A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Proportion of cases notified with hepatitis C who commence hepatitis C treatment
研究概览
简要总结
This project will utilise the notification process as a point of intervention to work with primary practitioners (GP) by contacting them directly when a notification of hepatitis C exposure is received by the Tasmanian department of Health (DoH). A designated role will exist within DoH of a specialist HCV health worker to contact GPs to provide supported assistance in the process of the follow up hepatitis C diagnoses with patients. The study will evaluate whether active follow up of providers with enhanced case management is effective in having patients linked to hepatitis C treatment compared to current standard of care of surveillance for new notifications. The study will also compare the cost-effectiveness of this approach compared to current standard of care after one of their patients is notified with a positive hepatitis C antibody result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Given the nature of the intervention, it is impossible to blind either the health care worker or the general practitioner to allocation. However, the analysis will be conducted by an analyst at the Burnet Institute who will not have contact with the general practitioners and will be blinded to intervention allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health
排除标准
- •Not based in Tasmania
- •Practitioner from correctional service
- •Specialist
- •Nurse practitioner who initiated test
- •Sexual health service doctor
- •Family planning
结局指标
主要结局
Proportion of cases notified with hepatitis C who commence hepatitis C treatment
时间窗: The study follow up period is 12 weeks
The primary outcome will be the proportion of cases notified with hepatitis C who commence hepatitis C treatment within 12 weeks of initial contact. This will be assessed using the information provided by practitioners at the 12-week follow-up phone call and will be compared across the two arms.
次要结局
- Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result(The study follow up period is 12 weeks)
- Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests(The study follow up period is 12 weeks)
- Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed(The study follow up period is 12 weeks)