Improving Quality of Primary Care for Anxiety Disorders

描述（由申请人提供）：本申请是我们有效性试验的竞争性更新，旨在优化181名患有恐慌和/或广泛性焦虑症（PD/GAD）的初级保健患者的治疗和12个月临床结果。初步数据表明，与pcp的“常规护理”相比，我们基于电话的协作护理干预显着改善了心理健康相关的生活质量（HRQoL）并减少了焦虑症状。我们试图在这些发现的基础上，对初级保健医生（PCP）认为患有PD/GAD的患者进行循证治疗系统的有效性和成本效益测试。我们建议对我们目前的方案进行一些改进，以支持其在常规临床实践中的可持续实施。这些措施包括：(1)根据PD/GAD患者在研究入组时的焦虑症状水平，对其进行风险分层，给予不同强度的护理；如果患者的临床状况恶化，则将低强度患者转移到资源更密集的护理水平；(2)增加以证据为基础的简短干预措施，减少酒精消费，以认识到这一人群中危险饮酒的大量合并症；(3)利用我们的研究实践的电子病历（EMR）系统来识别潜在的符合条件的研究对象，而不是昂贵的研究助理和/或已经负担过重的实践人员；(4)用材料和方案来增强我们目前的干预策略，以解决共病性抑郁症；(5)在男性和非裔美国人中招募新的更大的患者队列，以充分验证我们的研究假设。我们将在匹兹堡地区的三个初级保健诊所招募360名PD/GAD患者。在确认研究资格后，我们将对患者进行风险分层，并将症状最明显的患者随机分配到：(1)他们的pcp的“常规护理”或(2)一个为期12个月的基于电话的协作护理计划，用于治疗初级保健中看到的广谱PD/GAD患者。我们将在招募后进行长达24个月的盲法电话评估，以评估我们干预措施的有效性和持久性。我们的主要假设是，在高度症状性PD/GAD患者中，与接受pcp“常规护理”的患者相比，我们的干预将在随机化后12个月，通过SF-36心理成分总结（MCS）评分测量，在HRQoL方面产生至少具有临床意义的0.5效应量改善。我们的次要假设是，与接受pcp“常规护理”的患者相比，在更严重焦虑的PD/GAD患者中，那些随机接受我们积极干预的患者将获得更符合公认指南的PD和GAD治疗，并且经历更低水平的焦虑和情绪症状、酒精使用和健康服务利用。本研究旨在探讨我们成功的合作护理策略是否可以在日常实践中得到加强和重新设计，以提高其有效性和可持续性。此外，它还解决了酒精使用障碍——这是一个重要的公共卫生问题，此前在任何针对初级保健环境中的焦虑或情绪障碍的有效性研究中从未涉及过。

DESCRIPTION (provided by applicant): This application is a competing renewal of our effectiveness trial that aimed to optimize treatment and 12-month clinical outcomes for 181 primary care patients with panic and/or generalized anxiety disorder (PD/GAD). Preliminary data indicate that our telephone-based collaborative care intervention significantly improved mental health-related quality of life (HRQoL) and reduced anxiety symptomatology compared to PCPs' "usual care." We seek to build upon these findings by testing the effectiveness and cost-effectiveness of an evidence-based system of care for patients recognized by their primary care physician (PCP) as experiencing PD/GAD. We propose several enhancements to our current protocol to support its sustainable implementation into routine clinical practice. They include: (1) risk-stratifying PD/GAD patients to varying intensity levels of care depending upon their level of anxiety symptomatology at the time of study enrollment and shifting low-intensity patients to a more resource intensive level of care should their clinical condition worsen; (2) adding an evidence-based brief intervention for reducing alcohol consumption in recognition of the substantial co-morbidity of hazardous drinking within this population; (3) utilizing our study practices' electronic medical record (EMR) systems to identify potentially-eligible study subjects instead of costly research assistants and/or already overburdened practice staff; (4) augmenting our current intervention strategy with materials and protocols to address co-morbid depression; and (5) recruiting a new and larger patient cohort adequately powered to test our study hypotheses among males and African-Americans of both genders. We will recruit 360 patients with PD/GAD at three Pittsburgh-area primary care practices. Upon confirmation of study-eligibility, we will risk-stratify patients and randomize those most symptomatic to either: (1) their PCPs' "usual care" or (2) a 12-month telephone-based collaborative care program for treating the broad spectrum of PD/GAD patients seen in primary care. We will conduct blinded telephone assessments for up to 24-months following recruitment to evaluate both the effectiveness and durability of our intervention. Our primary hypothesis is that among highly symptomatic PD/GAD patients, our intervention will produce at least a clinically meaningful 0.5 effect size improvement in HRQoL, as measured by the SF-36 Mental Component Summary (MCS) score, at 12 months following randomization, compared to patients who receive their PCPs' "usual care." Our secondary hypotheses are that among more severely anxious PD/GAD patients, those randomized to our active intervention will obtain treatment for PD and GAD that is more consistent with accepted guidelines and experience lower levels of anxiety and mood symptoms, alcohol use, and health services utilization, compared to patients who receive their PCPs' "usual care." The proposed effectiveness study examines whether our successful collaborative care strategy can be enhanced and redesigned to improve its effectiveness and sustainability in routine practice. Furthermore, it addresses alcohol use disorders - an important public health problem never addressed before in any effectiveness study for an anxiety or a mood disorder in a primary care setting.