Development of a Virtual Health Care Platform to reduce emergency re-hospitalizations in Heart Failure Patients transitioning from hospital to home

Abstract-Summary The overall purpose of this SBIR Phase 1 project is the development and test of nucleusRx’s (NRx) Virtual Care Platform and remote intervention tool targeting post-acute care Heart Failure (HF) patients, providing a safe and cost-effective discharge transition plan from the hospital to home. HF is the largest common cause for

disease-related hospitalization in the US (estimated 1 million/year) and has a mortality rate of 42% within 5-years of initial diagnosis. An additional 4.1 million emergency visits, 3.4 million hospitalizations, and 231,000 deaths have HF as a comorbid or contributing cause. The economic impacts from heart failure, both direct and

indirect, are estimated to hit $70 billion by 2030. Despite many HF re-hospitalizations being considered preventable, HF related hospitalizations among older adults and Medicare beneficiaries have the highest readmission rate of any medical condition. Currently, there is no remote monitoring platform available in the market providing real-time, 24/7 visibility of

patient’s health and treatment compliance when discharged from the hospital to home after an acute episode of HF. The American Heart Association (AHA) recommends the implementation of the Guideline Directed Medical Therapy (GDMT) for post-acute HF treatment, which consists of a rapid initiation of four pillar drugs to

treat HF patients during hospitalization, and its continuation at home after discharge. However, over a 12- month period after initial diagnosis, less than 1% of HF patients in the US receive optimal GDMT doses. There is also no one fixed agreed guideline of introduction of all GDMT medications for the treatment of HF within 30

days of acute HF hospitalizations, although there is a general consensus of the need to initiate all four pillar therapies while the patients are in the hospital or during the first week of discharge to home. Our complete solution, nucleusRx’s Virtual Care Platform, consist of a physical device -a specially designed pill

dispenser and accompanying blood pressure monitor and weight scale- and an interconnected software platform, all connected to patient’s mobile phone. The platform works in an integrated manner to enable healthcare providers to implement a safe discharge transition plan from hospital to home, while allowing rapid

GDMT dose optimization remotely with total visibility on patient health status and therapy compliance. In this project, work is proposed in a short (28 days) clinical feasibility trial to determine the effectiveness of nucleusRx platform functionalities. HF patients discharged from the hospital will be provided with the device

and access to a patient companion digital app with information on their health and medication compliance, while doctors and other caregivers will monitor patients’ health status through a specially designed computer dashboard interface. Clinical assessments, performed as part of the second objective of the project, will help

determine the clinical impact of the Virtual Care Platform by assessing medication compliance and satisfaction and usability of the platform from the point of view of both patients and providers. Improvement of the software user interfaces based on feedback and experiences from patients, caregivers and providers, and integration of

the Virtual Care Platform with the major EPIC electronic health record software used in most hospitals are the final objectives in the project.