Clinical trial NCT03694431: Comparative Trial of Home-Based Palliative Care
Official title: A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Chronic Obstructive Pulmonary Disease
Heart Failure
Dementia
End Stage Liver Disease
End Stage Renal Disease
Neuromuscular Diseases
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-10-03
Enrollment: 3999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Change from baseline to 1 month
measure: Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC
timeFrame: Baseline to 12 months
measure: Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale
timeFrame: Change from baseline to 1 month
Secondary outcomes:
measure: Days at home between study enrollment and death or study completion (365 days)
timeFrame: Variable, up to 12 months
measure: Patient quality of life measured with the PROMIS-10 survey
timeFrame: Change from baseline to 1 and 6 months
measure: Patient general distress measured with the distress thermometer
timeFrame: Change from baseline to 1 and 6 months
measure: Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR)
timeFrame: Baseline and variable time periods due to reliance on available data from the EMR
measure: Patient satisfaction-care experience measured by a study-specific survey
timeFrame: 1 and 6 months
measure: Patient acute and post-acute care utilization
timeFrame: Baseline to 12 months
measure: Patient outpatient health care utilization
timeFrame: Baseline to 12 months
measure: Patient enrollment in and days on hospice before death
timeFrame: Baseline to 12 months
measure: Patient death
timeFrame: Baseline to 12 months
measure: Caregiver quality of life measured with the PROMIS-10
timeFrame: Change from baseline to 1 and 6 months
measure: Caregiver burden measured with the Zarit-12 Caregiver Burden Scale
timeFrame: Change from baseline to 1 and 6 months
measure: Caregiver acute and post-acute care utilization
timeFrame: Baseline to 12 months
measure: Caregiver outpatient health care utilization
timeFrame: Baseline to 12 months
measure: HBPC clinician perception of facilitators and barriers to implementation of HBPC services
timeFrame: Yearly, up to four years
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Huong Q Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Richard A Mularski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.