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A Non-Inferiority Comparative Effectiveness Trial of Home Based Palliative Care in Older Adults (HomePal)
Investigator (PI): Nguyen, Huong Q; Mularski, Richard
Performing Organization (PO): (Current): Kaiser Permanente Research, Department of Research & Evaluation / (626) 564-3455
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2021
Record Source/Award ID: PCORI/PLC-1609-36108
Funding: Total Award Amount: $14,000,000
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Multiple policy statements and clinical guidelines have affirmed the need to provide palliative care (PC) services across the medical care continuum to alleviate unnecessary suffering and improve quality of life for patients and caregivers. In situations where patients have burdensome symptoms and significant physical or mental limitations that make current clinic-based models unsuitable, home-based palliative care (HBPC) may be the best viable option. PC clinician leaders and health systems such as Kaiser Permanente, which has nearly 10 years of experience providing HBPC, need research guidance to determine how best to refine HBPC services to meet the rapidly growing demand for HBPC while preserving its effectiveness and affordability. Our study addresses this need by comparing a conventional physician-led HBPC model that includes routine physician home visits to a contemporary, more efficient nurse-led HBPC model that leverages remote physician supervision to improve access and affordability. We will conduct a cluster randomized trial across 15 sites in two Kaiser Permanente regions (Southern California and Northwest). Approximately 130 registered nurses will be randomly assigned to the nurse-led or physician-led HBPC model so that half of the patient caregiver families will receive nurse-led HBPC (~5,000 patients with about half having a caregiver participating) and the other half, physician-led HBPC (~5000 patients). We hypothesize that nurse led HBPC will be as effective as physician-led HBPC in improving outcomes that matter most to patients (two primary outcomes: short-term symptom improvement and in the longer term, days spent at home in the last six months of life) and caregivers (perception of preparedness to help care for their loved one). We will conduct a two-stage process using information from the medical record and phone calls to identify people over the age of 65 who have PC needs, regardless of their clinical condition, that are best met in their homes in a manner consistent with their preferences. Patients may continue receiving disease directed curative therapy. Specific criteria will be established through input obtained from stakeholders to ensure patients are directed to PC services that best meet their needs and priorities. Patients and caregivers in both arms will receive the following HBPC intervention components: comprehensive assessment of biopsychosocial spiritual needs and care planning, aggressive pain and symptom management, patient and caregiver education/skills training, medication review and management, emotional/spiritual support, care coordination, referral to community resources and other home health services as needed, and 24/7 phone assistance for urgent matters. If successful, the more efficient nurse-led HBPC model would translate to significantly expanded, affordable access to the fast growing number of older patients and their caregivers who are in desperate need of PC services in their homes.
MeSH Terms:
  • Aged
  • California
  • * Caregivers
  • Cluster Analysis
  • Community Health Services
  • Comparative Effectiveness Research
  • Geriatrics /organization & administration
  • Health Policy
  • Health Services Accessibility
  • Humans
  • Insurance, Health
  • Medical Records
  • * Nurses
  • Palliative Care /organization & administration
  • * Physicians
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Time Factors
Country: United States
State: California
Zip Code: 91101
UI: 20181686
CTgovId: NCT03694431
Project Status: Ongoing
Record History: ('2020: Project title changed (Prior title: A non-inferiority comparative effectiveness trial of physician-led vs. nurse-led home-based palliative care in older adults with advanced illness and their family caregivers); Project end date changed from 2024. 2018: Start date changed from 2017 to 2018 and project extended to 2024.',)