Title: Randomized Trial of an EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients

Completed · Not applicable

Conditions studied: Venous Thromboembolism

In brief

Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality. Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of bleeding. However, identifying patients at low risk for VTE can be difficult, because most patients have at least one risk factor for VTE and there are no validated risk prediction tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all approach with near-universal prophylaxis, putting many patients at unnecessary risk of bleeding. However, to provide care that is truly patient-centered, US physicians face several challenges. First, there is no accepted risk calculator that they can use to estimate an individual patient's risk. Second, risk calculators are not readily available at the point of care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an individual patient's risk of VTE. The tool is incorporated into the electronic health record in the form of a smart order set. In this randomized trial, we will assess the effects of the order set on physician behavior and patient outcomes . Examining the effectiveness of an electronic decision aid embedded in an EHR in routine clinical practice will test whether a smart order set can improve patient care by incorporating patient-specific factors into a complex decision process.

Key facts

Study ID

NCT03243708

Run by

The Cleveland Clinic

People needed

90537

Starts

2017-12-04

Expected to finish

2019-04-14

Last updated by the study team

2019-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All adult patients (age ≥18 years) admitted to a medical service, including intensive care units, between September 1, 2017 and August 31, 2018 will be eligible.

You may not qualify if…

• patients not eligible to receive VTE prophylaxis because they are already receiving anticoagulation for another purpose (e.g. warfarin for atrial fibrillation or LMWH for DVT or PE present on admission),
• patients admitted with a terminal condition who are receiving comfort care only
• Surgical patients who are admitted to the medical service temporarily (e.g. hip fracture)

Where it is running

• Cleveland Clinic Health System — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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