Clinical trial NCT05040386: Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Keywords: palliative care
supportive care
caregiver
geriatrics
telehealth
chronic obstructive pulmonary disease
COPD
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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)

Primary outcomes:
measure: Intervention Feasibility
timeFrame: Baseline to 6 months
measure: Trial and Survey Feasibility
timeFrame: Baseline to 6 months
measure: Acceptability (Quantitative)
timeFrame: 6 months
measure: Acceptability (Qualitative)
timeFrame: 6 months
Secondary outcomes:
measure: UAB Life Space Assessment (LSA)
timeFrame: Baseline, 3 months, 6 months
measure: Chronic Respiratory Questionnaire (CRQ)
timeFrame: Baseline, 3 months, 6 months
measure: PROMIS Global Health 10
timeFrame: Baseline, 3 months, 6 months
measure: Montgomery Borgatta Caregiver Burden
timeFrame: Baseline, 3 months, 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 3 months, 6 months
measure: Modified Telephone Interview for Cognitive Status (mTICS)
timeFrame: Baseline, 3 months, 6 months
measure: Katz Index of Activities of Daily Living
timeFrame: Baseline, 3 months, 6 months
measure: Lawton Instrumental Activities of Daily Living
timeFrame: Baseline, 3 months, 6 months
measure: Healthcare and palliative care utilization
timeFrame: 6 months
measure: De Jon Gierveld Loneliness Scale
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: