Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room (PACER)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Generalized Anxiety Disorder; Chest Pain; Panic
• Intervention / Treatment: Behavioral: Primary care follow-up; Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance; Behavioral: Therapist-Administered Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Avon, Indiana, United States, 46123
      • Indiana University Health West Hospital
    • Carmel, Indiana, United States, 46032
      • Indiana University Health North Hospital
    • Fishers, Indiana, United States, 46037
      • Indiana University Health Saxony Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital
    • Muncie, Indiana, United States, 47303
      • Indiana University Health Ball Memorial Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Primary care follow-up; Enhanced primary care coordination	Behavioral: Primary care follow-up; Those randomized to primary care and enhanced primary care coordination will receive the minimal intensity treatment that includes: (1) assistance in identifying a primary care provider for participants who do not have one, (2) sharing results of diagnostic testing (including anxiety screening) with the primary care provider (results sent via EMR note, mailed letter, or delivered by participant at appointment); and (3) an educational brochure on anxiety and treatment.
Active Comparator: Online Cognitive Behavioral Therapy; Online Self-Administered Anxiety Management Program plus Peer Support Guidance	Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance; Individuals randomized to the online Cognitive Behavioral Therapy (CBT) + peer support guidance arm will receive access to six online, evidence-based CBT modules in the This Way Up Generalized Anxiety Course to be completed weekly or bi-monthly. Individuals who screen positive on the PHQ panic measure will complete 2 additional panic-specific homework assignments applying exposure therapy to panic (in addition to Generalized Anxiety Disorder) experiences aligned with content from the This Way Up Panic Course.
Active Comparator: Therapist-Administered Cognitive Behavioral Therapy; Telehealth 8 one-hour sessions over the course of 8 to 10 weeks	Behavioral: Therapist-Administered Cognitive Behavioral Therapy; Individuals randomized to therapist-led CBT via telehealth will receive 8 one-hour sessions over the course of 8 to 10 weeks via telehealth (HIPAA compliant software such as Zoom Health or AmWell) or telephone. Therapists will be master's-degreed or eligible clinicians trained in CBT by our study psychologist. Therapists will follow a manualized protocol for delivering CBT for anxiety, specifically, with a primary focus on anxiety and worry management. Individuals who screen positive on the PHQ panic measure will have training in exposure therapy added to CBT. Although many CBT trials have a standard length of 12 sessions, brief CBT lasting 4-8 sessions is equally efficacious.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms	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	3 months after enrollment
Anxiety Symptoms	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	6 months after enrollment
Anxiety Symptoms	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	9 months after enrollment
Anxiety Symptoms	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	12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Panic Symptoms	PHQ Panic Screener adjusted for baseline	3 months after enrollment
Panic Symptoms	PHQ Panic Screener adjusted for baseline	6 months after enrollment
Panic Symptoms	PHQ Panic Screener adjusted for baseline	9 months after enrollment
Panic Symptoms	PHQ Panic Screener adjusted for baseline	12 months after enrollment
Chest Pain	Chest pain frequency as adjusted for baseline	3 months after enrollment
Chest Pain	Chest pain frequency as adjusted for baseline	6 months after enrollment
Chest Pain	Chest pain frequency as adjusted for baseline	9 months after enrollment
Chest Pain	Chest pain frequency as adjusted for baseline	12 months after enrollment
Physical Symptoms	PHQ-15 total score as adjusted for baseline	3 months after enrollment
Physical Symptoms	PHQ-15 total score as adjusted for baseline	6 months after enrollment
Physical Symptoms	PHQ-15 total score as adjusted for baseline	9 months after enrollment
Physical Symptoms	PHQ-15 total score as adjusted for baseline	12 months after enrollment
Depression symptoms	PHQ-8 total score as adjusted for baseline	3 months after enrollment
Depression symptoms	PHQ-8 total score as adjusted for baseline	6 months after enrollment
Depression symptoms	PHQ-8 total score as adjusted for baseline	9 months after enrollment
Depression symptoms	PHQ-8 total score as adjusted for baseline	12 months after enrollment
Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	3 months after enrollment
Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	6 months after enrollment
Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	9 months after enrollment
Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	12 months after enrollment
Global Anxiety Change	Patient-rated global anxiety change since enrollment	3 months after enrollment
Global Anxiety Change	Patient-rated global anxiety change since enrollment	6 months after enrollment
Global Anxiety Change	Patient-rated global anxiety change since enrollment	9 months after enrollment
Global Anxiety Change	Patient-rated global anxiety change since enrollment	12 months after enrollment
ED Utilization	Number of return visits to ED	12 months prior to enrollment
ED Utilization	Number of return visits to ED	3 months after enrollment
ED Utilization	Number of return visits to ED	6 months after enrollment
ED Utilization	Number of return visits to ED	9 months after enrollment
ED Utilization	Number of return visits to ED	12 months after enrollment
Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	3 months after enrollment
Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	6 months after enrollment
Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	9 months after enrollment
Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	12 months after enrollment

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Paul Musey, MD, Indiana University

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): August 17, 2025
• Study Completion (Estimated): August 17, 2025

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Anxiety Disorders; Chest Pain
• Other Study ID Numbers: 10296 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No