COPD (Chronic Obstructive Pulmonary Disease)PEACENCT07072039
Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation
A study testing Paramedic Evaluation for acute COPD Exacerbation in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Paramedic Evaluation for acute COPD Exacerbation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Diagnosis of COPD 4) Receives care in the UMass Memorial Medical Center System 5) 40 years of age or older 6) Speaks English 7) Resides in the geographical catchment area allowed by the UMass Memorial Medical Center MIH Program's license
Who cannot join
- No prior diagnosis of COPD
- Pregnancy
- Cannot provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation (PEACE) Intervention
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.
Read the 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.
- Being tested
- Paramedic Evaluation for acute COPD Exacerbation, Usual Care
- Keywords
- Community Paramedicine, Mobile Integrated Health, COPD (Chronic Obstructive Pulmonary Disease)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paramedic Evaluation for acute COPD ExacerbationProcedure or surgery
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
Usual CareProcedure or surgery
Patients will receive care as usual. They will be asked to complete survey instruments as part of their participation in the study
| Study group | Role | What they receive |
|---|---|---|
| PEACE Arm | Experimental | Patients in this arm will receive PEACE Intervention Receives: Procedure: Paramedic Evaluation for acute COPD Exacerbation |
| Control Arm | Placebo comparator | control arm participants will receive usual care Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Ratio of patients enrolled to total patients approached
Measured: At enrollment
Reason for Recruitment Refusal
Reason that approached patients did not enroll in the study
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 and 12 months after enrollment
Secondary outcomes (5)
PEACE Disposition
Distribution of participant clinical disposition after PEACE encounter (home versus emergency department)
Measured: 6 and 12 months after enrollment
Unanticipated ED Visits
ED visits within 72 hours after PEACE visit where patient was treated in place
Measured: From enrollment to completion of study activities at 1 year
Hospitalizations
Number and length of hospitalizations for COPD
Measured: From enrollment until completion of study activities at 1 year
Exacerbation Relapse Rate
Number of occurrences when patients experience worsening COPD symptoms requiring a second pharmacological intervention before resolution of symptoms from a treated exacerbation
Measured: From enrollment until completion of study activities at 1 year
COPD-related Medication changes
Number of adjustments made to study participants' COPD treatment regimen (initiation, discontinuation, dosage adjustment, or substitution of medications aimed at managing COPD)
Measured: From enrollment to completion of study activities at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Oct 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Laurel O'Connor, University of Massachusetts, Worcester
- Investigators
- Laurel O'Connor, MD, MSc, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072039
- Sponsor's protocol ID
- STUDY00002240
- Other IDs
- 1K23HL174454-01A1
- Acronym
- PEACE
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and laboratory data: Includes medical history, demographic information, and patient characteristics at enrollment. Other data will be extracted from the electronic health record and patient-facing instruments at 3, 6, and 12 months. This includes healthcare utilization patterns, instances of COPD exacerbation relapse, COPD-related medication adjustments, and mortality. Additionally, patient-reported COPD-related quality-of-life instruments will be captured and tracked throughout the study. These values will be reported as tabular data and stored in a REDCap secure electronic data capture system. Interview data: Semi-structured interviews will be performed with patients, clinicians, and administrators. Deidentified, raw transcripts will be generated and coded using methods described in the research strategy. Codebooks will be developed and used for coding transcripts. Codebooks and coding summary files will be shared as detailed below.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation (PEACE) Intervention
- ClinicalTrials.gov ID
- NCT07072039
- Acronym / sponsor ID
- PEACE / STUDY00002240
- Keywords
- Community Paramedicine, Mobile Integrated Health, COPD (Chronic Obstructive Pulmonary Disease)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEACE Arm | Experimental | Procedure: Paramedic Evaluation for acute COPD ExacerbationPatients in this arm will receive PEACE Intervention |
| Control Arm | Placebo comparator | Procedure: Usual Carecontrol arm participants will receive usual care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Diagnosis of COPD 4) Receives care in the UMass Memorial Medical Center System 5) 40 years of age or older 6) Speaks English 7) Resides in the geographical catchment area allowed by the UMass Memorial Medical Center MIH Program's license
Key exclusion criteria (3 listed)
- No prior diagnosis of COPD
- Pregnancy
- Cannot provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paramedic Evaluation for acute COPD ExacerbationThe 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 | Procedure or surgery | PEACE Arm |
| Usual CarePatients will receive care as usual. They will be asked to complete survey instruments as part of their participation in the study | Procedure or surgery | Control Arm |
Primary outcome
Recruitment Rate
Time frame: At enrollment
Ratio of patients enrolled to total patients approached
Reason for Recruitment Refusal
Time frame: At enrollment
Reason that approached patients did not enroll in the study
Intervention Acceptability
Time frame: from enrollment until completion of study activities at 1 year
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.
Protocol Fidelity
Time frame: From enrollment until study completion at 1 year
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.
Sample Retention
Time frame: From enrollment until completion of study activities at 1 year
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.
PEACE Referrals
Time frame: 6 and 12 months after enrollment
Investigators will track the total number of PEACE referrals requested during the study period
5 secondary outcomes
PEACE Disposition
Time frame: 6 and 12 months after enrollment
Unanticipated ED Visits
Time frame: From enrollment to completion of study activities at 1 year
Hospitalizations
Time frame: From enrollment until completion of study activities at 1 year
Exacerbation Relapse Rate
Time frame: From enrollment until completion of study activities at 1 year
COPD-related Medication changes
Time frame: From enrollment to completion of study activities at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. Clinical and laboratory data: Includes medical history, demographic information, and patient characteristics at enrollment. Other data will be extracted from the electronic health record and patient-facing instruments at 3, 6, and 12 months. This includes healthcare utilization patterns, instances of COPD exacerbation relapse, COPD-related medication adjustments, and mortality. Additionally, patient-reported COPD-related quality-of-life instruments will be captured and tracked throughout the study. These values will be reported as tabular data and stored in a REDCap secure electronic data capture system. Interview data: Semi-structured interviews will be performed with patients, clinicians, and administrators. Deidentified, raw transcripts will be generated and coded using methods described in the research strategy. Codebooks will be developed and used for coding transcripts. Codebooks and coding summary files will be shared as detailed below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurel O'Connor, MD, MSc principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedic Evaluation for acute COPD Exacerbation in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurel O'Connor, MD, MSc (508-421-1400, laurel.oconnor@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: At enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.