Condition category
Digestive System
Date applied
11/05/2020
Date assigned
27/05/2020
Last edited
21/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD) are an important clinical issue that has not received prompt attention by GPs. Although GPs are central to the identification and management of NAFLD, they seldom address the risk of advanced fibrosis in patients with frequent NAFLD comorbid conditions, including obesity, type 2 diabetes mellitus and dyslipidemia. European clinical practice guidelines suggest the use of non-invasive tests to improve early detection of advanced fibrosis and reduce unnecessary referrals. While strong collaboration between primary and specialty care is necessary for the effective diagnosis and management of NASH, respective pathways are currently limited. There is, as such, a need to establish and evaluate easily implementable, multidisciplinary, patient-centered models to enhance primary care screening and linkage to specialty care for high-risk NASH patients, to inform policies and drive decisions. Such models need to be evidence-informed and theory-driven, incorporating concepts of ‘risk perception’ and ‘health literacy’, which can affect health behavior and information communication.
The aim of this study is to evaluate the impact of an evidence-informed and locally adapted NASH Model of Care implemented by trained health care providers in increasing the numbers of patients screened for and diagnosed with NASH in primary care and linkage to specialty care compared to usual care.

Who can participate?
Adults over the age of 50 who have one of the following conditions: obesity, type 2 diabetes, or metabolic syndrome

What does the study involve?
A total of 12 primary care practices, four from each country (Greece, Spain, the Netherlands), are randomly assigned (like the toss of a coin) to either the NASH Model of Care group or the control group. All GPs in the NASH Model of Care group will receive the NASH training intervention and are supported with implementing it. The NASH Model of Care includes criteria for screening, diagnosis and referral of patients using a calculator. In the control group, GPs will follow their usual care procedures, tools and tests. In both groups outcomes will be assessed at 12 weeks. Semi-structured interviews and focus groups will be conducted with selected patients and stakeholders to explore communication pathways, integrated care provision, patient and provider satisfaction.

What are the possible benefits and risks of participating?
The study cannot promise any benefits to participants but the information from this study will help improve the treatment of people with NASH.

Where is the study run from?
1. University of Crete (Greece)
2. Maastricht University and Maastricht University Medical Centre (The Netherlands)
3. La Mina Primary Health Care Centre - IDIAP Jordi Gol (Spain)

Who is funding the study?
Gilead Sciences (USA)

Who is the main contact?
Prof. Christos Lionis
Lionis@med.uoc.gr

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christos Lionis

ORCID ID

Contact details

Chief Investigator
University Campus
Voutes
Heraklion
70013
Greece
+30 (0)2810394621
lionis@med.uoc.gr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EU-989-5753

Study information

Scientific title

Evaluating a clinical care pathway for NASH/NAFLD primary care patients: a multi-centre randomized controlled trial

Acronym

Study hypothesis

It is hypothesized that the proposed evidence-informed and locally adapted NASH Model of Care implemented by trained health care providers will increase the numbers of patients screened for and diagnosed with NASH in primary care (PC) and linked to specialty care compared to usual care.

Ethics approval

Approval pending, Research Ethics Committee University of Crete (Research Ethics Board, University of Crete, University Campus Voutes, 70013, Heraklion, Crete, Greece; +30 (0)2810 545206 (ext. 5206); ehde@uoc.gr), ref: 48/05.03.2020

Study design

Multi-centre parallel-group randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format

Condition

Non-alcoholic steatohepatitis (NASH)

Intervention

Twelve PC practices (four practices per country) will participate in the model evaluation.

Practices will be randomized to intervention and control groups in a 1:1 ratio. The randomization is computer generated by a faculty not involved in the study.

From all intervention and control practices, the researchers will recruit a representative sample of patients at high risk for NASH (age >50 years, obesity, type 2 diabetes or metabolic syndrome).

Intervention group:
Primary care providers will be asked to implement the NASH model of care which includes a standardized care pathway which involves a protocol defining different HP tasks for the screening, diagnosis, referral and management of patients at high risk for NASH.

