An interventional study of ADAPT Intervention in Heart Failure, Pulmonary Disease, Chronic Obstructive and Emphysema, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 306 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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.
Time frame: 6 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Mortality
The following events will be assessed during the study period through medical record review to supplement patient report: mortality.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
PEG (Pain)
The PEG measures pain intensity and interference (Krebs, 2009). Scale range 0-10 and higher score indicates more pain.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
K-BILD
Quality of life measure for interstitial lung disease. Score range 15-105 (lower score indicates lower health status).
Time frame: 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."
Time frame: 6 months
Hospitalization
The following events will be assessed during the study period through medical record review to supplement patient report: hospitalizations.
Time frame: 6 months
| Milestone | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 154 | 152 |
| Completed | 120 | 129 |
| Not completed | 34 | 23 |
| Milestone | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 148 | 148 |
| Completed | 122 | 122 |
| Not completed | 26 | 26 |
| Milestone | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 146 | 143 |
| Completed | 107 | 111 |
| Not completed | 39 | 32 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Function Assessment of Chronic Illness Therapy-General (FACT-G) | 59.0 ± 4.0 | 54.0 ± 4.0 |
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
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| General Symptom Distress Scale (GSDS) | 5.56 ± 0.64 | 6.0 ± 0.64 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Patient Health Questionnaire-8 (PHQ-8) | 10.02 ± 1.43 | 11.58 ± 1.42 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF) | 47.6 ± 3.47 | 43.05 ± 3.52 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Clinical COPD Questionnaire (CCQ) | 3.08 ± 0.1 | 3.21 ± 0.1 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| QUAL-E: Life Completion | 3.01 ± 0.23 | 2.88 ± 0.23 |
| QUAL-E: Relationship With Healthcare Provider | 3.05 ± 0.22 | 2.87 ± 0.22 |
| QUAL-E: Preparation | 3.86 ± 0.22 | 3.55 ± 0.22 |
| QUAL-E: Feel At Peace | 3.35 ± 0.29 | 3.18 ± 0.29 |
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.
| Participants | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Documented Advance Care Planning Discussion | 106 | 5 |
| Documented Advance Directive | 58 | 62 |
The following events will be assessed during the study period through medical record review to supplement patient report: mortality.
| participants | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Mortality | 6 | 5 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Generalized Anxiety Disorder Scale (GAD-7) | 5.82 ± 1.43 | 6.92 ± 1.42 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Advance Care Planning Engagement | 4.21 ± 0.34 | 3.68 ± 0.34 |
The PEG measures pain intensity and interference (Krebs, 2009). Scale range 0-10 and higher score indicates more pain.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| PEG (Pain) | 4.76 ± 0.72 | 5.04 ± 0.72 |
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.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Insomnia Severity Index (ISI) | 2.11 ± 0.26 | 2.26 ± 0.26 |
The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity. Scale range 0-4 and a higher score indicates more fatigue.
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| PROMIS Fatigue | 2.15 ± 0.26 | 2.22 ± 0.26 |
Quality of life measure for interstitial lung disease. Score range 15-105 (lower score indicates lower health status).
| score on a scale | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| K-BILD | 54.8 ± 17.4 | 50.8 ± 5.8 |
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."
| Participants | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Goal Concordance | 52 | 55 |
The following events will be assessed during the study period through medical record review to supplement patient report: hospitalizations.
| participants | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| Hospitalized Once | 24 | 17 |
| Hospitalized Twice or More | 9 | 9 |
Collected over Adverse event reporting is reported from the time participants were randomized until 6-months (for hospitalizations and all other adverse events) and 12-months (for mortality).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADAPT Intervention | 6/154 (3.9%) | 39/154 (25.3%) | 70/154 (45.5%) |
| Enhanced Usual Care | 5/152 (3.3%) | 31/152 (20.4%) | 34/152 (22.4%) |
| Event | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| HospitalizationGeneral disorders | 33/154 | 26/152 |
| MortalityGeneral disorders | 6/154 | 5/152 |
| Event | ADAPT Intervention | Enhanced Usual Care |
|---|---|---|
| All other AEs (not SAE)General disorders | 70/154 | 34/152 |
| Age, Categorical(Participants) | ADAPT Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 34 | 82 |
| >=65 years | 106 | 118 | 224 |
| Age, Continuous(years) | ADAPT Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 68.9 ± 8.0 | 68.9 ± 7.4 | 68.9 ± 7.7 |
| Sex: Female, Male(Participants) | ADAPT Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 139 | 137 | 276 |
| Ethnicity (NIH/OMB)(Participants) | ADAPT Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 18 |
| Not Hispanic or Latino | 128 | 127 | 255 |
| Unknown or Not Reported | 16 | 17 | 33 |
| Race (NIH/OMB)(Participants) | ADAPT Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 13 | 7 | 20 |
| White | 118 | 127 | 245 |
| More than one race | 16 | 14 | 30 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(Participants) | ADAPT Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 154 | 152 | 306 |
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