Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation

NCT07072039 | Recruiting

• 2 other identifiers: STUDY000022401K23HL174454-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  Ratio of patients enrolled to total patients approached

  At enrollment

• Reason for Recruitment Refusal

  Reason that approached patients did not enroll in the study

  At enrollment

• Intervention Acceptability

  Using the healthcare intervention acceptability qualitative framework, investigators will measure intervention acceptability from both patient and clinician perspectives. This validated framework assesses participants' affective attitudes, sense of intervention coherence, self-efficacy, the perceived ethicality of the intervention, intervention burden and anticipated cost, opportunity cost, and perceived effectiveness.

  from enrollment until completion of study activities at 1 year

• Protocol Fidelity

  Investigators will evaluate adherence to each component of the PEACE protocol by having two independent physician-reviewers audit the EHR and video recordings from every PEACE encounter to ensure that procedures were completed correctly and within the expected timeframe. Particular attention will be focused on visits with operational or clinical "failures," defined as any clinical or operational deviation from intervention protocol or any unexpected ED visit or hospitalization within 72 hours of a PEACE referral.

  From enrollment until study completion at 1 year

• Sample Retention

  Investigators will track the number of subjects who completed the entire study compared to the number of subjects initially enrolled. The investigators will also evaluate loss to follow-up rate, perceived reason for discontinuation and completeness of post-intervention data collection.

  From enrollment until completion of study activities at 1 year

• PEACE Referrals

  Investigators will track the total number of PEACE referrals requested during the study period

  6 and 12 months after enrollment

Secondary Outcomes (5)

• PEACE Disposition

  6 and 12 months after enrollment

• Unanticipated ED Visits

  From enrollment to completion of study activities at 1 year

• Hospitalizations

  From enrollment until completion of study activities at 1 year

• Exacerbation Relapse Rate

  From enrollment until completion of study activities at 1 year

• COPD-related Medication changes

  From enrollment to completion of study activities at 1 year

Study Arms (1)

PEACE Arm

EXPERIMENTAL

Patients in this arm will receive PEACE Intervention

Procedure: Paramedic Evaluation for acute COPD Exacerbation

Interventions

Paramedic Evaluation for acute COPD Exacerbation 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

PEACE Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No prior diagnosis of COPD
• Under 18 years of age
• Does not speak English
• Pregnancy
• Cannot provide informed consent

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurel O'Connor, MD, MSc

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurel O'Connor, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Baseline data (data collected before any intervention), such as demographics, that require no additional analyses, will be submitted within 4 months after enrollment is completed. After the study is complete, the study team will submit all remaining scientific data to the data repository and will mark the RCT status as "complete" in clinicaltrials.gov. Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
• Access Criteria: Prior to the release of individual-level data, researchers will be required to complete data sharing and confidentiality agreements as established by the data repository. Researchers must commit to 1) not attempting to re-identify participants, 2) securing the data with appropriate technology and enforcing strict access rules, 3) destroying data after analyses are completed, 4) meeting any requirements as stipulated by the health system involved in the study, and 5) if research is conducted within a covered entity, HIPAA requirements must be met prior to use.

Locations

US (1)