Risk Assessment Tool for Venous Thromboembolism
(MIRICLE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to evaluate whether the implementation of a real-time prognostic model can effectively identify and prevent blood clots among hospitalized patients. The main questions it aims to answer is:
1. Can the prognostic model reduce rates of hospital-acquired blood clots (also known as hospital-acquired venous thromboembolisms)?
2. Is the prognostic model an effective tool for initiating timely and appropriate preventive treatment (i.e., thromboprophylaxis)?
Researchers will compare the intervention arm with the control arm (standard of care) to determine whether the intervention reduces rates of blood clots and improves initiation of preventive treatment.
The intervention (clinical decision support that displays the prognostic model's output) will be implemented by displaying a risk score in clinicians' workflow in the electronic health record (EHR) to notify clinicians of patients who are at higher risk for sustaining a blood clot. The intervention will not dictate patient care and clinicians will continue to use their clinical knowledge and judgment in their clinical decision-making.
Are You a Good Fit for This Trial?
This trial is for adults who are hospitalized and at risk of developing blood clots in their veins. There are no specific inclusion or exclusion criteria listed, so it appears to be broadly open to most hospitalized patients.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- VTE Risk Assessment CDS Tool
Trial Overview
The study tests a new tool that alerts doctors if a patient is at high risk for blood clots during their hospital stay. The tool's effectiveness will be compared with usual care to see if it helps prevent more blood clots.
How Is the Trial Designed?
2
Treatment groups
Active Control
For patients randomized to the control arm, the clinical care team will administer standard of care at VUH and monitor their patients' risk for HA-VTE in accordance with existing protocols and procedures. Standard of care includes assessing patient risk for VTE and initiating prophylaxis if necessary, usually using an order set. If the clinical care team determines that the patient has elevated risk and no contraindications, they will initiate and order prophylaxis using their service line-specific order set and continue to monitor the patient for any complications. Providers caring for patients in the control arm will not be shown the HA-VTE risk score anywhere in the EHR, which is the status quo.
Standard of care plus risk assessment model: the prognostic model will automatically calculate a patient's risk score daily based on 17 risk factors. For patients randomized to the intervention, the clinical care team will see the patient's predicted risk score during their standard risk assessment process, which will be embedded in their EHR workflow. The clinical care team will have access to review the patient's risk score in conjunction with their clinical judgment to guide decision-making surrounding risk assessment and initiation of prophylaxis (if applicable).
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Vanderbilt University Medical Center
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.