Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation

NCT ID: NCT07072039

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2029-09-01

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.

Detailed Description

Evidence-based strategies to ensure that patients with COPD have reliable, timely, equitable access to treatment are lacking. This deficit is particularly evident in communities impacted by determinants of health that adversely impact preventive health behavior and care access.

On-demand Mobile Integrated Health (MIH) teams, comprised of community paramedics supported by centralized physicians, have been developed to care for patients outside of conventional hospital settings. These teams empower physicians to provide enhanced remote care by collecting essential clinical information about patients in their living environment, performing diagnostic testing, and administering therapy in the home. MIH programs decrease emergency medical services utilization and improve patient satisfaction in select populations, but the impact of MIH programs on the outcomes of patients with COPD exacerbation has not been evaluated.

In this project, the study team will implement and refine an MIH intervention for patients living with COPD. The Paramedic Evaluation for Acute COPD Exacerbation (PEACE) intervention will dispatch community paramedics to execute a home-based evaluation and treatment strategy in collaboration with a supervising physician and the patient's ambulatory medical team during and after acute COPD exacerbation to promote wellness and recovery. This intervention is intended to improve clinical outcomes and reduce acute care costs by eliminating barriers to care, generating actionable clinical data that can facilitate appropriate diagnosis, accelerating treatment, and simplifying care coordination. Our central hypothesis, based on preliminary data and input from key informants, is that an intervention that facilitates community-based management of COPD exacerbation will be acceptable and highly adoptable by patients and clinicians.

The Practical Robust Implementation and Sustainability Model (PRISM) implementation framework will be used to describe factors impacting project implementation, with the embedded Expanded RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model guiding outcomes measurements. Leveraging our prototypical intervention design, the study team will test and Refine the prototype PEACE intervention in real clinical practice with a cohort of patients who are at high risk of COPD exacerbation. The study team will use a mixed-methods approach to evaluate the usability and acceptability of each operational and clinical component of PEACE. Measures will include a systematic assessment of protocol adherence, survey instruments, and qualitative interviews to explore contextual factors impacting intervention performance. The study team will confirm our findings and adapt the protocols informed by a working group comprised of clinicians and community partners. Up to 25 patient participants will be enrolled in the intervention, plus up to 11 clinician participants will be enrolled to participate in usability/acceptability ratings and qualitative evaluations/focus groups.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEACE Arm

Patients in this arm will receive PEACE Intervention

Group Type: EXPERIMENTAL

Paramedic Evaluation for acute COPD Exacerbation

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Laurel O'Connor

Associate Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurel O'Connor, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Locations

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laurel O'Connor, MD, MSc

Role: CONTACT

laurel.oconnor@umassmed.edu

508-421-1400

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23HL174454-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002240

Identifier Type: -

Identifier Source: org_study_id