- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02713347
Advancing Symptom Alleviation With Palliative Treatment (ADAPT)
Palliative Care to Improve Quality of Life in CHF and COPD
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
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Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
The nurse and social worker visits are in-person or by phone. |
The intervention includes 3 components:
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?"
|
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.
|
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.
|
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.
|
6 months
|
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 months
|
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.
|
6 months
|
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.
|
6 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.
|
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.
|
6 months
|
PEG (Pain)
Time Frame: 6 months
|
The PEG measures pain intensity and interference (Krebs, 2009).
|
6 months
|
Insomnia Severity Index (ISI)
Time Frame: 6 months
|
The ISI measures insomnia severity (Bastien, 2000).
|
6 months
|
PROMIS Fatigue
Time Frame: 6 months
|
The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity.
|
6 months
|
K-BILD
Time Frame: 6 months
|
Quality of life measure for interstitial lung disease.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Publications and helpful links
General Publications
- Bekelman DB, Johnson-Koenke R, Ahluwalia SC, Walling AM, Peterson J, Sudore RL. Development and Feasibility of a Structured Goals of Care Communication Guide. J Palliat Med. 2017 Sep;20(9):1004-1012. doi: 10.1089/jpm.2016.0383. Epub 2017 Apr 19.
- Kavalieratos D, Gelfman LP, Tycon LE, Riegel B, Bekelman DB, Ikejiani DZ, Goldstein N, Kimmel SE, Bakitas MA, Arnold RM. Palliative Care in Heart Failure: Rationale, Evidence, and Future Priorities. J Am Coll Cardiol. 2017 Oct 10;70(15):1919-1930. doi: 10.1016/j.jacc.2017.08.036.
- Bekelman DB, Johnson-Koenke R, Bowles DW, Fischer SM. Improving Early Palliative Care with a Scalable, Stepped Peer Navigator and Social Work Intervention: A Single-Arm Clinical Trial. J Palliat Med. 2018 Jul;21(7):1011-1016. doi: 10.1089/jpm.2017.0424. Epub 2018 Feb 20.
- Bekelman DB, Allen LA, McBryde CF, Hattler B, Fairclough DL, Havranek EP, Turvey C, Meek PM. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):511-519. doi: 10.1001/jamainternmed.2017.8667.
- Portz JD, Cognetta S, Bekelman DB. Potential Technology Development for Palliative Care. J Palliat Med. 2018 Jul;21(7):899-900. doi: 10.1089/jpm.2018.0126. No abstract available.
- Bekelman DB, Knoepke CE, Turvey C. Identifying critical psychotherapy targets in serious cardiac conditions: The importance of addressing coping with symptoms, healthcare navigation, and social support. Palliat Support Care. 2019 Oct;17(5):531-535. doi: 10.1017/S1478951518001037.
- Graney BA, Au DH, Baron AE, Cheng A, Combs SA, Glorioso TJ, Paden G, Parsons EC, Rabin BA, Ritzwoller DP, Stonecipher JJ, Turvey C, Welsh CH, Bekelman DB. Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial. Trials. 2019 Jun 13;20(1):355. doi: 10.1186/s13063-019-3417-1.
- Bekelman DB. Improving Primary and Specialist Palliative Care in Cardiovascular Disease. JAMA Netw Open. 2019 May 3;2(5):e192356. doi: 10.1001/jamanetworkopen.2019.2356. No abstract available.
- Portz JD, Fruhauf C, Bull S, Boxer RS, Bekelman DB, Casillas A, Gleason K, Bayliss EA. "Call a Teenager... That's What I Do!" - Grandchildren Help Older Adults Use New Technologies: Qualitative Study. JMIR Aging. 2019 Jun 6;2(1):e13713. doi: 10.2196/13713.
- Portz JD, Bayliss EA, Bull S, Boxer RS, Bekelman DB, Gleason K, Czaja S. Using the Technology Acceptance Model to Explore User Experience, Intent to Use, and Use Behavior of a Patient Portal Among Older Adults With Multiple Chronic Conditions: Descriptive Qualitative Study. J Med Internet Res. 2019 Apr 8;21(4):e11604. doi: 10.2196/11604.
- Buck HG, Bekelman D, Cameron J, Chung M, Hooker S, Pucciarelli G, Stromberg A, Riegel B, Vellone E. A body of work, a missed opportunity: Dyadic research in older adults. J Am Geriatr Soc. 2019 Apr;67(4):854-855. doi: 10.1111/jgs.15749. Epub 2019 Jan 11. No abstract available.
- Giannitrapani KF, Walling AM, Garcia A, Foglia M, Lowery JS, Lo N, Bekelman D, Brown-Johnson C, Haverfield M, Festa N, Shreve ST, Gale RC, Lehmann LS, Lorenz KA. Pilot of the Life-Sustaining Treatment Decisions Initiative Among Veterans With Serious Illness. Am J Hosp Palliat Care. 2021 Jan;38(1):68-76. doi: 10.1177/1049909120923595. Epub 2020 May 8.
- Brown-Johnson C, Haverfield MC, Giannitrapani KF, Lo N, Lowery JS, Foglia MB, Walling AM, Bekelman DB, Shreve ST, Lehmann LS, Lorenz KA. Implementing Goals-of-Care Conversations: Lessons From High- and Low-Performing Sites From a VA National Initiative. J Pain Symptom Manage. 2021 Feb;61(2):262-269. doi: 10.1016/j.jpainsymman.2020.07.040. Epub 2020 Aug 8.
- Hadler RA, Curtis BR, Ikejiani DZ, Bekelman DB, Harinstein M, Bakitas MA, Hess R, Arnold RM, Kavalieratos D. "I'd Have to Basically Be on My Deathbed": Heart Failure Patients' Perceptions of and Preferences for Palliative Care. J Palliat Med. 2020 Jul;23(7):915-921. doi: 10.1089/jpm.2019.0451. Epub 2020 Jan 9.
- Schenker Y, Ellington L, Bell L, Kross EK, Rosenberg AR, Kutner JS, Bickel KE, Ritchie C, Kavalieratos D, Bekelman DB, Mooney KB, Fischer SM. The National Postdoctoral Palliative Care Research Training Collaborative: History, Activities, Challenges, and Future Goals. J Palliat Med. 2021 Apr;24(4):545-553. doi: 10.1089/jpm.2020.0411. Epub 2020 Sep 21.
- Cooney TM, Proulx CM, Bekelman DB. Changes in Social Support and Relational Mutuality as Moderators in the Association Between Heart Failure Patient Functioning and Caregiver Burden. J Cardiovasc Nurs. 2021 May-Jun 01;36(3):212-220. doi: 10.1097/JCN.0000000000000726.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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