Trial Outcomes & Findings for Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT (NCT NCT05040386)
NCT ID: NCT05040386
Last Updated: 2025-11-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Intervention (EPIC + Usual Care): Patient Participants
Patient participants randomized to the intervention arm receive the patient-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
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.
|
Intervention (EPIC + Usual Care): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
10
|
10
|
|
Overall Study
COMPLETED
|
14
|
15
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Intervention (EPIC + Usual Care): Patient Participants
Patient participants randomized to the intervention arm receive the patient-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
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.
|
Intervention (EPIC + Usual Care): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT
Baseline characteristics by cohort
| Measure |
Intervention (EPIC + Usual Care): Patient Participants
n=15 Participants
Patient participants randomized to the intervention arm receive the patient-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC + Usual Care): Caregiver Participants
n=10 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 8.1 • n=20 Participants
|
64.3 years
STANDARD_DEVIATION 15.8 • n=40 Participants
|
62.6 years
STANDARD_DEVIATION 6.1 • n=28 Participants
|
67.9 years
STANDARD_DEVIATION 11.9 • n=46 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
9 Participants
n=28 Participants
|
32 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
18 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
14 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
9 Participants
n=28 Participants
|
36 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=20 Participants
|
10 participants
n=40 Participants
|
10 participants
n=28 Participants
|
50 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This sample represents the total patient and caregiver participants who started the EPIC intervention and completed at least the introductory session.
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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=24 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
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.
|
Intervention (EPIC): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Intervention Feasibility
Mean (SD) Patient Core EPIC Sessions
|
—
|
9.2 Sessions
Standard Deviation 2.4
|
—
|
—
|
|
Intervention Feasibility
Mean (SD) Caregiver Core EPIC Sessions
|
—
|
6.4 Sessions
Standard Deviation 2.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patient and caregiver participants by study arms are analyzed.
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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=15 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=10 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Survey Feasibility
|
8 Participants
|
12 Participants
|
12 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This represents patient and caregiver participants separately who completed this survey.
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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=13 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=8 Participants
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.
|
Intervention (EPIC): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Intervention Acceptability Score
|
—
|
9.8 Score on a Scale
Standard Deviation 0.4
|
9.9 Score on a Scale
Standard Deviation 0.4
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.
Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=15 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=10 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Count of Acceptability Qualitative Interviews
|
7 Participants
|
12 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=14 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=8 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
UAB Life Space Assessment
|
90.3 Units on a Scale
Standard Deviation 17.6
|
46.6 Units on a Scale
Standard Deviation 20.3
|
52.1 Units on a Scale
Standard Deviation 29.1
|
100.5 Units on a Scale
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only patient participants completed this instrument.
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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Chronic Respiratory Questionnaire (CRQ)
CRQ Dyspnea Domain
|
—
|
4.0 Units on a Scale
Standard Deviation 1.7
|
3.9 Units on a Scale
Standard Deviation 1.7
|
—
|
|
Chronic Respiratory Questionnaire (CRQ)
CRQ Fatigue Domain
|
—
|
3.4 Units on a Scale
Standard Deviation 1.7
|
3.5 Units on a Scale
Standard Deviation 1.5
|
—
|
|
Chronic Respiratory Questionnaire (CRQ)
CRQ Mastery Domain
|
—
|
5.0 Units on a Scale
Standard Deviation 1.4
|
4.5 Units on a Scale
Standard Deviation 1.5
|
—
|
|
Chronic Respiratory Questionnaire (CRQ)
CRQ Emotional Function Domain
|
—
|
4.7 Units on a Scale
Standard Deviation 1.7
|
4.9 Units on a Scale
Standard Deviation 1.6
|
—
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=8 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
PROMIS Global Health 10
PROMIS Global Health - Physical Health Domain
|
51.1 Units on a Scale
Standard Deviation 5.5
|
36.5 Units on a Scale
Standard Deviation 6.1
|
35.5 Units on a Scale
Standard Deviation 8.3
|
52.2 Units on a Scale
Standard Deviation 8.9
|
|
PROMIS Global Health 10
PROMIS Global Health - Mental Health Domain
|
56.0 Units on a Scale
Standard Deviation 8.7
|
45.8 Units on a Scale
Standard Deviation 8.3
|
40.5 Units on a Scale
Standard Deviation 9.7
|
56.6 Units on a Scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only caregiver participants were included in the analysis of this outcome.
