Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 375
- 试验地点
- 10
- 主要终点
- Anxiety Symptoms
研究概览
简要总结
The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption.
详细描述
The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption. Low-risk (non-cardiac) chest pain patients with anxiety will be recruited to participate in the study using the SBIRT (screening, brief intervention, and referral to treatment) model and enrolled participants will be randomly assigned to one of three treatment arms: 1) referral to primary care with enhanced care coordinated (low intensity); 2) online CBT with support from a certified peer recovery specialist (medium intensity); and 3) therapist-led CBT via tele-health (high intensity). We expect improved symptoms and functional capacity, reduced ED return visits, and heterogenous treatment effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult emergency department (ED) patients (≥18yoa) presenting to the ED
- •Within 1 week of ED presentation if discharged at time of screening.
- •Chief complaint of chest pain or similar chief complaint leading to a standard of care diagnostic protocol to rule out possible acute coronary syndrome.
- •HEART Score of 0-3 indicating Major Adverse Cardiac Events (MACE) risk equivalent to ≤2%
- •"Functionally" low risk status - (moderate HEART score of 4-6) plus diagnostic protocol evaluation with at least two serial normal troponins spaced at least six hours apart with or without cardiovascular stress testing in the observation unit.
- •Moderate to severe anxiety as defined by a GAD-7 score ≥ 8 or a PHQ panic screener score ≥ 2
- •Expected to be discharged from the ED or only undergo observation <24 hours.
排除标准
- •> 1 week from ED discharge
- •Traumatic reason for chest pain
- •Those admitted to the hospital (inpatient status) as part of their ED presentation (those placed in the observation unit for planned observation less than <24 hours are eligible)
- •Active psychosis or behavioral issues requiring psychiatric monitoring or consultation of psychiatry for psychosis, schizophrenia, or suicidal ideation
- •Hemodynamic instability as assessed by the treating provider
- •Issues likely to affect follow up, including prisoners and homelessness
- •Inability to understand and speak English to participate in telehealth therapy sessions and peer support.
结局指标
主要结局
Anxiety Symptoms
时间窗: 12 months after enrollment
General Anxiety Disorder-7 scale score adjusted for baseline. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
次要结局
- Chest Pain(12 months after enrollment)
- Global Anxiety Change(12 months after enrollment)
- Adverse Cardiac Events(12 months after enrollment)
- ED Utilization(12 months after enrollment)
- Panic Symptoms(12 months after enrollment)
- Depression symptoms(12 months after enrollment)
- Work/family/social functioning(12 months after enrollment)
- Physical Symptoms(12 months after enrollment)
研究者
Paul Musey
Director of Research
Indiana University