Clinical Care Pathway for Non-Alcoholic Fatty Liver Disease
(NCCP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Unstable leadership, Focus group participation, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.
Will I have to stop taking my current medications?
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.
Is resmetirom safe for humans?
Resmetirom has been shown to be safe and well tolerated in a 52-week clinical trial for non-alcoholic fatty liver disease, with common side effects including diarrhea and nausea at the start of treatment.
12345What makes the NAFLD Clinical Care Pathway (Rezdiffra, resmetirom) treatment unique for non-alcoholic fatty liver disease?
The NAFLD Clinical Care Pathway is unique because it provides a structured approach to screening, diagnosing, and managing non-alcoholic fatty liver disease, focusing on accurate staging of liver fibrosis and integrating care across primary and secondary healthcare settings. This pathway emphasizes timely and evidence-based management, which is crucial for a condition that often shows no symptoms and lacks standard medication treatments.
678910Eligibility Criteria
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.Inclusion Criteria
Patient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center
Exclusion Criteria
PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization
PACTs participating in the focus groups in Aim 1
PACTs who do not treat NAFLD
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
The NCCP intervention is applied, including e-trigger generation, FIB-4 score assessment, and provider education on NAFLD management
6 months
Every 3 months (e-trigger generation)
Follow-up
Participants are monitored for NAFLD diagnosis, risk stratification, and referrals to weight loss and hepatology services
6 months
6 and 12 months (data extraction from EHR)
Summative Evaluation
Evaluation to identify patient and provider characteristics associated with the effectiveness of NCCP and assess future implementation
12 months
Participant Groups
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.
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.
NAFLD Clinical Care Pathway is already approved in United States for the following indications:
🇺🇸 Approved in United States as Rezdiffra for:
- Non-alcoholic steatohepatitis (NASH)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Michael E. DeBakey VA Medical Center, Houston, TXHouston, TX
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. [2023]Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. MAESTRO-NAFLD-1 was a 52-week randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety of resmetirom in adults with nonalcoholic fatty liver disease and presumed NASH. Patients were randomized to three double-blind arms (100 mg resmetirom (n = 325), 80 mg resmetirom (n = 327) or placebo (n = 320)) or open-label 100 mg resmetirom (n = 171). The primary end point was incidence of treatment-emergent adverse events (TEAEs) over 52 weeks and key secondary end points were LDL-C, apoB, triglycerides (over 24 weeks), hepatic fat (over 16 and 52 weeks) and liver stiffness (over 52 weeks). Resmetirom was safe and well tolerated. TEAEs occurred in 86.5% (open-label 100 mg resmetirom), 86.1% (100 mg resmetirom), 88.4% (80 mg resmetirom) and 81.8% (placebo) of patients. TEAEs in excess of placebo included diarrhea and nausea at the initiation of treatment. Key secondary end points included least square means difference from placebo at 80 mg, 100 mg resmetirom: LDL-C (-11.1%, -12.6%), apoB (-15.6%, -18.0%), triglycerides (-15.4%, -20.4%), 16-week hepatic fat (-34.9%, -38.6%), (P
Treatment options for nonalcoholic steatohepatitis - a safety evaluation. [2017]There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis. Expert opinion: Current therapies continue to remain suboptimal. Weight loss is effective but hard to achieve. Traditional and endoscopic bariatric procedures are promising although more randomized trials are needed and the long-term safety remains to be established. Clinical trials have demonstrated the efficacy of several drugs for the treatment of NASH. Of these, there remains some uncertainty about the long-term safety of vitamin E. Pioglitazone is associated with osteopenia, fluid retention and weight gain. Obeticholic acid causes pruritus in a substantial proportion of subjects and elafibranor has been associated with transient rises in creatinine. Several exciting therapies are under development and results of clinical and post-marketing trials will help elucidate their safety.
Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. [2021]Non-alcoholic steatohepatitis (NASH) is characterised by hepatic steatosis, inflammation, hepatocellular injury, and progressive liver fibrosis. Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity. We aimed to assess the safety and efficacy of resmetirom in patients with NASH.
