Improving Quality of Primary Care for Anxiety Disorders

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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.