# Patent

## Title
Rules-based patient care system for use in healthcare locations

## Abstract

A rules-base patient care system for use in healthcare locations. A patient rules generator creates rules for the patients. Performance measures indicative of the ability of a rule to predict changes in the condition of the patient are acquired by the rules generator. A determination is made from the rules performance measures whether to revise the rule. A rules engine applies a rule to selected data elements stored in the database to produce an output indicative of a change in the medical condition of the patient. The output from the rules engine is used to determine if intervention is warranted.

## Background
RELATIONSHIP TO OTHER APPLICATIONS
This application is a continuation in part of application Ser. No. 10/654,668 filed Sep. 04, 2003 and a continuation in part of application Ser. No. 10/946,548 filed Sep. 21, 2004, now U.S. Pat. No. 7,256,708 both of which are continuations-in-part of application Ser. No. 09/443,072 filed Nov. 18, 1999, now U.S. Pat. No. 6,804,656 issued Oct. 12, 2004, which claims the benefit of U.S. Provisional Application No. 60/141,520, filed Jun. 23, 1999. The Ser. Nos. 10/654,668, 10/946,548, 09/443,072, and the 60/141,520 applications are hereby incorporated by reference in their entirety for all purposes.


BACKGROUND
Embodiments of the present invention relate generally to a communication system for medical applications and monitoring of equipment used in the care of monitored patients. More particularly, embodiments of the present invention assess the status of a patient using a rule applied by a rules engine and use patient data to evaluate the effectiveness of the rule and to determine whether the rule requires modification.
Advances in communications, video displays, monitoring devices and computers have made it possible to remotely monitor hundreds of monitored patients. Alerting systems may be deployed to alert healthcare providers when certain conditions are met. For example, in U.S. Pat. No. 5,942,986 issued to Shabot, et. al for a “System And Method For Automatic Critical Event Notification,” describes a critical event notification system that permits review of a patient's diagnostic information, lab results, chart, or other data, automatically, by computer or similar equipment, and it provides for automatic paging of a responsible physician or physicians should a “critical event” be detected. The decision to page an individual is made automatically by the system, and does not require a direct human decision.
“Decision Support Systems in Critical Care” (Edited by M. Michael Shabot and Reed M. Gardner, 1994), is a compilation of articles that collectively describe the application of computers in health care settings. Decision support systems are defined as systems that receive medical data as input and produce medical information and/or knowledge as output. In some implementations, decision support systems utilize inferencing methods to detect associations between different pieces of information, alerting clinicians to certain patterns of events, which may be serious or life-threatening.
An example implementation of an inferencing method is described in the context of analyzing blood gas readings and laboratory results. Three different types of alerting algorithms are described: 1) high and low critical values 2) calculation-adjusted critical values, and 3) critical trends. (See, Decision Support Systems in Critical Care, pages 157-65.) The calculation-adjusted critical value algorithm reflects the dependence of the algorithm on multiple parameters. The application of the inferencing module produces an alert that is displayed on a screen or sent to a wireless device.
In U.S. Pat. No. 6,804,656 issued to Applicants, a smart alarm system was described. The smart alarm system of the '656 Patent, constantly monitors physiologic data and all other clinical information stored in the database (labs, medications, etc). The rules engine searches for patterns of data indicative of clinical deterioration. By way of illustration, one family of alarms looks for changes in vital signs over time, using pre-configured thresholds. These thresholds (also referred to as “rules”) are patient-specific and setting/disease-specific. Physiologic alarms can be based on multiple variables. For example, one alarm looks for a simultaneous increase in heart rate of 25% and a decrease in blood pressure of 20%, occurring over a time interval of 2 hours. Alarms also track additional clinical data in the patient database. Other rules follow laboratory data (e.g. looking for need to exclude active bleeding and possibly to administer blood). Regardless of the data elements that are used, the purpose of the rules is to facilitate detection of changes in a patient's condition (whether that condition is improving or degrading) in a predictive manner and to automate a response appropriate to the “new” condition.
Establishing rules requires an understanding the relationship between changes in the variables tracked by the rule and adverse clinical events. Historical patient data may be used to establish an initial rule. However, it would be useful if a smart alarm system were able to update a rule based on the effectiveness of the previous rule.
SUMMARY
An embodiment of the present invention uses a telecommunications network to facilitate rules-based care of patients receiving care in a healthcare location. As used herein, a healthcare location may be a remote clinic, a doctor's office, a field hospital, a disaster aid station, a patient transport vehicle and similar care facilities. A patient may be selected for monitoring based on criteria established by the treatment facility. By way of illustration and not as a limitation, a “monitored patient” comprises a critically ill patient, an acutely ill patient, a patient with a specific illness, a patient with serious injuries, and a patient with an uncertain diagnosis.