New anti-diabetic agents for the treatment of non-alcoholic fatty liver disease: a systematic review and network meta-analysis of randomized controlled trials. [2023]This network meta-analysis aims to compare the efficacy and safety of new anti-diabetic medications for the treatment of non-alcoholic fatty liver disease (NAFLD).
New drugs for NASH. [2021]Non-alcoholic steatohepatitis (NASH) is a result of inflammation and hepatocyte injury in the presence of hepatic steatosis which can progress to cirrhosis. NASH is the most rapidly growing aetiology for liver failure and indication for liver transplantation in the United States. Non-alcoholic fatty liver disease (NAFLD) is associated with obesity, type 2 diabetes, dyslipidaemia and metabolic syndrome. Because of the absence of approved pharmacotherapy, weight loss and lifestyle modifications remain the safest and most effective first-line treatment. However, this may not be effective in patients with advanced fibrosis or cirrhosis and long-term adherence is difficult to achieve. Therefore, effective drugs are urgently needed for the treatment of NASH. Drug development targeting pathological pathways in NASH have exploded in the past decade, with numerous new drugs under investigation. This review summarizes the results of pivotal finalized phase 2 studies and provides an outline of key active studies with trial data of drugs under development.
Evaluation of a primary to secondary care referral pathway and novel nurse-led one-stop clinic for patients with suspected non-alcoholic fatty liver disease. [2022]Non-alcoholic fatty liver disease (NAFLD) affects approximately one in four adults of the general population, with an important minority of cases at high risk of developing cirrhosis. We evaluated the utility of a primary care NAFLD pathway incorporating a specialist nurse-led NAFLD clinic and a two-step testing approach for advanced liver fibrosis.
Updates in non-alcoholic fatty liver disease (NAFLD). [2021]Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in childhood. There is an increase in disease prevalence and diagnoses as it is difficult to diagnose the problem. There are currently no effective medications. Management of NAFLD is a challenge for primary care clinicians and subspecialists. This paper provides guidelines for disease screening, diagnosis, management, and algorithm for subspecialty referral.
Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease. [2022]Find AGA's NASH Clinical Care Pathway App for iOS and Android mobile devices at nash.gastro.org. Scan this QR code to be taken directly to the website.Nonalcoholic fatty liver disease (NAFLD) is becoming increasingly common, currently affecting approximately 37% of US adults. NAFLD is most often managed in primary care or endocrine clinics, where clinicians must determine which patients might benefit from secondary care to address hepatic manifestations, comorbid metabolic traits, and cardiovascular risks of the disease. Because NAFLD is largely asymptomatic, and because optimal timing of treatment depends on accurate staging of fibrosis risk, screening at the primary care level is critical, together with consistent, timely, evidence-based, widely accessible, and testable management processes. To achieve these goals, the American Gastroenterological Association assembled a multidisciplinary panel of experts to develop a Clinical Care Pathway providing explicit guidance on the screening, diagnosis, and treatment of NAFLD. This article describes the NAFLD Clinical Care Pathway they developed and provides a rationale supporting proposed steps to assist clinicians in diagnosing and managing NAFLD with clinically significant fibrosis (stage F2-F4) based on the best available evidence. This Pathway is intended to be applicable in any setting where care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Retrospective analysis of a dedicated care pathway for nonalcoholic fatty liver disease in an integrated US healthcare system demonstrates support of weight management and improved ALT. [2021]A care pathway for nonalcoholic fatty liver disease (NAFLD) in Kaiser Permanente San Diego, California was instituted in August 2017 to improve efficiency of disease staging and promote lifestyle modification.
Performance of American Gastroenterological Association Clinical Care Pathway for the risk stratification of patients with nonalcoholic fatty liver disease in the US population. [2023]The American Gastroenterological Association (AGA) recently launched the Clinical Care Pathway for the Risk Stratification and Management of Patients with NAFLD to identify adults with significant fibrosis. We aimed to examine this pathway's performance in the US population.