The PFT Intervention: Linking triply-diagnosed inpatients to community care

PFT 干预：将三重诊断的住院患者与社区护理联系起来

基本信息

批准号：
8605443
负责人：
MICHAEL B BLANK
金额：
$ 66.42万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-01 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8605443
关键词：
Adherence Adverse effects Alcohol or Other Drugs use Anti-HIV Agents Attitude Back Binding Biological Blood specimen CD4 Lymphocyte Count Caring Cellular Phone Client Communicable Diseases Communication Communities Community Outreach Community Trial Comprehension Contracts Cost Effectiveness Analysis Data Data Set Devices Diagnosis Directly Observed Therapy Drug usage Education Effectiveness Enrollment Experimental Designs Family General Population HIV Health Health Personnel Health Status Health system Hospitals Human immunodeficiency virus test Individual Inpatients Intervention Investigation Knowledge Learning Link Measures Memory Mental Health Mental Health Services Mental disorders Methods Modeling Monitor Newly Diagnosed Nurses Outcome Participant Pennsylvania Persons Pharmaceutical Preparations Phase Phase II Clinical Trials Philadelphia Population Presbyterian Church Prostitution Provider Psychiatric therapeutic procedure Public Health Randomized Recruitment Activity Regimen Research Research Personnel Resistance Risk Risk Behaviors Sampling Scheme Seroprevalences Services Social Functioning Social Network Substance Use Disorder Substance abuse problem Target Populations Testing Treatment Protocols Treatment outcome Universities Victimization Viral Load result Virus Virus Diseases Vulnerable Populations Work base cost effectiveness design effectiveness trial experience high risk high risk sexual behavior improved inclusion criteria infectious disease treatment injection drug use inpatient service intervention effect meetings nursing intervention outreach patient population post intervention programs psychologic psychological outcomes psychosocial adjustment public health relevance randomized trial response severe mental illness therapy development transmission process treatment adherence vector

项目摘要

DESCRIPTION (provided by applicant): In response to PA-12-281, HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R01), we propose an effectiveness trial among persons triply diagnosed (mental illness, substance abuse, HIV) recruited from two inpatient psychiatric units within the University of Pennsylvania Health System (UPHS). Despite general recognition that persons with serious mental illness (SMI) are at heightened risk to contract and transmit human immunodeficiency virus (HIV), systematic HIV testing in mental health settings is rare. Using discarded bloods samples over a six month period, our research team (Rothbard et al., 2008) found in excess of 10% HIV seroprevalence in two inpatient psychiatric units in Philadelphia, the Wright 4 Unit at Presbyterian Hospital and the 4 Spruce Unit of Pennsylvania Hospital where the proposed study will occur. We argued then that HIV testing should be routinely conducted in those settings. In a five year longitudinal effectiveness trial, we will identify HIV positive SMI inpatients through rapid testing. Those who are newly diagnosed or who were previously diagnosed but not currently engaged in HIV treatment and who also are substance using will be offered an opportunity to participate in a randomized community trial. Previously we have conducted a Phase II trial of PATH for Positives (PFP) in which we observed broad and far-reaching effects of an intervention utilizing a nurse health navigator (NHN) model for HIV+ SMI clients. This proposal builds on what we learned previously to provide a nurse health navigator (NHN) model as integrated treatment of the targeted individuals in "real world" conditions and to monitor the implementation of PATH for Triples (PFT). The target population is arguably among the highest risk patient populations for poor treatment outcomes. Based on past experience, we expect to enroll about 75% of those eligible on a rolling basis, or ~240 participants who will then be randomized. This will yield ~120 PFT and ~120 TAU participants over a 36 month recruitment before attrition. A similar population in PFP resulted in a 17% attrition rate, so we estimate complete data for at least 75% of participants resulting in a complete dataset of ~180 participants (90 PFT, and 90 TAU). PFT participants will receive NHN services for 12 months. Data will be collected at baseline, 6, 12, and 18 months for each participant. Participants will be followed longitudinally for an additional 6 months post intervention to measure any decay of the intervention after it is withdrawn. Experimental participants will begin PFT while still receiving inpatient services and the project nurses will participate in discharge planning and facilitate linkage to Mental Health (MH), Substance Abuse (SA), and Infectious Disease (ID) care in the Philadelphia community. The NHN will also meet at least weekly with the experimental participants to implement the adherence component of PFT using approaches tailored to the communication and comprehension of the person that includes memory aids, education regarding side effects and other treatment aspects, engagement with participants' social networks and treatment providers, and active community outreach. PFT will be implemented for 12 months and participants will be followed for an additional 6 months to allow examination of potential decay of the intervention after it is withdrawn. We expect better retention in treatment for PFT participants and other outcomes include viral load, CD4, indicators of psychological and social functioning, and cost effectiveness.

