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临床试验/ISRCTN03563761
ISRCTN03563761进行中(未招募)未知

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

niversity of Southampton (UK)0 个研究点目标入组 910 人开始时间: 2013年8月22日最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
910

研究概览

简要总结

  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)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
niversity of Southampton (UK)

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