Diabetes Mellitus, Type 2, Liver Diseases, Liver Fat, Non-Alcoholic Steatohepatitis
Conditions
Brief summary
The purpose of this study is to promote the diagnosis and awareness of Non-Alcoholic Steatohepatitis (NASH) by linkage of care.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is an extremely common condition affecting 26% of the US general population but only 2% of the population has a more aggressive histological phenotype, nonalcoholic steatohepatitis (NASH) or evidence of liver fibrosis\[1\]. The American Association for the Study of Liver Diseases (AASLD) does not recommend routine screening of the general population for NAFLD\[2\] citing "uncertainties surrounding diagnostic tests and treatment options\[3\]", but does recommend referral to a hepatologist when there is a high index of suspicion for NASH and advanced fibrosis such as in patients with type 2 diabetes (T2D)\[4-6\], and in those with elevated fibrosis-4 index (FIB-4) \[7, 8\]. These aids are under-utilized by physicians that result in many patients who are at high risk for fibrosis and are not referred to hepatology\[9\]. Confusion regarding how to best define the population at risk is a major problem preventing the appropriate use of hepatology referral in the primary care setting.
Interventions
BEHAVIORALBest Practice Alert
To determine if rates of screening and referral to hepatology can be improved through an EMR-based BPA for an appropriate referral.
BEHAVIORALNo Intervention
The only intervention is the Best Practice Alert (BPA). Providers from three departments will be randomized to one of two groups: one that receives a BPA and one that does not. Thereafter, the study will observe patients who fit criteria for NASH referral, as defined by a diagnosis of T2DM and appropriate Fib4 score to determine if they have been referred to Hepatology for assessment.
Sponsors
University of Kansas Medical Center
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Providers from internal medicine, family medicine and endocrinology clinics.
Exclusion criteria
* Providers may choose to opt-out from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine if rates of referral to hepatology can be improved through EMR-based Best Practice Alert (BPA) for an appropriate referral. Name of the specific primary outcome measure | 12 months | Quantify the number of new referrals from providers who opt-in to have BPA notifications. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWinston Dunn, MD
University of Kansas Medical Center
Outcome results
None listed