Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Sustained Viral Response (SVR)
研究概览
简要总结
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
详细描述
Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).
Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
- •All patients 18 and 75 years old with confirmed HCV infection
- •Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate
- •Screening measures and cutoffs for inclusion were depression:
- •Beck Depression Inventory: (BDI) > 10
- •Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
- •PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
- •Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen
排除标准
- •Lacked a confirmed test of HCV RNA
- •Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
- •Had Hepatitis B (HBV) co-infection
- •Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
- •Had other significant near term life-threatening diseases
- •Were treatment non-responders with pegylated Interferon plus ribavirin
结局指标
主要结局
Sustained Viral Response (SVR)
时间窗: up to 24 weeks
The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
次要结局
- Percentage of Participants With Treatment Initiation and Completion(up to 24 weeks)
- Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%(up to 24 weeks)