MASLDeMPOWERNCT07382349
A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease
A study testing eMPOWER Decision Aid in people with MASLD, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD
- What is being tested?
- eMPOWER Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years)
- Outpatient clinic visit (in-person or telemedicine) at a participating clinic site
- Demonstrated Screening Need due to High Risk Profile, which includes the following: Diagnostic Codes for MASLD or Hepatic Steatosis on Imaging PLUS at least one cardiometabolic risk factors; OR Chronically Elevated Liver Enzymes (> 6 months); OR patient with impaired glycemic control (prediabetes/diabetes); OR 2 or more cardiometabolic risk factors present
Who cannot join
- Solid Organ Transplant Recipient
- Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years
- Active Cancer Diagnoses
- Diagnoses for Alcohol-Related Conditions
- Pregnant Individuals
- Receiving Palliative Care Services
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease
The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an electronic health record embedded algorithm for MASLD care management within ambulatory primary care, endocrinology, and general gastroenterology settings.
Read the detailed description
A pragmatic, randomized trial within selected clinical practices for primary care, endocrinology, and non-hepatology gastroenterology sites within Vanderbilt University Medical Center will be conducted over a period of 3 years with 12 months of follow up for each participant. Participants will be randomized 1:1 to intervention or usual care. In the intervention arm, the decision support aid (eMPOWER) will be used to alert consenting providers to participant-specific recommendations for steatotic liver disease care based on clinical features and risk factor profiles. The primary endpoint will be linkage to care determined by orders for referral to hepatology for advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests for indeterminate risk participants by FIB-4 (1.3-2.67 for participants under 65, 2.0-2.67 for participants 65 and older), completion rates of hepatology referrals, and time analyses to complete either referrals or elastography studies. Post-study surveys and interviews to participating clinicians will be applied.
- Conditions
- MASLD
- Being tested
- eMPOWER Decision Aid
- Keywords
- Electronic Health Record, MASLD, Clinical Decision Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMPOWER Decision AidOther
An electronic health record embedded decision aid utilizing clinical data from both structured and unstructured clinical data to guide risk stratification and care management for patients with steatotic liver disease. Providers will be alerted to patient specific recommendations during the clinical encounter and between encounters through asynchronous communications related to subsequent testing.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Care providers will treat subject per standard of care |
| Electronic Decision Aid Group | Experimental | 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 Receives: Other: eMPOWER Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this pragmatic trial is to assess the efficacy of the electronic decision support aid for increasing linkage to hepatology care for high-risk participants with MASLD
Number of participants with new referrals placed to Hepatology for evaluation of high-risk status
Measured: Baseline to 12 months
Secondary outcomes (5)
The secondary objective is to assess the efficacy of the electronic decision support aid for increasing elastography testing ordered by primary care and specialty care providers for indeterminate-risk participants with MASLD
Number of participants with orders placed by primary care and specialty care providers for noninvasive elastography assessments for evaluation of indeterminate risk status
Measured: Baseline to 12 months
Rate of Completion of Hepatology Referral
Of patients referred to Hepatology, number of participants with completed referrals for evaluation of high-risk status
Measured: Baseline to 12 months
Time to Completion of Hepatology Referral
Of patients referred to Hepatology, time to completion of referrals placed to Hepatology for evaluation of high-risk status determined by FIB-4 scoring
Measured: Baseline to 12 months
Rate of Completion of Noninvasive Elastography Studies
Of patients ordered for noninvasive fibrosis testing, number of completed orders placed by primary care and specialty care providers for evaluation of indeterminate risk status
Measured: Baseline to 12 months
Time to Completion of Noninvasive Elastography Studies
Of patients ordered for noninvasive fibrosis testing, time to completion of orders placed by primary care and specialty care providers for evaluation of indeterminate risk status
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Jul 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MASLDStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases
- Responsible party
- Principal investigator, Ashley Spann, Vanderbilt University Medical Center
- Investigators
- Ashley Spann, MD, MSACI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382349
- Sponsor's protocol ID
- 241192
- Acronym
- eMPOWER
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protected Health Information
Publications
Spann A, Bishop KM, Weitkamp AO, Stenner SP, Nelson SD, Izzy M. Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease. Hepatol Commun. 2023 Feb 9;7(3):e0035. doi: 10.1097/HC9.0000000000000035. eCollection 2023 Mar 1.
