CancerHomePalNCT03694431
Comparative Trial of Home-Based Palliative Care
A study testing Tech-supported HBPC and Standard HBPC in people with Cancer and Chronic Obstructive Pulmonary Disease, run by Kaiser Permanente at 2 sites in United States.
Trial summary
Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chronic Obstructive Pulmonary Disease, Heart Failure
- What is being tested?
- Tech-supported HBPC and Standard HBPC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,999 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2019to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria:
- Serious illness with 12-24 month life expectancy
- Homebound
- Need for skilled nursing care (only at KP Southern California)
- English or Spanish speakers
Patient Exclusion Criteria:
- Currently receiving HBPC
Caregiver Inclusion Criteria:
- Non-professional family, friend or other caregiver
- English or Spanish speakers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Southern California
Pasadena, California, 91101
Kaiser Permanente Northwest
Portland, Oregon, 97227
About this study
Official title: A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults
Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations.
Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC.
Read more
Design: Cluster randomized trial. Registered nurses (n~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models.
Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800)
Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance.
Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving.
Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.
- Conditions
- Cancer, Chronic Obstructive Pulmonary Disease, Heart Failure, Dementia, End Stage Liver Disease, End Stage Renal Disease
- Being tested
- Tech-supported HBPC, Standard HBPC
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure, Dementia, End Stage Liver Disease, Kidney Failure, Chronic, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tech-supported HBPCOther
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
Standard HBPCOther
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
| Study group | Role | What they receive |
|---|---|---|
| Standard HBPC | Active comparator | Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits Receives: Other: Standard HBPC |
| Tech-supported HBPC | Experimental | Patients and caregivers in tech-supported HBPC will receive synchronous video visits with a provider (physician or nurse practitioner) while the nurse is in the patient's home. Home visits by the palliative care team will be determined based on patients/caregivers' needs. Receives: Other: Tech-supported HBPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)
The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms.
Measured: Change from baseline to 1 month
Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC
Measured: Baseline to 12 months
Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale
The Preparedness for Caregiving Scale is a 9-item survey measuring caregivers' perception of their preparedness for caregiving. Scores range from 0-36 with higher scores indicating higher perception of preparedness
Measured: Change from baseline to 1 month
Secondary outcomes (14)
Days at home between study enrollment and death or study completion (365 days)
Measured: Variable, up to 12 months
Patient quality of life measured with the PROMIS-10 survey
The PROMIS-10 is a 10-item survey measuring general health related quality of life. Scores range from 0-100 with higher scores indicating better quality of life
Measured: Change from baseline to 1 and 6 months
Patient general distress measured with the distress thermometer
Scores for this single item distress thermometer range from 0-10 with higher scores indicating greater distress
Measured: Change from baseline to 1 and 6 months
Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR)
The Palliative Performance Scale measures overall functional status. A clinician completes this assessment using a scale of 0-100 with higher scores indicating better functional performance
Measured: Baseline and variable time periods due to reliance on available data from the EMR
Patient satisfaction-care experience measured by a study-specific survey
This 8-item satisfaction-care experience survey was developed specifically to measure satisfaction and care experience with home-based palliative care.
Measured: 1 and 6 months
Patient acute and post-acute care utilization
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay
Measured: Baseline to 12 months
Patient outpatient health care utilization
Frequency of primary and specialty care visits
Measured: Baseline to 12 months
Patient enrollment in and days on hospice before death
Measured: Baseline to 12 months
Patient death
Measured: Baseline to 12 months
Caregiver quality of life measured with the PROMIS-10
The PROMIS-10 is a 10-item survey measuring general health related quality of life. Scores range from 0-100 with higher scores indicating better quality of life
Measured: Change from baseline to 1 and 6 months
Caregiver burden measured with the Zarit-12 Caregiver Burden Scale
The Zarit-12 is a 12-item survey measuring caregiver burden. Scores range from 0-48 with higher scores indicating greater caregiver burden
Measured: Change from baseline to 1 and 6 months
Caregiver acute and post-acute care utilization
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay for caregivers who are members of Kaiser Permanente
Measured: Baseline to 12 months
Caregiver outpatient health care utilization
Frequency of primary and specialty care visits for caregivers who are members of Kaiser Permanente
Measured: Baseline to 12 months
HBPC clinician perception of facilitators and barriers to implementation of HBPC services
Study specific survey (under development)
Measured: Yearly, up to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start7 Jan 2019
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Why it stopped: Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC
- Masking
- None (open label)
- Enrolment
- 3,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Huong Q Nguyen, PhD, Principal investigator, Kaiser PermanenteRichard A Mularski, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694431
- Sponsor's protocol ID
- PLC-1609-36108
- Acronym
- HomePal
- Status last verified
- Feb 2020
- First submitted
- 27 Sep 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen HQ, Haupt EC, Duan L, Hou AC, Wang SE, Mariano JD, Lee JA, McMullen C. Hospital utilisation in home palliative care: caregiver health, preparedness and burden associations. BMJ Support Palliat Care. 2022 Jan 25:bmjspcare-2021-003455. doi: 10.1136/bmjspcare-2021-003455. Online ahead of print.
