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OpenTrials
Completed

NCT Number: NCT07580482

The Referral to Hepatology Can be Improved Through an Electronic Medical Record (EMR)-Based Best Practice Alert (BPA) for an Appropriate Referral

The purpose of this study is to promote the diagnosis and awareness of Non-Alcoholic Steatohepatitis (NASH) by linkage of care.

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Key information

Conditions

Liver Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Fat Metabolic Diseases Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Providers from internal medicine, family medicine and endocrinology clinics.

Exclusion criteria

  • Providers may choose to opt-out from this study.

Treatment and study plan

Best Practice Alert

Behavioral

To determine if rates of screening and referral to hepatology can be improved through an EMR-based BPA for an appropriate referral.

No intervention

Behavioral

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.

Primary outcomes

  1. 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

    Time frame: 12 months

    Quantify the number of new referrals from providers who opt-in to have BPA notifications.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Gilead Sciences

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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