描述（由申请人提供）：针对 PA-12-281、美国艾滋病毒/艾滋病、吸毒和弱势群体 (R01)，我们建议在三重诊断人群（精神疾病、药物滥用、艾滋病毒）中进行一项有效性试验。）从宾夕法尼亚大学卫生系统（UPHS）内的两个住院精神病科招募。尽管人们普遍认识到患有严重精神疾病 (SMI) 的人感染和传播人类免疫缺陷病毒 (HIV) 的风险较高，但在精神卫生机构中进行系统的艾滋病毒检测却很少。我们的研究小组（Rothbard 等人，2008 年）使用六个月内废弃的血液样本发现，费城的两个住院精神科病房（长老会医院的 Wright 4 病房和费城的 4 Spruce 病房）的 HIV 血清阳性率超过 10%。宾夕法尼亚医院将进行拟议的研究。我们当时认为，艾滋病毒检测应该在这些环境中常规进行。在一项为期五年的纵向有效性试验中，我们将通过快速检测来识别 HIV 阳性 SMI 住院患者。那些新诊断出或以前被诊断出但目前未接受艾滋病毒治疗且同时使用药物的人将有机会参加随机社区试验。此前，我们进行了 PATH for Positives (PFP) 的 II 期试验，其中我们观察到利用护士健康导航 (NHN) 模型对 HIV+ SMI 客户进行干预的广泛而深远的影响。该提案建立在我们之前了解到的基础上，提供护士健康导航（NHN）模型，作为“现实世界”条件下目标个体的综合治疗，并监测三人路径（PFT）的实施。目标人群可以说是治疗结果不佳风险最高的患者人群之一。根据过去的经验，我们预计将滚动招募约 75% 的合格参与者，即约 240 名参与者被随机化。在减员前的 36 个月招募中，这将产生约 120 名 PFT 和约 120 名 TAU 参与者。 PFP 中的类似人群导致了 17% 的流失率，因此我们估计至少 75% 的参与者的完整数据，从而形成约 180 名参与者的完整数据集（90 PFT 和 90 TAU）。 PFT 参与者将获得为期 12 个月的 NHN 服务。将在基线、6、12 和 18 个月时收集每位参与者的数据。参加者将是干预后又纵向随访 6 个月，以衡量干预措施撤回后的衰减情况。实验参与者将在接受住院服务的同时开始 PFT，项目护士将参与出院计划并促进与费城社区的心理健康 (MH)、药物滥用 (SA) 和传染病 (ID) 护理的联系。 NHN 还将至少每周与实验参与者会面，以实施 PFT 的依从性部分，使用适合个人沟通和理解的方法，包括记忆辅助、有关副作用和其他治疗方面的教育、参与参与者的社交网络和治疗提供者，以及积极的社区外展。 PFT 将实施 12 个月，并对参与者进行额外 6 个月的跟踪，以便检查干预措施撤回后的潜在衰退情况。我们期望 PFT 参与者能更好地保留治疗，其他结果包括病毒载量、CD4、心理和社会功能指标以及成本效益。