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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=8 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=10 Participants
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.
|
Intervention (EPIC): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Montgomery Borgatta Caregiver Burden
Subjective Stress Burden Domain
|
—
|
12.4 Units on a scale
Standard Deviation 0.9
|
12.9 Units on a scale
Standard Deviation 1.9
|
—
|
|
Montgomery Borgatta Caregiver Burden
Subjective Demand Burden Domain
|
—
|
11.5 Units on a scale
Standard Deviation 1.7
|
12.1 Units on a scale
Standard Deviation 1.8
|
—
|
|
Montgomery Borgatta Caregiver Burden
Objective Burden Domain
|
—
|
19.3 Units on a scale
Standard Deviation 2.4
|
20.9 Units on a scale
Standard Deviation 3.4
|
—
|
SECONDARY outcome
Timeframe: 6 months14-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.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=8 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
HADS Depression Subscale
|
2.6 Units on a scale
Standard Deviation 1.7
|
6.4 Units on a scale
Standard Deviation 3.3
|
8.3 Units on a scale
Standard Deviation 5.3
|
2.5 Units on a scale
Standard Deviation 1.9
|
|
Hospital Anxiety and Depression Scale (HADS)
HADS Anxiety Subscale
|
3.4 Units on a scale
Standard Deviation 2.2
|
5.1 Units on a scale
Standard Deviation 3.2
|
6.6 Units on a scale
Standard Deviation 4.3
|
2.5 Units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 6 months14-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).
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=13 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Modified Telephone Interview for Cognitive Status (mTICS)
|
—
|
28.6 Units on a scale
Standard Deviation 4.4
|
31.7 Units on a scale
Standard Deviation 6.6
|
—
|
SECONDARY outcome
Timeframe: 6 months6-item measure of independence in activities. Range 0-6. Higher scores associated with more independence; MCID=0.47.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=8 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Katz Index of Activities of Daily Living
|
6.0 Units on a scale
Standard Deviation 0.0
|
5.7 Units on a scale
Standard Deviation 0.7
|
5.3 Units on a scale
Standard Deviation 1.6
|
6.0 Units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 6 months8-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
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=8 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Lawton Instrumental Activities of Daily Living
|
7.7 Units on a scale
Standard Deviation 1.9
|
5.0 Units on a scale
Standard Deviation 2.0
|
5.7 Units on a scale
Standard Deviation 1.8
|
7.0 Units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 monthsRates of patient participant Advance Directive completion.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
Advance Directive Completion
|
—
|
7 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsA 6-item measure of loneliness with higher scores associated with more loneliness, range 0 (least lonely) to 6 (most lonely). Alpha=0.88.
Outcome measures
| Measure |
Control (Usual Care): Caregiver Participants
n=10 Participants
Participants randomized to this arm will receive usual care.
|
Intervention (EPIC + Usual Care)
n=14 Participants
Participants randomized to the intervention arm receive the EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention for patients with COPD and their caregivers informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care, alongside usual COPD care. ENABLE is 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. The patient-focused EPIC intervention includes six once weekly 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 with four caregiver-tailored nurse-coach sessions, instead of six sessions.
|
Control (Usual Care): Patient Participants
n=15 Participants
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.
|
Intervention (EPIC): Caregiver Participants
n=8 Participants
Caregiver participants randomized to the intervention arm alongside the patient participant receive the caregiver-focused EPIC (Empower People to Independence in COPD) intervention, a telephonic nurse coach-led palliative care intervention informed by the ENABLE (Educate, Nurture, Advise, Before Life Ends) model for early palliative care. ENABLE is 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 and their caregivers. The caregiver-focused EPIC intervention includes four once weekly telephone-based, nurse coach-led sessions tailored to caregivers of patients with COPD 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 and complete an Advance Directive.
|
|---|---|---|---|---|
|
De Jon Gierveld Loneliness Scale
|
0.8 Units on a scale
Standard Deviation 1.3
|
1.8 Units on a scale
Standard Deviation 1.4
|
2.6 Units on a scale
Standard Deviation 2.1
|
1.1 Units on a scale
Standard Deviation 1.6
|
Adverse Events
Intervention (EPIC + Usual Care): Patient Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care: Patient Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention (EPIC + Usual Care): Caregiver Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care: Caregiver Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place