Clinical trial identifies strategy to rapidly detect, respond to hospital outbreaks

Tool reduced the size of outbreaks by 64% in the pre-COVID-19 trial period in 82 hospitals nationwide

Orange, Calif., Boston, Nashville, Tenn., and Atlanta — An automated tool that improves outbreak detection for hundreds of pathogens successfully served as an early warning system to find and respond to potential hospital outbreaks, as reported today in the NEJM Evidence.

A Trial of Automated Outbreak Detection to Reduce Hospital Pathogen Spread was a large multi-state, real-world study conducted in 82 hospitals and led by Harvard Pilgrim Health Care Institute, HCA Healthcare, UCI Health and the Centers for Disease Control and Prevention (CDC).

Contagious bacteria and other pathogens can spread in hospitals, increasing the risk of harmful infections in patients. While hospitals and health systems work to prevent infections and reduce the opportunity for outbreaks to occur, there is no standardized approach for detecting transmission. Early detection can lead to a rapid response that reduces the chance for outbreaks to occur.

"Despite significant progress in reducing healthcare-associated infection outbreaks, including of antimicrobial-resistant pathogens, they remain an industry challenge and can present as clusters that signal potential for transmission to patients,” said Joseph Perz, DrPH, MA, Senior Advisor for Public Health Programs in CDC’s Division of Healthcare Quality Promotion, and committee member for the CDC’s Council for Outbreak Response: Healthcare-Associated Infections. “The CLUSTER trial provides evidence that early detection powered by automation tools and quick action can prevent outbreaks from growing."

Most hospitals focus on a small number of antibiotic-resistant organisms and miss outbreaks from other pathogens. To address this, investigators developed an algorithm-driven statistical outbreak detection tool that used clinical laboratory data to provide real-time alerts to hospital infection prevention programs about potential transmission of over 100 bacterial and fungal species. This method relied on an automated review of organisms grown from patients’ clinical cultures and a statistical assessment of whether an increase was seen compared to prior experience. Detected increases triggered an automatic notification for hospital personnel to implement a response protocol to prevent additional cases.

“Outbreaks in hospitals are often missed or detected late, after preventable infections have occurred. This study provides a practical and standardized approach to identify early transmission and halt events that could become an outbreak in hospitals,” said lead investigator, Meghan A. Baker, MD, ScD, Harvard Medical School assistant professor of population medicine at the Harvard Pilgrim Health Care Institute.

The automated outbreak detection method was tested from 2019-2022 in a randomized clinical trial in 82 hospitals across 16 states in the HCA Healthcare system, a leader in real-world evidence-based research. Half of the hospitals implemented the automated early detection method, and the other half continued with usual care. Hospitals that were assigned to receive and respond to the automated alerts experienced a 64% reduction in the size of potential outbreaks until the trial was interrupted by the COVID-19 pandemic. During the pandemic, personnel were not able to respond as effectively to automated alerts, and across the combined pre-pandemic and pandemic trial period, there was no overall effect. Nevertheless, in analyses restricted to the pre-pandemic period, the outbreak detection tool was associated with a demonstrable and significant reduction in cases. While the actual risks of an outbreak are low, even one outbreak can be significant. The automated system notified hospitals about possible events approximately three times per year per hospital so early preventative responses could be taken to maximize patient safety.

“This ongoing collaboration continues to leverage our scale – both the number of our hospitals and our advanced data ecosystem – as we work to rapidly answer clinical questions that benefit patients everywhere,” said Kenneth Sands, MD, MPH, chief epidemiologist at HCA Healthcare. “We are using this detection tool in the hospitals where we tested it and are evaluating implementation more widely across our system.”

The underlying software is available for free to all hospital systems but must be integrated into their respective electronic health record system or other clinical workflow platforms.

The study was funded by CDC and conducted through a longstanding scientific consortium, including HCA Healthcare, Harvard Pilgrim Health Care Institute's Department of Population Medicine, the University of California, Irvine and the CDC’s Prevention Epicenters Program. It is part of a growing body of work by the partners to improve patient care and reduce the risk of healthcare-associated infections.

About UCI Health

UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system based in Orange County. UCI Health is comprised of its main campus, UCI Medical Center, a 459-bed, acute care hospital in in Orange, Calif., four hospitals and affiliated physicians of the UCI Health Community Network in Orange and Los Angeles counties and ambulatory care centers across the region. Listed among America’s Best Hospitals by U.S. News & World Report for 23 consecutive years, UCI Medical Center provides tertiary and quaternary care and is home to Orange County’s only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center, gold level 1 geriatric emergency department and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on Facebook, Instagram, LinkedIn and Twitter.

About Harvard Pilgrim Health Care Institute’s Department of Population Medicine

The Harvard Pilgrim Health Care Institute's Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School. Created in 1992, it is the first appointing medical school department in the United States based in a health plan. The Institute focuses on improving health care delivery and population health through innovative research and education, in partnership with health plans, delivery systems, and public health agencies. Point32Health is the parent company of Harvard Pilgrim Health Care and Tufts Health Plan. Follow us on Twitter and LinkedIn.

About HCA Healthcare

Nashville-based HCA Healthcare is one of the nation’s leading providers of healthcare services comprising 186hospitals and approximately 2,400 ambulatory sites of care, including surgery centers, freestanding ERs, urgent care centers, and physician clinics, in 20 states and the United Kingdom. With its founding in 1968, HCA Healthcare created a new model for hospital care in the United States, using combined resources to strengthen hospitals, deliver patient-focused care and improve the practice of medicine. With a robust system for analyzing clinical data across large and diverse patient populations, HCA Healthcare is a leader in pragmatic research like the Swap Out, ABATE and REDUCE MRSA trials that can help identify new standards of care. HCA Healthcare is a learning health system that uses its more than 43 million annual patient encounters to advance science, improve patient care and save lives.

About the Centers for Disease Control and Prevention (CDC)

Whether diseases start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC’s world-leading experts protect lives and livelihoods, national security and the U.S. economy by providing timely, commonsense information, and rapidly identifying and responding to diseases, including outbreaks and illnesses. CDC drives science, public health research, and data innovation in communities across the country by investing in local initiatives to protect everyone’s health.