Patient monitoring equipment acquires monitored data elements from a patient monitoring station and transmits the monitored data (sometimes also referred to herein as, “monitoring data”) over a network to a remote command center. Monitored data comprises physiological data elements, video data elements, and audio data elements. The remote command center receives the monitored data from all patient monitoring stations. The remote command center also accesses other data relating to the condition of a patient. By way of illustration and not as limitation, the remote command center has access to data relating to personal information about the patient (name, address, marital status, age, gender, ethnicity, next of kin), medical histoiy (illnesses, injuries, surgeries, allergies, medications), admissions information (symptoms, physiological data, time of admission, observations of admitting caregiver), treatment, lab data, test reports (radiology reports and microbiology reports for example), physician's notes, a patient's diagnosis, prescriptions, histoiy, condition, laboratory results and other health-relevant data (collectively “patient data”) to the extent available from the healthcare location. The data available to the remote command center over the network, that is, the monitored data and the patient data, is collectively referred to as “assessment data.”
A rules engine applies a rule or rule set to the data elements selected from the assessment data from each monitored patient to determine whether the rule for that site has been contravened. In the event the rule has been contravened, an alert at the remote command center is triggered. Rules for each monitored patient may be established and changed at the remote command center for each as the patients' conditions warrant. In one embodiment of the present invention, a rule is established to determine whether a patient's condition is deteriorating. In another embodiment, a rule is established to determine whether a patient's condition is improving. In yet another embodiment of the present invention, an alert that a rule has been contravened comprises advice on treatment of the patient.
A patient rules generator establishes one or more rules for the monitored patient associated with a patient monitoring station. The patient rules generator collects rules performance measures indicative of the ability of the rule to predict changes in the condition of a patient and uses these measures to assess the efficacy of the rule. The patient rules generator may update a rule, determine that a rule is acceptable as is, or determine that there is insufficient data to revise a rule.
The patient rules generator may also evaluate the assessment data of patients with similar conditions to determine whether a predictive rule can be written and applied to patients with the same or similar conditions. The patient rules generator may also test a proposed rule against historical data to determine whether the rule is predictive of a change in a patient's condition.
In yet another embodiment of the present invention, the patient rules generator generates a rule that is consistent with the service level measures established by a site assessment module.
Another embodiment of the present invention provides continued care software that uses elements of the assessment data to provide decision support and that prompts a user for input to provide decision support to caregivers. A decision support algorithm responds to elements of assessment data to produce textural material describing a medical condition, scientific treatments and possible complications. This information is available in real time to assist in all types of clinical decisions from diagnosis to treatment to triage.
In still another embodiment of the present invention, order writing software facilitates the ordering of procedures and medications using patient-specific data. The order writing software and the continued care software are interactive allowing a caregiver to access features of both applications simultaneously, so that patient orders are given that are consistent and not conflicting with a patient's status and condition (i.e., allergies to medications or medications that may conflict with the order in question).
In an embodiment of the present invention, a healthcare location patient care system provides care to healthcare location patients based on the capabilities of the healthcare location. In this embodiment, the rules engine, the decision support algorithms, the order writing software facilities, and the continued care software are adapted to the capabilities of the healthcare location based on the application of site assessment rules to the healthcare location. In another embodiment of the present invention, components of a healthcare location patient care system may be supplied to the healthcare location to improve the level of its treatment capabilities. In still another embodiment of the present invention, components of the healthcare location are packaged and assigned a site assessment code. The code is used by the remote command center to predetermine elements of the site assessment process thereby simplifying that process.
In another embodiment of the present invention, patient monitoring equipment acquires monitored data elements from a patient monitoring station and stores monitoring data locally. The stored monitoring data is sent to a remote command center along with patient data at a pre-established time or when requested by remote command center. The remote command center evaluates the “delay” monitored data and assessment data in the same manner as if these data were received in real time. By way of illustration, the remote command center will apply the rules engine and the decision support algorithms to the delayed monitored data and patient data and provide guidance to the healthcare location. This embodiment of the present invention thus provides high quality care in environments where continuous high bandwidth communications are not available or economically infeasible.
In still another embodiment of the present invention, the delivery of stored monitoring data and patient data is expedited by an urgent consultation warning system (herein, the UCWS). The UCWS constantly evaluates the monitoring data and patient data before those data are stored to determine if an urgent consultation is warranted. By way of illustration and not as a limitation, changes in hemodynamic and respiratory measures over time indicative of a degrading condition of a patient would trigger an immediate reporting of all stored monitored and patient data to the remote command center for evaluation.
It is therefore an aspect of the present invention to receive at a remote command center monitoring data from a monitored patient over a communications network.
