Comparative Trial of Home-Based Palliative Care (HomePal)

Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes

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.

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

Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC

Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits

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

Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care

The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms.

Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC

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

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

Scores for this single item distress thermometer range from 0-10 with higher scores indicating greater distress

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

This 8-item satisfaction-care experience survey was developed specifically to measure satisfaction and care experience with home-based palliative care.

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

The Zarit-12 is a 12-item survey measuring caregiver burden. Scores range from 0-48 with higher scores indicating greater caregiver burden

Frequency of hospitalizations, emergency department visits and skilled nursing facility stay for caregivers who are members of Kaiser Permanente

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

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.