Defining Best Practices to Optimize Caregiving Requirements after Heart Replacement Therapies: A Pre-Implementation Study - 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.
