PROJECT SUMMARY/ABSTRACT This K99/R00 application describes the background and experience of the applicant, Rachel Wells, PhD, RN, and her plan to acquire the knowledge and training necessary to become a leading independent clinical investigator in developing and testing early palliative care interventions that optimize the outcomes of underserved individuals living with advanced heart failure (HF). This training and proposed research are of importance because: 1) substantial unmet palliative care needs of persons living with advanced HF; 2) few investigators are examining the mechanisms underlying palliative care intervention components to optimize intervention effect; and 3) the development of efficacious and scalable palliative care interventions in HF is a key research priority. The overall K99 goals are to gain advanced research training in developing behavioral interventions, conducting randomized controlled trials using the Multiphase Optimization Strategy (MOST), and advanced research ethics to refine and pilot test components of a lay navigator-led early palliative care intervention for underserved persons with advanced HF in the Southern U.S. The goal of the UPHOLDS intervention (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering), will be to improve quality of life (QOL) by activating advanced HF patients through trained lay navigators coaching. The specific training objectives during the K99 phase are to: (1) develop and tailor interventions that are: 1a) manualized with rigorous fidelity procedures for enhanced replication and scalability; 1b) tailored to underserved populations; and 1c) led by lay navigators; (2) develop skills to design and lead RCTs using the MOST framework; and (3) continue training in research ethics. A comprehensive training plan has been developed in concert with mentorship team of senior research experts and includes intensive face-to-face mentorship, formal coursework/workshops, clinical trial observerships, and conference attendance. The K99 research aim will be met using interviews with a) underserved persons with advanced HF, b) lay healthcare navigators, and c) palliative care and HF clinicians, to modify and refine the content, format and delivery of HF palliative care intervention components. The overall goal during the R00 phase is to conduct an optimization pilot using a 23 factorial design to assess acceptability, feasibility, and potential efficacy of the newly refined UPHOLDS intervention. The research specific aims during the R00 phase are to: 1) determine the feasibility and acceptability of using a highly innovative MOST factorial design approach to enroll and retain 40 advanced HF patients for 24 weeks and 2) explore the preliminary efficacy of individual intervention components and component interactions on patient outcomes (QOL, primary outcome) at 12- and 24- weeks after baseline. The results will directly support an R01 application to conduct a fully powered MOST factorial trial to test the effects of individual palliative care intervention components on advanced HF patient outcomes.

PROJECT NARRATIVE For the 6.2 million U.S. adults living with heart failure (HF), the burden of poor quality of life, high symptom burden, complex treatment decisions, and frequent hospitalizations on patients, family caregivers, and the healthcare system is significant and growing; by 2030, the prevalence of HF is projected to exceed 8 million adults with direct healthcare costs ballooning to over $77 billion annually. Despite recent guidelines recommending the early introduction of palliative care to address these considerable burdens, the development of efficacious and scalable palliative care interventions for this population remains sluggish. The proposed training and research application aligns with the NINR Strategic Plan and aims to optimize an early palliative care intervention to maximally benefit quality of life among underserved individuals living with advanced HF.