Trial Outcomes & Findings for Advancing Symptom Alleviation With Palliative Treatment (NCT NCT02713347)

NCT ID: NCT02713347

Last Updated: 2024-08-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 306 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-08-09

Participant Flow

Participant milestones

Measure	ADAPT Intervention 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: 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.	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.
Baseline to 4 Months STARTED	154	152
Baseline to 4 Months COMPLETED	120	129
Baseline to 4 Months NOT COMPLETED	34	23
4 Months to 6 Months STARTED	148	148
4 Months to 6 Months COMPLETED	122	122
4 Months to 6 Months NOT COMPLETED	26	26
6 Months to 12 Months STARTED	146	143
6 Months to 12 Months COMPLETED	107	111
6 Months to 12 Months NOT COMPLETED	39	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Advancing Symptom Alleviation With Palliative Treatment

Baseline characteristics by cohort

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.	Total n=306 Participants Total of all reporting groups
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	118 Participants n=5 Participants	127 Participants n=7 Participants	245 Participants n=5 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	154 Participants n=5 Participants	152 Participants n=7 Participants	306 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	34 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	106 Participants n=5 Participants	118 Participants n=7 Participants	224 Participants n=5 Participants
Age, Continuous	68.9 years STANDARD_DEVIATION 8.0 • n=5 Participants	68.9 years STANDARD_DEVIATION 7.4 • n=7 Participants	68.9 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants	137 Participants n=7 Participants	276 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=5 Participants	127 Participants n=7 Participants	255 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Total number reported here may be inconsistent from the participant flow number because (1) participants could skip completion of a survey and maintain enrollment in the study, and (2) FACT-G surveys may not have been completed enough for analysis (i.e., there were too many missing FACT-G items to score the measure).

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.

Outcome measures

Measure	ADAPT Intervention n=153 Participants 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: 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.	Enhanced Usual Care n=147 Participants 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.
Function Assessment of Chronic Illness Therapy-General (FACT-G)	59.0 score on a scale Standard Error 4.0	54.0 score on a scale Standard Error 4.0

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	ADAPT Intervention n=153 Participants 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: 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.	Enhanced Usual Care n=150 Participants 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.
General Symptom Distress Scale (GSDS)	5.56 score on a scale Standard Error 0.64	6.0 score on a scale Standard Error 0.64

SECONDARY outcome

Timeframe: 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. Score range 0-24 points with a higher score indicating more depressive symptoms.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Patient Health Questionnaire-8 (PHQ-8)	10.02 score on a scale Standard Error 1.43	11.58 score on a scale Standard Error 1.42

SECONDARY outcome

Timeframe: 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. Score range 0-100 and higher scores indicate better health status.

Outcome measures

Measure	ADAPT Intervention n=51 Participants 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: 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.	Enhanced Usual Care n=50 Participants 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.
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)	47.6 score on a scale Standard Error 3.47	43.05 score on a scale Standard Error 3.52

SECONDARY outcome

Timeframe: 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. Score range 0-6 with higher scores indicate worse health status.

Outcome measures

Measure	ADAPT Intervention n=105 Participants 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: 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.	Enhanced Usual Care n=101 Participants 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.
Clinical COPD Questionnaire (CCQ)	3.08 score on a scale Standard Error 0.1	3.21 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: 6 months

Population: Survey completeness differed by measure.

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.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Quality of Life at the End of Life (QUAL-EC) QUAL-E: Life Completion	3.01 score on a scale Standard Error 0.23	2.88 score on a scale Standard Error 0.23
Quality of Life at the End of Life (QUAL-EC) QUAL-E: Relationship With Healthcare Provider	3.05 score on a scale Standard Error 0.22	2.87 score on a scale Standard Error 0.22
Quality of Life at the End of Life (QUAL-EC) QUAL-E: Preparation	3.86 score on a scale Standard Error 0.22	3.55 score on a scale Standard Error 0.22
Quality of Life at the End of Life (QUAL-EC) QUAL-E: Feel At Peace	3.35 score on a scale Standard Error 0.29	3.18 score on a scale Standard Error 0.29

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Advance Care Planning Communication and Documentation Documented Advance Care Planning Discussion	106 Participants	5 Participants
Advance Care Planning Communication and Documentation Documented Advance Directive	58 Participants	62 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of deaths is reported

The following events will be assessed during the study period through medical record review to supplement patient report: mortality.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Mortality	6 participants	5 participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Generalized Anxiety Disorder Scale (GAD-7)	5.82 score on a scale Standard Error 1.43	6.92 score on a scale Standard Error 1.42

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Advance Care Planning Engagement	4.21 score on a scale Standard Error 0.34	3.68 score on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: 6 months

The PEG measures pain intensity and interference (Krebs, 2009). Scale range 0-10 and higher score indicates more pain.