It is another aspect of the present invention to make available other data relating to the condition of a patient to the remote command center.
It is yet another aspect of the present invention to establish and/or revise rules at the remote command center and to apply a rules engine to “assessment data” to determine whether a rule is contravened.
It is another aspect of the present invention to determine based on assessment data whether the condition of a monitored patient warrants revising a rule at the remote command center.
It is still another aspect of the present invention to issue an alert from the remote command center in the event a rule is contravened.
It is an aspect of the present invention to provide treatment information in an order for an intervention issued by the remote command center to a treatment facility where a monitored patient is receiving care.
It is a further aspect of the present invention to apply decision support algorithms to data relating to the condition of a patient to provide decision support to caregivers.
It is another aspect of the present invention to provide a video visitation system that allows a remote visitation participant to participate in a video/audio conferencing session with a patient and/or a local visitation participant.
It is yet another aspect of the present invention to periodically acquire rules performance measures and use those measures to assess the efficaciousness of a rule.
In an embodiment of the present invention, a rules-based patient care system comprises a network, a database accessible via the network, a rules engine connected to the network, and a patient rules generator connected to the network. By way of illustration and not as a limitation, the network may be a wired network, a wireless network, a satellite network, a public switched telephone network, an IP network, a packet switched network, a cell phone network, a cable network, a coax network, and a hybrid fiber coax network.
The database comprises patient data elements indicative of a medical condition associated with a patient. The rules engine is adapted for applying a patient rule to selected data elements stored in the database to produce an output indicative of a change in the medical condition of the patient. In various embodiments of the present invention, the selected data elements comprise: a physiological data element of the patient and a clinical data element of the patient, a physiological data element of the patient and a medication data element of the patient, a physiological data element of the patient and a laboratory data element of the patient, a clinical data element of the patient and a laboratory data element of the patient, and a physiological data element of the patient and another physiological data element of the patient. In another embodiment of the present invention, the selected data elements comprise at least two data elements of the patient selected from the group consisting of a physiological data element, a clinical data element of the patient, a medication data element of the patient, and a laboratory data element of the patient. In still another embodiment of the present invention, patient data elements are selected from the group consisting of physiological data elements and clinical data elements.
The output of the rules generator is used to determine if intervention is warranted. In an embodiment of the present invention, the patient data elements indicative of the change in the medical condition of the patient comprise data indicative of improvement of the condition of the patient. In another embodiment of the present invention, the data indicative of the change in the medical condition of the patient comprise data indicative of degradation of the condition of the patient.
In another embodiment of the present invention, intervention comprises issuing a patient intervention protocol and order. In yet another embodiment of the present invention, intervention comprises issuing a patient release protocol and order.
The patient rules generator is adapted for creating the patient rule, acquiring rules performance measures indicative of the ability of the rule to predict the change in the condition of the patient, and determining from the rules performance measures whether to revise the rule. In an embodiment of the present invention, the patient rule comprises an algorithm.
In an embodiment of the present invention, the rules performance measures are derived from information provided by health care providers. By way of illustration and not as a limitation, doctors, nurses, intensivists, surgeons, and laboratory technicians may provide information relating to the performance of a rule.
In another embodiment of the present invention, the patient rules generator is further adapted for accessing historical data, applying multivariate analyses to the historical data to produce a result that relates the other patient data elements, the rule, and the other patient outcomes, and generating a rules performance measure comparing the result to the patient rule. In another embodiment of the present invention, historical data comprises other patient data elements for a plurality of other patients and wherein the patient data elements of an other patient are associated with an outcome of the other patient.
In still another embodiment of the present invention, the patient rules generator is further adapted for generating a new rule from the result. In yet another embodiment of the present invention, the patient rules generator is further adapted for testing the new rule against the historical data.
In an embodiment of the present invention, the rules-based patient care system further comprises a site assessment module. The site assessment module is adapted for receiving site assessment data and determining from the site assessment data service level measures indicative of a capability of a health care location to provide diagnostic and treatment services to patients. In this embodiment, the rules generator is further adapted for receiving service level measures, and creating the patient rule consistent with the service level measures. In another embodiment of the present invention the site assessment data are indicative of the capability of the health care location to provide diagnostic and treatment services to patients.
In yet another embodiment of the present invention, the site assessment module is further adapted for prompting a user for the site assessment data and determining the service level measures based on the user response.
In an embodiment of the present invention, the health care location comprises a site assessment code and the site assessment module is further adapted for acquiring the site assessment code associated with the health care location, and determining the service level measures at least in part based on the site assessment code.
In still another embodiment of the present invention, the service level measures comprise an inventory of available monitoring data elements, an inventory of available diagnostic services, an inventory of available surgical treatment services, and an inventory of available laboratory services.



