Trial Outcomes & Findings for Expanding Access to Home-Based Palliative Care (NCT NCT03128060)
NCT ID: NCT03128060
Last Updated: 2025-09-22
Results Overview
The Edmonton Symptom Assessment Survey for patients is a brief and reliable self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms. Response scores range from 0 (no pain/symptoms) to 90 (highest pain symptoms) based on responses scored from 0 (no pain/symptoms) to 10 (highest pain/symptoms) on 9 items. Note: our data represents the composite score of the 9 items.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
1-month following baseline
Results posted on
2025-09-22
Participant Flow
Target sample size: 1,155 patients, 884 caregivers
Participant milestones
| Measure |
Home-based Palliative Care - Patients
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
Home-based Palliative Care - Caregivers
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Caregivers
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not collected for caregivers
Baseline characteristics by cohort
| Measure |
Home-based Palliative Care - Patients
n=13 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=15 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
Home-based Palliative Care - Caregivers
n=3 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Caregivers
n=4 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 12.6 • n=13 Participants
|
64.2 years
STANDARD_DEVIATION 12.6 • n=15 Participants
|
48.0 years
STANDARD_DEVIATION 11.8 • n=3 Participants
|
57.0 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 12.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=13 Participants
|
10 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=13 Participants
|
5 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=13 Participants
|
15 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=13 Participants
|
11 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Marital Status
Married
|
10 Participants
n=13 Participants
|
9 Participants
n=15 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=35 Participants
|
|
Marital Status
Single
|
1 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=35 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=13 Participants
|
3 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=35 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=35 Participants
|
|
Religion
Agnostic
|
0 Participants
n=13 Participants • Not collected for caregivers
|
1 Participants
n=15 Participants • Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
1 Participants
n=28 Participants • Not collected for caregivers
|
|
Religion
Catholic (Christian)
|
5 Participants
n=13 Participants • Not collected for caregivers
|
1 Participants
n=15 Participants • Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
6 Participants
n=28 Participants • Not collected for caregivers
|
|
Religion
Christian (other)
|
7 Participants
n=13 Participants • Not collected for caregivers
|
8 Participants
n=15 Participants • Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
15 Participants
n=28 Participants • Not collected for caregivers
|
|
Religion
None / Atheist
|
1 Participants
n=13 Participants • Not collected for caregivers
|
5 Participants
n=15 Participants • Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
0 Participants
Not collected for caregivers
|
6 Participants
n=28 Participants • Not collected for caregivers
|
|
Income
Less than $20,000
|
5 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=35 Participants
|
|
Income
$20,000 - $ 199,999
|
8 Participants
n=13 Participants
|
13 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=35 Participants
|
|
Income
$200,000 or more
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Income
Unknown
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Education
Less than high school
|
1 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=35 Participants
|
|
Education
High school graduate
|
3 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=35 Participants
|
|
Education
Some college
|
4 Participants
n=13 Participants
|
5 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=35 Participants
|
|
Education
College graduate
|
1 Participants
n=13 Participants
|
5 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=35 Participants
|
|
Education
Post-graduate school
|
4 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=35 Participants
|
|
Education
Unknown
|
0 Participants
n=13 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=35 Participants
|
|
