Clinical trial NCT04811521: Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Official title: Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Chest Pain
Panic
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-03-23
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 feasibility for real world adoption.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* \> 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.

Primary outcomes:
measure: Anxiety Symptoms
timeFrame: 3 months after enrollment
measure: Anxiety Symptoms
timeFrame: 6 months after enrollment
measure: Anxiety Symptoms
timeFrame: 9 months after enrollment
measure: Anxiety Symptoms
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Panic Symptoms
timeFrame: 3 months after enrollment
measure: Panic Symptoms
timeFrame: 6 months after enrollment
measure: Panic Symptoms
timeFrame: 9 months after enrollment
measure: Panic Symptoms
timeFrame: 12 months after enrollment
measure: Chest Pain
timeFrame: 3 months after enrollment
measure: Chest Pain
timeFrame: 6 months after enrollment
measure: Chest Pain
timeFrame: 9 months after enrollment
measure: Chest Pain
timeFrame: 12 months after enrollment
measure: Physical Symptoms
timeFrame: 3 months after enrollment
measure: Physical Symptoms
timeFrame: 6 months after enrollment
measure: Physical Symptoms
timeFrame: 9 months after enrollment
measure: Physical Symptoms
timeFrame: 12 months after enrollment
measure: Depression symptoms
timeFrame: 3 months after enrollment
measure: Depression symptoms
timeFrame: 6 months after enrollment
measure: Depression symptoms
timeFrame: 9 months after enrollment
measure: Depression symptoms
timeFrame: 12 months after enrollment
measure: Work/family/social functioning
timeFrame: 3 months after enrollment
measure: Work/family/social functioning
timeFrame: 6 months after enrollment
measure: Work/family/social functioning
timeFrame: 9 months after enrollment
measure: Work/family/social functioning
timeFrame: 12 months after enrollment
measure: Global Anxiety Change
timeFrame: 3 months after enrollment
measure: Global Anxiety Change
timeFrame: 6 months after enrollment
measure: Global Anxiety Change
timeFrame: 9 months after enrollment
measure: Global Anxiety Change
timeFrame: 12 months after enrollment
measure: ED Utilization
timeFrame: 12 months prior to enrollment
measure: ED Utilization
timeFrame: 3 months after enrollment
measure: ED Utilization
timeFrame: 6 months after enrollment
measure: ED Utilization
timeFrame: 9 months after enrollment
measure: ED Utilization
timeFrame: 12 months after enrollment
measure: Adverse Cardiac Events
timeFrame: 3 months after enrollment
measure: Adverse Cardiac Events
timeFrame: 6 months after enrollment
measure: Adverse Cardiac Events
timeFrame: 9 months after enrollment
measure: Adverse Cardiac Events
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: Avon
country: United States
facility: Indiana University Health West Hospital
state: Indiana
city: Carmel
country: United States
facility: Indiana University Health North Hospital
state: Indiana
city: Fishers
country: United States
facility: Indiana University Health Saxony Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hosptial
state: Indiana
Study officials:
affiliation: Indiana University
name: Paul Musey, MD
role: PRINCIPAL_INVESTIGATOR
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