Comparative Trial of Home-Based Palliative Care
NCT03694431 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3999
Last updated 2020-02-20
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.
Conditions
- Cancer
- Chronic Obstructive Pulmonary Disease
- Heart Failure
- Dementia
- End Stage Liver Disease
- End Stage Renal Disease
- Neuromuscular Diseases
Interventions
- OTHER
-
Tech-supported HBPC
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
- OTHER
-
Standard HBPC
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Kaiser Permanente
lead OTHER
Principal Investigators
-
Huong Q Nguyen, PhD · Kaiser Permanente
-
Richard A Mularski, MD · Kaiser Permanente
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-07
- Primary Completion
- 2020-01-24
- Completion
- 2020-01-24
Countries
- United States
Study Locations
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