RECRUITING

NAFLD Clinical Care Pathway

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Testing the Effectiveness of NAFLD Clinical Care Pathway in VA Primary Care

Quick Facts

Study Start:2024-02-02
Study Completion:2028-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06671886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization.
  2. * PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination.
  3. * PACTs meeting the following criteria will be excluded from randomization in Aim 2:
  4. * PACTs who do not treat NAFLD,
  5. * PACTs not located at the main hospital,
  6. * PACTs with less than 100 visits within 3 months.

Contacts and Locations

Study Contact

Hashem B El-Serag, MD MPH
CONTACT
(713) 794-8640
Hashem.El-Serag@va.gov
Kyler Godwin, PhD MPH BS
CONTACT
(713) 440-4672
kyler.godwin@va.gov

Principal Investigator

Hashem B. El-Serag, MD MPH
PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX

Study Locations (Sites)

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Hashem B. El-Serag, MD MPH, PRINCIPAL_INVESTIGATOR, Michael E. DeBakey VA Medical Center, Houston, TX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02
Study Completion Date2028-11-13

Study Record Updates

Study Start Date2024-02-02
Study Completion Date2028-11-13

Terms related to this study

Keywords Provided by Researchers

  • NAFLD
  • Veterans
  • Primary health care
  • MASLD

Additional Relevant MeSH Terms

  • NAFLD
  • MASLD