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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • California
      • Larkspur, California, United States, 94939
        • By the Bay Health
      • Sacramento, California, United States, 95825
        • Snowline Hospice
      • Signal Hill, California, United States, 90755
        • HavenHealth

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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