DESCRIPTION OF THE FIGURES
FIG. 1 illustrates a block diagram of the components of a monitored patient care system according to embodiments of the present invention.
FIG. 2 illustrates the components of a transportable patient care unit according to embodiments of the present invention.
FIG. 3 illustrates a display and control system according to an embodiment of the present invention.
FIG. 4 illustrates a decision support system according to an embodiment of the present invention.
FIG. 5 illustrates an order writing data flow according to an embodiment of the present invention.
FIGS. 6A, B, C, and 6D illustrate the flow of a decision support algorithm for acalculous cholecsystitis according to an embodiment of the present invention.



DETAILED DESCRIPTION
The following terms used in the description that follows. The definitions are provided for clarity of understanding:

    assessment data—assessment data is all data relevant to the health of a patient.
    healthcare location—A “healthcare location;” a facility, whether temporary or permanent, that is not generally equipped to provide expert medical care on a twenty-four basis. By way of illustration and not as a limitation, a healthcare location may be a remote clinic, a doctor's office, a field hospital, a disaster aid station, a patient transport vehicle and similar care facilities
    caregiver—an individual providing care to a patient. Examples include a nurse, a doctor, medical specialist (for example and without limitation an intensivist, cardiologist or other similar medical specialist).
    clinical data—data relating to the observed symptoms of a medical condition.
    monitored patient—a person admitted to a healthcare location.
    monitored data—data received from monitoring devices connected to a monitored patient.
    monitored patient—a monitored patient from whom monitored data is collected and whose condition is subject to continuous real-time assessment from a remote command center.
    patient data—data relating to a patient's diagnosis, prescriptions, history, condition, laboratory results and other health-relevant data.
    physiological data—any data relating to the functions of the human body and its processes.
    symptom—any sign or indication of a health condition that can be identified from patient reports and/or assessment data.


An embodiment of the present invention uses a telecommunications network to facilitate rules-based care of patients receiving care in a healthcare location. As used herein, a healthcare location may be a remote clinic, a doctor's office, a field hospital, a disaster aid station, a patient transport vehicle and similar care facilities. A patient may be selected for monitoring based on criteria established by the treatment facility. By way of illustration and not as a limitation, a “monitored patient” comprises a critically ill patient, an acutely ill patient, a patient with a specific illness, a patient with serious injuries, and a patient with an uncertain diagnosis.
Patient monitoring equipment acquires monitored data elements from a patient monitoring station and transmits the monitoring data over a network to a remote command center. Monitored data comprises physiological data elements, video data elements, and audio data elements. The remote command center receives the monitoring data from all patient monitoring stations. The remote command center also accesses other data relating to the condition of a patient. By way of illustration and not as limitation, the remote command center has access to data relating to personal information about the patient (name, address, marital status, age, gender, ethnicity, next of kin), medical history (illnesses, injuries, surgeries, allergies, medications), admissions information (symptoms, physiological data, time of admission, observations of admitting caregiver), treatment, lab data, test reports (radiology reports and microbiology reports for example), physician's notes, a patient's diagnosis, prescriptions, history, condition, laboratory results and other health-relevant data (collectively “patient data”) to the extent available from the healthcare location. The data available to the remote command center over the network, that is, the monitoring data and the patient data, is collectively referred to as “assessment data.”
In an embodiment of the present invention, a monitored patient care system provides care to monitored patients based on the capabilities of the healthcare location. In this embodiment, the rules engine, the decision support algorithms, the order writing software facilities, and the continued care software are adapted to the capabilities of the healthcare location based on the application of site assessment rules to the healthcare location. In another embodiment of the present invention, components of a healthcare location patient care system may be supplied to the healthcare location to improve the level of its treatment capabilities. In still another embodiment of the present invention, components of the healthcare location are packaged and assigned a site assessment code. The code is used by the remote command center to predetermine elements of the site assessment process thereby simplifying that process.
FIG. 1 illustrates a block diagram of the components of a monitored patient care system according to embodiments of the present invention. A monitored patient care system 100 comprises patient monitoring station “A” 105. While FIG. 1 illustrates a single patient monitoring station, the invention is not so limited. Multiple patient monitoring stations may be used without departing from the scope of the present invention. For the sake of clarity, the description that follows will refer to patient monitoring station “A” 105. However, the description applies to all patient monitoring stations within the monitored patient care system 100.
Patient monitoring station “A” 105 comprises a general purpose computer 110, a patient monitoring device 115, a camera 120, and a duplex audio system 125. While FIG. 1 illustrates a patient monitoring device, the invention is not so limited. Multiple patient monitoring devices may be used without departing from the scope of the present invention. For the sake of clarity, the description that follows will refer to patient monitoring 115.
