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.