All GPs in practices randomized to the intervention group will be exposed to NASH training intervention and supported with implementing the Model of Care.

The NASH Model of Care includes Screening algorithms will include serum biomarkers and calculation of FIB-4 (next-to-patient). Patient auto-calculation will be promoted. Patients with FIB-4 < 1.30 will be considered as having no sufficient evidence of liver fibrosis, thus not requiring referral to specialists. However, they will be advised to modify their diet and lifestyle and repeat FIB-4 every 2 years. For indeterminate FIB-4 values, patients will be referred to hospital care for transient elastography. Hospital specialists will interpret elastography results jointly with serum markers.

Control group: In the control group, GPs will follow their usual care procedures, tools and tests.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The following primary outcome measures will be assessed at 12 weeks:
1. Number of patients screened for NASH measured using prospective tracking of eligible patients
2. Number of patients diagnosed with advanced fibrosis measured using diagnostic criteria (case report form)
3. Number of patients referred to specialist using GP report (case report form)

Secondary outcome measures

The following secondary outcome measures will be assessed at 12 weeks:
1. Proportion of patients accepting assessment at PC, measured by GP report (case report form)
2. Proportion of patients accepting referral to specialists, measured by GP report (case report form)
3. Number of patients without advanced fibrosis (F1/F2) who did not need referral to a specialist, measured using GP report (case report form)
4. Number of patients with advanced fibrosis (F3/F4) receiving comprehensive care, measured using standardized criteria (case report form)
5. Number of high-risk patients screened for NASH allocated to PC, measured using GP report (case report form)
6. Direct/indirect costs of model implementation, measured by cost tracking of medical and non-medical expenses

Overall trial start date

01/05/2020

Overall trial end date

30/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Registered as a patient in the practice of the participating GP
2. Age >=50 years
3. One or more of the following conditions:
3.1. Obesity (BMI>30)
3.2. Type 2 diabetes (T2DM)
3.3. Metabolic syndrome (MetS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Not registered in the selected GPs practice
2. Unwillingness or inability to provide signed informed consent and complete study procedures due to cognitive impairment, dementia and/or terminal illness

Recruitment start date

01/07/2021

Recruitment end date

30/10/2021

Locations

Countries of recruitment

Greece, Netherlands, Spain

Trial participating centre

University of Crete
Clinic of Social and Family Medicine Andrea Kalokerinou 13, Giofirakia
Heraklion
71500
Greece

Trial participating centre

La Mina Primary Health Care Centre - IDIAP Jordi Gol
Gran Via Corts Catalanes
Barcelona
8708007
Spain

Trial participating centre

Maastricht University and Maastricht University Medical Centre
Department of Family Medicine and Department of Gastroenterology Universiteitssingel 40
Maastricht
6229 ER
Netherlands

Sponsor information

Organisation

University of Crete

Sponsor details

Clinic of Social and Family Medicine
School of Medicine
University Campus
Voutes
Heraklion
70013
Greece
+30 (0)2810394621
lionis@med.uoc.gr

Sponsor type

University/education

Website

http://www.fammed.uoc.gr/

Funders

Funder type

Industry

Funder name

Gilead Sciences

Alternative name(s)

Gilead, Gilead Sciences, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

Results will be published in peer-reviewed medical journals and presented at professional conferences. Results will be disseminated via patient groups, on the trial webpage and publicised on social media. A summary of the results will be sent to participants who specify that they would like to receive them.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the chief investigator Prof. Christos Lionis (Lionis@med.uoc.gr) on reasonable request. Data will be made available after the trial outcomes paper is published in a peer-reviewed journal; applicants must provide an as a minimum a publicly available pre-specified protocol describing the purpose, methods and analysis of the secondary research; de-identified data will be available indefinitely; consent from participants for secondary use of data will be obtained; patient identifiable data will never be shared with third parties.

Intention to publish date

30/10/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/05/2020: Trial's existence confirmed by Gilead Sciences.