Over the past decade, the University of Oklahoma College of Medicine has seen an increase in the number of highly complex infections. That's related to a few different factors. 

THE PROBLEM

First, the population of the Sooner State has been trending less healthy in general. Second, surgeons at the Oklahoma City-based medical school are performing more complex surgeries. And third, there has been a huge increase in immunosuppressive therapeutics for cancers and rheumatological and autoimmune diseases, all of which increase the risks for infection.

The health system is also noticing an increase in the incidence of antimicrobial resistance, which often limits therapeutic options to parenteral/intravenous antibiotics. At the same time, there has been an important push toward shortening hospital stays and moving bigger parts of healthcare to the patient's home, recognizing that prolonged hospital stays can take a significant toll on the patient's physical, emotional and financial wellbeing.

"This is what created the need for the outpatient parenteral antimicrobial therapy (OPAT) program, where patients are discharged to receive courses of intravenous antibiotics at home, often for weeks," said infectious diseases physician Dr. Joseph Sassine, assistant professor at the University of Oklahoma College of Medicine.

"With OPAT, an infusion company ships the antibiotic bags and supplies to the patient once a week and, depending on the patient's insurance plan, they receive either a once-weekly visit from a home health nurse or they go to an infusion clinic once a week to get their intravenous access dressing changed and safety labs performed."

But the day-to-day operations – the infusion of each antibiotic dose – is the responsibility of the patient or whoever lives with them.

"When a patient is in the hospital, we know they are taking their antibiotic because a nurse is administering it and charting it," Sassine explained. "But at home, we have no way to know if the patient is taking the antibiotic and is taking it correctly, other than relying on the patient's recollection, and there is plenty of data on recall bias.

"We also know if the antibiotic is administered, the patient's infection gets better and is cured," he continued. "However, all OPAT programs have faced the problem of hospital readmission. Patients are discharged home on IV antibiotics and come back to the hospital because their infection is not improving."

Thirty-day readmission rates for patients on OPAT can reach 25-30%, and the most common reasons are worsening infection, complications of antibiotic therapy like adverse drug events, and complications of the IV line from clots, infection or malfunction. So, the main question is: How can staff prevent readmissions in patients on OPAT? Is there a way to know patients on OPAT are actually taking their antibiotics? How can staff identify the causes of readmission before they lead to a readmission?

PROPOSAL

Remote therapeutic monitoring (RTM) technology has some appealing features in the OPAT setting, Sassine said. It does not require an in-person visit to the patient. Staff can monitor the patient while the patient is home and the clinician is in their hospital/clinic.

RTM allows staff to know if the patient is infusing their antibiotics according to the treatment plan. This eliminates the unknown variable of adherence to therapy. If the patient presents later with a worsening infection, staff do not have to guess anymore if the infection worsened because they were not taking their antibiotics, or because the antibiotic they were on truly failed and they need a different antibiotic, or maybe they need a surgical procedure, etc.

RTM allows staff to identify which patients are struggling and helps staff direct resources/attention preferentially toward them. It leads to a higher level of adherence through the Hawthorne effect.

While it is hard to quantify how much RTM improves adherence, simply because there is no data on adherence of patients who do not use RTM technology, it is known that the Hawthorne effect (by which individuals alter their behavior when they know they are being observed/monitored) is well-described in the medical literature.

This, in turn, is expected to improve patient outcomes through improved adherence.

MEETING THE CHALLENGE

"We designed a clinical trial at the University of Oklahoma to study the impact of RTM technology on patients discharged home on OPAT," Sassine noted. "I have to disclose that that trial was funded by Community Infusion Solutions and IV Ensure, which own the patent for an RTM device called IV Ensure.

"The clinical trial enrolled 95 patients between July 2023 and October 2024; these patients were adults who were admitted to OU Health University of Oklahoma Medical Center, diagnosed with an infection (we included all classes of infection) and were deemed to need at least one intravenous antibiotic to be taken at home after discharge," he continued.

The primary outcome was infection-related readmission at 30, 60 and 90 days, compared with contemporaneous controls who were discharged on OPAT during the same study period but did not receive RTM on discharge.

"First, let me discuss a bit how the device in question works," Sassine said. "The patented device latches onto the tube coming out of the IV antibiotic bag/pump/IV push (which gets attached to the IV line), and through proprietary technology, the device is capable of detecting the flow of medication through the tube.

"It records the date and time of start and end of the infusion, and it transmits the data through cellular communication to the company's AI system called IVE Mind, which compares the observed infusions to the expected infusions based on the patient's treatment plan prescribed by their physician," he continued. "It then generates an adherence rate and a weekly adherence report."

