Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages

NCT04241575 | Completed Results

• 1 other identifier: NAFLD-NIT-RCT
• Study Type: interventional
• Target: 1,061
• Locations: 1 country
• Sites: 1

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide and is a major cause of cirrhosis and liver cancer in Western countries. Because of its close association with obesity and diabetes, most patients are seen by primary care physicians and endocrinologists rather than hepatologists. Previous studies have shown that NAFLD is under-recognized outside specialist settings. As a result, many patients are undiagnosed and not receiving specific treatments. With this background, we aim to test the hypothesis that the use of simple fibrosis scores as part of a diabetes complications screening program followed by electronic reminder messages is more effective than usual care in prompting physicians to correctly identify patients with suspected NAFLD and advanced liver fibrosis for specialist referral or further liver assessment. Our secondary aim is to test the hypothesis that the use of fibrosis scores and electronic reminder messages can increase the number of patients with confirmed diagnosis of advanced liver fibrosis.

Conditions

Fatty Liver, Nonalcoholic; Diabetes Mellitus, Type 2

Keywords

Fatty liver; Non-invasive assessment; Case identification

Outcome Measures

Primary Outcomes (1)

• Action on Suspected Advanced Liver Fibrosis

  Proportion of patients with high fibrosis scores who are referred for specialist care or further liver assessments

  Within 1 year of the baseline visit

Secondary Outcomes (3)

• Referral for Specialist Care

  Within 1 year of the baseline visit

• Inappropriate Referral for Specialist Care

  Within 1 year of the baseline visit

• Confirmed Diagnosis of Advanced Liver Fibrosis

  Within 1 year of the baseline visit

Study Arms (2)

Intervention group

EXPERIMENTAL

For patients in the intervention group, we will calculate the fibrosis scores. For patients with increased fibrosis scores, we will type the following pop-up message in our electronic clinical management system: "This patient has high Fibrosis-4 index (and/or AST-to-platelet ratio index) of xxx suggestive of significant liver fibrosis. Please consider referring the patient to the hepatology clinic or arranging further test such as FibroScan." The reminder message will pop up when physicians see the patient at the clinic and use the electronic clinical management system. The message will remain active for one year. Although the message is entered manually at this stage, the arrangement mimics an automated computer system. If the study results are positive, the next step is to modify the system to automate the process.

Diagnostic Test: Simple fibrosis scores and electronic reminder messages

Control group

NO INTERVENTION

Patients in the control group will undergo the same assessments as patients in the intervention group. Although physicians will have access to the raw liver biochemistry results and platelet count, the fibrosis score results will not be specifically shown, and there will be no electronic reminder messages regardless of the fibrosis scores. This is to mimic usual care when there is no dedicated care model for case identification.

Interventions

Simple fibrosis scores and electronic reminder messages DIAGNOSTIC_TEST

For patients in the intervention group, we will calculate the fibrosis scores. For patients with increased fibrosis scores, we will type the following pop-up message in our electronic clinical management system: "This patient has high Fibrosis-4 index (and/or AST-to-platelet ratio index) of xxx suggestive of significant liver fibrosis. Please consider referring the patient to the hepatology clinic or arranging further test such as FibroScan." The reminder message will pop up when physicians see the patient at the clinic and use the electronic clinical management system. The message will remain active for one year. Although the message is entered manually at this stage, the arrangement mimics an automated computer system. If the study results are positive, the next step is to modify the system to automate the process.

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Having type 2 diabetes
• Provided informed written consent

You may not qualify if:

• Type 1 diabetes
• Already receiving specialist care by gastroenterologists or hepatologists
• Current or past history of hepatocellular carcinoma or liver decompensation
• Active malignancies other than hepatocellular carcinoma, unless in complete remission for more than 5 years

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Zhang X, Yip TC, Wong GL, Leow WX, Liang LY, Lim LL, Li G, Ibrahim L, Lin H, Lai JCT, Chim AM, Chan HLY, Kong AP, Chan WK, Wong VW. Clinical care pathway to detect advanced liver disease in patients with type 2 diabetes through automated fibrosis score calculation and electronic reminder messages: a randomised controlled trial. Gut. 2023 Nov 24;72(12):2364-2371. doi: 10.1136/gutjnl-2023-330269.

  PMID: 37549979 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Vincent Wong
• Organization: The Chinese University of Hong Kong

wongv@cuhk.edu.hk

+85235054205

Study Officials

• Vincent Wong, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: May 19, 2020
• Primary Completion: October 31, 2022
• Study Completion: January 31, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1-5 years after the publication of the full paper.
• Access Criteria: Researchers with clear plans of collaboration and analysis

Locations

HK (1)