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: 9114550
• 负责人: MICHAEL B BLANK
• 金额: $ 57.43万
• 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/9114550
• 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; Philadelphia; Population; Presbyterian Church; Prostitution; Provider; 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; 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 psychiatric treatment; inpatient service; intervention effect; meetings; nursing intervention; outreach; patient population; personalized approach; phase II trial; post intervention; programs; psychologic; psychological outcomes; psychosocial adjustment; randomized trial; response; severe mental illness; sexual victimization; therapy development; treatment adherence; vector; viral transmission

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(申请人提供)：为了回应PA-12-281，艾滋病毒/艾滋病，药物使用，和美国的弱势人群(R01)，我们建议在从宾夕法尼亚大学卫生系统(UPHS)内的两个住院精神病室招募的三重诊断(精神疾病，药物滥用，艾滋病毒)的人中进行一项有效性试验。尽管人们普遍认识到，患有严重精神疾病的人感染和传播人类免疫缺陷病毒的风险更高，但在精神卫生环境中进行系统的艾滋病毒检测是罕见的。使用六个月的废弃血液样本，我们的研究团队(Rothbard等人，2008年)发现，在费城的两个住院精神科病房，长老会医院的Wright 4病房和宾夕法尼亚医院的4 Spruce病房中，HIV血清阳性率超过10%，拟议的研究将在那里进行。我们当时认为，艾滋病毒检测应该在这些环境中例行进行。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确定HIV阳性的SMI住院患者。那些新诊断的或以前被诊断但目前没有参与艾滋病毒治疗的人，以及也在使用药物的人，将有机会参加随机社区试验。此前，我们已经进行了阳性路径(PFP)的第二阶段试验，在该试验中，我们观察了利用护士健康导航器(NHN)模型对HIV+SMI客户进行干预的广泛和深远的影响。这项建议建立在我们之前所学的基础上，提供一个护士健康导航器(NHN)模型，作为在“真实世界”条件下对目标个人的综合治疗，并监测三联路径(Path for Triple，PFT)的实施。目标人群可以说是治疗结果不佳的最高风险患者人群之一。根据过去的经验，我们预计将以滚动方式招募约75%的合格参与者，或约240名参与者 随机化。这将在自然减员前的36个月内产生约120名PFT和约120名TAU参与者。PFP中相似的人群导致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个月、12个月和18个月收集每个参与者的数据。参与者将是 在干预后再纵向跟踪6个月，以衡量干预措施在撤销后是否衰退。实验参与者将在仍在接受住院服务的情况下开始PFT，项目护士将参与出院计划，并促进与费城社区的精神健康(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，使用为患者的沟通和理解量身定做的方法来实施PFT的遵守部分，其中包括记忆辅助工具、关于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接触以及积极的社区推广。PFT将实施12个月，参与者将再跟踪6个月，以便在干预措施撤销后审查其潜在的衰败。我们预计PFT参与者的治疗效果会更好，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。