Comparative Trial of Home-Based Palliative Care

Cancer Clinical Trial

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Official title:

A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03694431
• Other study ID #: PLC-1609-36108
• Status: Terminated
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: January 24, 2020

Study information

• Verified date: February 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3999
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Tech-supported HBPC
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
• Standard HBPC
Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California	Pasadena	California
United States	Kaiser Permanente Northwest	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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