Remote Therapeutic Monitoring Reduces Infection-Related Hospital Readmissions in OU Clinical Trial

Patients discharged from the hospital after treatment for a major infection often continue receiving antibiotics through an IV line at home. However, medication adherence can be challenging because of a variety of barriers, and patients often find themselves readmitted to the hospital with infection-related complications. IV Ensure, an innovative remote therapeutic monitoring device being studied in a University of Oklahoma clinical trial, reduced the odds of infection-related hospital readmission by 76% at 30 days after hospital discharge and by 68% up to 90 days after discharge.

Early results from the trial, presented last week during ID Week, the premier meeting of several national infectious diseases professional societies, also showed that trial participants using the device had a 94% median infusion adherence rate. IV Ensure was developed by Community Infusion Solutions, a Dallas-based public health solutions company with more than two decades of working with chronically ill patients and medication adherence across the United States.

“Hospital readmissions are a major challenge for most health systems, especially among patients who are taking IV antibiotics at home,” said trial principal investigator Joseph Sassine, M.D., an OU Health infectious diseases physician and assistant professor in the OU College of Medicine. “As clinicians, we have historically been in the dark because many of our patients live alone, and we don’t know if they are actually taking their medication infusions and what barriers they are facing. We do know this: If patients receive their medication, they get better. This is why the overall impact of IV Ensure is revolutionary – it expands the care our patients can safely and effectively receive at home, and it prevents readmissions.”

IV Ensure is approved by the U.S. Food and Drug Administration, and the Centers for Medicare and Medicaid Services considers it a covered device for Medicare beneficiaries. The non-invasive device, which fits in the palm of a hand, hooks to the patient’s IV setup, where it records infusion-related information, including start and end times and the number of infusions per day. The device transmits data in real time via a cellular connection to case managers with Community Infusion Solutions, where adherence reports are generated. Case managers stay in touch with patients weekly and contact them more often if they notice a dip in adherence. The device also features “happy” and “sad” buttons that patients can press, prompting a phone call if they face challenges.

Mitchell Berenson, president and CEO of Community Infusion Solutions and developer of IV Ensure, said the trial results were even better than anticipated.

“Collectively, we agreed that if we could achieve a meaningful increase in medication adherence and a 10% decrease in 90-day readmissions, that would be a significant win for patients and for health care systems. However, ‘being present’ in the home using IV Ensure, we almost eliminated readmissions and saw close to full medication adherence. It’s incredible,” Berenson said.

Reducing the probability of a second hospital stay is important for patients, health systems and payers. Complications due to poor medication adherence cost the U.S. health care system billions annually, and readmission rates surpass 50% for some chronically ill patients. With hospital readmissions, patients face a significant emotional toll, on top of physical risks such as falls, blood clots and hospital-acquired infections, Sassine said.

IV Ensure, in addition to improving medication adherence, provides objective data that physicians never had for patients receiving IV antibiotics at home, Sassine said.

“For example, in this study, 53% of the patients using IV Ensure required an extra phone call beyond what was scheduled, and 62% of those calls happened in the first week a patient was back home,” Sassine said. “Transitions of care are a critical time when the patient is very vulnerable and perhaps needs extra support, or something falls through the cracks in the plan of care as the transition is made from hospital to home.”

The clinical trial involved nearly 100 OU Health University of Oklahoma Medical Center patients who were discharged with at-home IV antibiotic prescriptions and agreed to participate. About 40% of participants had been hospitalized for a bone and joint infection, such as a diabetic foot infection. The next most common infection was endovascular, including blood infections and heart valve infections. Sassine plans to publish the full results of the trial in the coming months.

“What Community Infusion Solutions learned by working closely with 80,000 rural, chronically ill patients over the last 15 years in 22 states taught us the value of high patient antibiotic adherence,” said Berenson, “and that patients could be managed remotely from Dallas to Oregon to the Mississippi Delta and positively impact readmission rates among some of the most challenging chronic diseases.”