Comparative Trial of Home-Based Palliative Care (HomePal)

• ClinicalTrials.gov Identifier: NCT03694431
• Recruitment Status: Terminated
• First Posted: October 3, 2018
• Last Update Posted: February 20, 2020
• Sponsor: Kaiser Permanente
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Kaiser Permanente

Tracking Information

• First Submitted Date: September 27, 2018
• First Posted Date: October 3, 2018
• Last Update Posted Date: February 20, 2020
• Actual Study Start Date: January 7, 2019
• Actual Primary Completion Date: January 24, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2018)

• Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: Change from baseline to 1 month ]
  The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms.
• Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC [ Time Frame: Baseline to 12 months ]
• Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale [ Time Frame: Change from baseline to 1 month ]
  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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 1, 2018)

• Days at home between study enrollment and death or study completion (365 days) [ Time Frame: Variable, up to 12 months ]
• Patient quality of life measured with the PROMIS-10 survey [ Time Frame: Change from baseline to 1 and 6 months ]
  The PROMIS-10 is a 10-item survey measuring general health related quality of life. Scores range from 0-100 with higher scores indicating better quality of life
• Patient general distress measured with the distress thermometer [ Time Frame: Change from baseline to 1 and 6 months ]
  Scores for this single item distress thermometer range from 0-10 with higher scores indicating greater distress
• Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR) [ Time Frame: Baseline and variable time periods due to reliance on available data from the EMR ]
  The Palliative Performance Scale measures overall functional status. A clinician completes this assessment using a scale of 0-100 with higher scores indicating better functional performance
• Patient satisfaction-care experience measured by a study-specific survey [ Time Frame: 1 and 6 months ]
  This 8-item satisfaction-care experience survey was developed specifically to measure satisfaction and care experience with home-based palliative care.
• Patient acute and post-acute care utilization [ Time Frame: Baseline to 12 months ]
  Frequency of hospitalizations, emergency department visits and skilled nursing facility stay
• Patient outpatient health care utilization [ Time Frame: Baseline to 12 months ]
  Frequency of primary and specialty care visits
• Patient enrollment in and days on hospice before death [ Time Frame: Baseline to 12 months ]
• Patient death [ Time Frame: Baseline to 12 months ]
• Caregiver quality of life measured with the PROMIS-10 [ Time Frame: Change from baseline to 1 and 6 months ]
  The PROMIS-10 is a 10-item survey measuring general health related quality of life. Scores range from 0-100 with higher scores indicating better quality of life
• Caregiver burden measured with the Zarit-12 Caregiver Burden Scale [ Time Frame: Change from baseline to 1 and 6 months ]
  The Zarit-12 is a 12-item survey measuring caregiver burden. Scores range from 0-48 with higher scores indicating greater caregiver burden
• Caregiver acute and post-acute care utilization [ Time Frame: Baseline to 12 months ]
  Frequency of hospitalizations, emergency department visits and skilled nursing facility stay for caregivers who are members of Kaiser Permanente
• Caregiver outpatient health care utilization [ Time Frame: Baseline to 12 months ]
  Frequency of primary and specialty care visits for caregivers who are members of Kaiser Permanente
• HBPC clinician perception of facilitators and barriers to implementation of HBPC services [ Time Frame: Yearly, up to four years ]
  Study specific survey (under development)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparative Trial of Home-Based Palliative Care
• Official Title: A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition

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

Intervention

• 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

Study Arms

• Active Comparator: Standard HBPC
  Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits
  Intervention: Other: Standard HBPC
• Experimental: 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.
  Intervention: Other: Tech-supported HBPC

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 18, 2020): 3999
• Original Estimated Enrollment (submitted: October 1, 2018): 14800
• Actual Study Completion Date: January 24, 2020
• Actual Primary Completion Date: January 24, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03694431
• Other Study ID Numbers: PLC-1609-36108
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kaiser Permanente
• Original Responsible Party: Same as current
• Current Study Sponsor: Kaiser Permanente
• Original Study Sponsor: Same as current
• Collaborators: Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Huong Q Nguyen, PhD; Kaiser Permanente
• Principal Investigator: Richard A Mularski, MD; Kaiser Permanente

• PRS Account: Kaiser Permanente
• Verification Date: February 2020