- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140004
Home-Based Palliative Care Impact on Providers
November 17, 2023 updated by: Alexis Coulourides Kogan, PhD, University of Southern California
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Larkspur, California, United States, 94939
- By the Bay Health
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Sacramento, California, United States, 95825
- Snowline Hospice
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Signal Hill, California, United States, 90755
- HavenHealth
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
• Current member of the Home-Based Palliative Care (HBPC) team or organization's leadership team
Exclusion Criteria:
- No interaction with palliative care patients or palliative care arm of organization
- Unable to speak and read English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confidence in Self
Time Frame: 12-months
|
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)
|
12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alexis Coulourides Kogan, PhD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2016
Primary Completion (Actual)
June 27, 2019
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
November 14, 2023
First Submitted That Met QC Criteria
November 14, 2023
First Posted (Actual)
November 18, 2023
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HS-17-00279
- 1K99AG052647-01 (U.S. NIH Grant/Contract)
- 5K99AG052647-02 (U.S. NIH Grant/Contract)
- 4R00AG052647-03 (U.S. NIH Grant/Contract)
- 5R00AG052647-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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