Advancing Symptom Alleviation With Palliative Treatment (ADAPT)

• ClinicalTrials.gov Identifier: NCT02713347
• Recruitment Status: Active, not recruiting
• First Posted: March 18, 2016
• Last Update Posted: November 27, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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

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 Design

• 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: December 31, 2020
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: ADAPT Intervention; The intervention includes 3 components: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain.; social worker provides structured counseling targeting adjustment to illness and depression and advance care planning.; 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: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain.; social worker provides structured counseling targeting adjustment to illness and depression and advance care planning.; 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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Colorado

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States, 80045

United States, Washington

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

Seattle, Washington, United States, 98108

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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

More Information

Publications of Results:

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. Review.

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.

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, Barón 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.

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.

Bekelman DB, Fink RM, Sannes T, Kline DM, Borrayo EA, Turvey C, Fischer SM. Puente para cuidar (bridge to caring): A palliative care patient navigator and counseling intervention to improve distress in Latino/as with advanced cancer. Psychooncology. 2020 Apr;29(4):688-695. doi: 10.1002/pon.5313. Epub 2019 Dec 27.

Dickman Portz J, Ford K, Bekelman DB, Boxer RS, Kutner JS, Czaja S, Elsbernd K, Bull S. "We're Taking Something So Human and Trying to Digitize": Provider Recommendations for mHealth in Palliative Care. J Palliat Med. 2020 Feb;23(2):240-247. doi: 10.1089/jpm.2019.0216. Epub 2019 Sep 17.

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.

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.

Portz JD, Lum HD, Bull S, Boxer RS, Bekelman DB, Ford KL, Gleason K, Casillas A, Bayliss EA. Perceptions of Patient Portal Use for Advance Directive Documentation among Older Adults with Multiple Chronic Conditions. J Soc Work End Life Palliat Care. 2020 Jul-Sep;16(3):238-249. doi: 10.1080/15524256.2020.1771806. Epub 2020 Jun 1.

Other Publications:

Portz JD, Ford KL, Doyon K, Bekelman DB, Boxer RS, Kutner JS, Czaja S, Bull S. Using Grounded Theory to Inform the Human-Centered Design of Digital Health in Geriatric Palliative Care. J Pain Symptom Manage. 2020 Dec;60(6):1181-1192.e1. doi: 10.1016/j.jpainsymman.2020.06.027. Epub 2020 Jun 29.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02713347
• Other Study ID Numbers: IIR 14-346
• First Posted: March 18, 2016
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We will consider a plan to share individual patient data in consultation with VA privacy, information security, and research and development offices.

• 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:

Lung Diseases; Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Emphysema; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases, Obstructive