PROJECT SUMMARY/ ABSTRACT
Heart replacement therapies (HRT) (i.e., heart transplants and left ventricular assist devices [LVADs]) can
improve quality of life and survival in patients dying of advanced HF. The patient selection pathway for
receiving HRT is heterogeneous between centers with no universal consensus, increasing inequities and
limiting access to potentially life-saving therapies. The medical evaluation for HRT is standardized, but the
psychosocial assessment is different at each center, carries significant weight for candidacy, and is a
frequent cause for patients’ ineligibility for HRT. During the psychosocial evaluation, inadequate duration of
caregiving post-HRT is the most common perceived contraindication to candidacy. Caregiving requirements
in the U.S. currently have clusters of centers requiring up to 1 month, 1-3 months, or 3+ months. No
evidence exists to identify an ideal duration of caregiving to optimize patient outcomes. Variability in
caregiver requirements creates healthcare inequities, particularly among vulnerable populations where
socioeconomics can affect the ability for caregivers to devote longer durations of time away from work and/or
child rearing. However, these variations are also understandable since there are tradeoffs associated with a
decrease in caregiving requirements, including increased clinical staff burden after HRT. Per consensus,
longer caregiving durations create institutionalized structures that exacerbate inequitable access to life-
saving therapies, and 3+ months of continuous caregiving is considered “excessive” because centers with
lower requirements still report optimal clinical outcomes. Given a lack of true empirical basis for caregiving
standards and the willingness of some centers to create flexible, inclusive, creative solutions for patients
whose social resources are limited, our ultimate goal is to conduct an R01 type 1 hybrid effectiveness-
implementation trial that will: (1) test non-inferiority of shorter duration caregiving (1-month) at centers that
currently require 3+ months of caregiving and (2) create an evidence base to define associations between
caregiving and outcomes. However, changing center-specific caregiver rules will require significant planning,
resources, and adaptations prior to implementation. This grant proposal uses the PRISM implementation
science framework to conduct critical pre-implementation work. We will assess best practices and
organizational processes needed to decrease caregiving requirements using the positive deviance approach
(Aim 1), and will use implementation mapping to identify and adapt interventions that will allow centers to
shorten caregiving requirements while simultaneously limiting clinical staff burden and maintaining optimal
clinical outcomes (Aim 2). The goals of this research are consistent with the NHLBI’s strategic goals: (1) to
investigate factors that account for differences in health among populations and (2) to optimize clinical and
implementation research to improve health and reduce disease and inequities in care. The pre-
implementation work proposed is essential for center-level changes that will be adaptable, acceptable,
feasible, and sustainable as preliminary data for an R01 application.
