The present disclosure relates to alerts for improving patient outcomes and, more particularly, the present disclosure relates to integrating clinical information to provide real-time alerts for improving patient outcomes.
Real-time patient management may use real-time clinical data and physiological measures in light of the patient's condition and past medical and surgical history to estimate the patient's clinical state. Clinical management decisions can be made based on the patient's estimated clinical state. Better clinical management decisions may be made from better estimation of the patient's clinical state and from a better understanding of the association between medical interventions and patient outcomes. Medical interventions which occur soon after a patient enters a clinical state associated with poor patient outcomes typically yield better outcomes than medical interventions made after a patient has spent a longer time in this clinical state. Consequently, a real-time clinical decision support system is desired in order to provide alerts soon after patients enter untoward or unfavorable clinical states. This real-time support system may be designed to help physicians achieve improved patient outcomes.
The above and other features of the present disclosure, its nature and various advantages will be more apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings in which:
A combination of information representing a patient's clinical state is provided to a monitoring system. This patient information may include both patient characteristics and patient clinical information. Patient characteristics include, for example, a patient's medical history, surgical history, demographic information (e.g., age, sex, weight, body mass index (BMI), etc.). Patient clinical information includes, for example, information that can be measured from a patient (e.g., heart rate (HR), respiratory rate, blood pressure (BP—Mean Arterial Pressure (MAP), Systolic Pressure, Diastolic Pressure), as well as derived hemodynamic parameters (ratios, product or differences of heart rate and the components of BP e.g., Systolic/Diastolic or MAP/HR), Bispectral Index® (BIS®), SpO2, temperature, ScO2, etc.) and information about patient interventions (e.g., the start of a surgical procedure, intubation of the patient, the administration of drugs, etc.). The patient information may be combined by the monitoring system in order to provide a risk assessment that may guide the decision making of a physician. The updated patient information may be provided to the monitoring system in real-time which may allow the risk-assessment to be provided to the physician in real-time.
The real-time delivery of a risk assessment may allow a physician to make decisions sooner and better with more information. The monitoring system may provide alarms to alert the physician to a patient entering an undesirable state at any given moment. The alarms may further alert the physician that this undesirable state is associated with a particular outcome. For example, the alarm may indicate that the patient is going into a low BIS value state and that this state is associated with increased mortality. The physician may then provide an intervention for the patient to help place the patient in a more desirable state.
In system 100, inputs 108 and 110 may be coupled to processor 107. Processor 107 may be any suitable software, firmware, and/or hardware, and/or combinations thereof for processing inputs 108 and 110. For example, processor 107 may include one or more hardware processors (e.g., integrated circuits), one or more software modules, computer-readable media such as memory, firmware, or any combination thereof. Processor 107 may, for example, be a computer or may be one or more chips (i.e., integrated circuits). Processor 107 may perform the calculations associated with generating risk-assessment information and alerts, as well as the calculations associated with determining patient state information. Processor 107 may perform any suitable signal processing of inputs 108 and 110, such as any suitable band-pass filtering, adaptive filtering, closed-loop filtering, and/or any other suitable filtering, and/or any combination thereof.
Processor 107 of patient monitoring system 100 may be coupled to one or more memory devices (not shown) or incorporate one or more memory devices such as any suitable volatile memory device (e.g., RAM, registers, etc.), non-volatile memory device (e.g., ROM, EPROM, magnetic storage device, optical storage device, flash memory, etc.), or both. The memory may be used by the processor to, for example, store data corresponding to patient information.
Processor 107 may be coupled to display 102. Alternatively, or in addition to display 102, processor 107 may be coupled to any suitable output device such as, for example, one or more medical devices (e.g., a medical monitor that displays various physiological parameters, a medical alarm, or any other suitable medical device that either displays physiological parameters or uses the output of processor 107 as an input), one or more display devices (e.g., monitor, PDA, mobile phone, any other suitable display device, or any combination thereof), one or more audio devices, one or more memory devices (e.g., hard disk drive, flash memory, RAM, optical disk, any other suitable memory device, or any combination thereof), one or more printing devices, any other suitable output device, or any combination thereof.
