A Cluster Randomised Trial of Pharmacy Led HCV Therapy Versus Conventional Treatment Pathways for HCV Positive Patients Receiving Daily OST in Pharmacies in Health Boards Within NHS Scotland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 6
- 主要终点
- Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy
研究概览
简要总结
Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers.
The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff.
Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy.
The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.
详细描述
The SuperDOT-C study will evaluate a new pathway of care for patients on OST who are already receiving OST therapy on a daily basis from a pharmacist. Newer therapies for HCV have recently become much simpler to initiate and supervise with much improved effectiveness and as described below it is now proposed to extend the role of community pharmacists into initiating HCV therapy alongside the existing OST The SuperDOT-C study will utilise this existing environment and relationship to smooth the pathway into HCV therapy with co-administration of OST alongside the anti-HCV therapy under the supervision of the pharmacist compared with the established pathway of referral to another site and treatment with a nurse led ant-HCV treatment program. This new pathway may have positive effects on the movement towards HCV cure at multiple levels. The planned pathway is different to current care at each point, from testing and diagnosis through adherence to cure. In the planned pathway, the patient interacts with the pharmacist on a daily basis, as compared to intermittent interaction with a secondary care team member. The result being that the patient has a shorter care pathway, with less travelling and better access to anti-HCV treatment. The daily interaction with the pharmacy provides opportunities to assess and support the patient, provide sound advice and care, with the added benefit of being able to directly observe treatment, (DOT), thus potentially improving adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV PCR positive,
- •Stable OST dose for greater than 12 weeks prior to study enrolment
排除标准
- •Evidence of current or previous decompensated liver disease,
- •Currently receiving HCV eradication treatment
- •HIV infection,
- •HBsAg positive with detectable HBV DNA,
- •Pregnancy
- •Cirrhosis or high fibrosis score
- •Genotype deemed unsuitable for treatment with available study drugs
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Pharmacist Led
This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists
干预措施: Pharmacist Led (Other)
Nurse Led
This arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses
干预措施: Nurse led (Other)
结局指标
主要结局
Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy
时间窗: 12 week SVR, (12 weeks post completion of HCV treatment)
Blood test result; PCR - based measurement of levels of hepatitis C virus.
次要结局
- To determine whether the Pharmacist-led pathway compared with the Conventional Pathway leads to more people on OST being tested and initiating treatment(Span of study ie 24 months)
- To explore whether adherence and persistence to HCV therapy in the pharmacy setting is at least similar to that in the Conventional pathway(Span of study ie 24 months)
- Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway(Span of study ie 24 months)
- To compare the number of patients who drop out of the study between the two pathways(Span of study ie 24 months)
- To compare the acceptability of the Pharmacist-led pathway versus the conventional treatment pathway for OST clients(Span of study ie 24 months)
- To measure re-infection rate at 1 year after end of treatment in patients with SVR(Span of study ie 24 months)