Comparative Trial of Home-Based Palliative Care (HomePal)

Kaiser Permanente

Status: Terminated

Conditions: Neuromuscular Diseases; Chronic Obstructive Pulmonary Disease; End Stage Renal Disease; Heart Failure; Cancer; End Stage Liver Disease; Dementia

Treatments: Other: Tech-supported HBPC; Other: Standard HBPC

Study type: Interventional

Funder types: Other

Identifiers

NCT03694431

PLC-1609-36108

Details and patient eligibility

About

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.

Enrollment: 3,999 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,999 participants in 2 patient groups

Standard HBPC

Active Comparator group

Description:

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

Treatment:

Other: Standard HBPC

Tech-supported HBPC

Experimental group

Description:

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.

Treatment:

Other: Tech-supported HBPC