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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3,999
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
Kaiser Permanente Southern California
Pasadena, California, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
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.
Time frame: 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
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
Time frame: Change from baseline to 1 month
Days at home between study enrollment and death or study completion (365 days)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 1 and 6 months
Patient acute and post-acute care utilization
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay
Time frame: Baseline to 12 months
Patient outpatient health care utilization
Frequency of primary and specialty care visits
Time frame: Baseline to 12 months
Patient enrollment in and days on hospice before death
Time frame: Baseline to 12 months
Patient death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 12 months
Caregiver outpatient health care utilization
Frequency of primary and specialty care visits for caregivers who are members of Kaiser Permanente
Time frame: Baseline to 12 months
HBPC clinician perception of facilitators and barriers to implementation of HBPC services
Study specific survey (under development)
Time frame: Yearly, up to four years
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