Improving care for Veterans with non-alcoholic fatty liver disease
Testing the Effectiveness of NAFLD Clinical Care Pathway in VA Primary Care
This study tests a new way to help Veterans with non-alcoholic fatty liver disease by using a structured plan to improve diagnosis and treatment compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06671886 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on enhancing the diagnosis and treatment of non-alcoholic fatty liver disease (NAFLD) among Veterans by implementing a Clinical Care Pathway (NCCP). The NCCP utilizes an algorithmic approach to identify at-risk patients, assess their risk of severe NAFLD, and educate primary care providers on appropriate management strategies. The study aims to compare the effectiveness of this structured intervention against usual care in increasing diagnosis rates and facilitating referrals for treatment. By addressing the significant gap in care for NAFLD within the VA system, the study seeks to improve patient outcomes and reduce complications associated with the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans receiving care at the Michael E. DeBakey VA Medical Center who are at risk for NAFLD.
Not a fit: Patients who do not have access to the main hospital or those whose care teams do not treat NAFLD will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to earlier diagnosis and better management of NAFLD in Veterans, ultimately reducing the risk of severe liver complications.
How similar studies have performed: Other studies have shown success with similar structured care pathways in improving diagnosis and management of chronic diseases, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Hashem B. El-Serag, MD MPH — Michael E. DeBakey VA Medical Center, Houston, TX
- Study coordinator: Hashem B El-Serag, MD MPH
- Email: Hashem.El-Serag@va.gov
- Phone: (713) 794-8640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.