Hospital Anxiety and Depression Scale (HADS_PT_CG)
|
16.8 score on a scale
STANDARD_DEVIATION 6.0 • n=13 Participants
|
18.6 score on a scale
STANDARD_DEVIATION 4.5 • n=15 Participants
|
6.0 score on a scale
STANDARD_DEVIATION 8.7 • n=3 Participants
|
10.8 score on a scale
STANDARD_DEVIATION 7.1 • n=4 Participants
|
17.8 score on a scale
STANDARD_DEVIATION 5.2 • n=35 Participants
|
|
Patient Health Questionnaire (PT)
|
11.0 score on a scale
STANDARD_DEVIATION 5.2 • n=13 Participants • Not collected for caregivers
|
12.9 score on a scale
STANDARD_DEVIATION 5.1 • n=15 Participants • Not collected for caregivers
|
—
|
—
|
12.0 score on a scale
STANDARD_DEVIATION 5.2 • n=28 Participants • Not collected for caregivers
|
|
Edmonton Symptom Assessment Scale
|
37.7 units on a scale
STANDARD_DEVIATION 14.4 • n=13 Participants • Not collected for caregivers
|
32.1 units on a scale
STANDARD_DEVIATION 16.4 • n=15 Participants • Not collected for caregivers
|
—
|
—
|
34.7 units on a scale
STANDARD_DEVIATION 15.5 • n=28 Participants • Not collected for caregivers
|
|
Herth Hope Index (PT)
|
38.2 units on a scale
STANDARD_DEVIATION 5.1 • n=13 Participants • Not collected for caregivers
|
35.0 units on a scale
STANDARD_DEVIATION 5.5 • n=15 Participants • Not collected for caregivers
|
—
|
—
|
36.5 units on a scale
STANDARD_DEVIATION 5.5 • n=28 Participants • Not collected for caregivers
|
|
Assessment of Peace (PT)
|
3.8 units on a scale
STANDARD_DEVIATION 0.8 • n=12 Participants • 1 missing in HBPC group
|
2.9 units on a scale
STANDARD_DEVIATION 1.0 • n=15 Participants • 1 missing in HBPC group
|
—
|
—
|
3.33 units on a scale
STANDARD_DEVIATION 1.0 • n=27 Participants • 1 missing in HBPC group
|
|
Consultation Care Measure (PT_CG)
|
48.2 units on a scale
STANDARD_DEVIATION 10.9 • n=13 Participants
|
56.6 units on a scale
STANDARD_DEVIATION 13.1 • n=15 Participants
|
40.0 units on a scale
STANDARD_DEVIATION 21.2 • n=3 Participants
|
52.5 units on a scale
STANDARD_DEVIATION 9.7 • n=4 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 12.7 • n=35 Participants
|
PRIMARY outcome
Timeframe: 1-month following baselineThe Edmonton Symptom Assessment Survey for patients is a brief and reliable self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms. Response scores range from 0 (no pain/symptoms) to 90 (highest pain symptoms) based on responses scored from 0 (no pain/symptoms) to 10 (highest pain/symptoms) on 9 items. Note: our data represents the composite score of the 9 items.
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=9 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=10 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Edmonton Symptom Assessment Survey for Patients
|
35.2 score on a scale
Standard Deviation 12.5
|
28.1 score on a scale
Standard Deviation 10.6
|
PRIMARY outcome
Timeframe: 1-month following baselineThe Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression using a 4-point Likert scale. The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D). The total score for each subscale ranges from 0 to 21, and the total score is the sum of the two subscale scores. Low scores indicate normal responses while high scores are abnormal (0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=9 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=10 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) for Patients
|
15.9 score on a scale
Standard Deviation 6.9
|
14.4 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 1-months following baselineThe Patient Health Questionnaire-9 is a 9-item assessment to diagnose depression, with each item scores from 0 (not at all) to 3 (nearly every day). It is based on the nine DSM-IV criteria for depression. Scores range from a minimum of 0 to a maximum of 27. Low scores indicate no depression, while high scores indicate depression. For example, a score of 15 or greater is considered major depression, 20 or more is severe major depression.
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=9 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=10 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9) for Patients
|
10.8 score on a scale
Standard Deviation 5.4
|
8.7 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 1-month following baselineThis is a 1-item probe that assesses an individual's feeling of being at peace. On a scale of 1 to 5, with 1 being "Not at all at peace," and 5 being "Completely at peace". High scores indicate better outcomes. Scores range from a minimum of 1 (worse outcome) to a maximum of 5 (best outcome).
