Advancing Symptom Alleviation With Palliative Treatment

NCT02713347 | Completed Results DMC

• 1 other identifier: IIR 14-346
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Emphysema; Pulmonary Fibrosis, Interstitial Lung Disease

Keywords

Quality of Life; Symptom Assessment; Palliative Care; Disease Management; Delivery of Health Care; Advance Care Planning

Outcome Measures

Primary Outcomes (1)

• Function Assessment of Chronic Illness Therapy-General (FACT-G)

  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 Outcomes (15)

• General Symptom Distress Scale (GSDS)

  6 months

• Patient Health Questionnaire-8 (PHQ-8)

  6 months

• Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)

  6 months

• Clinical COPD Questionnaire (CCQ)

  6 months

• Quality of Life at the End of Life (QUAL-EC)

  6 months

Study Arms (2)

ADAPT Intervention

EXPERIMENTAL

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

Enhanced usual care

NO INTERVENTION

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.

Interventions

ADAPT Intervention BEHAVIORAL

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.

ADAPT Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

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

Seattle, Washington, 98108, United States

Location

Related Publications (23)

• 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.

  PMID: 28422561 BACKGROUND

• 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.

  PMID: 28982506 BACKGROUND

• 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.

  PMID: 29461908 BACKGROUND

• 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.

  PMID: 29482218 BACKGROUND

• 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.

  PMID: 29975619 BACKGROUND

• 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.

  PMID: 30702055 BACKGROUND

• 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.

  PMID: 31196156 BACKGROUND

• 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.

  PMID: 31050771 BACKGROUND

• 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.

  PMID: 31518274 BACKGROUND

• 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.

  PMID: 30958272 BACKGROUND

• 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.

  PMID: 30632603 BACKGROUND

• 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.

  PMID: 32383388 BACKGROUND

• 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.

  PMID: 32781166 BACKGROUND

• 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.

  PMID: 31916910 BACKGROUND

• 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.

  PMID: 32955969 BACKGROUND

• 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.

  PMID: 32740225 BACKGROUND

• Deng LR, Masters KS, Schmiege SJ, Hess E, Bekelman DB. Two Factor Structures Possible for the FACIT-Sp in Patients With Heart Failure. J Pain Symptom Manage. 2021 Nov;62(5):1034-1040. doi: 10.1016/j.jpainsymman.2021.05.009. Epub 2021 May 19.

  PMID: 34019976 BACKGROUND

• Deng LR, Masters KS, Schmiege SJ, Hess E, Bekelman DB. Factor Structure of Functional Assessment of Chronic Illness Therapy: Spiritual Well-Being Scale in Patients with Heart Failure Depends on Method Used. J Palliat Med. 2021 Jun;24(6):807-808. doi: 10.1089/jpm.2021.0064. No abstract available.

  PMID: 34061665 BACKGROUND

• Ma JE, Haverfield M, Lorenz KA, Bekelman DB, Brown-Johnson C, Lo N, Foglia MB, Lowery JS, Walling AM, Giannitrapani KF. Exploring expanded interdisciplinary roles in goals of care conversations in a national goals of care initiative: A qualitative approach. Palliat Med. 2021 Sep;35(8):1542-1552. doi: 10.1177/02692163211020473. Epub 2021 Jun 3.

  PMID: 34080488 BACKGROUND

• Portz JD, Graney BA, Bekelman DB. "Made Me Realize That Life Is Worth Living": A Qualitative Study of Patient Perceptions of a Primary Palliative Care Intervention. J Palliat Med. 2022 Jan;25(1):28-38. doi: 10.1089/jpm.2021.0015. Epub 2021 Jul 14.

  PMID: 34264752 BACKGROUND

• Bekelman DB, Feser W, Morgan B, Welsh CH, Parsons EC, Paden G, Baron A, Hattler B, McBryde C, Cheng A, Lange AV, Au DH. Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial. JAMA. 2024 Jan 16;331(3):212-223. doi: 10.1001/jama.2023.24035.

  PMID: 38227034 RESULT

• Ladebue A, Barnard JG, Haverhals LM, Morgan B, Blanchard K, Sloan M, Bekelman DB. Advancing Symptom Alleviation With Palliative Treatment (ADAPT): A Qualitative Study to Understand How a Nurse and Social Worker Palliative Telecare Team Improved Quality of Life in Chronic Illness. J Appl Gerontol. 2025 May 22:7334648251343506. doi: 10.1177/07334648251343506. Online ahead of print.

  PMID: 40400366 DERIVED

• Lange AV, Feser WJ, Hess E, Baron AE, Ma JE, Bekelman DB. Serious Illness Communication in a Randomized Trial of a Nurse and Social Worker Palliative Telecare Team. J Am Geriatr Soc. 2025 Mar 22. doi: 10.1111/jgs.19445. Online ahead of print.

  PMID: 40119839 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Emphysema; Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Results Point of Contact

• Title: Dr. David Bekelman
• Organization: VA

david.bekelman@va.gov

7207236388

Study Officials

• David Bekelman, MD MPH

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)