Comparative Trial of Home-Based Palliative Care

NCT03694431 | Terminated DMC

• 1 other identifier: PLC-1609-36108
• Study Type: interventional
• Target: 3,999
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)

  The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms.

  Change from baseline to 1 month

• 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

  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

  Change from baseline to 1 month

Secondary Outcomes (14)

• 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

• Patient general distress measured with the distress thermometer

  Change from baseline to 1 and 6 months

• 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

• Patient satisfaction-care experience measured by a study-specific survey

  1 and 6 months

Study Arms (2)

Standard HBPC

ACTIVE COMPARATOR

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

Other: Standard HBPC

Tech-supported HBPC

EXPERIMENTAL

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

Interventions

Tech-supported HBPC OTHER

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

Tech-supported HBPC

Standard HBPC OTHER

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

Standard HBPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serious illness with 12-24 month life expectancy
• Homebound
• Need for skilled nursing care (only at KP Southern California)
• English or Spanish speakers

You may not qualify if:

• \- Currently receiving HBPC
• Non-professional family, friend or other caregiver
• English or Spanish speakers

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• 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.

  PMID: 35078873 DERIVED

• 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.

  PMID: 34735285 DERIVED

• 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.

  PMID: 31486724 DERIVED

MeSH Terms

Conditions

Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure; Dementia; End Stage Liver Disease; Kidney Failure, Chronic; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Huong Q Nguyen, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Richard A Mularski, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 3, 2018
• Study Start: January 7, 2019
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)