Outcome measures

Measure	ADAPT Intervention n=152 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
PEG (Pain)	4.76 score on a scale Standard Error 0.72	5.04 score on a scale Standard Error 0.72

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	ADAPT Intervention n=153 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Insomnia Severity Index (ISI)	2.11 score on a scale Standard Error 0.26	2.26 score on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: 6 months

The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity. Scale range 0-4 and a higher score indicates more fatigue.

Outcome measures

Measure	ADAPT Intervention n=153 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
PROMIS Fatigue	2.15 score on a scale Standard Error 0.26	2.22 score on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: 6 months

Quality of life measure for interstitial lung disease. Score range 15-105 (lower score indicates lower health status).

Outcome measures

Measure	ADAPT Intervention n=5 Participants 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: 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.	Enhanced Usual Care n=5 Participants 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.
K-BILD	54.8 score on a scale Standard Deviation 17.4	50.8 score on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: 6 months

Population: Number analyzed = # of patients who we had complete data at 6 months and who were not unsure of their goals of care at the 6-month time point. The count of participants in the outcome measure data table is the number of patients who were considered goal concordant at 6 months for the control/intervention groups; this is the number of people who meet the criteria listed (Patients who answered 0-3 for both questions, 4-6 for both questions, or 7-10 for both questions).

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."

Outcome measures

Measure	ADAPT Intervention n=85 Participants 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: 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.	Enhanced Usual Care n=85 Participants 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.
Goal Concordance	52 Participants	55 Participants

SECONDARY outcome

Timeframe: 6 months

Population: participants

The following events will be assessed during the study period through medical record review to supplement patient report: hospitalizations.

Outcome measures

Measure	ADAPT Intervention n=154 Participants 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: 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.	Enhanced Usual Care n=152 Participants 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.
Hospitalization Hospitalized Twice or More	9 participants	9 participants
Hospitalization Hospitalized Once	24 participants	17 participants

Adverse Events

ADAPT Intervention

Serious events: 39 serious events

Other events: 70 other events

Deaths: 6 deaths

Enhanced Usual Care

Serious events: 31 serious events

Other events: 34 other events

Deaths: 5 deaths

Serious adverse events

Measure	ADAPT Intervention n=154 participants at risk 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: 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.	Enhanced Usual Care n=152 participants at risk 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.
General disorders Hospitalization	21.4% 33/154 • 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). Serious adverse events included hospitalizations and mortality. Other adverse events (collected non-systematically) included events reported by patients or viewed in medical records. For example, ED visits, potential medication side effects, or symptoms of disease exacerbation/progression. Other adverse events were tracked more carefully (and more likely to be reported) in the intervention arm due to increased interventionist contact with participants compared to the enhanced usual care arm.	17.1% 26/152 • 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). Serious adverse events included hospitalizations and mortality. Other adverse events (collected non-systematically) included events reported by patients or viewed in medical records. For example, ED visits, potential medication side effects, or symptoms of disease exacerbation/progression. Other adverse events were tracked more carefully (and more likely to be reported) in the intervention arm due to increased interventionist contact with participants compared to the enhanced usual care arm.
General disorders Mortality	3.9% 6/154 • 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). Serious adverse events included hospitalizations and mortality. Other adverse events (collected non-systematically) included events reported by patients or viewed in medical records. For example, ED visits, potential medication side effects, or symptoms of disease exacerbation/progression. Other adverse events were tracked more carefully (and more likely to be reported) in the intervention arm due to increased interventionist contact with participants compared to the enhanced usual care arm.	3.3% 5/152 • 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). Serious adverse events included hospitalizations and mortality. Other adverse events (collected non-systematically) included events reported by patients or viewed in medical records. For example, ED visits, potential medication side effects, or symptoms of disease exacerbation/progression. Other adverse events were tracked more carefully (and more likely to be reported) in the intervention arm due to increased interventionist contact with participants compared to the enhanced usual care arm.

Other adverse events

Measure	ADAPT Intervention n=154 participants at risk 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: 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.	Enhanced Usual Care n=152 participants at risk 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.
General disorders All other AEs (not SAE)	45.5% 70/154 • 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). Serious adverse events included hospitalizations and mortality. Other adverse events (collected non-systematically) included events reported by patients or viewed in medical records. For example, ED visits, potential medication side effects, or symptoms of disease exacerbation/progression. Other adverse events were tracked more carefully (and more likely to be reported) in the intervention arm due to increased interventionist contact with participants compared to the enhanced usual care arm.	22.4% 34/152 • 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). Serious adverse events included hospitalizations and mortality. Other adverse events (collected non-systematically) included events reported by patients or viewed in medical records. For example, ED visits, potential medication side effects, or symptoms of disease exacerbation/progression. Other adverse events were tracked more carefully (and more likely to be reported) in the intervention arm due to increased interventionist contact with participants compared to the enhanced usual care arm.

Additional Information

Dr. David Bekelman

VA

Phone: 7207236388

Email: david.bekelman@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place