General purpose computer 110 provides data entry, display and printing capabilities through means known to those skilled in the art.
As will be appreciated by those skilled in the art, monitoring station “A” 105 may be portable without departing from the scope of the present invention. In an embodiment of the present invention, monitoring station “A” 105 is integrated into a patient supporting device, as for example and not as a limitation, a bed, a gurney, or a wheelchair. Monitoring station “A” 105 may also be assembled on a cart or other mobile structure.
The components of patient monitoring station “A” 105 are connected to network 145 via network interface 140. Network 145 may be a wired network, a wireless network, a satellite network, a public switched telephone network, an IP network, a packet switched network, a cell phone network, a cable network, and a coax network, a hybrid fiber coax network.
Pharmacological supplies 180 comprise an inventory of medicines that is provided to a healthcare location depending on circumstances. By way of illustration and not as a limitation, a monitored patient care system 100 may be operated in a full service hospital facility or dropped shipped to a disaster area where the primary concern is sanitation-based illnesses. In the former instance, the full service hospital would have access to all available medications. However, in the case of the drop shipped field hospital, pharmacological supplies 180 would comprise those medications, diagnostic tools, and preventive agents that are useful in countering the expected diseases and not readily available to the healthcare location. In contrast, if the disaster area is most likely to experience patients with physical injuries, pharmacological supplies would be weighted to supplies needed to diagnose, treat, and comfort the wounded.
An optional site assessment module 130 and an optional patient assessment module 135 connect to network interface 140 via general purpose computer 110. It is anticipated that a monitored patient care system 100 equipped with the optional site assessment module 130 and the optional patient assessment module 135 will be used in healthcare locations that have limited resources. Site assessment module 130 provides information indicative of the ability of a healthcare location to provide diagnostic, laboratory, surgical, and pharmacological services. In an embodiment of the present invention, the site assessment module acquires data from the healthcare location produces service level measures comprising an inventory of available monitoring data elements, an inventory of available diagnostic services, an inventory of available surgical treatment services, and an inventory of available laboratory services. These data may be acquired via a survey or by reference to a database in which the survey data of the healthcare location are stored. Alternatively, in another embodiment of the present invention, a monitored patient care system comprises an assessment code that details the capability of the monitored patient care system 100. By way of illustration and not as a limitation, the assessment code may indicate the number of monitoring devices incorporated into the monitored patient care system 100, the patient parameters that can be acquired using the monitoring devices, and the pharmacological supplies 180 provided with the monitored patient care system 100.
Optional patient assessment module 135 provides patient condition data indicative of a monitored patient to remote command center 150. In an embodiment of the present invention, patient assessment module 135 acquires data relating to a patient's diagnosis, prescriptions, history, condition, laboratory results and other health-relevant data. These data may be acquired via a survey or by reference to a database in which the patient condition data are stored.
As will appreciated by those skilled in the art, site assessment module 130 and a patient assessment module 135 may be standalone components or may be software applications operating on general purpose computer 110.
Also connected to network 145 is remote command center 150. Remote command center 150 comprises a patient rules generator 155, a rules engine 160, decision support system 155, display and control system 165, and audio/video (A/V) conferencing server 170. Decision support system 158 issues instructions to the rules generator 155 when rules required for a patient. Once the rules are generated by rules generator 155, the decision support system 158 causes the rule to be referred to the rules engine 160 for subsequent application to the specific patient for whom the rule was originally generated. A network interface 175 provides connectivity between network 145 and the other elements of the remote command center. Network 145 is configured to permit access to external networks (not illustrated), such as the Internet.
Video camera 120 is movable both horizontally and vertically and zoomable through remote commands from the display and control system 165 of remote command center 150 so that specific views of the patient may be obtained both up close and generally. Duplex audio system 125 comprises a speaker and microphone (not illustrated) to permit both one-way audio monitoring of the patient and two-way communication with the patient or others in proximity to patient monitoring station “A” 105.
Patient monitoring device 115 acquires physiological data from a patient in real-time. In an embodiment of the present invention, general purpose computer 110 comprises a printer that receives and prints orders and instructions from an authorized remote caregiver. By way of illustration and not as a limitation, an order comprises a lab order, a medication, and a procedure. Orders are tailored to the capabilities of the healthcare location patient care system 100.
A network interface 140 provides access to network 145 for transmission of the monitored data, video signal, and audio signals to the remote command center 125 and the receipt of the audio signals and, optionally, printer signals at the monitoring station.
