Advancing Symptom Alleviation With Palliative Treatment (ADAPT)

June 28, 2024 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADAPT Intervention

The intervention includes 3 components:

  1. nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain.
  2. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning.
  3. 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

The intervention includes 3 components:

  1. nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain.
  2. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning.
  3. 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.
No Intervention: Enhanced usual care
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function Assessment of Chronic Illness Therapy-General (FACT-G)
Time Frame: 6 months
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. The total score range is 0-108 with a higher score meaning greater quality of life.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Symptom Distress Scale (GSDS)
Time Frame: 6 months
The General Symptom Distress Scale (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?" Minimum value 0 Maximum value 10 Higher scores mean more distress
6 months
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: 6 months
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. Score range 0-24 points with a higher score indicating more depressive symptoms.
6 months
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)
Time Frame: 6 months
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. Score range 0-100 and higher scores indicate better health status.
6 months
Clinical COPD Questionnaire (CCQ)
Time Frame: 6 months
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. Score range 0-6 with higher scores indicate worse health status.
6 months
Quality of Life at the End of Life (QUAL-EC)
Time Frame: 6 months
The QUAL-EC is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. Each item is rated from 1 to 5, and mean scores for multiple items in a domain, i.e., subscale were estimated. Minimum score for each subscale is 1, maximum is 5. A higher score is a better perception of quality of life for each subscale.
6 months
Advance Care Planning Communication and Documentation
Time Frame: 6 months
Advance care planning discussions and advance directive documentation in the electronic medical record will be assessed via electronic medical record review. An advance directive includes either a living will and/or durable power of attorney for health care.
6 months
Mortality
Time Frame: 12 months
The following events will be assessed during the study period through medical record review to supplement patient report: mortality.
12 months
Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: 6 months
The GAD-7 is a valid and reliable self-report measure of anxiety tested in medically ill outpatient populations. Score range 0-21 and higher scores indicate more anxiety symptoms.
6 months
Advance Care Planning Engagement
Time Frame: 6 months

This survey was designed to measure behaviors related to surrogate decision makers, values and quality of life, and informed decision making. Specifically, the Advance Care Planning-4 (ACP-4) measure (Sudore et al) was used.

Minimum value is 1, maximum value is 5. Higher scores indicate higher levels of readiness to engage in advance care planning.
6 months
PEG (Pain)
Time Frame: 6 months
The PEG measures pain intensity and interference (Krebs, 2009). Scale range 0-10 and higher score indicates more pain.
6 months
Insomnia Severity Index (ISI)
Time Frame: 6 months
The ISI measures insomnia severity (Bastien, 2000). There are 6 items and a mean was used. Minimum score is 0, maximum score is 4. A higher score indicates more severe insomnia.
6 months
PROMIS Fatigue
Time Frame: 6 months
The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity. Scale range 0-4 and a higher score indicates more fatigue.
6 months
K-BILD
Time Frame: 6 months
Quality of life measure for interstitial lung disease. Score range 15-105 (lower score indicates lower health status).
6 months
Goal Concordance
Time Frame: 6 months
Two questions with Likert scale responses of 1 to 10: (1) Kind of medical care is most important to you; answers range from 0 = I prefer medical care that focuses on extending life, even if it means having more pain and discomfort, to 10 = I prefer medical care that focuses on relieving pain and discomfort, even if it means not living as long. (2) Medical care right now; answers range from 0 = My current medical care is focused on extending life, even if it means having more pain and discomfort to 10 = My current medical care is focused on relieving pain and discomfort, even if it means not living as long. Goal concordant = answers of 0-3 for both questions, 4-6 for both questions, or 7-10 for both questions. Patients who answered "I am not sure of the goals of my medical care" were considered "unsure of care focus."
6 months
Hospitalization
Time Frame: 6 months
The following events will be assessed during the study period through medical record review to supplement patient report: hospitalizations.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimated)

March 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 14-346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will consider a plan to share individual patient data in consultation with VA privacy, information security, and research and development offices.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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