HepGuide™ Decision Support Software for UF Heparin
HepGuide DSS is designed to provide assistance with heparin dosing decisions to physicians, nurses and pharmacists by improving their ability to maintain a patient within the therapeutic aPTT range. Automedics expects that HepGuide DSS will improve the safety and quality of care offered to acute care patients by eliminating error prone manual calculations and complex paper-based nomograms. HepGuide DSS will individualize dosing and sampling regimens based on patient response. By simply providing the software with the current aPTT lab result, it provides an individualized IV heparin dosing recommendation designed to achieve the specified target aPTT range, and the next time to obtain a blood sample to measure aPTT.
HepGuide replaces spreadsheets of physician preferences and worksheets used by nurses full of manual calculations for managing patient anticoagulation levels. Such methods are inefficient but also susceptible to human error. This approach provides an effective tool to impose centralized and consistent management of anticoagulation. HepGuide comes with a specific protocol based on sophisticated algorithms focused on anticoagulation control, taking all that complexity at the point of care and replacing with sophisticated mathematical modelling and control laws to patient response in order to individualize their therapy.
HepGuide DSS will be deployed in several ways in the hospital environment. It can be deployed on existing hospital application servers and any computers already in the hospital environment including nursing stations, patients’ rooms, and clinicians’ offices. It could also be deployed on freestanding PCs or mobile tablet computers, and IV infusion pumps. HepGuide DSS can be integrated with the hospital information system to provide patient location and demographics.
The screens are designed to be simple and intuitive for hospital personnel to use requiring minimal user entry. A prototypical dosing screen shot from HepGuide DSS:
Example of HepGuide DSS output screen. Screen shows last aPTT reading (47 sec); current infusion rate (800 units/hr); recommended heparin infusion rate (950 units/hr); and optimum time for next aPTT sample (4 hours at 12:55 pm).
Decision Support Architecture
HepGuide DSS uses a proprietary control algorithm based on a pharmacodynamic patient model for UF heparin. The algorithm will use information supplied by hospital personnel on patient characteristics, UF heparin dose, and aPTT measurement. The software will display a recommendation of the optimal UF heparin infusion rate as well as the next optimal time to draw blood to measure aPTT in order to quickly achieve and maintain the patient within the specified therapeutic range. The software will also have a safety infrastructure consisting of alarms and alerts to notify hospital personnel if a patient is outside of the desired therapeutic range, has an unexpected response, or displays a variety of other critical situations.
The figure below shows a diagram of this unique proprietary control system algorithm architecture. The pharmacodynamic model was based on over 800 patients evaluated in 5 studies involving over 3,600 aPTT observations.
Decision Support Architecture. This pharmacodynamic model is a unique algorithmic approach to analyzing and predicting patient response to a medication.
Key Benefits
HepGuide DSS is designed to reduce the complexity associated with critical UF heparin dosing adjustment decisions and remove human subjectivity. The software is expected to be quick and easy to use, requiring only a few simple inputs, and have customizable targets, allow tracking of a patient’s progress, and provide medication administration records and QA reports. The expected benefits include:
- Learns an individual patient’s pharmacodynamic response
- Determines and recommends the appropriate infusion rate of UF heparin
- Utilizes multiple data points to avoid single inaccurate results influencing dosing decisions
- Compensates for time delays in obtaining measurements
- Recommends the optimum time for the next sample
- Responds to physician-selected high and low limits for aPTT
- Provides safety alarms and alerts if the patient response is out of range
- Transitions patients to outpatient dosing of warfarin if required
HepGuide DSS addresses many of the requirements called out by the Joint Commission in their 2008 National Patient Safety Goals for anticoagulants. The Company expects that the ability to control patients within therapeutic range by using HepGuide DSS will lead to improved outcomes e.g. less bleeding events and lower thromboembolic events, resulting in better patient safety, improved efficiencies, and cost savings in the hospital – and become the standard of care.