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Behavioral Intervention
Clinical Care Pathway for Non-Alcoholic Fatty Liver Disease (NCCP Trial)
N/A
Recruiting
Led By Hashem B. El-Serag, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to improve the diagnosis and treatment of non-alcoholic fatty liver disease (NAFLD) among Veterans by implementing a new intervention called the NAFLD Clinical Care Pathway (NCC
Who is the study for?
This trial is for individuals at risk of Non-alcoholic Fatty Liver Disease (NAFLD), which is often undiagnosed and untreated among Veterans. The study aims to improve diagnosis and treatment by using an automated system called NCCP to identify patients, assess their NAFLD severity, and guide primary care providers.
What is being tested?
The intervention being tested is the NAFLD Clinical Care Pathway (NCCP), which uses electronic triggers (E-trigger) to automatically identify veterans at risk for severe NAFLD, calculate their risk scores, and educate healthcare providers on managing the condition.
What are the potential side effects?
Since this trial focuses on a diagnostic and educational intervention rather than a medication or medical procedure, there are no direct side effects associated with traditional clinical trials. However, any potential indirect impacts will be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NAFLD Diagnosis and risk stratification
Secondary study objectives
Enrollment in weight loss services
Fibroscan Test
Hepatology Clinic Visit
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: E-triggerExperimental Treatment1 Intervention
The NCCP Intervention is made up of multiple components. The investigators will start by applying the e-trigger and assessing the FIB-4 score, and then will train and educate PACT personnel on managing patients with positive triggers, including making treatment recommendations in collaboration with an inter-professional team. The e-trigger will be generated every three months.
Group II: Usual careActive Control1 Intervention
The control group will receive no additional training or education. PACTs will provide usual care.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,777 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
244 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Hashem B. El-Serag, MD MPHPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX