Palliative CareNCT06140004
Home-Based Palliative Care Impact on Providers
An observational study of Palliative Care and Health Personnel, run by University of Southern California at 3 sites in United States.
Trial summary
This research challenges our current approach to fee-for-service palliative care and is significant because it will advance the fields of palliative and person-centered care, clinical practice, public policy, and health care financing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Health Personnel
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2016to 31 Oct 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participant were members of the HBPC service at each organization. The investigators sought participants with a wide variety of disciplines, roles, and experiences. This included targeting frontline providers consistent with the core clinical team outlined in the HBPC model (i.e., physician, nurse [RNs], social worker [LCSWs, MSWs], and chaplain), in addition to other site team members such as advance practice providers (NPs, PAs), patient coordinators/liaisons, admissions assistants, and leadership.
Who may be able to join
- Current member of the Home-Based Palliative Care (HBPC) team or organization's leadership team
Who cannot join
- No interaction with palliative care patients or palliative care arm of organization
- Unable to speak and read English
Trial locations and contacts
3 sites in 1 country.
United States3 sites
By the Bay Health
Larkspur, California, 94939
Snowline Hospice
Sacramento, California, 95825
HavenHealth
Signal Hill, California, 90755
About this study
Official title: Investigating the Impact of Person-Centered Home-Based Palliative Care on Providers
This research challenges our current approach to fee-for-service palliative care and is significant because it will advance the fields of palliative and person-centered care, clinical practice, public policy, and health care financing. However, the most important effect will be on seriously ill patients and their families through increased access to palliative care outside of hospitals, enhanced palliative continuity across health settings, and improved affordability via reformed payment structures. Nation-wide replication of reimbursable HBCP models is anticipated.
Read the detailed description
This study will undertake an effort to address the two-pronged gap in providing palliative care in the U.S. (episodic care and misaligned financing structures). This will be done by implementing an evidence-based Home-Based Palliative Care (HBPC) model-originally developed in managed care-into primary fee-for-service as a covered health benefit; the very first translation of this model by a private health insurer in the U.S. The purpose of the present study is to investigate the provider and organizational-level impact of implementing reimbursable HBPC in primary care with the goal of characterizing a set of implementation strategies and eliciting key mechanisms on how to widely replicate person-centered, reimbursable HBPC in primary care settings across the country. To this end, seven research questions will be answered that address the study purpose pertaining to feasibility, barriers, facilitators, person-centeredness, and job satisfaction. This study is guided by the Diffusion of Innovations theory. The investigators will conduct primary collection and analysis of qualitative focus group data at each study site. Key outcomes for the qualitative component include feasibility, barriers, and facilitators of translating HBPC, as well as characteristics associated with rate of HBPC diffusion and implementation strategies. This project challenges our current approach to fee-for-service palliative care and seeks to shift current research. Nation-wide replication of reimbursable HBCP models is anticipated.
- Conditions
- Palliative Care, Health Personnel
- Keywords
- Home-based palliative care, Healthcare providers, Qualitative methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HBPC Site 1: Northern/East California | This site implemented an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor. At this site, this core team was housed in an independent hospice agency and was also convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline. | |
| HBPC Site 2: Northern/West California | This site implemented an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor. At this site, this core team was housed in an independent hospice agency and was also convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline. | |
| HBPC Site 3: Southern California | This site implemented an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor. At this site, this core team was housed in an independent hospice and home health agency and was also convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confidence in Team
Self-reported rating of confidence in HBPC team to implement the intervention as stated, on a scale of 1-10 (1=not confident at all; 10=extremely confident)
Measured: 12-months
Secondary outcomes (1)
Confidence in Self
Self-reported rating of confidence in self to implement the intervention as stated, on a scale of 1-10 (1=not confident at all; 10=extremely confident)
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Sep 2016
- Primary completion27 Jun 2019
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Alexis Coulourides Kogan, PhD, University of Southern California
- Investigators
- Alexis Coulourides Kogan, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140004
- Sponsor's protocol ID
- HS-17-00279
- Other IDs
- 1K99AG052647-01, 5K99AG052647-02, 4R00AG052647-03, 5R00AG052647-04
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD in the form of focus groups transcripts and demographic survey data will be shared upon request. Legitimate requests by researchers can be made in writing directly to the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Person-Centered Home-Based Palliative Care on Providers
- ClinicalTrials.gov ID
- NCT06140004
- Acronym / sponsor ID
- HS-17-00279
- Conditions
- Palliative Care, Health Personnel
- Keywords
- Home-based palliative care, Healthcare providers, Qualitative methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 18 Nov 2023 (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.
This research challenges our current approach to fee-for-service palliative care and is significant because it will advance the fields of palliative and person-centered care, clinical practice, public policy, and health care financing. However, the most important effect will be on seriously ill patients and their families through increased access to palliative care outside of hospitals, enhanced palliative continuity across health settings, and improved affordability via reformed payment structures. Nation-wide replication of reimbursable HBCP models is anticipated.
Detailed description
This study will undertake an effort to address the two-pronged gap in providing palliative care in the U.S. (episodic care and misaligned financing structures). This will be done by implementing an evidence-based Home-Based Palliative Care (HBPC) model-originally developed in managed care-into primary fee-for-service as a covered health benefit; the very first translation of this model by a private health insurer in the U.S. The purpose of the present study is to investigate the provider and organizational-level impact of implementing reimbursable HBPC in primary care with the goal of characterizing a set of implementation strategies and eliciting key mechanisms on how to widely replicate person-centered, reimbursable HBPC in primary care settings across the country. To this end, seven research questions will be answered that address the study purpose pertaining to feasibility, barriers, facilitators, person-centeredness, and job satisfaction. This study is guided by the Diffusion of Innovations theory. The investigators will conduct primary collection and analysis of qualitative focus group data at each study site. Key outcomes for the qualitative component include feasibility, barriers, and facilitators of translating HBPC, as well as characteristics associated with rate of HBPC diffusion and implementation strategies. This project challenges our current approach to fee-for-service palliative care and seeks to shift current research. Nation-wide replication of reimbursable HBCP models is anticipated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBPC Site 1: Northern/East California | – | –This site implemented an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor. At this site, this core team was housed in an independent hospice agency and was also convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline. |
| HBPC Site 2: Northern/West California | – | –This site implemented an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor. At this site, this core team was housed in an independent hospice agency and was also convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline. |
| HBPC Site 3: Southern California | – | –This site implemented an evidence-based model of HBPC that consists of home visits by a trained, interdisciplinary palliative care team composed of a physician, nurse, social worker, and spiritual counselor. At this site, this core team was housed in an independent hospice and home health agency and was also convened in-house by the ACO contract or MA plan. The insurance provider contracts with the core team, using a per member per month payment for patients enrolled in HBPC. The core team will provide pain and symptom management, psychosocial support, advanced care planning, disease management education, spiritual counseling, grief counseling, and other services in response to patient and caregiver needs. HBPC patients and their caregivers also will have access to a 24/7 helpline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant were members of the HBPC service at each organization. The investigators sought participants with a wide variety of disciplines, roles, and experiences. This included targeting frontline providers consistent with the core clinical team outlined in the HBPC model (i.e., physician, nurse [RNs], social worker [LCSWs, MSWs], and chaplain), in addition to other site team members such as advance practice providers (NPs, PAs), patient coordinators/liaisons, admissions assistants, and leadership.
Key inclusion criteria (1 listed)
- Current member of the Home-Based Palliative Care (HBPC) team or organization's leadership team
Key exclusion criteria (2 listed)
- No interaction with palliative care patients or palliative care arm of organization
- Unable to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confidence in Team
Time frame: 12-months
Self-reported rating of confidence in HBPC team to implement the intervention as stated, on a scale of 1-10 (1=not confident at all; 10=extremely confident)
1 secondary outcome
Confidence in Self
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. De-identified IPD in the form of focus groups transcripts and demographic survey data will be shared upon request. Legitimate requests by researchers can be made in writing directly to the study PI.
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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.
Alexis Coulourides Kogan, PhD principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Health Personnel, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confidence in Team (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2023.