Comparing the effectiveness of existing anxiety treatment options among patients evaluated for chest pain and anxiety in the emergency department setting: Study protocol for the PACER pragmatic randomized comparative effectiveness trial

Abstract

ackground Anxiety disorders are a common underlying cause of symptoms among low-risk chest pain patients evaluated in the emergency department setting. However, anxiety is often undiagnosed and undertreated in any setting, and causes considerable functional impairment to work, family, and social life. Objectives The Patient-Centered Treatment of Anxiety after Low-Risk Chest Pain in the Emergency Room (PACER) study is a pragmatic randomized trial to test the comparative effectiveness of existing anxiety treatments of graduated intensities and determine what options work best for patient subgroups based on anxiety severity and other comorbidities. Methods The PACER trial will enroll 375 emergency department patients with low-risk chest pain and anxiety (GAD-7 score ≥ 8) and randomize them to either: 1) referral to primary care with enhanced care coordination, 2) online self-administered cognitive behavioral therapy with guided peer support, or 3) therapist-administered cognitive behavior therapy. Outcomes include anxiety symptoms (primary) as well as physical symptom burden, depression symptoms, functional impairment, ED recidivism, and occurrence of major adverse cardiac events. Statistical analyses will be conducted primarily using linear mixed models to perform a repeated measures analysis of patient-reported outcomes, assessed at 3, 6, 9, and 12-month follow-ups. Discussion PACER is an innovative and pragmatic clinical trial that will compare the effectiveness of several evidence-based telecare-delivered treatments for anxiety. Results have the potential to inform clinical guidelines for evaluation and management of low-risk chest pain patients and promote adoption of findings in ED departments across the country.