HomePal: Comparative Trial of Home-Based Palliative Care
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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 |
Other: Standard HBPC
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. |
Other: Tech-supported HBPC
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
|
Outcome Measures
Primary Outcome Measures
- Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS) [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.
- 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 [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
Secondary Outcome Measures
- 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 [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
- Patient general distress measured with the distress thermometer [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
- Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR) [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
- Patient satisfaction-care experience measured by a study-specific survey [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.
- Patient acute and post-acute care utilization [Baseline to 12 months]
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay
- Patient outpatient health care utilization [Baseline to 12 months]
Frequency of primary and specialty care visits
- 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 [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
- Caregiver burden measured with the Zarit-12 Caregiver Burden Scale [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
- Caregiver acute and post-acute care utilization [Baseline to 12 months]
Frequency of hospitalizations, emergency department visits and skilled nursing facility stay for caregivers who are members of Kaiser Permanente
- Caregiver outpatient health care utilization [Baseline to 12 months]
Frequency of primary and specialty care visits for caregivers who are members of Kaiser Permanente
- HBPC clinician perception of facilitators and barriers to implementation of HBPC services [Yearly, up to four years]
Study specific survey (under development)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Southern California | Pasadena | California | United States | 91101 |
| 2 | Kaiser Permanente Northwest | Portland | Oregon | United States | 97227 |
Sponsors and Collaborators
- Kaiser Permanente
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Huong Q Nguyen, PhD, Kaiser Permanente
- Principal Investigator: Richard A Mularski, MD, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLC-1609-36108