Accountability/monitoring occurs at two levels: The company provides a team of infusion case managers monitoring the daily adherence data for each infusion event, and they communicate with the patient if there is any lapse in adherence. The weekly adherence reports are also scanned into the patient's medical record, so they are available to their treating physician and any other clinicians taking care of them.

The software is capable of interfacing with the Epic EHR.

"Upon consenting, the patient is given a monitoring device and receives structured follow-up support," Sassine explained. "The first phone call occurs the day after discharge to confirm enrollment and address any immediate questions. Following this, the patient receives weekly check-in calls to monitor progress and encourage adherence. Additional calls are scheduled if any adherence issues arise, ensuring timely support to keep the patient engaged and on track with their care."

RESULTS

The University of Oklahoma College of Medicine did an interim analysis with 64 patients enrolled on RTM and 95 contemporaneous controls. This included patients enrolled until June 15, 2024, who had at least 90 days of follow-up.

And while the purpose of the interim analysis was initially to present at a scientific conference (ID Week), staff felt the results were too compelling not to be shared more broadly.

"I would like first to highlight that the two groups were similar in terms of baseline demographic characteristics, type of infection being treated, insurance coverage, comorbid conditions, prior healthcare utilization, duration of outpatient therapy, and number of antibiotic doses per day," Sassine noted. "This is important for it to be a fair comparison.

"For the results, we noticed a sharp decrease in infection-related readmissions in the RTM group," he continued. "If you look at the raw unadjusted numbers, at 30 days it was a 74% reduction (4.7% versus 17.9%), at 60 days a 72% reduction (7.8% versus 28.4%) and at 90 days a 56% reduction (14.1% versus 31.6%). The lower numbers are in the RTM group and the higher numbers in the control group."

Then, when the organization built a multivariable logistic regression model, controlling for age, race, class of infection, comorbidities and insurance coverage, the odds of infection-related readmissions were decreased in the RTM group by 76% at 30 days, 80% at 60 days and 68% at 90 days.

Sassine noted two major takeaways.

"The amplitude of the reduction – I am not aware of any intervention out there that can reduce hospital readmissions by this much," he said. "The durability of the response – the patients in each group received a median of 35 days of antibiotics, yet we see a significant reduction in infection-related readmissions all the way to 90 days, which shows the effects of RTM last even after RTM and antibiotic therapy are over."

The sustained response is very important and shows that staff are able to get these patients out of a vicious circle of never-ending infections and hospital readmissions, he added.

"The other important finding from the study, which we plan to investigate further once we have complete data on all enrolled patients, is that we are starting to learn so much about what happens to patients when they go home on IV antibiotics," he said. "In our interim analysis, the median overall adherence rate in the RTM group was 94%, but the range was 18% to 100%.

"So, there are patients out there who need more support," he continued. "More than half of our patients in the RTM group needed an extra intervention from the study team, and two-thirds of these interventions happened within the first week after hospital discharge. This is a critical time window because we know things can fall through the cracks during transitions of care, so being able to identify these issues early on allowed us to set our patients up for success."

Without RTM, staff would not have been able to identify most of these issues upfront, and patients could have experienced unnecessary hospital admissions, he added.

"We also are starting to look into adherence data generated from RTM and evaluating whether we can predict, in an evidence-based, data-driven manner, which patients will have good adherence to therapy and which patients need extra support," Sassine observed. "This has never been looked at in OPAT, specifically because we never had this data. RTM allowed us to get this data, and I hope it will generate interesting results once I analyze the entire dataset that includes all enrolled patients."

ADVICE FOR OTHERS

Remote therapeutic monitoring is a major technological breakthrough that will help healthcare advance the quality of care offered to patients when they go home, Sassine stated.

"It has the power to change clinical outcomes in a tangible and beneficial way, and now we have the data to support it," he said. "I would certainly advise healthcare organizations and physician practices to evaluate how RTM could be incorporated into their clinical practice and their value-based care models.

"I certainly believe it has a wide range of applications in healthcare delivery, not only within OPAT, but also within any other home infusion models, even within pharmaceutical research," he continued. "In our clinical trial, it allowed us to reduce infection-related readmissions, and it allowed us to identify patients who were struggling with their home infusions so we could provide the support they needed."

The data generated by RTM actually drove the University of Oklahoma College of Medicine to simplify some of the antibiotic regimens for some patients, which subsequently increased their adherence to 100%.

"The feedback we received from patients enrolled in our trial was also great," Sassine concluded. "They told us they felt supported during their transition of care and throughout their antibiotic course. I believe this helped set them up for success."

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