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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

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 more

Awards & 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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