Comparative Trial of Home-Based Palliative Care

Study Overview
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Brief Summary
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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.

Official Title
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A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults

Conditions
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Cancer, Chronic Obstructive Pulmonary Disease, Heart Failure, Dementia, End Stage Liver Disease, End Stage Renal Disease, Neuromuscular Diseases

Intervention / Treatment
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* Other: Tech-supported HBPC
* Other: Standard HBPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard HBPC<br>Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits | Other: Standard HBPC<br>* Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care<br>|
| Experimental: Tech-supported HBPC<br>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<br>* Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS) | 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 |  | Baseline to 12 months | 
| Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale | 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) |  | Variable, up to 12 months | 
| Patient quality of life measured with the PROMIS-10 survey | 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 | 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) | 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 | 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 | Frequency of hospitalizations, emergency department visits and skilled nursing facility stay | Baseline to 12 months | 
| Patient outpatient health care utilization | Frequency of primary and specialty care visits | Baseline to 12 months | 
| Patient enrollment in and days on hospice before death |  | Baseline to 12 months | 
| Patient death |  | Baseline to 12 months | 
| Caregiver quality of life measured with the PROMIS-10 | 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 | 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 | 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 | 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 | Study specific survey (under development) | Yearly, up to four years |