Candidate. The purpose of this K01 mentored career development award is to support Dionysios Kavalieratos, Ph.D. in establishing a clinical research program that will improve patient, caregiver, and systems outcomes 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 improve 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 intentionally-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 (expertise: 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 interventions) and Jeffrey Teuteberg, MD (advanced HF). In addition, Dr. Kavalieratos has assembled a Career Advisory Committee to evaluate his progress towards career independence, comprising: Larry A. Allen, MD (cardiovascular 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, facilities, 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 Development and Evaluation of RCTs for Complex Interventions. Second, we will conduct a pilot randomized controlled 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 palliative 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 trial. 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 intervention 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 being cared for in community cardiology clinics. In turn, this award will contribute to Dr. Kavalieratos's development 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 improving patient, caregiver, and systems outcomes.

Public Health Relevance

The proposed research and career development plan are relevant to public health because identifying feasible, scalable, and pragmatic strategies to alleviate the burdens of advanced HF have the potential to improve outcomes among individuals affected by HF, including quality of life, symptom control, emotional health, caregiver burden, and care coordination. The completion of this research will advance the evidence base for palliative care in cardiology by providing data on novel intervention to address sources of burden among individuals affected by advanced HF, informed by the perspectives of patients with HF, their caregivers, and clinicians. Therefore, these research and career development aims align with the NHLBI's mission of promoting evidence- based treatments for heart disease to enhance the health and wellbeing of individuals.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Scientist Development Award - Research & Training (K01)
Project #
5K01HL133466-04
Application #
9730577
Study Section
NHLBI Mentored Clinical and Basic Science Review Committee (MCBS)
Program Officer
Cooper, Lawton S
Project Start
2016-08-01
Project End
2020-05-31
Budget Start
2019-06-01
Budget End
2020-05-31
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15260
Schenker, Yael; Bahary, Nathan; Claxton, Rene et al. (2018) A Pilot Trial of Early Specialty Palliative Care for Patients with Advanced Pancreatic Cancer: Challenges Encountered and Lessons Learned. J Palliat Med 21:28-36
Lindell, Kathleen Oare; Kavalieratos, Dio; Gibson, Kevin F et al. (2017) The palliative care needs of patients with idiopathic pulmonary fibrosis: A qualitative study of patients and family caregivers. Heart Lung 46:24-29
Kavalieratos, Dio; Gelfman, Laura P; Tycon, Laura E et al. (2017) Palliative Care in Heart Failure: Rationale, Evidence, and Future Priorities. J Am Coll Cardiol 70:1919-1930
Kavalieratos, Dio; Siconolfi, Daniel E; Steinhauser, Karen E et al. (2017) ""It Is Like Heart Failure. It Is Chronic … and It Will Kill You"": A Qualitative Analysis of Burnout Among Hospice and Palliative Care Clinicians. J Pain Symptom Manage 53:901-910.e1
Gelfman, Laura P; Kavalieratos, Dio; Teuteberg, Winifred G et al. (2017) Primary palliative care for heart failure: what is it? How do we implement it? Heart Fail Rev 22:611-620
Hanmer, Janel; Hess, Rachel; Sullivan, Sarah et al. (2016) Benchmarking health-related quality-of-life data from a clinical setting. Am J Manag Care 22:669-675
Kamal, Arif H; Bull, Janet; Kavalieratos, Dio et al. (2016) Development of the Quality Data Collection Tool for Prospective Quality Assessment and Reporting in Palliative Care. J Palliat Med 19:1148-1155
Kavalieratos, Dio; Corbelli, Jennifer; Zhang, Di et al. (2016) Association Between Palliative Care and Patient and Caregiver Outcomes: A Systematic Review and Meta-analysis. JAMA 316:2104-2114