FIG. 2 illustrates the components of a transportable patient care unit according to embodiments of the present invention. A transportable patient care unit 200 comprises the components illustrated in FIG. 1 mounted on a cart 250. Video camera 205 is movable both horizontally and vertically and zoomable through remote commands from the display and control system 165 of remote command center 150 (see, FIG. 1) so that specific views of the patient may be obtained both up close and generally. A microphone 210 and a speaker 215 permit both one-way audio monitoring of the patient and two-way communication with the patient or others located in proximity to transportable patient care unit 200. Patient monitoring devices 220A-220D acquire physiological data from a patient in real-time. A printer 230 receives and print orders from an authorized caregiver. By way of illustration and not as a limitation, an order comprises a lab order, a medication, and a procedure. A network interface 255 provides access to a network (see FIG. 1, 150) for transmission of the monitored data, video signal, and audio signals to a remote command center and the receipt of the audio signals and printer signals at the monitoring station. A general purpose computer 210 allows on site care givers to provide additional data that may be germane to the care of the patient.
Referring again to FIG. 1, the remote command center 125 receives monitored data from patient monitoring station “A” 105 and patient condition data from patient assessment module 135 via network 145 through network interface 175. Monitored data comprises real-time data received from monitoring equipment at patient monitoring station “A” 105 that is configured to receive physiological data monitored patient and associated with patient monitoring station “A” 105.
The rules generator 155 and the rules engine 160 facilitate detection of impending problems and automate problem detection thereby allowing for intervention before a patient condition reaches a crisis state. Rules engine generator 155 establishes one or more rules for the monitored patient associated with patient monitoring station “A” 105. In an embodiment of the present invention, rules generator 155 generates a rule that is consistent with the patient assessment data and with the service level measures established by the site assessment module 130. The rules engine 160 continuously applies a rule to selected data elements of patient assessment data (assessment data is all data relevant to the health of a patient) to determine whether the rule for a monitored patient has been contravened. In the event the rule has been contravened, the remote command center issues an alert.
In one embodiment of the present invention, a rule is established to determine whether a patient's condition is deteriorating and an alert comprises an intervention order and protocol. In another embodiment of the present invention, the rules engine is further adapted to determine whether a monitored patient requires monitoring by a monitoring station. If not, a release protocol and order are issued. In still another embodiment of the present invention, a rule dictates threshold limits for changes over time of specific vital sign data. Thresholds that are patient-specific disease-specific are established. The rules engine then evaluates the monitored data for the specific vital sign data to determine if a change threshold has been exceeded.
For example, a patient with coronary artery disease can develop myocardial ischemia with relatively minor increases in heart rate. Heart rate thresholds for patients with active ischemia (e.g. those with unstable angina in a coronary care unit) are set to detect an absolute heart rate of 75 beats per minute. In contrast, patients with a history of coronary artery disease in a surgical ICU have thresholds set to detect either an absolute heart rate of 95 beats per minute or a 20% increase in heart rate over the baseline. For this threshold, current heart rate, calculated each minute based on the median value over the preceding 5 minutes, is compared each minute to the baseline value (the median value over the preceding 4 hours).
In another embodiment of the present invention, a rule is based on multiple variables. By way of illustration, a rule is contravened if the rules engine determines that monitored data reflects both a simultaneous increase in heart rate of 25% and a decrease in blood pressure of 20%, occurring over a time interval of 2 hours.
For multi-variable rules, thresholds rely on known or learned associations between changes in multiple variables, which variables may comprise diverse data types. Thus, a rule may associate monitored physiological data with patient clinical data. The association may change depending on the diagnosis of the patient, the medication given the patient, and the results of laboratory data. For example, a rule may associate central venous pressure and urine output, because simultaneous decreases in these two variables can indicate that a patient is developing hypovolemia. Another rule may cause the rules engine to evaluate laboratory data (e.g. looking for need to exclude active bleeding and possibly to administer blood).
In an embodiment of the present invention, a rule established for a monitored patient and the monitored patient is associated with a particular monitoring station. In this embodiment, if the patient were later associated with a different monitoring station, the remote command center would associate the rule with the different monitoring station at the time that the association between the monitored patient and the different monitoring station is made. In this way, rules “move” with the patient without manual intervention.
In another embodiment of the present invention, patient rules generator 155 establishes one or more rules for the monitored patient associated with patient monitoring station “A” 105. The patient rules generator 155 receives rules performance measures indicative of the ability of the rule to predict changes in the condition of a patient and uses these measures to assess the efficacy of the rule. By way of illustration and not as a limitation, the rules performance measures may be derived from survey data from healthcare professionals with experience with the rule or with the relationship of certain variables used by the rule to other variables or to a particular medical condition. Alternatively or in conjunction with survey data, the patient rules generator 155 may review historical data using multivariate analyses to relate variables, rules, and patient outcomes. By way of illustration and not as a limitation, the patient rules generator 155 may use ANOVA or BSS to automatically produce rules performance measures of existing rules and to identify new relationships among variables that may be used to form new rules. The patient rules generator 155 may update a rule, determine that a rule is acceptable as is, or determine that there is insufficient data to revise a rule.
