Advancing Symptom Alleviation With Palliative Treatment

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02713347
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Bekelman, MD MPH
Principal Investigator Affiliation Rocky Mountain Regional VA Medical Center, Aurora, CO
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Fibrosis, Interstitial Lung Disease
Additional Details

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.#46; 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Seattle, Washington

Status

Recruiting

Address

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108

Site Contact

David H Au, MD MS

david.au@va.gov

206-277-6132

Aurora, Colorado

Status

Recruiting

Address

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045

Site Contact

Sandra G Marcus, BS MHS

Sandra.Marcus@va.gov

720-857-5110

Terms of Service

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