Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05040386
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EPIC (Empower People to Independence in COPD) — BEHAVIORAL
    EPIC (Empower People to Independence in COPD) is a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, a rigorously tested multicomponent early palliative care model that improved quality of life and emotional symptoms in patients with advanced cancer. The PI adapted and refined ENABLE for COPD and older adults. EPIC includes weekly (6 for patients and 4 for caregivers) telephone-based, nurse coach-led sessions aided by a manualized curriculum (Charting Your Course), followed by three once-monthly follow up sessions. Participants also complete activities on solving problems and making difficult decisions, complete an Advance Directive, and attend a supportive care clinic visit. Caregiver participants are randomized to the same study arm as the patient participant and receive the caregiver-focused EPIC intervention.
  • Usual Care — OTHER
    Participants randomized to this arm receive standard of care for COPD. This includes routine clinic visits with their clinician, medications, inhalers, vaccinations, tobacco cessation counseling, illness education, cardiopulmonary rehabilitation, specialist referrals, and other COPD therapies deemed appropriate by their clinician. Caregiver participants are randomized to the same study arm as the patient participant.

Study Details

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 care (control) versus EPIC (intervention). The primary outcomes are intervention feasibility and acceptability. Secondary outcomes include Life-Space mobility, quality of life, cognitive impairment, functional status, palliative care uptake, and care partner burden.

Key Dates

Start date
May 19, 2022
Status verified
Oct 2025
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Usual Care
    Patient participants randomized to this arm will receive the standard of care for COPD. Caregiver participants, if available, will be randomized to the same study arm as the patient participant.
  • Experimental: Intervention (EPIC)
    Participants randomized to this arm will receive the experimental treatment for COPD (i.e. EPIC). Caregiver participants, if available, will be randomized to the same study arm as the patient participant.

Primary Outcome Measure

Intervention Feasibility [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, AL

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