Clinical trial NCT03128060: Expanding Access to Home-Based Palliative Care
Official title: Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-04-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background and Significance

Patients with serious illness from cancer, heart failure (HF), and chronic obstructive pulmonary disease (COPD) often receive poor quality of care, resulting in unmitigated pain and related symptoms, unmet psychosocial needs, and significant caregiver burden. Palliative care, a patient-centered approach that provides pain and symptom management and psychosocial and spiritual support, has strong evidence for improved outcomes for these seriously ill patients. Palliative care differs from hospice in that it is offered early in the illness course and in conjunction with other therapies intended to prolong life. Most palliative care programs are hospital-based; few offer care at home, where patients spend the most time and require the most support.

Study Aims

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.

The study's specific aims are:

* Specific Aim 1: Determine differences in improvement on measures of physical and psychological well-being between patients receiving HBPC and patients receiving enhanced usual care (EUC).
* Specific Aim 2: Determine differences in survival time between patients receiving HBPC and patients receiving EUC.
* Specific Aim 3: Determine differences in number of emergency department (ED) visits and hospital admissions between patients receiving HBPC and patients receiving EUC.
* Specific Aim 4: Determine differences in improvement on patient-provider communication between patients receiving HBPC and patients receiving EUC.
* Specific Aim 5: Determine differences in improvement on psychosocial outcomes between caregivers of patients receiving HBPC and caregivers of patients receiving EUC.

Study Description

Study Population. The study will enroll 1,155 patients and approximately 883 caregivers from primary care medical groups operating under ACO contracts with Blue Shield of California (Blue Shield), the study's insurance partner. About 75% of patients will be age 65 or older; about 55% will be female. About 45% of patients will be ethnic minority members, predominantly of Hispanic decent.

Comparators. The study will compare outcomes from two groups: patients who receive EUC (with usual care enhanced by: 1) provider training in palliative care; 2) case management for EUC patients; and 3) provider support through palliative care consultation) and patients who receive HBPC provided by an HBPC team. HBPC 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.

Outcomes. Primary outcomes are change in patient pain, symptoms, depression, and anxiety. These measures will be collected via patient self-report at baseline and at one- and two-months following enrollment. Change in survival, ED visits, and hospital episodes (including length of stay, when applicable) also are primary outcomes that will be collected from the electronic medical record (EMR). These data will be collected following patient death or at study's end. Secondary patient outcomes are peace, patient-physician communication, and hope.Secondary caregiver outcomes are change in caregiver depression, anxiety, burden, and patient-physician communication, with these assessments all collected at baseline and one- and two-months following enrollment. Caregiver's experience of patient death will be collected one month following patient death, when applicable.

Analytic Methods. Investigation of the main effect of HBPC and EUC on outcomes will be conducted at each follow-up and then on the longitudinal trend. Baseline outcome measures will be treated as covariates to control for potential baseline differences. Repeated measures analyses will be used to investigate the longitudinal effects of program conditions on outcome measures. Sub-analyses will examine outcome differences by patient age, diagnosis, and race.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older;
2. diagnosis of HF, COPD, or advanced cancer;
3. one or more hospitalizations or ED visits in the previous year;
4. an Australia-Modified Karnofsky Performance Scale score of 70% or less; and
5. English- or Spanish-speaking.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Score on the Edmonton Symptom Assessment for patients
timeFrame: At baseline and 1- and 2- months following baseline
measure: Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients
timeFrame: At baseline and 1- and 2- months following baseline
Secondary outcomes:
measure: Change in Score on the Patient Health Questionnaire-9 (PHQ-9) for patients
timeFrame: At baseline and 1- and 2- months following baseline
measure: Change in rating of being at peace among patients
timeFrame: At baseline and 1- and 2- months following baseline
measure: Change in Score on Hearth Hope Index for patients
timeFrame: At baseline and 1- and 2- months following baseline
measure: Change in Consultation Care Measure (CCM) for patients
timeFrame: At baseline and 1- and 2- months following baseline
measure: Change in Score on Zarit Burden (ZBI) Interview among caregivers
timeFrame: At baseline and 1- and 2-months following baseline
measure: Caregiver's experience of death rating on Family Assessment of Treatment at End of Life (FATE-S), when applicable
timeFrame: Whenever a patient death occurs during the 2-month study period
measure: Change in Score on Hospital Anxiety and Depression Scale (HADS) for caregivers
timeFrame: At baseline and 1- and 2- months following baseline
measure: Change in Consultation Care Measure (CCM) for caregivers
timeFrame: At baseline and 1- and 2- months following baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Davis School of Gerontology
state: California
Study officials:
affiliation: USC Davis School of Gerontology
name: Susan Enguidanos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.