The overarching goal of this PFA is to generate needed CER evidence to: a) support care planning over time that is consistent with the goals and preferences of adult patients with advanced illnesses and their caregivers, and b) support the delivery of coordinated, community-based palliative care that effectively implements those care plans. PCORI seeks to fund multiple, large, multi-site, community-based CER studies to generate evidence in support of this goal.

Background

PCORI’s mission is to help people make informed healthcare decisions, and improve healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community. PCORI relies on input from multiple stakeholders to set its research priorities. On March 7, 2016, PCORI convened a large multi-stakeholder workshop to discuss specific CER questions on patient-centered palliative care delivery that could be addressed by PCORI-funded research. This workshop focused on decisional dilemmas commonly faced by patients with advanced illnesses, their caregivers, clinicians, healthcare systems, and other stakeholders, and identified opportunities for research to compare different efficacious and/or widely used intervention approaches to address those dilemmas in real-world settings. The meeting was open to the public via teleconference and webinar. Summary information from that meeting is available on the Palliative Care Workgroup page.

Research Initiative Highlights

Based on the key gaps noted in the literature, input from our large multi-stakeholder workshop, and guidance from the PCORI Board of Governors’ Scientific Oversight Committee, this PFA solicits applications that respond to the following two priority comparative effectiveness research questions:

1. Advance Care Planning:

What is the comparative effectiveness of different patient and caregiver-directed, clinician-directed, and combination approaches to facilitating advance care planning conversations between adult patients living with advanced illnesses, their caregivers, and clinicians on patient-centered and other outcomes over time?

Applicants responding to this research question should:

• Focus on geographically and racially/ethnically diverse patients living at home with any serious advanced illness and who experience a high symptom burden and/or functional limitations, their caregivers, and/or clinicians providing health care to patients with advanced illness. Conditions may include but are not limited to advanced heart failure, COPD, advanced kidney disease, advanced neurodegenerative diseases, advanced cancers, as well as combinations of the above.
• Compare two or more efficacious and/or widely used programs and/or interventions designed to facilitate advance care planning conversations and documentation of goals of care over time. Interventions should target patients, caregivers, and/or clinicians as well as combined approaches.
• Measure and evaluate an appropriate balance of proximal, intermediate, and long-term outcomes including measures of care planning process and behavior outcomes, measures of patient and caregiver experiences and health outcomes, and measures of goal concordance of care.
• Conduct the studies in community-based settings such as hospital-based clinics, solo or group physician practices, and the patient’s home. In-patient institutionalized settings such as nursing homes and hospices are not included under this announcement.
• Propose a randomized controlled trial or cluster randomized controlled trial study design. Well-designed, comparative observational studies and natural experiments of established programs with evidence of efficacy may also be proposed. 
• Have strong endorsement and study participation by patient organizations, professional organizations, payer or purchaser organizations, and other relevant stakeholder groups.

2. Community-Based Models of Palliative Care

What is the comparative effectiveness of different established models of palliative care in community settings on improving patient-centered and other outcomes among adult patients with advanced illnesses and their caregivers?

Applicants responding to this research question should:

• Focus on geographically and racially/ethnically diverse patients living at home with any serious advanced illness and who experience a high symptom burden and/or functional limitations, and their caregivers. Conditions may include but are not limited to advanced heart failure, COPD, advanced kidney disease, advanced neurodegenerative diseases, advanced cancers, as well as combinations of the above.
• Compare two or more established palliative care models that vary on one or more of the following parameters: level of integration between primary/subspecialty clinicians and palliative care specialists (e.g., consultative model, nurse-led case management model, co-management model); site of palliative care delivery (outpatient clinic/doctor’s office, home, or both); method of care delivery (in-person visit, remote/telemedicine, or both).
• Measure and evaluate patient- and family-centered outcomes as primary end points (e.g., patient and caregiver quality of life, patient symptom burden, patient and caregiver distress, caregiver burden, receipt of goal concordant care); secondary outcomes may include patient experiences and satisfaction with care, measures of healthcare utilization, and patient and caregiver out-of-pocket costs.
• Conduct the studies in community-based settings such as hospital-based clinics, solo or group physician practices, and the patient’s home. Inpatient institutionalized settings such as nursing homes and hospices are not included under this announcement.
• Propose a cluster randomized controlled trial study design. Alternate randomized trial designs or well-designed comparative observational studies and natural experiments of established programs with evidence of efficacy may also be proposed.
• ​Have strong endorsement and study participation by patient organizations, professional organizations, payer or purchaser organizations, and other relevant stakeholder groups. 

Helpful Resource

Additional information can be found in the Board of Governors meeting slides related to this upcoming funding announcement, as well as in summary materials from the PCORI multi-stakeholder workgroup meeting.