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

Nurse Coach-Led Early Palliative Care for Older Adults With Chronic Obstructive Pulmonary Disease and Their Care Partners: The Project EPIC Pilot Randomized Controlled 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 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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Usual Care; Behavioral: EPIC (Empower People to Independence in COPD)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Patients

Inclusion criteria (must meet ALL of the following):

1. ≥60 years;
2. COPD on routinely collected spirometry (FEV1/FVC <0.70 + FEV1<80%);
3. Able to speak English;
4. At least one of the following:

4a) Severe breathlessness as defined by a documented modified Medical Research Council (mMRC) Dyspnea Scale Score >2 in the medical record or any of the following levels of severe breathlessness by medical review: breathless after walking about 100 yards, breathless after a walking few minutes on level ground, or too breathless to leave the house or when dressing); OR, 4b) ≥1 hospitalization in the year prior but >30 days from enrollment; OR, 4c) On supplemental oxygen (exertional or continuous).

Exclusion criteria (can be excluded for ANY of the following):

1. No access to a dedicated telephone service;
2. Recent hospitalization for any reason or exacerbation of COPD in the past 30 days or ongoing exacerbation symptoms requiring treatment with antibiotics and steroids;
3. Treated within the past 60 days for an advanced cancer defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, and hematologic malignancies by self report or chart review;
4. Active schizophrenia, major depressive disorder, bipolar disorder, suicidal ideations, or substance abuse by self-report or chart review (Active means currently being treated for schizophrenia, bipolar disorder, or suicidal ideations or having active and untreated major depressive disorder, i.e. not under the care of a clinician or not on medications such as antidepressants or mood stabilizers, or having active and untreated substance abuse, i.e. not on medication or enrolled in a substance abuse program);
5. Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids);
6. Severe cognitive impairment (score ≤3 points on 6-item Callahan Screener): a) Correctly identify current year (1 point); b) Correctly identify current month (1 point); c) Correctly identify current day (1 point); d) Correctly recall "apple" after 5 minutes (1 point); e) Correctly recall "table" after 5 minutes (1 point); f) Correctly recall "penny" after 5 minutes (1 point).

Care partners

Inclusion criteria (must meet ALL of the following):

1. ≥18 years;
2. Self-reporting as "an unpaid spouse or care partner, relative, or friend who knows [the patient] well and is involved in their medical care";
3. Able to speak English.

Exclusion criteria (can be excluded for ANY of the following):

