Advancing Symptom Alleviation With Palliative Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD) and interstitial lung disease (i.e., pulmonary fibrosis) have commonalities that make them ideal for early palliative care provided alongside disease-specific treatments. Quality of life is reduced in these illnesses because, despite disease-specific treatments, the same symptoms (e.g., shortness of breath, fatigue) often persist in these illnesses. Quality of life is also reduced because between 50-60% of people with either illness have clinically significant depressive symptoms. Finally, while CHF, COPD, and interstitial lung disease are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning. Providing palliative care concomitantly with other medical care offers an important opportunity to improve quality of life and advance care planning for people with CHF, COPD, or interstitial lung disease. For other conditions such as lung cancer, when provided early, prior to the end of life, palliative care improves quality of life, depressive symptoms, and survival while reducing health care utilization. While palliative care has been well-studied in patients with advanced cancer, it has not been adequately studied in CHF, COPD, or interstitial lung disease. The goal of this project is to determine whether the benefits of early palliative care extend to CHF, COPD or interstitial lung disease. The investigators developed and demonstrated early success with a patient-centered palliative care intervention to improve quality of life (i.e., symptoms, function) and advance care planning in CHF and COPD. The intervention consists of the following components: (1) algorithm-guided management of breathlessness, fatigue, and pain, provided by a nurse; the algorithms supplement disease-focused treatments with palliative and behavioral treatments; (2) a 6-session psychosocial care program targeting adjustment to illness and depression, provided by a social worker; and (3) engagement of patients and providers in advance care planning. The nurse and social worker are teamed with a palliative care specialist and representative primary care provider in brief weekly meetings. The team is integrated into primary care through nurse interaction with primary care providers and through electronic medical record communication. The investigators will conduct a hybrid effectiveness and implementation study. Population-based sampling methods will be used to enroll 300 Veterans with CHF, COPD, or interstitial lung disease who have poor quality of life and are at high risk for hospitalization or death. The primary aim is to test the effectiveness of the intervention in a randomized controlled trial (intervention vs. enhanced usual care) in two VA health care systems. In a secondary aim, the investigators will examine the implementation of the intervention to guide future implementation and dissemination, increase the relevance to operational partners, and maximize the effectiveness of subsequent palliative care and team-based interventions. Aim 1: Determine the effect of the intervention on (a) quality of life as a primary outcome, and (b) depression, symptom burden, advance care planning communication and documentation, disease-specific health status, emergency department visits, hospitalizations, and mortality as secondary outcomes. Aim 2: Examine the implementation of the intervention. Aim 2a: Assess the degree, barriers, and facilitators of implementation of various components. Identify which intervention components and processes are most critical from the perspectives of patients, intervention team members, and primary care providers whose patients received the intervention. Aim 2b. Evaluate the resources (e.g., personnel time and other costs) associated with the intervention, and estimate the resources needed for implementation and maintenance in other VA settings. The proposed study is significant because it addresses patient-centered needs in illnesses that are major sources of disability. The study is innovative because it tests the effectiveness of palliative care in CHF, COPD, and interstitial lung disease, leading causes of death among Veterans. In addition, the intervention is integrated into primary care, and the intervention components are structured to ease replication, implementation, and dissemination.

Official Title
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Palliative Care to Improve Quality of Life in CHF and COPD

Conditions
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Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Fibrosis, Interstitial Lung Disease

Intervention / Treatment
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* Behavioral: ADAPT Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADAPT Intervention<br>The intervention includes 3 components: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning. collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone. | Behavioral: ADAPT Intervention<br>* The intervention includes 3 components: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning. collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone.<br>|
| No Intervention: Enhanced usual care<br>Patients in the control group will continue to receive care at the discretion of their providers, which may include referrals to and ongoing care from cardiology, pulmonary, palliative care, or mental health. They will also have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency. Patients' providers will be given the results of baseline depression surveys if they screen positive for depression, and patients will be given an information sheet that outlines self-care for CHF or COPD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function Assessment of Chronic Illness Therapy-General (FACT-G) | The FACT-G is a widely used, valid, reliable, and responsive self-report measure of health-related quality of life that includes domains of physical, social/family, emotional, and functional well-being. The primary outcome will be the difference in FACT-G score at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Symptom Distress Scale (GSDS) | The GSDS is a single item measure of overall symptom distress that is reliable and valid and asks, In general, how distressing are all of your symptoms to you? | 6 months | 
| Patient Health Questionnaire-8 (PHQ-8) | The PHQ-8 is a 8-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-8 was developed in medically-ill outpatients. | 6 months | 
| Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF) | The KCCQ-SF is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ-SF is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The KCCQ-SF will be administered to participants with heart failure. | 6 months | 
| Clinical COPD Questionnaire (CCQ) | The CCQ is a self-administered 10-item measure of COPD symptoms, functioning, and emotional well-being. It is well-validated, reliable, and responsive and will be administered to participants with COPD. | 6 months | 
| Quality of Life at the End of Life (QUAL-E) | The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. | 6 months | 
| Advance care planning communication and documentation | Advance care planning communication will be measured via patient self-report through the question, At your last appointment with Dr. [Primary Care Provider] (PCP), did you discuss your treatment preferences should you become very ill? (response items: yes, no, I don't know). Care preferences and care concurrence with preferences will be measured through two questions asking to choose a preference and then choosing the goals of current care. Advance care planning documentation (scanned advance directive (either a living will or durable power of attorney for health care); or medical orders for life-sustaining treatment) in the electronic medical record will be assessed via electronic medical record review. | 6 months | 
| Interim events | The following events will be assessed during the study period through medical record review to supplement patient report: hospitalization and mortality. Vital status will also be ascertained via the VA Vital Status File and the National Death Index. | 6 months | 
| Generalized Anxiety Disorder Scale (GAD-7) | The GAD-7 is a valid and reliable self-report measure of anxiety tested in medically ill outpatient populations. | 6 months | 
| Advance Care Planning Engagement | This survey was designed to measure behaviors related to surrogate decision makers, values and quality of life, and informed decision making. | 6 months | 
| PEG (Pain) | The PEG measures pain intensity and interference (Krebs, 2009). | 6 months | 
| Insomnia Severity Index (ISI) | The ISI measures insomnia severity (Bastien, 2000). | 6 months | 
| PROMIS Fatigue | The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity. | 6 months | 
| K-BILD | Quality of life measure for interstitial lung disease. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Symptom Assessment, Palliative Care, Disease Management, Delivery of Health Care, Advance Care Planning