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=9 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=10 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Rating of Being at Peace Among Patients
|
4.0 score on a scale
Standard Deviation 1.2
|
3.2 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 1-month following baselineThe Hearth Hope Index is a 12-item scale is used to assess hope as it relates to a person's ability to cope with medical illness, loss, and related psychosocial stressors. The scale for each question ranges from 1 (strongly disagree) to 4 (strongly agree), with the exception of items 3 and 6, which are reverse-coded. Possible scores range from 12 to 48, with higher scores indicating higher level of hope (positive outcome).
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=9 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=10 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Hearth Hope Index for Patients
|
37.7 score on a scale
Standard Deviation 2.8
|
37.3 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: At 1 months following baselineThe Consultation Care Measure (CCM) is a patient-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life. WThis measure includes 20 likert scale questions for with response ranging from 1 to 4 for each (1 = very strongly agree... 4 = Neutral/disagree). The total score ranges from 20 to 80 and the lower score is the better score.
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=9 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=10 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Consultation Care Measure (CCM) for Patients
|
43.9 score on a scale
Standard Deviation 10.8
|
56.7 score on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: At 1 month following baselineThe Zarit Burden Interview: Short (ZBI) is a 12-item instrument that has been used with caregivers for a wide range of patients, including those with chronic illnesses. Total score range is 0 to 48, with higher scores indicating higher burden. Interpretation of score: 0-10=no to mild burden; 10-20= mild to moderate burden; and \> 20= high burden.
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=2 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=1 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Zarit Burden: Short (ZBI) Interview Among Caregivers
|
7.5 score on a scale
Standard Deviation 10.6
|
17 score on a scale
|
SECONDARY outcome
Timeframe: Two months following the death of a patientPopulation: \* There were no patient deaths during the study period.
FATE-S scores are expressed as a percentage of valid responses for which families provided the best possible response; higher percentages reflect better experience of care.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 month following baselineThe Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression using a 4-point Likert scale. The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D). The total score for each subscale ranges from 0 to 21, and the total score is the sum of the two subscale scores. Low scores indicate normal responses while high scores are abnormal (0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=2 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=1 Participants
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) for Caregivers
|
6.5 score on a scale
Standard Deviation 9.2
|
0 score on a scale
|
SECONDARY outcome
Timeframe: At 1- month following baselinePopulation: Only two caregivers reported follow-up CCM, both of them are in HBPC group.
This caregiver-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life. The Consultation Care Measure (CCM)assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life. This measure includes 20 likert scale questions for with response ranging from 1 to 4 for each (1 = very strongly agree... 4 = Neutral/disagree). The total score ranges from 20 to 80 and the lower score is the better score.
Outcome measures
| Measure |
Home-based Palliative Care - Patients
n=2 Participants
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|
|
Consultation Care Measure (CCM) for Caregivers
|
32.5 score on a scale
Standard Deviation 23.3
|
—
|
Adverse Events
Home-based Palliative Care - Patients
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Enhanced Usual Care - Patients
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Home-based Palliative Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home-based Palliative Care - Patients
n=13 participants at risk
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=15 participants at risk
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
Home-based Palliative Care - Caregivers
n=3 participants at risk
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Caregivers
n=4 participants at risk
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|---|---|
|
General disorders
ER visit or hospitalization
|
15.4%
2/13 • 2 months
|
6.7%
1/15 • 2 months
|
0.00%
0/3 • 2 months
|
0.00%
0/4 • 2 months
|
Other adverse events
| Measure |
Home-based Palliative Care - Patients
n=13 participants at risk
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Patients
n=15 participants at risk
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
Home-based Palliative Care - Caregivers
n=3 participants at risk
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Home-based palliative care: The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
|
Enhanced Usual Care - Caregivers
n=4 participants at risk
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
Enhanced usual care: Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
|
|---|---|---|---|---|
|
General disorders
Severe pain
|
15.4%
2/13 • 2 months
|
0.00%
0/15 • 2 months
|
0.00%
0/3 • 2 months
|
0.00%
0/4 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place