Study Assessing Feasibility and Effectiveness of Community-Based Heart Failure Care (SAFE-HF)) - PROJECT SUMMARY Heart failure affects million adults in the U.S., is associated with high mortality, and is a leading cause for hospitalizations. The long-term objective of this project is to understand the impact of an existing, trauma- informed, community-based, nurse-led heart failure disease management program that provides care to heart failure patients with adverse social determinants of health and unmet social needs (poverty, unstable housing, substance use, mental illness). The Community Heart Failure Program (CHFP) is operated out of a safety-net hospital in the Pacific Northwest and delivers an innovative model of care, where staff provide clinical care in the location of the patient’s choosing, often a shelter, tent, apartment, or other non-clinic-based location. Point- of-care labs and ultrasound support clinical decision-making. Using trauma-informed care principles, including safety, trustworthiness, collaboration, empowerment, and choice, the CHFP and this research project were designed to engage patients with adverse social determinants of health and unmet social needs. This project advances health equity by removing barriers to high quality clinical care and clinical research participation. The short-term objective of this project is to establish feasibility of research study protocols that were designed to evaluate the impact of this innovative existing program. The proposed study is a prospective, longitudinal design (N=40). The specific aims of this project are to: 1) evaluate feasibility of research protocols, 2) compare healthcare utilization 6 months pre- and post-CHFP enrollment, and 3) compare guideline-directed medical therapy (GDMT), biomarkers, and patient-reported outcomes (PROs) at baseline and 3- and 6-months post-enrollment, and 4) examine associations between CHFP conceptual model key components (trust/relationship building, shared-decision making, care coordination, harm reduction) and outcomes (healthcare utilization, GDMT, biomarkers, and PROs). Descriptive statistics will be used for Aim 1. For Aim 2 and 3, paired t-tests (or Wilcoxon signed-rank test) will be used to compare outcomes pre- and post- enrollment, and effect sizes will be calculated to inform future intervention studies in this patient population. For aim 4, correlations (continuous variables) and chi-squared (categorical variables) will be used to examine the direction and strength of associations between key components of the conceptual model and model outcomes, in addition to multivariate regression to determine the independent effect of key components on outcomes. The goals of this project align with the strategic mission of the National Institute of Nursing Research to prioritize research that advances health equity by removing barriers to research participation, optimizes health for individuals and communities, and addresses pressing health challenges.
