Expanding Access to Home-Based Palliative Care

Cancer Clinical Trial

Official title:

Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03128060
• Other study ID #: PCORI-1234
• Status: Terminated
• Phase: N/A
• Start date: August 19, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Home-based palliative care
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.
• Enhanced usual care
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.

Locations

Country	Name	City	State
United States	USC Davis School of Gerontology	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Score on the Edmonton Symptom Assessment for patients	This is a brief and reliable (Cronbach alpha: 0.85) self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms.	At baseline and 1- and 2- months following baseline
Primary	Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients	The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D).	At baseline and 1- and 2- months following baseline
Secondary	Change in Score on the Patient Health Questionnaire-9 (PHQ-9) for patients	This is a 9-item assessment to diagnose depression. It is based on the nine DSM-IV criteria for depression	At baseline and 1- and 2- months following baseline
Secondary	Change in rating of being at peace among patients	This is a 1-item probe that assesses an individual's feeling of being at peace.	At baseline and 1- and 2- months following baseline
Secondary	Change in Score on Hearth Hope Index for patients	This 12-item scale is used to assess hope as it relates to a person's ability to cope with medical illness, loss, and related psychosocial stressors.	At baseline and 1- and 2- months following baseline
Secondary	Change in Consultation Care Measure (CCM) for patients	This patient-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life.	At baseline and 1- and 2- months following baseline
Secondary	Change in Score on Zarit Burden (ZBI) Interview among caregivers	The Zarit Burden Interview (ZBI) is a 12-item instrument that has been used with caregivers for a wide range of patients, including those with chronic illnesses. The instrument demonstrates good internal reliability, with a Cronbach's alpha of 0.93, and test-retest reliability of 0.89.	At baseline and 1- and 2-months following baseline
Secondary	Caregiver's experience of death rating on Family Assessment of Treatment at End of Life (FATE-S), when applicable	We will use the Family Assessment of Treatment at End of Life (FATE) to measure caregiver's experience of death . This survey is reliable and valid and is used by the Veteran's Administration across the country.	Whenever a patient death occurs during the 2-month study period
Secondary	Change in Score on Hospital Anxiety and Depression Scale (HADS) for caregivers	The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D).	At baseline and 1- and 2- months following baseline
Secondary	Change in Consultation Care Measure (CCM) for caregivers	This caregiver-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life.	At baseline and 1- and 2- months following baseline