Nurse Coach-Led Early Palliative Care for Older Adults with COPD and Their Care Partners: the Project EPIC Pilot RCT
- Conditions
- COPD
- Interventions
- Other: Usual COPD CareBehavioral: EPIC
- Registration Number
- NCT05040386
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual COPD Care Usual COPD Care Participants randomized to this arm will receive the standard of care for COPD. Intervention (EPIC plus Usual COPD Care) EPIC Participants randomized to this arm will receive the experimental treatment for COPD (i.e. EPIC plus usual COPD care).
- Primary Outcome Measures
Name Time Method Intervention Feasibility Baseline to 6 months For participants randomized to the intervention arm, we will measure completion of EPICcomponents (CYC sessions and assignments) and tabulate completion rates (# participants completing each component). We will define ≥80% completion of components as evidence of feasibility.
Acceptability (Quantitative) 6 months Post-intervention survey on intervention acceptability with Likert scale rated 1 to 10; 10 being most acceptable. Overall average score ≥8 of 10 defined as acceptable.
Acceptability (Qualitative) 6 months Post-intervention semi-structured, in-depth interviews by telephone conducted by study coordinator to explore acceptability, barriers, facilitators, and survey burden.
Trial and Survey Feasibility Baseline to 6 months Rates of screening, enrollment, retention, reasons for exclusion and refusals, and attrition. Survey completion rates will be measured, and survey feasibility will be defined as participants completing ≥80% of instruments.
- Secondary Outcome Measures
Name Time Method PROMIS Global Health 10 Baseline, 3 months, 6 months 10-item measure with physical and mental health domains; 9 questions are rated on a 5-point Likert-scale, and the 10th question rates pain on a scale of 0 to 10. Raw scores converted to standardized t-scores ranging from 0 to 100, with lower scores associated with worse quality of life.
Chronic Respiratory Questionnaire (CRQ) Baseline, 3 months, 6 months 20-item measure along domains of dyspnea, fatigue, emotional function, and mastery. Higher scores are associated with better quality of life with an MCID of 0.5 points and an alpha=0.70.
Katz Index of Activities of Daily Living Baseline, 3 months, 6 months 6-item measure of independence in activities. Range 0-6. Higher scores associated with more independence; MCID=0.47.
Healthcare and palliative care utilization 6 months Rates of emergency room visits, hospitalizations, intensive care unit admissions, imaging, procedures, palliative care, hospice, change in code status, advance directive completion, identified surrogate decision maker, goals of care documentation
De Jon Gierveld Loneliness Scale Baseline, 3 months, 6 months 6-item measure of loneliness. Alpha=0.88.
UAB Life Space Assessment (LSA) Baseline, 3 months, 6 months 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 0-120, and lower scores are associated with more restricted Life-Space mobility. A threshold LSA 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. We have also demonstrated that restricted Life-Space mobility predicts severe exacerbations of COPD. MCID=5 points with an alpha=0.80.
Hospital Anxiety and Depression Scale (HADS) Baseline, 3 months, 6 months 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.
Montgomery Borgatta Caregiver Burden Baseline, 3 months, 6 months 14-item measure of care partner burden along domains of objective burden (alpha=0.87-0.90), subjective demand burden (alpha =0.68-0.82), and subjective stress burden (alpha=0.81-0.88). Higher scores are associated with greater burden.
Modified Telephone Interview for Cognitive Status (mTICS) Baseline, 3 months, 6 months 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).
Lawton Instrumental Activities of Daily Living Baseline, 3 months, 6 months 8-item measure of functioning in independent living. MCID=0.47; Higher scores associated with higher functioning. alpha=0.85
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States