Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups
Phase: NA
Conditions: Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
Sponsor: University of Southern California

Expanding Access to Home-Based Palliative Care 
Through Primary Care Medical Groups 
Clinicaltrials.org ID: NCT03128060 
March 22, 2018

 
Study Protocol 
  
• 
Summary  
Patients with serious illness arising 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 seriously ill patients. Although similar 
to hospice care in its focus on comfort measures, palliative care differs from hospice 
in that it may be offered early in the course of an illness 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 most of their time and require the most 
support.  
  
This study compares outcomes from two groups: patients who receive enhanced 
usual care (EUC), with usual care enhanced by provider training in palliative care, 
and patients who receive home-based palliative (HBPC) care provided by a primary 
care team. About 1,155 seriously ill patients with cancer, HF, or COPD (and 884 of 
their caregivers) will be randomly assigned to either group. The HBPC model will be 
integrated into primary care clinics. HBPC team members—a physician, nurse, 
social worker, and chaplain—will provide pain and symptom management, 
psychosocial and spiritual support, disease management education, and other 
services in response to patient and caregiver needs. Services are delivered at the 
patient’s home. The model also features a 24/7 call center.  
  
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Objectives:   
  
1. Primary objective:  To test the comparative effectiveness of an evidence-based 
model of HBPC integrated within Medicare Advantage and ACO-participating 
primary care clinics and enhanced usual care (EUC) on patient and caregiver 
outcomes.   
  
2. Secondary objectives:   
Evaluate the effectiveness of HPBC compared to EUC in patient subgroups defined 
by: (1) medical condition (cancer, CHF, COPD), (2) age, (3) race (white/nonwhite).  
    
Determine the ability to engage primary care physicians in primary palliative care 
training and practice.  
  
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Subjects: Seriously ill patients (and their caregivers) who receive primary care from 
regional Accountable Care Organizations (ACOs) in California. Specifically:  
  

Patient Inclusion Criteria:   
1. Age 18 or older  
2. Diagnosis of heart failure (HF), COPD or advanced cancer  
3. ≥2 hospitalizations or ED visits in the past year  
4. Palliative Performance Scale: <fully able on both Ambulation and Self-Care          
5. English- or Spanish-speaking  
  
Patient Exclusion Criteria:  
1. Receiving hospice care  
2. End stage renal disease    
3. Lives in a nursing or assisted living facility or a group home  
       
Caregiver Inclusion Criteria:  
1. English- or Spanish-speaking  
2. Age 18 or older  
3. Able to provide informed consent  
  
Caregiver Exclusion Criteria:  
1. Professional paid caregiver  
   
• 
Sample size: 1155 participants (approx. 577 per treatment arm); 884 caregivers  
  
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Interventions: Patients will be randomized in a 1:1 allocation ratio to HBPC or EUC.  
Randomization will be stratified on ACO; randomization will be further blocked within 
ACO strata.  
  
1. Home-based Palliative Care (HBPC): The HBPC model will consist of home 
visits by a trained, interdisciplinary primary palliative care team comprising a 
physician, nurse, social worker, and chaplain. This core team will provide pain 
and symptom management, psychosocial support, ACP, disease management 
education, spiritual counseling, grief counseling, and other services in response 
to patient and caregiver needs.  Following the patient’s initial assessment, the 
frequency of subsequent home visits will be based on the patient’s and 
caregiver’s needs and preferences. At a minimum, a core team member will visit 
the patient at home once per week.  
  
2. Enhanced Usual Care (EUC): We will enhance the usual primary care services 
provided by each participating medical group with training in palliative care to all 
PCPs at the regional ACOs. The training program will align with CAPC’s 
recommended curriculum for enhancing the palliative care skills of frontline 
clinicians and address core elements of palliative care.  
  
3. All patients (HBPC and EUC) enrolled in the study may continue to seek and 
receive curative and usual care in addition to palliative care  

  
  
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Follow-up:  Trial recruitment is planned for 2.5 years.  Each patient and caregiver 
will be followed with outcome assessments at baseline, 1 month, and 2 months.  
Caregivers will receive an additional assessment 2 months following a patient death.  
  
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Primary patient outcomes:   
1. Patient-reported symptoms (measured by Condensed Memorial Symptom  
Assessment Scale [CMSAS])  
2. Depression (measured by Hospital Anxiety and Depression Scale [HADS] and 
the PHQ-9)  
3. Anxiety (measured by Hospital Anxiety and Depression Scale [HADS])  
  
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Secondary patient outcomes:    
1. Hope (measured by the Herth Hope Index)  
2. Patient-physician communication (measured by Consultation Care Measure)  
3. Survival time  
4. Number of emergency department (ED) visits, number of hospitalizations, length 
of hospital stay  
  
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Secondary caregiver outcomes:  
1. Caregiver burden (Zarit Burden Scale)  
2. Experience of death (measured by Family Assessment of Treatment at the End 
of Life)  
3. Depression and anxiety (HADS)  
4. Quality of Life (Promis)