VTE history
D-dimer (>2X ULN)

Who cannot join

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)

Show all 10Show fewer

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 locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

North Shore University Hospital
Manhasset, New York, 11030
The Institute for Health Innovations and Outcomes Research
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Lenox Hill Hospital
New York, New York, 10075
Staten Island University Hospital
Staten Island, New York, 10305

Other trials in United States

About this study

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.

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.

Read the 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.

Conditions: Venous Thromboembolism, Arterial Thromboembolism
Being tested: IMPROVE DD VTE Tool
Medical subject headings: Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04768036
Study group	Role	What they receive
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. Receives: Other: IMPROVE DD VTE Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 90 days

Secondary outcomes (12)

Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE
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).
Measured: 90 days
Number of participants with VTE-related readmissions
The combined total number of VTE-related readmissions of patients at up to 90 days.
Measured: 90 days
Number of participants with all cause readmissions
The combined total of the number of patients with all cause hospital readmissions.
Measured: 90 days
Change in diagnosis-related group
Change in diagnosis-related group of patients from baseline up to 90 days.
Measured: 90 days
Change in type of insurance
Change in type of insurance for patients from baseline up to 90 days.
Measured: 90 days
Change in drug cost
Change in drug cost for patients from baseline up to 90 days.
Measured: 90 days
Change in prescriber patterns of LMWH (low molecular weight heparin)
Change in prescriber patterns for patient use of LMWH, enoxaparin, compared to standard of 40mg SQ QD.
Measured: 90 days
Change in prescriber patterns of UFH (unfractionated heparin)
Change in prescriber patterns of patient use of UFH, as compared to standard of 5000U SQ BID or TID.
Measured: 90 days
Change in prescriber patterns of fondaparinux
Change in prescriber patterns of patient use of fondaparinux, as compared to standard of 2.5mg SQ QD.
Measured: 90 days
Change in prescriber patterns of rivaroxaban
Change in prescriber patterns of patient use of direct oral anticoagulant, rivaroxaban, as compared to a standard of 10mg PO QD.
Measured: 90 days
Arterial thromboembolism (ATE)
including stroke, transient ischemic attack (TIA), myocardial infarction (MI)
Measured: 90 days
Total thromboembolism (VTE and ATE)
Including stroke, transient ischemic attack (TIA), myocardial infarction (MI) systemic embolism, acute limb ischemia, lower extremity deep vein thrombosis (DVT).
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 202021 Jan 2022

First posted24 Feb 2021
Study start21 Dec 2020
Primary completion21 Jan 2022
Study completion21 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Care provider
Enrolment: 10,699 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04768036
Sponsor's protocol ID: 20-0752
Status last verified: Jul 2022
First submitted: 1 Feb 2021
Last updated: 2 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 21436241
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.
PubMed 28640324

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04768036
Acronym / sponsor ID: 20-0752
Conditions: Venous Thromboembolism, Arterial Thromboembolism
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,699 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: 21 Dec 2020 (actual)
Primary completion: 21 Jan 2022 (actual)
Study completion: 21 Jan 2022 (actual)
First posted: 24 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
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.

Arm	Type	Receives
Usual Medical Care	No intervention	–As per standard of care
"SMART on FHIR" application of the IMPROVE DD VTE CPR	Experimental	Other: IMPROVE DD VTE ToolThis 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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

Patients with the following factors:
Therapeutic anticoagulation
History of recent bleeding.
Active gastroduodenal ulcer
Thrombocytopenia (admission platelet count< 75x 109 cells/L )

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMPROVE DD VTE ToolUniversal "SMART on FHIR" platform-based EHR-embedded IMPROVE VTE CPR with electronic order entry incorporated into required admission and discharge EHR workflow.	Other	"SMART on FHIR" application of the IMPROVE DD VTE CPR

Primary outcome

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.

12 secondary outcomes

Rates of patient VTE as assessed by the diagnostic and imaging codes for VTE
Time frame: 90 days
Number of participants with VTE-related readmissions
Time frame: 90 days
Number of participants with all cause readmissions
Time frame: 90 days
Change in diagnosis-related group
Time frame: 90 days
Change in type of insurance
Time frame: 90 days
Change in drug cost
Time frame: 90 days
Change in prescriber patterns of LMWH (low molecular weight heparin)
Time frame: 90 days
Change in prescriber patterns of UFH (unfractionated heparin)
Time frame: 90 days
Change in prescriber patterns of fondaparinux
Time frame: 90 days
Change in prescriber patterns of rivaroxaban
Time frame: 90 days
Arterial thromboembolism (ATE)
Time frame: 90 days
Total thromboembolism (VTE and ATE)
Time frame: 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Background: PubMed 21436241Spyropoulos 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.
Background: PubMed 28640324Spyropoulos 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.

Related trials for Venous Thromboembolism

RecruitingObservational study
Danang Cerebral Venous Thrombosis Registry
Cerebral Venous Sinus Thrombosis, Stroke
Active, not recruitingObservational study
Epidemiology of Venous Thrombosis and Pulmonary Embolism
Cardiovascular Diseases, Pulmonary Embolism
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
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Not yet recruitingObservational study
TOF-MRV Versus Post-Contrast 3D T1 MRI in Dural Venous Sinus Thrombosis
Cerebral Thrombosis, Venous Thrombosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alex Spyropoulos, MD principal investigator

Northwell Health

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IMPROVE DD VTE Tool in people with Venous Thromboembolism and Arterial Thromboembolism, run by Northwell Health at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04768036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.