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

• 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
• 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

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）：响应PA-12-281，艾滋病毒/艾滋病，吸毒和美国脆弱人群（R01），我们提出了在宾夕法尼亚州宾夕法尼亚大学（Uppery of Pennsylvania Sealty Systems）内的两个患者心理单位（Upperiatient of triply诊断的人）（精神疾病，药物滥用，HIV，HIV）中的有效试验。尽管普遍认识到患有严重精神疾病（SMI）的人有收缩和传播人类免疫缺陷病毒（HIV）的风险增加，但在心理健康环境中的系统HIV检测很少见。 我们的研究小组（Rothbard等，2008）使用废弃的血液样本在费城的两个住院精神病学部队，长老会医院的Wright 4单位和宾夕法尼亚州医院的4个云杉单元的宾夕法尼亚州医院单位将在拟议的研究中进行研究。然后，我们认为应在这些情况下定期进行艾滋病毒测试。在一项为期五年的纵向有效性试验中，我们将通过快速测试确定HIV阳性SMI住院患者。 那些被新诊断或以前被诊断出但目前未接受艾滋病毒治疗并且也是使用物质的人将有机会参加随机的社区试验。以前，我们已经进行了II期正面试验（PFP），其中我们观察到使用护士健康导航器（NHN）模型的HIV+ SMI客户的干预措施的广泛而深远的影响。这项提案以我们先前学到的为基础，以提供护士健康导航器（NHN）模型作为对目标个体在“现实世界”条件下的综合处理，并监视三倍（PFT）的实施。目标人群可以说是治疗效果不佳的最高风险患者人群之一。根据过去的经验，我们希望约有75％的符合条件的人，或者约有240名参与者 是随机的。这将产生约120个PFT和〜120个TAU参与者，并在损耗前36个月招募。 PFP中相似的人群导致了17％的流失率，因此我们估计至少75％的参与者的完整数据，导致了约180名参与者（90个PFT和90个TAU）的完整数据集。 PFT参与者将获得NHN服务12个月。每个参与者将在基线，6、12和18个月收集数据。参与者会 在干预后6个月后纵向进行纵向，以测量干预措施的任何衰减。实验参与者将在仍在接受住院服务的同时开始PFT，项目护士将参与出院计划，并促进与精神健康（MH），药物滥用（SA）和传染病（ID）护理（ID）的联系。 NHN还将至少每周与实验参与者见面，以使用针对包括记忆辅助工具的人的沟通和理解，副作用和其他治疗方面的教育，与参与者的社交网络和治疗提供者的互动以及积极的社区外展的人的沟通和理解来实施PFT的依从性。 PFT将进行12个月，并将遵循6个月的参与者，以允许撤回干预措施的潜在衰减。我们预计在PFT参与者的治疗中保留更好，其他结果包括病毒载荷，CD4，心理和社会功能指标以及成本效益。