CompletedNot Applicable

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

United States10,699 participantsStarted 2020-12-21

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the impact of implementing a multicenter QI program using a universal for type and duration of thromboprophylactic agent

Timeframe: 90 days

Trial details

NCT IDNCT04768036

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-21

View on ClinicalTrials.gov More Venous Thromboembolism trials