Nurse-Led Palliative Care for COPD

Overseen By Jazmine Coffee-Dunning

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Antidepressants, Mood stabilizers

Disqualifiers: Recent hospitalization, Advanced cancer, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older Americans. COPD increases in frequency with age, and older adults with COPD often have significant unmet geriatrics-palliative care needs that results in reduced quality of life, high healthcare utilization, and care at the end of life that does not align with the values and wishes of patients and their care partners. Older adults with COPD could benefit from proactive geriatrics-palliative care before the end of life. However, no geriatrics-palliative care interventions have been systematically developed and tested in community-dwelling older adults with COPD and their care partners. As the number of older adults with COPD increases to levels unmatched by current palliative care workforce trends, innovative strategies are desperately needed to improve the delivery of geriatrics-palliative care in COPD before the end of life. Project EPIC (Empowering People to Independence in COPD) is a multiphase study to refine and pilot test the EPIC telephonic nurse coaching intervention in older adults with COPD and their care partners. EPIC is informed by the ENABLE (Educate, Nurture, Advise Before Life Ends) early palliative care intervention that improved quality of life and mood for patients with advanced cancer and has been iteratively refined over decades and rigorous randomized controlled trial testing. In the 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 following a manualized curriculum. We conducted a formative evaluation in a diverse and multidisciplinary group of stakeholders to refine ENABLE for patients with COPD and pilot tested the potential feasibility of the refined intervention, EPIC, in patients and their care partners. The current study summatively evaluates EPIC through a hybrid effectiveness-implementation pilot randomized controlled trial in dyads of community-dwelling older adults with moderate to very severe COPD and their care partners randomized to usual COPD care (control) versus usual COPD care + EPIC (intervention). The primary outcomes are trial and intervention feasibility and acceptability. Secondary geriatrics-palliative care outcomes include Life-Space mobility, quality of life, cognitive impairment, functional status, healthcare utilization, palliative care uptake, and care partner burden.

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 data supports the effectiveness of the treatment EPIC for COPD?

The EPIC treatment, which involves early palliative care for COPD, has shown promise in improving patient satisfaction, care coordination, and support for patients' preferred end-of-life care. Studies suggest that integrating palliative care early in the treatment of COPD can enhance quality of life and provide significant benefits for both patients and their caregivers. ^{1 2 3 4 5}

Is nurse-led palliative care for COPD safe for humans?

The research on nurse-led palliative care for COPD, including the EPIC project, does not specifically mention safety concerns, suggesting it is generally considered safe for humans. However, the studies focus more on the integration and benefits of palliative care rather than detailed safety data. ^{1 2 3 5 6}

How is the EPIC treatment for COPD different from other treatments?

The EPIC treatment for COPD is unique because it involves early palliative care led by nurses, focusing on addressing the unmet needs of patients through telehealth. This approach integrates palliative care into the regular management of COPD, which is not commonly done in traditional treatments. ^{1 2 3 7 8}

Eligibility Criteria

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 be able to speak English

Exclusion Criteria

Care partner must be able to speak English

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Intervention (EPIC plus Usual COPD Care) Experimental Treatment 1 Intervention

Participants randomized to this arm will receive the experimental treatment for COPD (i.e. EPIC plus usual COPD care).

Group II: Usual COPD Care Active Control 1 Intervention

Participants randomized to this arm will receive the standard of care for COPD.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led integration of palliative care for chronic obstructive pulmonary disease: An integrative literature review. Ora, L., Mannix, J., Morgan, L., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Nurse-led integration of palliative care for chronic obstructive pulmonary disease: An integrative literature review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A conceptual model: Redesigning how we provide palliative care for patients with chronic obstructive pulmonary disease. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Project EPIC (Early Palliative Care In COPD): A Formative and Summative Evaluation of the EPIC Telehealth Intervention. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Developing a service for patients with very severe chronic obstructive pulmonary disease (COPD) within resources. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The Role of Palliative Care in COPD. [2023]

6. England pubmed.ncbi.nlm.nih.gov

"A palliative end-stage COPD patient does not exist": a qualitative study of barriers to and facilitators for early integration of palliative home care for end-stage COPD. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative Study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Assigned nurses and a professional relationship: a qualitative study of COPD patients' perspective on a new palliative outpatient structure named CAPTAIN. [2023]