Title: Randomized Trial of an EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03243708|
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Behavioral: Risk calculator||Not Applicable|
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
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|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Step-Wedge Randomized controlled trial (RCT)|
|Masking:||None (Open Label)|
|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|
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
- 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
- Total patients receiving prophylaxis [ Time Frame: 14 days ]All patients who received any chemoprophylaxis during hospitalization, regardless of risk status.
- 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.
- 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.
- Rate of major bleeding among high risk patients [ Time Frame: 14 days ]Major bleeding events among patients with risk factors for bleeding.
- Average cost of prophylaxis [ Time Frame: 14 days ]Total cost of prophylaxis received during hospitalization
- Average cost of hospitalization [ Time Frame: Up to 30 days ]Cost of hospitalization as determined by the hospital cost accounting system
- Average length of stay [ Time Frame: Up to 30 days ]Total days in hospital
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
|Contact: Michael Rothberg, MDfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland Clinic Health System||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Michael Rothberg, MD 216-445-0719 ROTHBEM@ccf.org|
|Principal Investigator:||Michael Rothberg||The Cleveland Clinic|