Nurse-Led Palliative Care for COPD

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

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.

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

+2 more

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.

+11 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (EPIC plus Usual COPD Care)Experimental Treatment1 Intervention

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

Group II: Usual COPD CareActive Control1 Intervention

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