PubMed 35078873Mularski RA, Mittman B, Haupt E, Wang S, Scholle S, McMullen C, Henry M, Shen E, Nguyen HQ; HomePal Research Group. Performance of Patient-Reported Outcome Measures in a Large Pragmatic Trial of Home-Based Palliative Care (HomePal): Methodological and Practical Considerations for Embedded Patient-Centered Design. J Palliat Med. 2022 Apr;25(4):620-627. doi: 10.1089/jpm.2021.0164. Epub 2021 Nov 3.
PubMed 34735285Nguyen HQ, Mularski RA, Edwards PE, Lynn J, Machado MT, McBurnie MA, McMullen C, Mittman BS, Reinke LR, Shen E, Wang SE, Werch HS; HomePal Research Group. Protocol for a Noninferiority Comparative Effectiveness Trial of Home-Based Palliative Care (HomePal). J Palliat Med. 2019 Sep;22(S1):20-33. doi: 10.1089/jpm.2019.0116.
PubMed 31486724
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults
- ClinicalTrials.gov ID
- NCT03694431
- Acronym / sponsor ID
- HomePal / PLC-1609-36108
- Conditions
- Cancer, Chronic Obstructive Pulmonary Disease, Heart Failure, Dementia, End Stage Liver Disease, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes
- Enrolment
- 3,999 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations.
Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC.
Design: Cluster randomized trial. Registered nurses (n~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models.
Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800)
Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance.
Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving.
Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC
| Arm | Type | Receives |
|---|---|---|
| Standard HBPC | Active comparator | Other: Standard HBPCPatients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits |
| Tech-supported HBPC | Experimental | Other: Tech-supported HBPCPatients and caregivers in tech-supported HBPC will receive synchronous video visits with a provider (physician or nurse practitioner) while the nurse is in the patient's home. Home visits by the palliative care team will be determined based on patients/caregivers' needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tech-supported HBPCPalliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care | Other | Tech-supported HBPC |
| Standard HBPCPalliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care | Other | Standard HBPC |
Primary outcome
Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)
Time frame: Change from baseline to 1 month
The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms.
Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC
Time frame: Baseline to 12 months
Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale
Time frame: Change from baseline to 1 month
The Preparedness for Caregiving Scale is a 9-item survey measuring caregivers' perception of their preparedness for caregiving. Scores range from 0-36 with higher scores indicating higher perception of preparedness
14 secondary outcomes
Days at home between study enrollment and death or study completion (365 days)
Time frame: Variable, up to 12 months
Patient quality of life measured with the PROMIS-10 survey
Time frame: Change from baseline to 1 and 6 months
Patient general distress measured with the distress thermometer
Time frame: Change from baseline to 1 and 6 months
Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR)
Time frame: Baseline and variable time periods due to reliance on available data from the EMR
Patient satisfaction-care experience measured by a study-specific survey
Time frame: 1 and 6 months
Patient acute and post-acute care utilization
Time frame: Baseline to 12 months
Patient outpatient health care utilization
Time frame: Baseline to 12 months
Patient enrollment in and days on hospice before death
Time frame: Baseline to 12 months
Patient death
Time frame: Baseline to 12 months
Caregiver quality of life measured with the PROMIS-10
Time frame: Change from baseline to 1 and 6 months
Caregiver burden measured with the Zarit-12 Caregiver Burden Scale
Time frame: Change from baseline to 1 and 6 months
Caregiver acute and post-acute care utilization
Time frame: Baseline to 12 months
Caregiver outpatient health care utilization
Time frame: Baseline to 12 months
HBPC clinician perception of facilitators and barriers to implementation of HBPC services
Time frame: Yearly, up to four years
Results and safety
The study was stopped early (reason given: Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 35078873Nguyen HQ, Haupt EC, Duan L, Hou AC, Wang SE, Mariano JD, Lee JA, McMullen C. Hospital utilisation in home palliative care: caregiver health, preparedness and burden associations. BMJ Support Palliat Care. 2022 Jan 25:bmjspcare-2021-003455. doi: 10.1136/bmjspcare-2021-003455. Online ahead of print.
- Derived from this study: PubMed 34735285Mularski RA, Mittman B, Haupt E, Wang S, Scholle S, McMullen C, Henry M, Shen E, Nguyen HQ; HomePal Research Group. Performance of Patient-Reported Outcome Measures in a Large Pragmatic Trial of Home-Based Palliative Care (HomePal): Methodological and Practical Considerations for Embedded Patient-Centered Design. J Palliat Med. 2022 Apr;25(4):620-627. doi: 10.1089/jpm.2021.0164. Epub 2021 Nov 3.
- Derived from this study: PubMed 31486724Nguyen HQ, Mularski RA, Edwards PE, Lynn J, Machado MT, McBurnie MA, McMullen C, Mittman BS, Reinke LR, Shen E, Wang SE, Werch HS; HomePal Research Group. Protocol for a Noninferiority Comparative Effectiveness Trial of Home-Based Palliative Care (HomePal). J Palliat Med. 2019 Sep;22(S1):20-33. doi: 10.1089/jpm.2019.0116.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huong Q Nguyen, PhD principal investigator
Kaiser Permanente
Richard A Mularski, MD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tech-supported HBPC and Standard HBPC in people with Cancer and Chronic Obstructive Pulmonary Disease, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS) (time frame: Change from baseline to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694431, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.