Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
2016年5月5日 更新者：VA Office of Research and Development
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
83
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Diego、California、美国、92161
- VA San Diego Healthcare System, San Diego, CA
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Integrated Care
Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
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The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD.
Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc).
Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
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无干预：Usual Care
The usual care group received "standard of care" required for HCV patients as currently performed in each clinic.
All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sustained Viral Response (SVR)
大体时间：up to 24 weeks
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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.
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up to 24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Treatment Initiation and Completion
大体时间：up to 24 weeks
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The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion.
Treatment data from the HCV clinics were reviewed for each patient at each site.
Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment.
Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
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up to 24 weeks
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Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
大体时间：up to 24 weeks
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Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
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up to 24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Samuel B Ho, MD、VA San Diego Healthcare System, San Diego, CA
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2015年12月21日
首先提交符合 QC 标准的
2016年1月4日
首次发布 (估计)
2016年1月6日
研究记录更新
最后更新发布 (估计)
2016年5月20日
上次提交的符合 QC 标准的更新
2016年5月5日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.