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



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:December 4, 2017
End Date:February 28, 2019
Contact:Michael Rothberg, MD
Email:rothbem@ccf.org
Phone:216-445-0719

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Title: EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients

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.

Specific Aim:

Assess the effects of a VTE risk calculator embedded in the admission order set vs. usual
care on physician behavior and patient outcomes in a randomized trial

Research Strategy:

Utilizing a Step-Wedge design, this randomized controlled trial (RCT) will be conducted at 10
Cleveland Clinic hospitals in efforts to assess the effects of a VTE (venous thromboembolism)
risk calculator embedded in the admission order set vs. usual care on physician behavior and
patient outcomes. Hospitals will be randomized to display the risk calculator to physicians
admitting patients or to the usual order set that contains only a description of VTE risk
factors. The risk calculator will produce a predicted risk of VTE together with a
recommendation regarding the use of prophylaxis for an individual patient. Physicians will be
free to ignore the calculator or override its results if they so choose.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44195
Phone: 216-445-0719
?
mi
from
Cleveland, OH
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