Recruiting

PEACE Program

Sponsor:

University of Massachusetts, Worcester

Code:

NCT07072039

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paramedic Evaluation for acute COPD Exacerbation

Study Details

Brief summary:

Chronic Obstructive Pulmonary Disease (COPD) is a serious lung condition that affects millions of people in the United States. Each year, it leads to about 150,000 deaths, nearly 900,000 emergency room visits, and 700,000 hospital stays. When COPD symptoms suddenly get worse-called an exacerbation-it can seriously harm a person's quality of life and often requires emergency care. Treating these flare-ups early can help prevent hospital visits, but right now, there aren't many good ways to make sure people get care quickly.

Mobile Integrated Health (MIH) programs send specially trained paramedics, guided remotely by doctors, to care for patients in their homes. This approach could help people with COPD get faster, more effective care without needing to go to the hospital.

In this project, the investigators are testing a new program called PEACE (Paramedic Evaluation for Acute COPD Exacerbation). The PEACE program sends community paramedics to patients' homes-when needed and in partnership with their regular doctors-to manage worsening COPD symptoms early. The study team will adapt the PEACE program to meet the needs of adults living at home with moderate to severe COPD, gather feedback from patients and healthcare providers, and run a small pilot study to see if the program is practical and helpful.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Study ID

NCT07072039

Start date

Oct 1, 2025

Status verified date

Nov, 2025

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of COPD
2. At least one COPD exacerbation resulting in ED utilization in the six months prior to enrollment
3. COPD GOLD Score letter designation of B, C, or D
4. Receives care in the UMass Memorial Medical Center Pulmonary Clinic or Benedict Family Health Clinic
5. Over 18 years of age
6. Speaks English
7. Resides in the geographical catchment area allowed by the UMass Memorial Medical Center MIH Program's license

Exclusion Criteria:

1. No prior diagnosis of COPD
2. Under 18 years of age
3. Does not speak English
4. Pregnancy
5. Cannot provide informed consent

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PEACE Arm

Patients in this arm will receive PEACE Intervention

Interventions

Paramedic Evaluation for acute COPD Exacerbation

The Paramedic Evaluation for Acute COPD Exacerbation (PEACE) program is a mobile integrated health initiative that aims to evaluate and treat COPD exacerbation in the home. The goal of the intervention is to expedite the recognition and treatment of COPD exacerbation as well as For this intervention, ambulatory teams can refer patients for PEACE visits when a patient has been identified as suffering from symptoms consistent with COPD exacerbation. Once a visit is requested via electronic health record order, a community paramedic presents to the patient's home within 2 hours, evaluates the patient using mobile diagnostic testing, and initiates pharmacological therapies protocolized by the pulmonary team. A standardized clinical approach and documentation strategy is used including a focused history and physical exam, venous blood gas, trending pulse-oximetry, and mobile x-ray. The community paramedic is supervised in real-time by an emergency physician to establish a care plan and di

Primary outcome measure

  • Recruitment Rate [ Time Frame: At enrollment ]
  • Reason for Recruitment Refusal [ Time Frame: At enrollment ]
  • Intervention Acceptability [ Time Frame: from enrollment until completion of study activities at 1 year ]
  • Protocol Fidelity [ Time Frame: From enrollment until study completion at 1 year ]
  • Sample Retention [ Time Frame: From enrollment until completion of study activities at 1 year ]
  • PEACE Referrals [ Time Frame: 6 and 12 months after enrollment ]

Central Contacts and Locations

Central contacts

Laurel O'Connor, MD, MSc

508-421-1400laurel.oconnor@umassmed.edu

Locations

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • Community Paramedicine
  • Mobile Integrated Health
  • COPD (Chronic Obstructive Pulmonary Disease)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2025-11-26.