Advancing Symptom Alleviation With Palliative Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Cardiology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 2/17/2019 |
| Start Date: | September 1, 2016 |
| End Date: | December 31, 2020 |
| Contact: | Marilyn Sloan, BS |
| Email: | marilyn.sloan@va.gov |
| Phone: | (507) 250-2429 |
Palliative Care to Improve Quality of Life in CHF and COPD
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.
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.
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.
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.
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
We found this trial at
2
sites
Seattle, Washington 98108
Phone: 206-277-6132
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Aurora, Colorado 80045
Principal Investigator: David Bekelman, MD MPH
Phone: 720-857-5110
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