For ease of illustration, system 100 is shown as having two inputs, inputs 108 and 110. It will be understood that any suitable number of inputs may be used. Input 108 may receive patient characteristics including, for example, a patient's medical history, surgical history, demographic information (e.g., age, sex, weight, body mass index (BMI), etc.). Input 108 may also receive population characteristics, for example, data from a patient population database. The population characteristics may include information about a reference population. The reference population may include a data set of patient characteristics and patient clinical information for a set of patients. Input 110 may receive patient clinical information including, for example, measured physiological parameters from the patient (e.g., heart rate (HR), respiratory rate, blood pressure (BP—Mean Arterial Pressure (MAP), Systolic Pressure, Diastolic Pressure), as well as derived hemodynamic parameters (ratios, product or differences of heart rate and the components of BP e.g., Systolic/Diastolic or MAP/HR), Bispectral Index® (BIS®), SpO2, temperature, SeO2, etc.) and information about patient interventions (e.g., the start of a surgical procedure, intubation of the patient, the administration of drugs, etc.). This information may be provided to inputs 108 and 110 directly from one or more medical devices, may be accessed from one or more databases, or may be input by a user.
Any other suitable physiological parameters may be selected for monitoring by patient monitoring system 100 including, for example, other measures of hemodynamic state and cardiovascular function such as heart rate, diastolic pressure, systolic pressure, stroke volume, cardiac output and flow, and other brain monitoring measurements as well as other measures of patient brain state. Any physiological parameter that may be monitored may be considered. These physiological parameters may be the parameters that the physician is monitoring during a surgical procedure. In an embodiment, only selected physiological parameters are provided to patient monitoring system 100 to calculate patient risk. In another embodiment, multiple physiological parameters are provided to patient monitoring system 100 and only selected physiological parameters are monitored and used to calculate patient risk.
After the initial patient data is entered into patient monitoring system 100 (step 202) and a reference set has been calculated (step 204), the patient monitoring system 100 defines patient states associated with the monitored physiological parameters. The patient states define the relationship between each monitored physiological parameter of the patient and the reference set. For example, a current value of the monitored parameter in a patient may be higher than, lower than, or equal to a reference state for that parameter. In this example, higher than, lower than, and equal to the reference state are three patient states associated with the physiological parameter. In an embodiment, population-based norms may be used to define patient states. For example, a reference set for a monitored physiological parameter may be associated with a mean value or mean range of values for the parameter calculated from a patient population database. The patient state may be defined based on where the patient falls, higher than, lower than, or equal to the reference state. In an embodiment, the patient states may be adjusted from the population-based characteristics based on patient characteristics (e.g., age). The definition of patient states will be described in greater detail with respect to the examples below.
After the patient states are defined (step 206), an endpoint or a plurality of endpoints may be chosen at step 208. Endpoints are patient clinical states or patient outcomes of interest. For example, during and after a surgical procedure or hospitalization of other period of medical treatment, an endpoint may be a patient's likelihood of mortality, the length of post-operative stay of the patient, the occurrence of post surgical complications, the time to achieve an adequate level of post-operative pain, the likelihood of postoperative delirium, the likelihood of postoperative nausea and vomiting, or degree of patient satisfaction.
At step 210, patient monitoring system 100 may collect patient clinical information, for example, from inputs 108 and 110. In an embodiment, the patient clinical information may be collected in real time or substantially in real time. At step 212, patient monitoring system 100 may combine the collected patient clinical information with previously obtained patient information to classify the patient into the defined patient states. In an embodiment, patient state classifications may be determined in real time or substantially in real time.
The patient state classifications may then be used by patient monitoring system 100 to calculate risks associated with the chosen endpoints at step 214. Patient state information and risk assessment information may be displayed at step 216. Patient state information may be displayed as, for example, patient state information 104 in display 102. Patient state information may also be displayed with the determined risk assessment information. For example, patient state information 104 in display 102 may indicate that the patient is in a low BIS value state. The patient state information 104 in display 102 may also indicate that the low BIS value state is associated with an increased risk of mortality. At step 218, patient monitoring system 100 may also generate and provide one or more alerts when the patient is an undesirable patient state. The alert may be audible, visual, tactile or any other suitable alert. In some embodiments, patient monitoring system 100 may output the current patient state, the current risk assessment associated with a given endpoint, and alerts based on time spent in a particular state.
