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

NCT07580482 | Completed

• 2 other identifiers: STUDY00145358IN-US-989-5752
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Diseases; Liver Fat; Diabetes Mellitus, Type 2; Non-Alcoholic Steatohepatitis

Outcome Measures

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

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

  12 months

Study Arms (2)

Experimental Unit:

EXPERIMENTAL

Providers from internal medicine, family medicine and endocrinology clinics.

Behavioral: Best Practice Alert

Observation Unit:

OTHER

Patients from internal medicine, family medicine, and endocrinology clinics. Patients with an ICD 10 diagnosis of T2D E11.9. Patients have the most recent calculated FIB-4 Score of \>3.25.

Behavioral: No Intervention

Interventions

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.

Experimental Unit:

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.

Observation Unit:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (25)

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Related Links

• Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE).
• Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE).
• AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH.
• Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR 4).
• Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS).
• Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR 3).

MeSH Terms

Conditions

Liver Diseases; Fatty Liver; Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Winston Dunn, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: May 12, 2026
• Study Start: July 15, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)