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

NCT ID: NCT04241575

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1061 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-19
• Study Completion Date: 2023-01-31

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.

Detailed Description

This will be a parallel group, randomized controlled trial. Patients fulfilling the inclusion and exclusion criteria above will be randomized 1:1 to two groups. Randomization will be carried out through the use of computer-generated list of random numbers in variable blocks of 4 to 10. Concealment of group allocation will be achieved through putting the group allocation cards in consecutively-numbered and sealed envelopes. The patients and physicians will know that the patients are in the intervention group if they see the reminder messages. When they do not see a reminder message, there will not be a specific indicator of whether the patient is in the control group or in the intervention group but having low fibrosis scores. Furthermore, the outcome assessors will be blinded to the group assignment.

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.

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.

Conditions

Fatty Liver, Nonalcoholic; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Simple fibrosis scores and electronic reminder messages

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Simple fibrosis scores and electronic reminder messages

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 Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Vincent WS Wong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 37549979 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NAFLD-NIT-RCT

Identifier Type: -

Identifier Source: org_study_id