Status:
ACTIVE_NOT_RECRUITING
Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Generalized Anxiety Disorder
Chest Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 feasibil...
Detailed Description
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 feasibil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \> 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 17 2025
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT04811521
Start Date
April 1 2021
End Date
August 17 2025
Last Update
July 30 2024
Active Locations (5)
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1
Indiana University Health West Hospital
Avon, Indiana, United States, 46123
2
Indiana University Health North Hospital
Carmel, Indiana, United States, 46032
3
Indiana University Health Saxony Hospital
Fishers, Indiana, United States, 46037
4
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202