Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM)

Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes

Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study

The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT >/= 40 IU/mL in males, ALT >/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse). Intervention content will include: 1) NAFLD education; 2)diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care. Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.

Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care

Patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria. We will deem this approach feasible if detection rates are >70%.

We will calculate the mean and standard deviation of the Treatment Acceptability and Preferences (TAP);Minimum value = 0; Maximum value = 4; Higher score is a better outcome (ie more acceptable). We will define acceptable score as mean TAP ≥ 3.

The SEMCD is a 6-item scale with a minimum value = 1; Maximum value = 10; Higher score is a better outcome (ie greater self-efficacy) Maximum value = 60, Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of >/=1.

The HCCQ is a 5-item scale with a minimum value = 1; Maximum value = 5; Higher score is a better outcome (ie greater self-management) Will be measured by a change of >/=1 as being clinically significant.

The SF-12 is a 5-item scale with a minimum value = 0; Maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant.

Change as measured by the Voils Non-adherence measure. Minimum value = 0; maximum value = 5. Higher score is worse outcome (ie more non-adherence). Will be measured by change of >/= 1.

Inclusion Criteria: People who identify as either: Latino/Latina/Hispanic ethnicity and/or Black or African American race People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx. Patients with elevated serum alanine aminotransferase (ALT) within Duke University Healthcare System (DUHS). Elevated ALT will be defined as having at least two ALT ≥40 IU/mL in males or ≥31 IU/mL in females in the preceding 12 months Exclusion Criteria: People with hepatitis B or C infection People with known alcohol overuse People with current use of chemotherapy or other drugs known to affect liver function People who have not been seen by a DUHS Primary Care Physician (PCP) or Endocrinologist in the preceding year.