Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
2019年7月29日 更新者：NYU Langone Health
This study assesses the impact of a hepatitis C care coordination program on rates of linkage to hepatitis C care following release from New York City jails.
Adult patients (age 18 years and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison clinic from July 1, 2015 through December 31, 2016 will be offered participation in a transitional care coordination program.
The rates of linkage of these individuals following release from jail will be compared to a historical cohort of adult patients with chronic Hepatitis C infection at the 19 North prison clinic from January 1, 2014 through June 31, 2015.
研究概览
研究类型
观察性的
注册 (实际的)
105
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
-
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New York
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New York、New York、美国、10016
- NYU Langone Health
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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 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
描述
Inclusion Criteria:
- HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
Exclusion Criteria:
- Individuals who refuse to participate in the study when approached
- Individuals who are unable or unwilling to sign a consent form agreeing to participate. Participants must have sufficient literacy to sign their name, as written informed consent is required for study participation
- Individuals who are unable to successfully negotiate the use of a telephone interpreter if required
- Individuals who have received a sentence that extends beyond the interval of follow up (one year sentence in city jail)
- Individuals who will be moved upstate to prison directly from jail
- Individuals who die prior to discharge from Rikers Island
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Standard of Care transitional care coordination
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Research transitional care coordination
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Though care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The proportion of adult inmates linked to care following release from jail between the period of January 1st 2014 to January 31st 2014 compared with February 1st 2015 to December 31st 2015 after the implementation of care coordination.
大体时间：2 Years
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2 Years
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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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The proportion of those adult inmates who were successfully linked to care at Bellevue Hospital Center (BHC) during the period before and after the implementation of care coordination who subsequently had at least two visits with an HCV provider.
大体时间：2 Years
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2 Years
|
|
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The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then initiated Hepatitis C Virus (HCV) treatment.
大体时间：2 Years
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2 Years
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The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then went onto achieve an Sustained Virologic Response (SVR) when treated.
大体时间：2 Years
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2 Years
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The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who were linked to ancillary services.
大体时间：2 Years
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2 Years
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Retention in care as defined as two sequential clinic ID clinic visits during 12 months
大体时间：2 Years
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Number of patients who are able to retain 2 sequential visits during 12 months
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2 Years
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Documented sustained virologic response (SVR)
大体时间：2 Years
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no detectable RNA in 2 years post treatment
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2 Years
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Documented sustained HCV cure
大体时间：2 Years
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Showing no symptoms of HCV for 2 years
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2 Years
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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：Benjamin Eckhardt, MD、New York Langone Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2015年5月1日
初级完成 (实际的)
2017年4月1日
研究完成 (实际的)
2017年12月14日
研究注册日期
首次提交
2019年7月19日
首先提交符合 QC 标准的
2019年7月25日
首次发布 (实际的)
2019年7月30日
研究记录更新
最后更新发布 (实际的)
2019年7月31日
上次提交的符合 QC 标准的更新
2019年7月29日
最后验证
2019年7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.
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