Condition category
Digestive System
Date applied
22/08/2013
Date assigned
22/08/2013
Last edited
26/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The purpose of this study is to find out the possibility of integrating a new liver diagnostic pathway in GP practices using a liver health nurse in the practice team and a risk assessment tool. The aim is to improve upon patient outcomes and reduce costs in the early detection, diagnosis and treatment of patients with liver conditions within GP practices.

Who can participate?
Patients are approached by the participating practices to attend clinic for a liver health check-up

What does the study involve?
The practices are randomly allocated to either the control group or the intervention group. Patients with suspected liver disease are invited to undergo a liver health check performed by a liver health nurse. Intervention group practices direct their patients for further investigation and disease management with the specialist supervisors of the study and their own General Practitioners. It is anticipated that this level of access to specialist liver experts is the same as attending a liver clinic with all the benefits involved.

What are the possible benefits and risks of participating?
There are no guaranteed benefits to participants from taking part in this study, but there is a small chance that their liver might be unhealthy or damaged. If this is the case, by taking part in this study they will find out more about the health of their liver.

Where is the study run from?
This study takes place in selected GP practices in Southampton and is coordinated by the University of Southampton (UK)

When is study starting and how long is it expected to run for?
November 2013 to April 2018

Who is funding the study?
British Liver Trust (UK)

Who is the main contact?
Ms Tina Reinson
t.reinson@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Tina Reinson

ORCID ID

http://orcid.org/0000-0002-2436-1906

Contact details

Tremona Road
Southampton
SO16 6YD
United Kingdom
-
t.reinson@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14131

Study information

Scientific title

A community based study to determine the feasibility of remodelling the diagnosis and management of liver disease in primary care to improve patient outcomes and reduce service delivery costs

Acronym

LOCATE

Study hypothesis

LOCATE is a cluster randomised service intervention in a primary care setting. The primary objective is to evaluate the feasibility of integrating a new diagnostic pathway in primary care with the implementation of a liver health nurse and a liver risk stratification tool. The secondary objective is to determine if the new pathway improves the effectiveness of the detection and management of chronic liver disease and leads to improved long-term outcomes together with the net NHS costs.

Ethics approval

First MREC approval date 05/07/2013, ref: 13/SC/0012

Study design

Both; Interventional; Design type: Diagnosis, Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

10 GP practices will be randomised to either the intervention or control arm. Both groups will undertake two audits of liver care, one before the intervention and one after.

Control: The practices randomised to the control arm will follow their existing local map of medicine.

Prior to randomisation, all practices will undertake an audit of liver care at their site.; Intervention, The intervention practices will receive the services of a liver health nurse, who will facilitate three intervention modules:

Intervention Module 1
Improved access to liver health assessment for incident liver abnormalities arising from routine care.

Intervention Module 2
Nurse led case finding using data already available in the clinical records to identify those at risk of significant liver disease.

Intervention Module 3
Nurse-led population screening for excess alcohol use using t; Study Entry : Other; Details: Identified in an initial audit of liver care and contacted with a letter and information leaflet.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Effectiveness and cost effectiveness of the detection and management of liver disease; Timepoint(s): 12 months

Secondary outcome measures

1. Impact of risk stratification on behaviours in patients consuming harmful/hazardous alcohol levels; Timepoint(s): 12 months
2. Increased detection rate of serious liver disease; Timepoint(s): 12 months

Overall trial start date

04/11/2013

Overall trial end date

01/04/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Pre-Intervention Audit and Post-Intervention Audit
1. Elevated ALT (above ULN), other abnormal liver function test (Alk Phos or bilirubin above ULN, or Albumin <LLN) or new diagnosis of liver disease coded on the GP system within a twelve month period between the last 18 and 6 months.

Intervention Module 1
1. Clinical liver disease
2. Any patient newly identified by the practice with suspected liver disease in the one year of the prospective phase.

Intervention Module 2
1. All patients identified with a positive cTL on tests in the previous 6m

A sample from each of the following groups:
1. pre-existing abnormalities in liver function but without liver diagnosis and management plan identified in the practice audit
2. Type 2 diabetes
3. obesity BMI > 40 and no type 2 diabetes
4. patients with clinical record suggestive of hazardous alcohol use will be enrolled in Module 3 where appropriate

Intervention Module 3:
1. A sample (1000) of patients aged 30 to 65 together with any patients with suspected alcohol misuse from clinical records will be sent a postal invitation as part of the practice liver health programme. The invitation will include an AUDIT questionnaire
2. WHO AUDIT score either > 15 or >7 with alcohol intake on 4 days or more (AUDIT Q1), and alcohol intake of 7 units or more on a drinking occasion (AUDIT Q2) or estimated weekly alcohol intake > 28 units.
Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 30 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1500; UK Sample Size: 1500

Participant exclusion criteria

Pre-Intervention Audit and Post-Intervention Audit:
1. Patients with known terminal illness.

Intervention Module 1:
1. Patients with known terminal illness.

Intervention Module 2:
1. Patients with known terminal illness.
2. Patients with alcohol misuse will be enrolled via Module 3 where appropriate

Intervention Module 3:
1. Patients with known terminal illness
2. Patients identified on GP system as having pre-existing liver disease.
3. Those invited for a check in module 2

Recruitment start date

04/11/2013

Recruitment end date

01/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The participating GP surgeries are anonymous
-
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Liver Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

El-Gohary, M; Moore M; Roderick P; Watkins, E; Dash, J; Reinson,T; Newell, C; Kim, M; Stuart, B; Becque, T; Sheron, N. LOcal CAre and TrEatment of liver disease (LOCATE) – a feasibility study to discover, assess and manage early liver disease in primary care. PLOS One - under peer review. Contact Tina Reinson for a copy of the submitted paper.

Reinson, T; Bradbury, K; Moore, M; Sheron, N.Healthcare practitioners’ experiences of an intervention to detect and treat patients with liver disease (the LOCATE intervention): a qualitative process evaluation. Ready for submission to BMJ Open; expected to submit August 2018.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available because the consented patients only agreed that a member of the study team could have access to their data and the data is disclosive and cannot be put in the public domain.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/07/2018: The following changes were made to the trial record: 1. Contact details updated. 2. The recruitment end date was changed from 03/11/2015 to 01/10/2016. 3. The overall trial end date was changed from 03/11/2015 to 01/04/2018. 4. Publication and dissemination plan added. 06/12/2017: No publications found, verifying study status with principal investigator.