INTEGRATING PALLIATIVE CARE WITH DISEASE MANAGEMENT TO IMPROVE OUTCOMES AMONG PATIENTS WITH ADVANCED HEART FAILURE: INTERVENTIONAL RESEARCH CAREER DEVELOPMENT

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PROJECT SUMMARY/ABSTRACT Candidate. The purpose of this K01 mentored career development award is to support Dionysios Kavaliera- tos, Ph.D. in establishing a clinical research program that will improve patient, caregiver, and systems out- comes in advanced heart failure (HF) through the delivery of palliative care. His long-term goal is to become an independent health services researcher conducting patient-centered comparative effectiveness research to im- prove quality of life for individuals affected by serious cardiopulmonary illness. Through this K01, his short- term goal is to learn how to design and evaluate scalable and widely disseminable interventions to integrate palliative care principles into standard cardiac management of advanced HF. Specifically, Dr. Kavalieratos will strengthen his research expertise by way of four interrelated career development objectives: (1) to deepen his understanding of the clinical management of patients with HF and the state-of-the-science regarding palliative care interventions in HF; (2) to develop expertise in designing, conducting, and evaluating complex behavioral interventions; (3) to learn dissemination and implementation science theory and methods; and (4) to develop practical skills in the management, leadership, and ethics involved in clinical research. Mentoring and Environment. Supporting Dr. Kavalieratos's career development experience is an inten- tionally-designed mentoring team composed of renowned clinicians and researchers who have an outstanding track record of mentoring junior investigators. His Primary Mentors are: Robert M. Arnold, MD FAAHPM (ex- pertise: palliative care) and Bruce L. Rollman, MD MPH (comparative effectiveness trials of collaborative care interventions). His Secondary Mentors are: Marie Bakitas, DNSc FAAN (nurse-led palliative care interven- tions) and Jeffrey Teuteberg, MD (advanced HF). In addition, Dr. Kavalieratos has assembled a Career Adviso- ry Committee to evaluate his progress towards career independence, comprising: Larry A. Allen, MD (cardio- vascular outcomes research), David Bekelman, MD MPH (palliative care interventions in HF), and Morris Weinberger, PhD (pragmatic clinical trials). As an Assistant Professor of Medicine within the University of Pittsburgh's Division of General Internal Medicine, Dr. Kavalieratos will have full access to the resources, facili- ties, and institutional capital of the School of Medicine, its Clinical and Translational Science Institute, and the University of Pittsburgh Medical Center. The Division has a strong record of developing successful independent investigators; more than 30 of its investigators have held or do hold individual career development awards. Research. Background: Over 6 million Americans live with the physical, psychosocial, and healthcare burdens of HF. Palliative care, when provided by a palliative care specialist, has been demonstrated to alleviate many of these burdens. Unfortunately, the specialty palliative care workforce is so severely limited that specialty palliative care is neither a feasible or scalable strategy to meet the needs of a growing HF population. As such, there is a critical need for innovative solutions to integrate palliative care into standard HF management, particularly for patients receiving care outside of major academic medical centers. This proposal focuses on “primary palliative care,” defined as basic palliative care delivered by clinicians without palliative care specialty training. Specific Aims: First, we will develop a patient-centered, nurse-led primary palliative care intervention for patients with advanced HF in outpatient cardiology clinics. With formative data generated in Dr. Kavalieratos's K12 award, we will develop a structured intervention using the Medical Research Council's Framework for De- velopment and Evaluation of RCTs for Complex Interventions. Second, we will conduct a pilot randomized con- trolled trial (RCT) of the intervention versus usual care to assess feasibility and fidelity. This intervention, based on the Chronic Care Model, will partner with an existing cardiology clinic nurse to deliver primary pallia- tive care, targeting the challenges and outcomes important to patients with HF and their caregivers. We will randomize 50 individuals with NYHA Class III/IV HF to the intervention or usual care. Third, we will refine the intervention by exploring its acceptability, barriers, facilitators, and mechanisms of action among patients, caregivers, and clinicians. Using the RE-AIM framework of intervention impact, we will conduct a rigorous mixed-methods evaluation of the intervention in preparation for a fully-powered comparative effectiveness tri- al. To ensure that this work is impactful, feasible, and sustainable, we have assembled an advisory board of patients, caregivers, clinicians, and administrators to provide input on all phases of this project, from interven- tion development through interpretation of results. The proposed research will provide Dr. Kavalieratos with the preliminary data, training, and experience to develop and lead a fully-powered R01-level pragmatic RCT to compare the effectiveness of primary palliative care versus usual HF care in patients with advanced HF be- ing cared for in community cardiology clinics. In turn, this award will contribute to Dr. Kavalieratos's devel- opment as a leader within the cardiopulmonary outcomes research community as he will develop, test, then deploy clinically-relevant, patient-centered strategies to promote the provision of palliative care, thereby im- proving patient, caregiver, and systems outcomes.