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LOCATE - LOcal Care And Treatment Evaluation

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03563761
Enrollment
1500
Registered
2013-08-22
Start date
2013-11-04
Completion date
Unknown
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care Research Network for England

Interventions

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:
Intervention, The intervention practices will receive the services of a liver health nurse, who will facilitate three intervention modules: Intervention Module 1 Impro
Details: Identified in an initial audit of liver care and contacted with a letter and information leaflet.

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026