The patient rules generator 155 may also evaluate the assessment data of patients with similar conditions to determine whether a predictive rule can be written and applied to patients with the same or similar conditions. The rules generator 155 may also test a proposed rule against historical data to determine whether the rule is predictive of a change in a patient's condition.
In yet another embodiment of the present invention, the patient rules generator 155 generates a rule that is consistent with the service level measures established by a site assessment module 130.
In another embodiment of the present invention, patient monitoring equipment acquires monitored data elements from a patient monitoring station and stores monitoring data in general purpose computer 110. The stored monitoring data is sent from general purpose computer 110 to the remote command center 150 along with patient data under control of an optional communications scheduler 112 at a pre-established time such as hour or when an “event” occurs as noted below, or when requested by remote command center 150. The remote command center 150 evaluates the “delayed” monitored data and assessment data in the same manner as if these data were received in real time. By way of illustration, the remote command center will generate rules using patient rules generator 155, apply those rules using rules engine 160 to the delayed monitored data and patient data and provide guidance to the monitored patient care system 100. The decision support algorithms of decision support system 158 may also be applied to the delayed monitored data and patient data. This embodiment of the present invention thus provides high quality care in environments where continuous high bandwidth communications are not available or economically infeasible.
In still another embodiment of the present invention, the delivery of stored monitoring data and patient data is expedited by an urgent consultation warning system (herein, the UCWS) operated by general purpose computer 110. The UCWS constantly evaluates the monitoring data and patient data before those data are stored to determine if an event has occurred that warrants an urgent consultation. By way of illustration and not as a limitation, changes in hemodynamic and respiratory measures over time indicative of a degrading condition of a patient would trigger an immediate reporting of all stored monitored and patient data to the remote command center 150 for evaluation.
Referring to FIG. 1, the display and control system 165 provides the human interface for the remote command center. FIG. 3 illustrates a display and control system according to an embodiment of the present invention. A display and control system 165 comprises a video display unit 305, a computer terminal 310, a camera control 315, and an audio control 320. The video display unit 305 displays real-time monitoring data and video images from patient monitoring station “A” 105. The computer terminal 310 allows selecting the layout and content displayed on the video display unit 305, provides access to the record of the patient associated with patient monitoring station “A” 105, and permits entry of data into that record. The camera control 315 permits control from the remote command center 125 of the video camera 120 (see FIG. 1) at the patient monitoring station “A” 105. The audio control permits control from the remote command center 150 of a microphone and a speaker within the duplex audio system 125 of patient monitoring station “A” 105. Connectivity between the components of the display and control systems 165 and patient monitoring station “A” 105 is provided by network interface 175, network 145, and network interface 140.
Referring again to FIG. 1, the remote command center 150 comprises decision support system 158. FIG. 4 illustrates a decision support system according to an embodiment of the present invention. Referring to FIG. 4, decision support system 158 is connected to network interface 175 and comprises a computer 405. Computer 405 operates continued care software 420 and order writing software 415. Continued care software 410 and order writing software 415 make calls to datastore 425 to access the assessment data related to a particular monitored patient associated with patient monitoring station “A” 105 (see, FIG. 1).
Continued care software 420 comprises decision support algorithms that operate on elements of assessment data and/or input from a caregiver to facilitate decisions relating to diagnosis, treatment and triage. Continued care software may be applied at the time the patient is admitted and throughout the patient's stay within a treatment facility. Thus, a diagnosis may be made based on the initial data acquired during admission, following the completion of laboratory procedures, or after other pertinent information is acquired. In an embodiment of the present invention, continued care software 420 evaluates selected data elements of assessment data continuously and provides an alert if those data are indicative of a different diagnosis. The alert may take the form of suggested diagnoses that are vetted by a series of questions posed by the continued care software 420 to a caregiver. Based on the responses to the questions, a suggested diagnosis may be eliminated. The alert may also comprise instructions for specific tests to be run on the monitored patient to help formulate a new diagnosis. Once a diagnosis is confirmed, the continued care software 420 continues to monitor changes in patient data and issues an alert if the current diagnosis should be reevaluated by a caregiver.
Decision support system 158 also issues instructions to the rules generator 155 when rules required for a patient. Once the rules are generated by rules generator 155, the decision support system 158 causes the rule to be referred to the rules engine 160 for subsequent application to the specific patient for whom the rule was originally generated.
