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Protocol for a multi-site randomized controlled trial of a stepped-care intervention for emergency department

Sharon C Sung¹, Leslie Lim², Swee Han Lim²

¹Duke-NUS Medical School Singapore, 8 College Road, Singapore, 169857, Singapore. sharon.sung@duke-nus.edu.sg.

|December 16, 2022

Abstract

Background:

Approximately 40% of Emergency Department (ED) patients with chest pain meet diagnostic criteria for panic-related anxiety, but only 1-2% are correctly diagnosed and appropriately managed in the ED. A stepped-care model, which focuses on providing evidence-based interventions in a resource-efficient manner, is the state-of-the art for treating panic disorder patients in medical settings such as primary care. Stepped-care has yet to be tested in the ED setting, which is the first point of contact with the healthcare system for most patients with panic symptoms.

Methods:

This multi-site randomized controlled trial (RCT) aims to evaluate the clinical, patient-centred, and economic effectiveness of a stepped-care intervention in a sample of 212 patients with panic-related anxiety presenting to the ED of Singapore's largest public healthcare group. Participants will be randomly assigned to either: 1) an enhanced care arm consisting of a stepped-care intervention for panic-related anxiety; or 2) a control arm consisting of screening for panic attacks and panic disorder. Screening will be followed by baseline assessments and blocked randomization in a 1:1 ratio. Masked follow-up assessments will be conducted at 1, 3, 6, and 12 months. Clinical outcomes will be panic symptom severity and rates of panic disorder. Patient-centred outcomes will be health-related quality of life, daily functioning, psychiatric comorbidity, and health services utilization. Economic effectiveness outcomes will be the incremental cost-effectiveness ratio of the stepped-care intervention relative to screening alone.

Discussion:

This trial will examine the impact of early intervention for patients with panic-related anxiety in the ED setting. The results will be used to propose a clinically-meaningful and cost-effective model of care for ED patients with panic-related anxiety.

Trial Registration:

ClinicalTrials.gov NCT03632356. Retrospectively registered 15 August 2018.

Keywords:

Chest pain Cognitive behavioural therapy Emergency department Panic attack Panic disorder Panic-related anxiety Randomized controlled trial Stepped-care model

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