- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694431
Comparative Trial of Home-Based Palliative Care (HomePal)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Pasadena, California, United States, 91101
- Kaiser Permanente Southern California
-
-
Oregon
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Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard HBPC
Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits
|
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
|
Experimental: Tech-supported HBPC
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.
|
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
Time Frame: Baseline to 12 months
|
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
|
Change from baseline to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days at home between study enrollment and death or study completion (365 days)
Time Frame: Variable, up to 12 months
|
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
|
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
|
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
|
Scores for this single item distress thermometer range from 0-10 with higher scores indicating greater distress
|
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
|
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
|
Baseline and variable time periods due to reliance on available data from the EMR
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Patient satisfaction-care experience measured by a study-specific survey
Time Frame: 1 and 6 months
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This 8-item satisfaction-care experience survey was developed specifically to measure satisfaction and care experience with home-based palliative care.
|
1 and 6 months
|
Patient acute and post-acute care utilization
Time Frame: Baseline to 12 months
|
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay
|
Baseline to 12 months
|
Patient outpatient health care utilization
Time Frame: Baseline to 12 months
|
Frequency of primary and specialty care visits
|
Baseline to 12 months
|
Patient enrollment in and days on hospice before death
Time Frame: Baseline to 12 months
|
Baseline to 12 months
|
|
Patient death
Time Frame: Baseline to 12 months
|
Baseline to 12 months
|
|
Caregiver quality of life measured with the PROMIS-10
Time Frame: Change from baseline to 1 and 6 months
|
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
|
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
|
The Zarit-12 is a 12-item survey measuring caregiver burden.
Scores range from 0-48 with higher scores indicating greater caregiver burden
|
Change from baseline to 1 and 6 months
|
Caregiver acute and post-acute care utilization
Time Frame: Baseline to 12 months
|
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay for caregivers who are members of Kaiser Permanente
|
Baseline to 12 months
|
Caregiver outpatient health care utilization
Time Frame: Baseline to 12 months
|
Frequency of primary and specialty care visits for caregivers who are members of Kaiser Permanente
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Baseline to 12 months
|
HBPC clinician perception of facilitators and barriers to implementation of HBPC services
Time Frame: Yearly, up to four years
|
Study specific survey (under development)
|
Yearly, up to four years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Huong Q Nguyen, PhD, Kaiser Permanente
- Principal Investigator: Richard A Mularski, MD, Kaiser Permanente
Publications and helpful links
General Publications
- Mularski 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.
- Nguyen 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Nervous System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Liver Diseases
- End Stage Liver Disease
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Kidney Failure, Chronic
- Neuromuscular Diseases
Other Study ID Numbers
- PLC-1609-36108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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