eMPOWER Decision Aid for Steatotic Liver Disease
(eMPOWER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new electronic tool called the eMPOWER Decision Aid, designed to assist doctors in making better decisions for patients with metabolic-dysfunction associated steatotic liver disease (MASLD), a liver condition linked to metabolism issues. The trial will compare usual care with care enhanced by this decision aid to determine its effectiveness in managing the liver disease. Suitable participants have liver issues shown in scans or tests and also have conditions like diabetes or high cholesterol. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future care for liver disease patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the eMPOWER Decision Aid is safe for use in managing steatotic liver disease?
Research shows that electronic tools like eMPOWER can safely and effectively help manage liver disease. Studies have found that these tools improve care for patients with fatty liver disease by providing doctors with personalized advice. This guidance helps doctors make better decisions without adding direct medical risks to patients.
As a decision-making tool rather than a drug, eMPOWER does not carry the usual safety concerns associated with new medications. Instead, it guides doctors in using existing treatments. No negative effects have been reported from using eMPOWER itself, suggesting it is safe and well-tolerated in clinical settings.12345Why are researchers excited about this trial?
Researchers are excited about the eMPOWER Decision Aid because it leverages technology to enhance the management of steatotic liver disease. Unlike traditional treatments that rely solely on the healthcare provider's standard protocol, this decision aid provides personalized recommendations based on individual risk stratification. This tailored approach aims to optimize care by ensuring that each patient receives the most suitable management strategy for their specific condition, potentially improving outcomes and making treatment more efficient.
What evidence suggests that the eMPOWER Decision Aid is effective for managing steatotic liver disease?
Research has shown that the eMPOWER Decision Aid, available to participants in this trial, can help manage metabolic-dysfunction associated steatotic liver disease (MASLD) by providing doctors with personalized treatment advice. In one study, patients who used digital health tools like eMPOWER for nine months lost an average of 4 kg (about 9 pounds), and their liver fat decreased by 2.5%. These changes are significant because reducing liver fat can improve liver health in people with MASLD. Overall, the eMPOWER Decision Aid positively impacts the management of this condition.12567
Who Is on the Research Team?
Ashley Spann, MD, MSACI
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
Adults over 18 with a high risk of metabolic-dysfunction associated steatotic liver disease (MASLD) can join. They must have MASLD diagnostic codes or liver fat on scans, elevated liver enzymes for more than 6 months, prediabetes/diabetes, or at least two cardiometabolic risks. Participants need to visit a clinic in person or via telemedicine.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants are randomized to either the usual care group or the electronic decision aid group, where the eMPOWER Decision Aid is used to provide participant-specific recommendations for steatotic liver disease management
Follow-up
Participants are monitored for safety and effectiveness after the intervention, with a focus on linkage to hepatology care and completion of elastography testing
What Are the Treatments Tested in This Trial?
Interventions
- eMPOWER Decision Aid
Trial Overview
The trial is testing an electronic decision aid called eMPOWER to see if it helps doctors make better decisions for patients with MASLD. It's also looking at how easy the tool is to use and what might stop doctors from using it in their practices.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
the eMPOWER Decision Aid will be used to alert care providers to the patient specific recommendations for management of steatotic liver disease based on risk stratification
Care providers will treat subject per standard of care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
American Association for the Study of Liver Diseases
Collaborator
Citations
A Study of Electronic Clinical Decision Support Tools ...
Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease. Hepatol Commun. 2023 Feb 9;7(3): ...
eMPOWER Decision Aid for Steatotic Liver Disease
Adults over 18 with a high risk of metabolic-dysfunction associated steatotic liver disease (MASLD) can join. They must have MASLD diagnostic codes or liver fat ...
Long-Term Feasibility and Outcomes of a Digital Health ... - PMC
At 9 months, compared to baseline, the mean weight loss was 4.0 kg (SD 5.0; P<.001). Liver fat decreased by 2.5% (SD 4.5; P<.001), with an 18.4% ...
4.
diabetesjournals.org
diabetesjournals.org/care/article/48/7/1057/160536/Metabolic-Dysfunction-Associated-Steatotic-LiverMetabolic Dysfunction–Associated Steatotic Liver Disease ...
Economic burden and patient-reported outcomes of nonalcoholic fatty liver disease ... fatty liver disease: an individual participant-level data ...
Artificial intelligence applications for managing metabolic ...
Deep CNNs and other AI models can detect subtle changes in hepatic fat distribution and fibrosis on imaging, enabling the early prediction of treatment response ...
Electronic decision aids enhance management of primary ...
Electronic decision aids enhance management of primary care patients with steatotic liver disease: Proof of concept pilot study. Hepatol ...
A call to action to address the steatotic liver disease public ...
This is the basis of the sub-categories: metabolic dysfunction-associated steatotic liver disease (MASLD, formerly called non-alcoholic fatty ...
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