| NCT ID | NCT06671886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | NAFLD |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-02-02 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Patient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center Exclusion Criteria: * The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization. * PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination. * PACTs meeting the following criteria will be excluded from randomization in Aim 2: * PACTs who do not treat NAFLD, * PACTs not located at the main hospital, * PACTs with less than 100 visits within 3 months.
Contact & Investigator
Hashem B. El-Serag, MD MPH
PRINCIPAL INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX
Frequently Asked Questions
Who can join the NCT06671886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671886 currently recruiting?
Yes, NCT06671886 is actively recruiting participants. Contact the research team at Hashem.El-Serag@va.gov for enrollment information.
Where is the NCT06671886 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06671886 clinical trial?
NCT06671886 is sponsored by VA Office of Research and Development. The principal investigator is Hashem B. El-Serag, MD MPH at Michael E. DeBakey VA Medical Center, Houston, TX. The trial plans to enroll 32 participants.