Improving Quality of Primary Care for Anxiety Disorders

描述(由申请人提供)：此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个月的临床结果。初步数据显示，与PCP的“常规护理”相比，我们基于电话的协作式护理干预显著改善了精神健康相关的生活质量(HRQOL)，并减少了焦虑症状。我们试图通过测试循证护理系统的有效性和成本效益来建立在这些发现的基础上，该系统针对被其初级保健医生(PCP)确认为经历PD/GAD的患者。我们建议对我们目前的协议进行几项增强，以支持其在常规临床实践中的可持续实施。它们包括：(1)根据PD/GAD患者在研究登记时的焦虑症状水平，将他们划分为不同强度的护理水平，并在他们的临床状况恶化时，将低强度患者转移到更资源密集型的护理水平；(2)增加基于证据的短暂干预，以减少酒精消费，以认识到危险饮酒在这些人群中的显著共同发病率；(3)利用我们研究实践的电子病历(EMR)系统来确定潜在的合格研究对象，而不是昂贵的研究助理和/或已经负担过重的实习人员；(4)用材料和方案加强我们目前的干预策略，以解决共病抑郁症；以及(5)招募一个新的、更大的患者队列，足够有能力在男性和非裔美国人中测试我们的研究假设，无论男女。我们将在匹兹堡地区的三家初级保健诊所招募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，并将症状最严重的患者随机分配到：(1)他们的PCP的“日常护理”或(2)为期12个月的电话协作护理计划，用于治疗初级保健中看到的广泛范围的PD/GAD患者。我们将在招募后进行长达24个月的盲目电话评估，以评估我们干预的有效性和持久性。我们的基本假设是，在高度症状性PD/GAD患者中，我们的干预将在随机化后12个月时，与接受PCP“通常护理”的患者相比，通过SF-36心理成分摘要(MCS)评分衡量，我们的干预将在HRQL中产生至少有临床意义的0.5效果大小的改善。我们的第二个假设是，在更严重焦虑的PD/GAD患者中，那些被随机分配到我们积极干预组的患者将获得更符合公认指南的PD和GAD治疗，并且与接受初级保健计划的患者相比，他们的焦虑和情绪症状、酒精使用和医疗服务利用水平较低。拟议的有效性研究审查了我们成功的协作护理战略是否可以得到加强和重新设计，以提高其在日常实践中的有效性和可持续性。此外，它还解决了酒精使用障碍--这是一个重要的公共健康问题，以前从未在任何初级保健环境中针对焦虑或情绪障碍的有效性研究中得到解决。

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.