Comparative Trial of Home-Based Palliative Care (HomePal)

February 18, 2020 updated by: Kaiser Permanente

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

Study Type

Interventional

Enrollment (Actual)

3999

Phase

  • Not Applicable

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

    • California
      • Pasadena, California, United States, 91101
        • Kaiser Permanente Southern California
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

  • 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
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.
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Huong Q Nguyen, PhD, Kaiser Permanente
  • Principal Investigator: Richard A Mularski, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 7, 2019

Primary Completion (Actual)

January 24, 2020

Study Completion (Actual)

January 24, 2020

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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