OCATE - LOcal Care And Treatment Evaluatio

Not Applicable

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Digestive System

• Registration Number: ISRCTN03563761
• Lead Sponsor: niversity of Southampton (UK)

Brief Summary

1. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30576330 2. 2019 qualitative results in doi: 10.1136/bmjopen-2018-028591 (added 12/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-22
• Last Update Posted: 25 May 2020
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 910

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
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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