Heart FailureADAPTNCT02713347
Advancing Symptom Alleviation With Palliative Treatment
A study testing ADAPT Intervention in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by VA Office of Research and Development at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema
- What is being tested?
- ADAPT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Fibrosis, Interstitial Lung Disease
- Being tested
- ADAPT Intervention
- Keywords
- Quality of Life, Symptom Assessment, Palliative Care, Disease Management, Delivery of Health Care, Advance Care Planning
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPT InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (15)
General Symptom Distress Scale (GSDS)
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
Measured: 6 months
Patient Health Questionnaire-8 (PHQ-8)
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.
Measured: 6 months
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)
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.
Measured: 6 months
Clinical COPD Questionnaire (CCQ)
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.
Measured: 6 months
Quality of Life at the End of Life (QUAL-EC)
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.
Measured: 6 months
Advance Care Planning Communication and Documentation
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.
Measured: 6 months
Mortality
The following events will be assessed during the study period through medical record review to supplement patient report: mortality.
Measured: 12 months
Generalized Anxiety Disorder Scale (GAD-7)
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.
Measured: 6 months
Advance Care Planning Engagement
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.
Measured: 6 months
PEG (Pain)
The PEG measures pain intensity and interference (Krebs, 2009). Scale range 0-10 and higher score indicates more pain.
Measured: 6 months
Insomnia Severity Index (ISI)
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.
Measured: 6 months
PROMIS Fatigue
The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity. Scale range 0-4 and a higher score indicates more fatigue.
Measured: 6 months
K-BILD
Quality of life measure for interstitial lung disease. Score range 15-105 (lower score indicates lower health status).
Measured: 6 months
Goal Concordance
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."
Measured: 6 months
Hospitalization
The following events will be assessed during the study period through medical record review to supplement patient report: hospitalizations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start1 Sep 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David Bekelman, MD MPH, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713347
- Sponsor's protocol ID
- IIR 14-346
- Acronym
- ADAPT
- Status last verified
- Jun 2024
- First submitted
- 14 Mar 2016
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will consider a plan to share individual patient data in consultation with VA privacy, information security, and research and development offices.
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.
PubMed 28422561Kavalieratos 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.
PubMed 28982506Bekelman 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.
PubMed 29461908Bekelman 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.
PubMed 29482218Portz 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.
PubMed 29975619Bekelman 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.
PubMed 30702055Graney 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.
PubMed 31196156Bekelman 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.
PubMed 31050771Portz 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.
PubMed 31518274Portz 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.
PubMed 30958272Buck 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.
PubMed 30632603Giannitrapani 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.
PubMed 32383388Brown-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.
PubMed 32781166Hadler 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.
PubMed 31916910Schenker 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.
PubMed 32955969
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care to Improve Quality of Life in CHF and COPD
- ClinicalTrials.gov ID
- NCT02713347
- Acronym / sponsor ID
- ADAPT / IIR 14-346
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| ADAPT Intervention | Experimental | Behavioral: ADAPT InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- Previous diagnosis of dementia
- Active substance abuse
- Comorbid metastatic cancer
- Nursing home resident
- Heart or lung transplant or left ventricular assist device (LVAD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAPT InterventionThe 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. | Behavioural | ADAPT Intervention |
Primary outcome
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.
15 secondary outcomes
General Symptom Distress Scale (GSDS)
Time frame: 6 months
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 6 months
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)
Time frame: 6 months
Clinical COPD Questionnaire (CCQ)
Time frame: 6 months
Quality of Life at the End of Life (QUAL-EC)
Time frame: 6 months
Advance Care Planning Communication and Documentation
Time frame: 6 months
Mortality
Time frame: 12 months
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 6 months
Advance Care Planning Engagement
Time frame: 6 months
PEG (Pain)
Time frame: 6 months
Insomnia Severity Index (ISI)
Time frame: 6 months
PROMIS Fatigue
Time frame: 6 months
K-BILD
Time frame: 6 months
Goal Concordance
Time frame: 6 months
Hospitalization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28422561Bekelman 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.
- Background: PubMed 28982506Kavalieratos 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.
- Background: PubMed 29461908Bekelman 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.
- Background: PubMed 29482218Bekelman 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.
- Background: PubMed 29975619Portz 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.
- Background: PubMed 30702055Bekelman 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.
- Background: PubMed 31196156Graney 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.
- Background: PubMed 31050771Bekelman 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.
- Background: PubMed 31518274Portz 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.
- Background: PubMed 30958272Portz 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.
- Background: PubMed 30632603Buck 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.
- Background: PubMed 32383388Giannitrapani 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.
- Individual participant dataSharing planned: No. We will consider a plan to share individual patient data in consultation with VA privacy, information security, and research and development offices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bekelman, MD MPH principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT Intervention in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function Assessment of Chronic Illness Therapy-General (FACT-G) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713347, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.