Clinical trial NCT04241575: Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages
Official title: Identification of Fatty Liver With Advanced Fibrosis in Patients With Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Diabetes Mellitus, Type 2
Keywords: Fatty liver
Non-invasive assessment
Case identification
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 1061
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Action on Suspected Advanced Liver Fibrosis
timeFrame: Within 1 year of the baseline visit
Secondary outcomes:
measure: Referral for Specialist Care
timeFrame: Within 1 year of the baseline visit
measure: Inappropriate Referral for Specialist Care
timeFrame: Within 1 year of the baseline visit
measure: Confirmed Diagnosis of Advanced Liver Fibrosis
timeFrame: Within 1 year of the baseline visit
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Vincent Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: