Nurse-Led Palliative Care for COPD

JC
Overseen ByJazmine Coffee-Dunning
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for older adults with chronic obstructive pulmonary disease (COPD), who often have unmet palliative care needs. It tests a treatment called EPIC, which involves nurse-led coaching over the phone to help patients manage their condition better. Participants will continue their usual COPD care, but some will also receive this additional support to determine if it aids daily life and reduces healthcare visits. Ideal candidates are those over 60 with COPD who experience severe breathlessness or use supplemental oxygen. As an unphased trial, this study offers a unique opportunity for patients to contribute to research that could enhance COPD care and support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the EPIC intervention is safe for older adults with COPD?

Research shows that the EPIC program is designed to be safe and easy to manage. In past studies, similar nurse-led care models have improved the quality of life and mood for patients with serious illnesses like cancer. These models have been tested for many years, proving their safety for patients.

While specific evidence about side effects from EPIC is not yet available, the methods it uses have been carefully tested for other diseases. Since EPIC doesn't involve medication and focuses on phone coaching by trained nurses, it likely poses very low risk. The main goal is to determine if participants find the sessions helpful and easy to understand, rather than focusing on physical side effects.

Overall, although specific data on side effects is not yet available, the EPIC program is based on proven methods considered safe for similar patient groups.12345

Why are researchers excited about this trial?

Researchers are excited about EPIC for COPD because it adds a personalized, nurse-led palliative care approach to the usual treatment for COPD. While standard care mainly focuses on managing symptoms with medications like bronchodilators and steroids, EPIC emphasizes holistic support, addressing physical, emotional, and social needs. This approach could greatly improve quality of life and provide more comprehensive care for those living with COPD.

What evidence suggests that the EPIC intervention is effective for COPD?

Research has shown that starting palliative care early, as in the EPIC program, can improve life for people with COPD. In this trial, participants in the intervention arm will receive the EPIC program alongside usual COPD care. Studies have found that care led by specialists and nurses helps those with serious illnesses feel better and reduces their need for medical services. Data from the EPIC project indicate that this approach is practical and well-received by people with COPD and their caregivers. Early palliative care also makes daily life easier and more manageable. While the EPIC program is still being tested, it uses proven palliative care methods that have been successful for patients with other serious conditions.678910

Are You a Good Fit for This Trial?

This trial is for older adults over 60 with moderate to very severe COPD, confirmed by spirometry tests. Participants must speak English and have a care partner willing to join the study. They should experience severe breathlessness or have had a hospitalization in the past year but not within the last 30 days, or be on supplemental oxygen. People with recent hospitalizations, certain cognitive impairments, advanced cancers, active major psychiatric disorders or substance abuse issues, other primary lung diseases, or non-correctable hearing impairment cannot participate.

Inclusion Criteria

I am 60 years old or older.
I have COPD confirmed by a breathing test showing specific results.
Patient participant must have a care partner who is willing to participate, defined as a person who knows the patient well and is involved in their medical care
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Exclusion Criteria

My care partner does not have untreated mental health issues or substance abuse.
I haven't been hospitalized or had severe COPD symptoms needing treatment in the last 30 days.
Patient participant will be excluded if they have non-correctable hearing impairment
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Palliative care-trained nurse coaches deliver the Charting Your Course Curriculum over the phone to patients (six sessions) and their care partners (four sessions), with activities and monthly telephone follow-up

6 months
Monthly telephone follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • EPIC
Trial Overview The EPIC pilot RCT is testing an early palliative care intervention called EPIC for older adults with COPD and their care partners against usual COPD care alone. The intervention involves nurse coaches delivering a curriculum via phone sessions followed by monthly follow-ups to improve quality of life and reduce healthcare utilization.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (EPIC)Experimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Nurse-led models integrating palliative care for patients with chronic obstructive pulmonary disease (COPD) are rare, but when implemented, they have shown positive outcomes, particularly in advance care planning and improving end-of-life discussions.
The review highlighted a significant gap in qualitative research on nurse-led palliative care models for COPD, indicating a need for further exploration to address the comprehensive needs of patients and their caregivers.
Nurse-led integration of palliative care for chronic obstructive pulmonary disease: An integrative literature review.Ora, L., Mannix, J., Morgan, L., et al.[2020]

Citations

Study Protocol for a Hybrid Effectiveness-Implementation ...Specialist and nurse-led early palliative care has been shown to improve quality of life and reduce healthcare utilization for people living ...
Project EPIC (Early Palliative Care In COPD): A Formative ...Data have demonstrated palliative care's positive impact on people living with chronic obstructive pulmonary disease (COPD), through more ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36496113/
Project EPIC (Early Palliative Care In COPD) - PubMed - NIHConclusion: EPIC was acceptable and feasible in patients with COPD and their family caregivers. Larger feasibility and effectiveness trials are warranted.
Project EPIC (Empowering People to Independence in ...Specialist and nurse-led early palliative care has been shown to improve quality of life and reduce healthcare utilization for people living with advanced ...
The Project EPIC (Early Palliative Care In COPD) Hybrid ...A series of studies following the NIH Stage Model to develop, refine, and pilot test a telephonic nurse coach–led early palliative care intervention in COPD.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38458558/
Project EPIC (Empowering People to Independence in COPD)A blinded data collector will assess exploratory outcomes (e.g., Life-Space mobility, quality of life, caregiver burden, emotional symptoms, ...
Nurse-Led Palliative Care for COPD · Info for ParticipantsThis N/A medical study run by University of Alabama at Birmingham needs participants to evaluate whether EPIC will have tolerable side effects & efficacy ...
Effectiveness and implementation of palliative care ...Controlled studies with sufficient power are needed to evaluate the effectiveness of palliative care on patients with COPD and their informal caregivers.
Project EPICSpecialist and nurse-led early palliative care has been shown to improve quality of life and reduce healthcare utilization for people living with advanced ...
Nurse-Led Interventions in Chronic Obstructive Pulmonary ...This systematic review was conducted to identify and assess nurse-led interventions in COPD patients in terms of mental, physical, and clinical status.
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