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Comparative Trial of Home-Based Palliative Care (HomePal)

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ClinicalTrials.gov Identifier: NCT03694431
Recruitment Status : Terminated (Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes)
First Posted : October 3, 2018
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cancer Chronic Obstructive Pulmonary Disease Heart Failure Dementia End Stage Liver Disease End Stage Renal Disease Neuromuscular Diseases Other: Tech-supported HBPC Other: Standard HBPC Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : January 24, 2020
Actual Study Completion Date : January 24, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Other: Standard HBPC
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.
 Other: Tech-supported HBPC
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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


Secondary Outcome Measures :
  1. Days at home between study enrollment and death or study completion (365 days) [ Time Frame: Variable, up to 12 months ]
  2. 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

  3. 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

  4. 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

  5. Patient satisfaction-care experience measured by a study-specific survey [ Time Frame: 1 and 6 months ]
    This 8-item satisfaction-care experience survey was developed specifically to measure satisfaction and care experience with home-based palliative care.

  6. Patient acute and post-acute care utilization [ Time Frame: Baseline to 12 months ]
    Frequency of hospitalizations, emergency department visits and skilled nursing facility stay

  7. Patient outpatient health care utilization [ Time Frame: Baseline to 12 months ]
    Frequency of primary and specialty care visits

  8. Patient enrollment in and days on hospice before death [ Time Frame: Baseline to 12 months ]
  9. Patient death [ Time Frame: Baseline to 12 months ]
  10. 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

  11. 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

  12. 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

  13. 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

  14. HBPC clinician perception of facilitators and barriers to implementation of HBPC services [ Time Frame: Yearly, up to four years ]
    Study specific survey (under development)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694431


Locations
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United States, California
Kaiser Permanente Southern California
Pasadena, California, United States, 91101
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Huong Q Nguyen, PhD Kaiser Permanente
Principal Investigator: Richard A Mularski, MD Kaiser Permanente
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03694431    
Other Study ID Numbers: PLC-1609-36108
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Neuromuscular Diseases
Kidney Failure, Chronic
Lung Diseases
Respiratory Tract Diseases
 Nervous System Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Liver Failure
Hepatic Insufficiency