Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advancing Symptom Alleviation With Palliative Treatment (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713347
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Pulmonary Disease, Chronic Obstructive Emphysema Pulmonary Fibrosis, Interstitial Lung Disease Behavioral: ADAPT Intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Statistician
Primary Purpose: Health Services Research
Official Title: Palliative Care to Improve Quality of Life in CHF and COPD
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. General Symptom Distress Scale (GSDS) [ Time Frame: 6 months ]
    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?"

  2. 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.

  3. 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.

  4. 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.

  5. Quality of Life at the End of Life (QUAL-E) [ Time Frame: 6 months ]
    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. Advance care planning communication and documentation [ Time Frame: 6 months ]
    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.

  7. Interim events [ Time Frame: 6 months ]
    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.

  8. 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.

  9. 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.

  10. PEG (Pain) [ Time Frame: 6 months ]
    The PEG measures pain intensity and interference (Krebs, 2009).

  11. Insomnia Severity Index (ISI) [ Time Frame: 6 months ]
    The ISI measures insomnia severity (Bastien, 2000).

  12. PROMIS Fatigue [ Time Frame: 6 months ]
    The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity.

  13. K-BILD [ Time Frame: 6 months ]
    Quality of life measure for interstitial lung disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713347


Contacts
Layout table for location contacts
Contact: Marilyn Sloan, BS (507) 250-2429 marilyn.sloan@va.gov
Contact: David Bekelman, MD MPH (720) 857-5088 david.bekelman@va.gov

Locations
Layout table for location information
United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Recruiting
Aurora, Colorado, United States, 80045
Contact: Sandra G Marcus, BS MHS    720-857-5110    Sandra.Marcus@va.gov   
Contact: Kelty B Fehling, BS MPH    (720) 857-5126    Kelty.Fehling@va.gov   
Principal Investigator: David Bekelman, MD MPH         
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: David H Au, MD MS    206-277-6132    david.au@va.gov   
Sub-Investigator: David H. Au, MD MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: David Bekelman, MD MPH Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications of Results:

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02713347     History of Changes
Other Study ID Numbers: IIR 14-346
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
Quality of Life
Symptom Assessment
Palliative Care
Disease Management
Delivery of Health Care
Advance Care Planning
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Pulmonary Fibrosis
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Emphysema
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive