Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
No prior diagnosis of COPD
Pregnancy
Cannot provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Paramedic Evaluation for acute COPD Exacerbation
Procedure/SurgeryThe 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 Care
Procedure/SurgeryPatients will receive care as usual. They will be asked to complete survey instruments as part of their participation in the study
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: PEACE ArmExperimental treatment 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Ratio of patients enrolled to total patients approached
Time frame
At enrollment2
Reason for Recruitment Refusal
Reason that approached patients did not enroll in the study
Time frame
At enrollment3
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.
Time frame
from enrollment until completion of study activities at 1 year4
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.
Time frame
From enrollment until study completion at 1 yearSecondary outcomes
1
PEACE Disposition
Distribution of participant clinical disposition after PEACE encounter (home versus emergency department)
Time frame
6 and 12 months after enrollment2
Unanticipated ED Visits
ED visits within 72 hours after PEACE visit where patient was treated in place
Time frame
From enrollment to completion of study activities at 1 year3
Hospitalizations
Number and length of hospitalizations for COPD
Time frame
From enrollment until completion of study activities at 1 year4
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
Time frame
From enrollment until completion of study activities at 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov