N/A
N=306
Advancing Symptom Alleviation With Palliative Treatment
Heart Failure · Pulmonary Disease, Chronic Obstructive · Emphysema · Pulmonary Fibrosis, Interstitial Lung Disease
Bottom Line
View on ClinicalTrials.gov: NCT02713347 ↗Enrolled (actual)
306
Serious AEs
22.9%
Results posted
Aug 2024
Primary outcome: Primary: Function Assessment of Chronic Illness Therapy-General (FACT-G) — 59.0; 54.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ADAPT Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Function Assessment of Chronic Illness Therapy-General (FACT-G) |
59.0; 54.0 | — |
| SECONDARY General Symptom Distress Scale (GSDS) |
5.56; 6.0 | — |
| SECONDARY Patient Health Questionnaire-8 (PHQ-8) |
10.02; 11.58 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF) |
47.6; 43.05 | — |
| SECONDARY Clinical COPD Questionnaire (CCQ) |
3.08; 3.21 | — |
| SECONDARY Quality of Life at the End of Life (QUAL-EC) |
3.01; 2.88; 3.05; 2.87; 3.86; 3.55 | — |
| SECONDARY Advance Care Planning Communication and Documentation |
106; 5; 58; 62 | — |
| SECONDARY Mortality |
6; 5 | — |
| SECONDARY Generalized Anxiety Disorder Scale (GAD-7) |
5.82; 6.92 | — |
| SECONDARY Advance Care Planning Engagement |
4.21; 3.68 | — |
| SECONDARY PEG (Pain) |
4.76; 5.04 | — |
| SECONDARY Insomnia Severity Index (ISI) |
2.11; 2.26 | — |
| SECONDARY PROMIS Fatigue |
2.15; 2.22 | — |
| SECONDARY K-BILD |
54.8; 50.8 | — |
| SECONDARY Goal Concordance |
52; 55 | — |
| SECONDARY Hospitalization |
24; 17; 9; 9 | — |
Summary
Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (i.e., pulmonary fibrosis) are common serious illnesses. Despite disease-specific medical care, people with these illnesses often left with poor quality of life (i.e., burdensome symptoms, impaired function). Furthermore, while these illnesses are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning, the process of considering and communicating healthcare values and goals. The investigators are conducting a randomized clinical trial to study a symptom management, psychosocial care and advance care planning intervention to improve quality of life. The study is important because it aims to improve quality of life and provision of care according to peoples' goals and preferences in common, burdensome illnesses. Furthermore, this study will generate information that supports the broader dissemination and implementation of the intervention and informs the development of future palliative care and team-based interventions in the VA.
Eligibility Criteria
Inclusion Criteria
- Veterans enrolled in VA Eastern Colorado Health Care System or VA Puget - Sound Health Care System
- Diagnosis of CHF, pulmonary fibrosis, or COPD in 2 years prior to enrollment
- High risk for hospitalization and death
- Poor quality of life
- Symptomatic
- Primary care or other provider who is willing to facilitate intervention medical recommendations
- Able to read and understand English
- Consistent access to and able to use a standard telephone
Exclusion Criteria
- Previous diagnosis of dementia
- Active substance abuse
- Comorbid metastatic cancer
- Nursing home resident
- Heart or lung transplant or left ventricular assist device (LVAD)
- Currently receiving hospice, palliative or home-based primary care
- Currently pregnant
- Currently a prisoner
Data sourced from ClinicalTrials.gov (NCT02713347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.