Expanding Access to Home-Based Palliative Care

NCT03128060 | Terminated Results DMC

• 1 other identifier: PCORI-1234
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of integrating an evidence-based model of home-based palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill patients (and approximately 884 family caregivers) who receive primary care from 30-40 regional accountable care organizations (ACOs) in California to one of two study groups: HBPC or enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate, following the death of the patient.

Conditions

Cancer; Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Edmonton Symptom Assessment Survey for Patients

  The Edmonton Symptom Assessment Survey for patients is a brief and reliable self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms. Response scores range from 0 (no pain/symptoms) to 90 (highest pain symptoms) based on responses scored from 0 (no pain/symptoms) to 10 (highest pain/symptoms) on 9 items. Note: our data represents the composite score of the 9 items.

  1-month following baseline

• Hospital Anxiety and Depression Scale (HADS) for Patients

  The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression using a 4-point Likert scale. The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D). The total score for each subscale ranges from 0 to 21, and the total score is the sum of the two subscale scores. Low scores indicate normal responses while high scores are abnormal (0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).

  1-month following baseline

Secondary Outcomes (8)

• Patient Health Questionnaire-9 (PHQ-9) for Patients

  1-months following baseline

• Rating of Being at Peace Among Patients

  1-month following baseline

• Hearth Hope Index for Patients

  1-month following baseline

• Consultation Care Measure (CCM) for Patients

  At 1 months following baseline

• Zarit Burden: Short (ZBI) Interview Among Caregivers

  At 1 month following baseline

Study Arms (2)

Home-based Palliative Care

EXPERIMENTAL

Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.

Other: Home-based palliative care

Enhanced Usual Care

ACTIVE COMPARATOR

Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.

Other: Enhanced usual care

Interventions

Home-based palliative care OTHER

The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.

Also known as: Home-based primary palliative care

Home-based Palliative Care

Enhanced usual care OTHER

Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management. These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.

Enhanced Usual Care

Eligibility Criteria

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

You may qualify if:

• years of age or older;
• diagnosis of HF, COPD, or advanced cancer;
• one or more hospitalizations or ED visits in the previous year;
• an Australia-Modified Karnofsky Performance Scale score of 70% or less; and
• English- or Spanish-speaking.

You may not qualify if:

• is receiving hospice care;
• has end-stage renal disease; and/or
• lives in a nursing home.

Sponsors & Collaborators

• University of Southern California: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

USC Davis School of Gerontology

Los Angeles, California, 90089, United States

Location

Related Publications (3)

• Enguidanos S, Rahman A, Lomeli S. A Tale of Two Trials: A Comparative Case Study of Successful versus Terminated Home-Based Palliative Care Trials. J Palliat Med. 2022 Dec;25(12):1767-1773. doi: 10.1089/jpm.2022.0065. Epub 2022 Jun 8.

  PMID: 35675655 DERIVED

• Enguidanos S, Rahman A. Early Termination of a Palliative Care Trial: Perspectives of Multiple Stakeholders on Barriers to Palliative Care and Research. J Palliat Med. 2022 Jan;25(1):54-59. doi: 10.1089/jpm.2021.0234. Epub 2021 Jun 30.

  PMID: 34191594 DERIVED

• Enguidanos S, Rahman A, Fields T, Mack W, Brumley R, Rabow M, Mert M. Expanding Access to Home-Based Palliative Care: A Randomized Controlled Trial Protocol. J Palliat Med. 2019 Sep;22(S1):58-65. doi: 10.1089/jpm.2019.0147.

  PMID: 31486727 DERIVED

MeSH Terms

Conditions

Neoplasms; Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

After 18 months of significant enrollment challenges, largely based on our health insurance company providing palliative care to everyone who qualified and subsequent challenges in obtaining patient referrals to the study, we elected to terminate the trial.

Results Point of Contact

• Title: Susan Enguidanos
• Organization: University of Southern California

enguidan@usc.edu

(213) 740-9822

Study Officials

• Susan Enguidanos, Ph.D.

  USC Davis School of Gerontology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gerontology

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 25, 2017
• Study Start: August 19, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)