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

Primary Purpose

Generalized Anxiety Disorder, Chest Pain, Panic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary care follow-up
Online Self-Administered Anxiety Management Program plus Peer Support Guidance
Therapist-Administered Cognitive Behavioral Therapy
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana University Health West Hospital
  • Indiana University Health North Hospital
  • Indiana University Health Saxony Hospital
  • Indiana University Health Methodist Hospital
  • Indiana University Health Ball Memorial Hosptial

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Primary care follow-up

Online Cognitive Behavioral Therapy

Therapist-Administered Cognitive Behavioral Therapy

Arm Description

Enhanced primary care coordination

Online Self-Administered Anxiety Management Program plus Peer Support Guidance

Telehealth 8 one-hour sessions over the course of 8 to 10 weeks

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2021
Last Updated
May 3, 2023
Sponsor
Indiana University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04811521
Brief Title
Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Acronym
PACER
Official Title
Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Chest Pain, Panic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary care follow-up
Arm Type
Active Comparator
Arm Description
Enhanced primary care coordination
Arm Title
Online Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Online Self-Administered Anxiety Management Program plus Peer Support Guidance
Arm Title
Therapist-Administered Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Telehealth 8 one-hour sessions over the course of 8 to 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Primary care follow-up
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Self-Administered Anxiety Management Program plus Peer Support Guidance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-Administered Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety Symptoms
Description
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
Time Frame
3 months after enrollment
Title
Anxiety Symptoms
Description
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
Time Frame
6 months after enrollment
Title
Anxiety Symptoms
Description
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
Time Frame
9 months after enrollment
Title
Anxiety Symptoms
Description
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
Time Frame
12 months after enrollment
Secondary Outcome Measure Information:
Title
Panic Symptoms
Description
PHQ Panic Screener adjusted for baseline
Time Frame
3 months after enrollment
Title
Panic Symptoms
Description
PHQ Panic Screener adjusted for baseline
Time Frame
6 months after enrollment
Title
Panic Symptoms
Description
PHQ Panic Screener adjusted for baseline
Time Frame
9 months after enrollment
Title
Panic Symptoms
Description
PHQ Panic Screener adjusted for baseline
Time Frame
12 months after enrollment
Title
Chest Pain
Description
Chest pain frequency as adjusted for baseline
Time Frame
3 months after enrollment
Title
Chest Pain
Description
Chest pain frequency as adjusted for baseline
Time Frame
6 months after enrollment
Title
Chest Pain
Description
Chest pain frequency as adjusted for baseline
Time Frame
9 months after enrollment
Title
Chest Pain
Description
Chest pain frequency as adjusted for baseline
Time Frame
12 months after enrollment
Title
Physical Symptoms
Description
PHQ-15 total score as adjusted for baseline
Time Frame
3 months after enrollment
Title
Physical Symptoms
Description
PHQ-15 total score as adjusted for baseline
Time Frame
6 months after enrollment
Title
Physical Symptoms
Description
PHQ-15 total score as adjusted for baseline
Time Frame
9 months after enrollment
Title
Physical Symptoms
Description
PHQ-15 total score as adjusted for baseline
Time Frame
12 months after enrollment
Title
Depression symptoms
Description
PHQ-8 total score as adjusted for baseline
Time Frame
3 months after enrollment
Title
Depression symptoms
Description
PHQ-8 total score as adjusted for baseline
Time Frame
6 months after enrollment
Title
Depression symptoms
Description
PHQ-8 total score as adjusted for baseline
Time Frame
9 months after enrollment
Title
Depression symptoms
Description
PHQ-8 total score as adjusted for baseline
Time Frame
12 months after enrollment
Title
Work/family/social functioning
Description
Sheehan Disability scale as adjusted for baseline
Time Frame
3 months after enrollment
Title
Work/family/social functioning
Description
Sheehan Disability scale as adjusted for baseline
Time Frame
6 months after enrollment
Title
Work/family/social functioning
Description
Sheehan Disability scale as adjusted for baseline
Time Frame
9 months after enrollment
Title
Work/family/social functioning
Description
Sheehan Disability scale as adjusted for baseline
Time Frame
12 months after enrollment
Title
Global Anxiety Change
Description
Patient-rated global anxiety change since enrollment
Time Frame
3 months after enrollment
Title
Global Anxiety Change
Description
Patient-rated global anxiety change since enrollment
Time Frame
6 months after enrollment
Title
Global Anxiety Change
Description
Patient-rated global anxiety change since enrollment
Time Frame
9 months after enrollment
Title
Global Anxiety Change
Description
Patient-rated global anxiety change since enrollment
Time Frame
12 months after enrollment
Title
ED Utilization
Description
Number of return visits to ED
Time Frame
12 months prior to enrollment
Title
ED Utilization
Description
Number of return visits to ED
Time Frame
3 months after enrollment
Title
ED Utilization
Description
Number of return visits to ED
Time Frame
6 months after enrollment
Title
ED Utilization
Description
Number of return visits to ED
Time Frame
9 months after enrollment
Title
ED Utilization
Description
Number of return visits to ED
Time Frame
12 months after enrollment
Title
Adverse Cardiac Events
Description
Number of major adverse cardiac events (death, myocardial infarction, revascularization)
Time Frame
3 months after enrollment
Title
Adverse Cardiac Events
Description
Number of major adverse cardiac events (death, myocardial infarction, revascularization)
Time Frame
6 months after enrollment
Title
Adverse Cardiac Events
Description
Number of major adverse cardiac events (death, myocardial infarction, revascularization)
Time Frame
9 months after enrollment
Title
Adverse Cardiac Events
Description
Number of major adverse cardiac events (death, myocardial infarction, revascularization)
Time Frame
12 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Musey, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health West Hospital
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Indiana University Health North Hospital
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Indiana University Health Saxony Hospital
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46037
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Ball Memorial Hosptial
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room

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