The American College of Cardiology (ACC) and HealthReveal, a leading clinical artificial intelligence company, are collaborating to employ HealthReveal's personalized clinical AI solution to ACC's TRANSFORM studies. Through the collaboration, study data will be used to recommend life-saving patient care interventions to increase physicians' adherence to guideline-directed medical therapy (GDMT), preempt future adverse cardiovascular events and improve patient outcomes.
ACC and HealthReveal will collaborate on studies for three TRANSFORM programs. The first, TRANSFORM HFrEF, will provide GDMT for patients who have heart failure with reduced ejection fraction (HFrEF). Heart failure affects an estimated six million Americans, while poor heart failure management is the leading cause of hospitalizations and readmissions among older adults. Meanwhile, the quality of healthcare in the U.S. has not improved in nearly 20 years: only about half of patients receive the recommended care for the leading causes of death, including heart disease.
"The complexities of care are growing exponentially each year, and it's no longer feasible for any one physician to keep up with the latest medical guidelines and clinical best practices," said Jim Januzzi, MD, principal investigator of the TRANSFORM HFrEF study, ACC Board of Trustees member, and director of the Dennis and Marilyn Barry Fellowship in Cardiology Research at Massachusetts General Hospital. "HealthReveal represents a new paradigm for the dissemination and adoption of new medical research, which could potentially accelerate the adoption of GDMT in clinical practice and the use of real-world evidence in clinical trials more broadly. Through this TRANSFORM program, we're rigorously testing these hypotheses."
Despite substantial clinical evidence demonstrating the effectiveness of GDMT, clinical adoption of guidelines for cardiovascular care can be slow and incomplete. For example, a 2018 study found that less than 25% of HFrEF patients received the pharmacotherapies recommended by GDMT, and fewer than 1% of patients received the correct prescription at medically appropriate doses. Lagging GDMT adoption translates into lives lost as well as higher costs: the price tag for heart failure alone is expected to increase from $30.7 billion in 2012 to $69.7 billion by 2030.
"Guidelines clearly outline the most appropriate treatments for HFrEF patients, but we know that these patients are often under-treated and adherence to guidelines is suboptimal," said Dipti Itchhaporia, MD, FACC, ACC president. "Through this study and collaborations that optimize technology-enabled approaches, we're addressing this problem and transforming the care these vulnerable patients receive."
Unlike most clinical trials where patients follow a set schedule for initial and follow-up visits with their doctors, patients in the TRANSFORM studies will be continuously monitored by HealthReveal. The company will continually curate the latest guidelines and automatically apply them to individual patient data to generate Reveals - personalized care recommendations that help physicians intervene and adjust treatment in real time, even between care visits. Reveals will be embedded into the electronic health record (EHR) workflows at some trial sites, thereby ensuring a seamless experience for participating clinicians.
TRANSFORM HFrEF will enroll approximately 3,072 patients at multiple health systems, beginning in Spring 2021. Each patient will participate for a period of six months, and the study will span three years from first patient to first comprehensive reporting, with the last patient visit expected in mid-2022.
TRANSFORM HFrEF is the first of three planned studies thus far in which ACC and HealthReveal will evaluate the potential of Reveals to increase GDMT adherence, improve patient care and reduce future adverse events. The second trial, TRANSFORM CVRiD, will aim to drive meaningful improvements in cardiovascular outcomes for patients with Type 2 diabetes. The 12-month study is expected to start this fall.
ACC and HealthReveal are also planning a third study to be announced this spring.
"The TRANSFORM model will fundamentally change the way medical guidelines for cardiovascular diseases are developed and implemented," said Lonny Reisman, MD, FACC, founder and CEO, HealthReveal. "It is an innovative approach to deploying current guidelines into clinical practice and measuring their real-world impact. Over time, we can then iteratively apply machine learning to those insights to further personalize the guidelines and meaningfully improve patient outcomes."
ACC introduced TRANSFORM in 2019 as a new kind of quality research program aimed to improve health care by transforming the quality of care across the multi-faceted areas of cardiovascular disease. TRANSFORM programs leverage EHR data, office-based interventions and partnerships to include the pharmaceutical and medical device industry, health plans, employers, clinicians and patients.
About the American College of Cardiology
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its 54,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.
HealthReveal is a clinical artificial intelligence (AI) company focused on ensuring patients receive optimal, personalized chronic care to preempt adverse outcomes. The company's solution assembles a digital twin of individual patient health data and continually applies the latest medical guidelines to produce Reveals-personalized diagnostic and treatment recommendations. Reveals improve clinical and financial outcomes, track and measure real-world evidence (RWE) for providers, payers, and life sciences partners. Learn more at http://www.healthreveal.com.