In the illustrative examples described herein, the monitoring system monitors and provides risk assessment information based on three physiological measures. The three physiological measures include, a measure of consciousness and sedation such as the Bispectral Index® (BIS®), a measure of blood pressure such as mean arterial pressure (MAP), and a measure of delivered anesthetic agent concentration such as mean alveolar concentration (MAC). It will be understood by those of skill in the art that any other suitable patient information may be used to provide risk assessment information (e.g., heart rate (HR), respiratory rate, blood pressure (BP—Mean Arterial Pressure (MAP), Systolic Pressure, Diastolic Pressure), as well as derived hemodynamic parameters (ratios, product or differences of heart rate and the components of BP e.g., Systolic/Diastolic or MAP/HR), SpO2, temperature, ScO2, etc.). Furthermore, while the illustrative patient risk assessment displays described below show patient state and risk assessment information based on these three physiological measures, it will be understood that any number of patient information variables may be used by the monitoring system to generate risk-assessment information and alerts.
The following example will illustrate the operation of patient monitoring system 100 in accordance with an embodiment. A data set of patient characteristics and patient clinical information for a set of patients may be obtained. The patient characteristics include, for example, electronic medical and surgical records for a set of patients. The patient clinical information includes, intra-operative data such as minute-by-minute measurements of: blood pressure (systolic, diastolic, MAP), heart rate, the anesthetic agent concentrations being used (delivered or expired), and other drugs that were given (e.g., muscle relaxants, analgesics, etc.).
The data set may be used to develop a set of rules to evaluate various patient risks and outcomes. The present embodiment monitors physiological parameters MAP, BIS, and MAC as measures of patient clinical state. Other embodiments may derive patient states and risk assessment information using other physiological parameters, including: other measures of hemodynamic state and cardiovascular function (e.g., heart rate, diastolic pressure, systolic pressure, SpO2, stoke volume, cardiac output and flow), other brain monitoring measurements, as well as other measures of patient brain state.
The data set may be evaluated by calculating for each patient, and from the start of the case to the end of the case, the average MAC value, the average BIS value, and the average MAP value.
In addition to the reference state, eight additional patient states may be defined by being outside of the reference state and being either higher or lower than the population mean of MAP, MAC and BIS. As illustrated in Table 1, patient states may be defined based on the sections of the population that do not fall within the reference group, as either being high or low relative to the reference population, thus creating eight cells. These eight cells may also be represented as part of a three-dimensional cube (
Each patient state may have one or more associated hazard ratios derived from a model.
After patient information is collected and the patient is classified into one or more patient states (e.g., at steps 210 and 212 of
After patient state information is determined (and displayed), the risk associated with the chosen endpoint(s) may be calculated (and displayed). In the example illustrated in
After the hazard ratios are calculated, the ratios may be analyzed to determine if the relative risk of mortality at each of the patient states is significantly statistically different from the reference population (p<0.05). In the example illustrated in
The following are additional illustrative examples in which clinical data and physiological measures may be used to estimate a patient's clinical state in accordance with an embodiment. A duration of the “triple low” (i.e., low MAP, low MAC, and low BIS value states) may be associated with various outcomes, including: complications, post-operative pain, length of stay, readmission, and 30-day and 1-year mortality. In one example, increasing duration of the triple low may be associated with worsened postoperative recovery (pain, complications, excess LOS), 30-day readmission, and postoperative mortality (30-day and 1-year). Early recognition of the triple low may allow adjustments in anesthetic or medical management that could improve patient outcomes. According to another example, the risk of one year postoperative mortality may be higher among patients who did not receive vasopressor administration while in a triple low state. Thus, vasopressor administration soon after patients enter the triple low state may improve the risk of mortality, as compared to later vasopressor administration. According to yet another example, the combination of low MAC and low MAP values may be a strong and highly statistically significant predictor for mortality. When combined with a low BIS value, mortality may be even greater. The combination of low MAC, low MAP, and low BIS (i.e., a triple low) may be associated with a nearly tripled risk of mortality at 30 days, and nearly doubled risk of mortality at one year.
The foregoing is merely illustrative of the principles of this disclosure and various modifications can be made by those skilled in the art without departing from the scope and spirit of the disclosure.
This application claims the benefit of U.S. Provisional Patent Application No. 61/165,672 filed Apr. 1, 2009 and entitled “System and Method for Integrating Clinical Information to Provide Real-Time Alerts for Improving Patient Outcomes,” the entirety of which is incorporated herein by reference.
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