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

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ClinicalTrials.gov Identifier: NCT03243708
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Rothberg, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Behavioral: Risk calculator Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50000 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Step-Wedge Randomized controlled trial (RCT)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Title: EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 3, 2018
Estimated Study Completion Date : December 3, 2018

Arm Intervention/treatment
No Intervention: Usual Care
Control: Standard order set without risk calculator (usual care)
Active Comparator: Risk calculator
Intervention: VTE risk calculator embedded in the smart order set incorporated into the EHR and activated for all medical patients
Behavioral: Risk calculator
Venous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis




Primary Outcome Measures :
  1. Appropriate VTE prophylaxis [ Time Frame: within 48 hours of index hospitalization admission ]
    Proportion of patients at high risk of VTE who receive prophylaxis and the proportion of patients at low risk who do not receive prophylaxis


Secondary Outcome Measures :
  1. Total patients receiving prophylaxis [ Time Frame: 14 days ]
    All patients who received any chemoprophylaxis during hospitalization, regardless of risk status.

  2. Rate of VTE among high risk patients [ Time Frame: 14 days ]
    Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.

  3. Rate of VTE among high risk patients [ Time Frame: 45 days ]
    Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.

  4. Rate of major bleeding among high risk patients [ Time Frame: 14 days ]
    Major bleeding events among patients with risk factors for bleeding.

  5. Average cost of prophylaxis [ Time Frame: 14 days ]
    Total cost of prophylaxis received during hospitalization

  6. Average cost of hospitalization [ Time Frame: Up to 30 days ]
    Cost of hospitalization as determined by the hospital cost accounting system

  7. Average length of stay [ Time Frame: Up to 30 days ]
    Total days in hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243708


Contacts
Contact: Michael Rothberg, MD 216-445-0719 rothbem@ccf.org

Locations
United States, Ohio
Cleveland Clinic Health System Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michael Rothberg, MD    216-445-0719    ROTHBEM@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Michael Rothberg The Cleveland Clinic

Publications:

Responsible Party: Michael Rothberg, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03243708     History of Changes
Other Study ID Numbers: 17-396
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Rothberg, The Cleveland Clinic:
Venous Thromboembolism Risk Calculator

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases