Clinical Validation

Summary

These clinical outcomes validate that automating infection control and antibiotic stewardship using SmartSteward™ results in significant reductions in infection rates, the use of unnecessary antibiotics, and outbreaks of dangerous MRDOs. It also increases the effectiveness of current antibiotics and reduces the time and cost of care.

Clinical Performance

This chart demonstrates the rapid reduction in the pilot facility infection rate from about 5.00 to about 1.00 (per 1,000 patient-days) in just ten months. This rate is far below commonly reported rates of 3.00 to 6.00. This magnitude of improvement is not unusual with a new clinical team commitment to a serious infection control program. Standardized definitions (of infections)using the McGeer Criteria, reduced quantities of antibiotics (especially those that induce resistance), and newer patient and environmental cleaning protocols suggested by SmartSteward™ account for this finding.

In this instance, the decrease in facility-acquired infections occurred in two phases. The reductions in the first phase (early 2019) were mostly due to the consistent application of the modified McGeer Criteria. Later, steady reductions were multifactorial and included the Hawthorne Effect (the mere fact that caretakers know they are being observed will change behavior), regular feedback to the facility administration and providers, and reduced unnecessary antibiotics. The larger decrease in infections in Medicare patients mostly likely is due to the fact that this group of patients is less stable based on multiple measures and more susceptible to improvements in care patterns. This type of result is seen in robust infection control programs.

A leading indicator of SmartSteward™’s impact on a facility is the level of antibiotic therapy for UTIs not meeting McGeer Criteria, which is highly correlated to the practice of prescribing antibiotics to patients with asymptomatic bacteriuria. The decline clearly demonstrates how the doctors successfully changed their prescribing behavior. The spike indicates there is still work to be done. Reducing the use of unnecessary antibiotics can reduce resistance and increase the effectiveness of antibiotics overall.

This 30% reduction in average antibiotic exposure (Days of Therapy) was correlated with regular physician feedback that we believe caused a reduction in duration of therapy. Another significant reduction is expected as providers stop treating asymptomatic bacteriuria.

With SmartSteward™, hours devoted to patient treatment time decline since there are fewer infections requiring treatment. SmartSteward™ also saves time by streamlining the process of communicating with the physician, sending prescriptions to the pharmacy and reporting the infection event, all of which are now largely automated.

Lab tests, imaging and catheters are examples of costs related to treating infections. These costs declined over the nine-month period. The cost structure of MDRO care is higher, as isolation is often required. Displaying costs of treating common infections and MDROs helps facility managers focus on where they incur costs and motivates the team to respect infection control protocols.

Resistance patterns and MDRO frequencies can be used to algorithmically guide clinicians’ antibiotic usage. For example, if there is an increasing frequency of C. diff events, a drastic decrease in the usage of Fluoroquinolone antibiotics (Cipro, Levaquin and others) along with a cut in second and third generation Cephalosporins (Vantin, Fortaz and others), is a well-documented method of control.

Over time, the sensitivity of gram-negative bacteria to the major antibiotic classes has gradually increased. The decreased antibiotic usage, especially high-risk antibiotics, as well as the patient and environmental cleaning techniques advocated by SmartSteward™, account for this positive trend in increasing the effectiveness of currently used antibiotics.

The SmartSteward™ metrics do more than report percentages and levels – they help the team visualize the impact of their hard work. The infection reports showed a spike of non-McGeer infection events beginning in August, when a new IPCO was being trained,while actual infection events continued to decline.

The infection breakdown alerts the team to changes in specific infection types and, in combination with the surveillance module, enables the IPCO to quickly develop and execute containment strategies.

The pilot is also experiencing a downward trend in hospital readmissions. Although it is early and the trend looks positive, more data is needed to confirm the anticipated meaningful reduction in readmissions.

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