1. No access to a dedicated telephone service;
2. Active schizophrenia, major depressive disorder, bipolar disorder, suicidal ideation, or substance abuse by self-report (Active schizophrenia, major depressive disorder, bipolar disorder, suicidal ideation, or substance abuse by self-report or chart review (Active means currently being treated for schizophrenia, bipolar disorder, or suicidal ideations or having active and untreated major depressive disorder, i.e. not under the care of a clinician or not on medications such as antidepressants or mood stabilizers, or having active and untreated substance abuse, i.e. not on medication or enrolled in a substance abuse program);
3. Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids);
4. Severe cognitive impairment (score ≤3 points on a 6-item Callahan screener): a) Correctly identify current year (1 point); b) Correctly identify current month (1 point); c) Correctly identify current day (1 point); d) Correctly recall "apple" after 5 minutes (1 point); e) Correctly recall "table" after 5 minutes (1 point); f) Correctly recall "penny" after 5 minutes (1 point)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Usual Care; 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.
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.	Behavioral: EPIC (Empower People to Independence in COPD); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility	In participants randomized to the intervention arm, we will measure the mean (SD) number of core EPIC patient and caregiver telephonic nurse coaching sessions out of a possible 10 and 8 sessions completed, respectively.	6 months
Survey Feasibility	Survey completion rates will be measured and presented as the count of patient and caregiver participants who completed 100% of all available survey sets across the study.	6 months
Intervention Acceptability Score	Mean (SD) score on a scale of 1 being very poor and 10 being excellent for the EPIC intervention as rated by patient and caregiver participants randomized to the intervention group.	6 months
Count of Acceptability Qualitative Interviews	Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UAB Life Space Assessment	The UAB Life Space Assessment is a 15-item measure of Life-Space mobility, or the frequency, distance, and independence of movement in the 4 weeks prior to administration. Scores range from 0 (lowest) to 120 (best), and lower scores are associated with more restricted Life-Space mobility. A threshold score of >=60 is used to identify restricted Life-Space mobility, which is a marker of social isolation, frailty, and predictor of healthcare utilization in older adults. MCID=5 points with an alpha=0.80.	6 months
Chronic Respiratory Questionnaire (CRQ)	The Chronic Respiratory Questionnaire (CRQ) is a 20-item measure of quality of life along 4 domains: CRQ dyspnea, CRQ fatigue, CRQ mastery, and CRQ emotional function. Each domain score ranges from 1 (most severe impairment) to 7 (no impairment). Higher scores are better on each domain, with MCID of 0.5 points and an alpha=0.70. The CRQ Dyspnea Domain has a range of 1 to 7, with higher scores associated with a better outcome. The CRQ Fatigue Domain has a range of 1 to 7, with higher scores associated with better outcome. The CRQ Mastery Domain has a range of 1 to 7, with higher scores associated with better outcome. The CRQ Emotional Function Domain has a range of 1 to 7, with higher scores associated with better outcome.	6 months
PROMIS Global Health 10	The PROMIS Global Health 10 is a 10-item measure of quality of life along 2 domains: physical and mental health. There are 9 questions rated on a 5-point Likert-scale, and the 10th question rates pain on a scale of 0 to 10. Raw scores are then converted to standardized t-scores ranging from 0 to 100, with lower scores associated with worse quality of life. PROMIS Global Health Physical Health Domain has a range of 0 to 100, with lower scores associated with worse quality of life. The PROMIS Global Health Mental Health Domain has a range of 0 to 100, with lower scores associated with worse quality of life.	6 months
Montgomery Borgatta Caregiver Burden	14-item measure of caregiver burden along 3 domains: objective burden (alpha=0.87-0.90; Range 6 to 30), subjective stress burden (alpha=0.81-0.88; Range 4 to 20), and subjective demand burden (alpha =0.68-0.82; Range 4 to 20). Higher scores are associated with worse outcome on each domain.	6 months
Hospital Anxiety and Depression Scale (HADS)	14-item measure of emotional symptoms with a 7-item anxiety subscale and a 7-item depression subscale. Each question has a 4-point Likert scale, and scores from 0-21 per subscale, with higher scores associated with more severe anxiety and depressive symptoms. A subscale score >=8 on each subscale is the accepted threshold for clinically-elevated anxiety or depressive symptoms. The minimal clinically important difference is 1.5 points on each subscale with an alpha=0.82-0.83.	6 months
Modified Telephone Interview for Cognitive Status (mTICS)	14-item measure of cognitive impairment, which has been validated in COPD. Scores range from 0-50 with higher scores associated with more cognitive impairment. Validated over telephone (alpha=0.80).	6 months
Katz Index of Activities of Daily Living	6-item measure of independence in activities. Range 0-6. Higher scores associated with more independence; MCID=0.47.	6 months
Lawton Instrumental Activities of Daily Living	8-item measure of function in independent living, with an MCID=0.47. Scores range from 1 to 8, with higher scores associated with higher functioning. alpha=0.85	6 months
Advance Directive Completion	Rates of patient participant Advance Directive completion.	6 months
De Jon Gierveld Loneliness Scale	A 6-item measure of loneliness with higher scores associated with more loneliness, range 0 (least lonely) to 6 (most lonely). Alpha=0.88.	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Aging (NIA)

Publications and helpful links

General Publications

• Byun JY, Wells R, Bechthold AC, Coffee-Dunning J, Armstrong M, Taylor R, O'Hare L, Dransfield MT, Brown CJ, Vance DE, Odom JN, Bakitas M, Iyer AS. Project EPIC (Empowering People to Independence in COPD): Study protocol for a hybrid effectiveness-implementation pilot randomized controlled trial of telephonic, geriatrics-palliative care nurse-coaching in older adults with COPD and their family caregivers. Contemp Clin Trials. 2024 May;140:107487. doi: 10.1016/j.cct.2024.107487. Epub 2024 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: palliative care; COPD; geriatrics; supportive care; caregiver; telehealth; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IRB-300007901; K76AG064327 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No