PubMed 36757410Spann A, Bishop K, Marbach S, Ji X, Slaughter J, Weitkamp A, Stenner S, Nelson S, Lopez C, Theobald C, Izzy M. Electronic decision aids enhance management of primary care patients with steatotic liver disease: Proof of concept pilot study. Hepatol Commun. 2025 Sep 5;9(9):e0794. doi: 10.1097/HC9.0000000000000794. eCollection 2025 Sep 1.
PubMed 40906885
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07382349
- Acronym / sponsor ID
- eMPOWER / 241192
- Conditions
- MASLD
- Keywords
- Electronic Health Record, MASLD, Clinical Decision Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an electronic health record embedded algorithm for MASLD care management within ambulatory primary care, endocrinology, and general gastroenterology settings.
Detailed description
A pragmatic, randomized trial within selected clinical practices for primary care, endocrinology, and non-hepatology gastroenterology sites within Vanderbilt University Medical Center will be conducted over a period of 3 years with 12 months of follow up for each participant. Participants will be randomized 1:1 to intervention or usual care. In the intervention arm, the decision support aid (eMPOWER) will be used to alert consenting providers to participant-specific recommendations for steatotic liver disease care based on clinical features and risk factor profiles. The primary endpoint will be linkage to care determined by orders for referral to hepatology for advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests for indeterminate risk participants by FIB-4 (1.3-2.67 for participants under 65, 2.0-2.67 for participants 65 and older), completion rates of hepatology referrals, and time analyses to complete either referrals or elastography studies. Post-study surveys and interviews to participating clinicians will be applied.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Care providers will treat subject per standard of care |
| Electronic Decision Aid Group | Experimental | Other: eMPOWER Decision Aidthe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years)
- Outpatient clinic visit (in-person or telemedicine) at a participating clinic site
- Demonstrated Screening Need due to High Risk Profile, which includes the following: Diagnostic Codes for MASLD or Hepatic Steatosis on Imaging PLUS at least one cardiometabolic risk factors; OR Chronically Elevated Liver Enzymes (> 6 months); OR patient with impaired glycemic control (prediabetes/diabetes); OR 2 or more cardiometabolic risk factors present
Key exclusion criteria (6 listed)
- Solid Organ Transplant Recipient
- Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years
- Active Cancer Diagnoses
- Diagnoses for Alcohol-Related Conditions
- Pregnant Individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eMPOWER Decision AidAn electronic health record embedded decision aid utilizing clinical data from both structured and unstructured clinical data to guide risk stratification and care management for patients with steatotic liver disease. Providers will be alerted to patient specific recommendations during the clinical encounter and between encounters through asynchronous communications related to subsequent testing. | Other | Electronic Decision Aid Group |
Primary outcome
The primary objective of this pragmatic trial is to assess the efficacy of the electronic decision support aid for increasing linkage to hepatology care for high-risk participants with MASLD
Time frame: Baseline to 12 months
Number of participants with new referrals placed to Hepatology for evaluation of high-risk status
5 secondary outcomes
The secondary objective is to assess the efficacy of the electronic decision support aid for increasing elastography testing ordered by primary care and specialty care providers for indeterminate-risk participants with MASLD
Time frame: Baseline to 12 months
Rate of Completion of Hepatology Referral
Time frame: Baseline to 12 months
Time to Completion of Hepatology Referral
Time frame: Baseline to 12 months
Rate of Completion of Noninvasive Elastography Studies
Time frame: Baseline to 12 months
Time to Completion of Noninvasive Elastography Studies
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 36757410Spann A, Bishop KM, Weitkamp AO, Stenner SP, Nelson SD, Izzy M. Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease. Hepatol Commun. 2023 Feb 9;7(3):e0035. doi: 10.1097/HC9.0000000000000035. eCollection 2023 Mar 1.
- Background: PubMed 40906885Spann A, Bishop K, Marbach S, Ji X, Slaughter J, Weitkamp A, Stenner S, Nelson S, Lopez C, Theobald C, Izzy M. Electronic decision aids enhance management of primary care patients with steatotic liver disease: Proof of concept pilot study. Hepatol Commun. 2025 Sep 5;9(9):e0794. doi: 10.1097/HC9.0000000000000794. eCollection 2025 Sep 1.
- Individual participant dataSharing planned: No. Protected Health Information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Spann, MD, MSACI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eMPOWER Decision Aid in people with MASLD, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael McGill (6153224643, michael.g.mcgill@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this pragmatic trial is to assess the efficacy of the electronic decision support aid for increasing linkage to hepatology care for high-risk participants with MASLD (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07382349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.