Comparative Trial of Home-Based Palliative Care

NCT ID: NCT03694431

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3999 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2020-01-24

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard HBPC

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

Group Type: ACTIVE_COMPARATOR

Standard HBPC

Intervention Type: OTHER

Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care

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.

Group Type: EXPERIMENTAL

Tech-supported HBPC

Intervention Type: OTHER

Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care

Interventions

Tech-supported HBPC

Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care

Intervention Type: OTHER

Standard HBPC

Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care

Intervention Type: OTHER

Eligibility Criteria

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

• Non-professional family, friend or other caregiver
• English or Spanish speakers

Exclusion Criteria

• Currently receiving HBPC

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huong Q Nguyen, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Richard A Mularski, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Southern California

Pasadena, California, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Countries

United States

References

Nguyen HQ, Haupt EC, Duan L, Hou AC, Wang SE, Mariano JD, Lee JA, McMullen C. Hospital utilisation in home palliative care: caregiver health, preparedness and burden associations. BMJ Support Palliat Care. 2022 Jan 25:bmjspcare-2021-003455. doi: 10.1136/bmjspcare-2021-003455. Online ahead of print.

Reference Type: DERIVED

PMID: 35078873 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34735285 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31486724 (View on PubMed)

Other Identifiers

PLC-1609-36108

Identifier Type: -

Identifier Source: org_study_id