In another embodiment of the present invention, patient monitoring equipment acquires monitored data elements from a patient monitoring station and stores monitoring data in general purpose computer 110. The stored monitoring data is sent from general purpose computer 110 to the remote command center 150 along with patient data under control of an optional communications scheduler 112 at a pre-established time such as hour or when an “event” occurs as noted below, or when requested by remote command center 150. The continued care decision support system 158 evaluates selected data elements of the assessment data in the same manner as if these data were received in real time and provides an alert if those data are indicative of a different diagnosis.
In still another embodiment of the present invention, the delivery of stored monitoring data and patient data is expedited by an urgent consultation warning system (herein, the UCWS) operated by general purpose computer 110. The UCWS constantly evaluates the monitoring data and patient data before those data are stored to determine if an event has occurred that warrants an urgent consultation. By way of illustration and not as a limitation, changes in hemodynamic and respiratory measures over time indicative of a degrading condition of a patient would trigger an immediate reporting of all stored monitored and patient data to the decision support system 158 for evaluation.
In still another embodiment of the present invention, continued care software 420 operates on a diagnosis to “triage” a patient. For example and without limitation a caregiver requests an Apache II score based on the diagnosis. Continued care software 420 calls selected data elements from datastore 425 appropriate to the diagnosis. The values of the selected data elements are weighted according to an algorithm and a patient severity score is determined. This patient severity score is used to determine whether the patient is treated in a patient monitoring station. For example, if one embodiment of the present invention, if the severity score is greater than or equal to a particular threshold, the patient is identified as requiring observation via a patient monitoring station. If the severity score is less than that threshold, the patient is triaged to a facility other than a patient monitoring station, thereby assigning patient monitoring stations to patients who are most likely to benefit from monitoring and continued assessment.
In another embodiment of the present invention, computer 405 operates order writing software 415, either independently or in conjunction with the operation of continued care software 420 to order tests to complete the data required for a potential diagnosis.
According to another embodiment of the present invention, the orders issued by order writing software 415 are consistent with the service level measures established by the site assessment module 130.
FIG. 5 illustrates an order writing data flow according to an embodiment of the present invention. Referring to FIG. 5, order entry user interface 500 allows the caregiver to order procedures and medication to assist the patients at a patient monitoring station. For example, the caregiver can order an ECG 504. Thereafter the order is reviewed and a digital signature relating to the caregiver is supplied 506. Once reviewed and signed off, the order is approved 507 and sent to the data output system 510. Thereafter the data output system prints the order to the printer at a patient monitoring station 516. For record keeping purposes the order is exported in the HL7 language to the hospital data system 518. In addition the data output system adds an item to the database that will subsequently cause a caregiver to check the ECG results. This notification to the task list is provided to the database 514. In addition, as part of the database an orders file relating to the specific patient is also kept. The fact that an ECG has been ordered is entered in the orders file for that patient.
In a similar fashion using the order entry user interface 500 the caregiver can order medications 502 for a patient. The medication order then is provided to an order checking system 508. The order checking system retrieves information from the database 514 relating to allergies of the patient and medication list that comprises medications that are already being administered to the patient. This allows for the order checking system to check for drug allergies and drug interactions. Further laboratory data is extracted from the database 514 and the order checking system checks to insure that there will be no adverse impact of the recommended dosage upon the renal function of the patient. Once the order checking system 508 is completed, the order is approved and provided to the order review and signature module 506. In this module the digital signature of a caregiver is affixed to the order electronically and the order is approved 507. Thereafter it is provided to the data output system 510 where again the orders are printed or transmitted via HL7 for the patient monitoring station 516, for the pharmacy 517 and for the treatment facility data system 518. In this case, any medications that are ordered are then provided to the medications list file in the database 514 so that the complete list of all medications that are being administered to the patient is current.
In an embodiment of the present invention, order checking system 508 determines whether the order is consistent with the service level measures established by the site assessment module 130. If the order is not consistent with the service level measures, the order is suppressed and the caregiver is notified that an alternative treatment is required.
As noted, the order writing software 415 may also interact with continued care software 410. Referring again to FIG. 4, a caregiver selects a suggested diagnosis from the continued care software 420 and enters the order writing software 415. As previously described, the orders issued by order writing software 415 are consistent with the service level measures established by the site assessment module 130. The order writing software identifies the appropriate test or tests and issues the actual order or orders for the identified tests. Each order is then sent to the appropriate testing facility. The tests are conducted, and the completion of the order is reported to the data store 425 and the completion information is received by the order writing software 415. Additionally, continued care software 420 acquires the test results from the datastore 425 and updates the list of suggested diagnoses.
Continued care software 420 provides reference material directed to the standardized treatment of the monitored patient. In order to standardize treatment provided to monitored patients at the highest possible level, decision support algorithms are used in the present invention. These include textural material describing the topic, scientific treatments and possible complications. This information is available in real time to assist in all types of clinical decisions from diagnosis to treatment to triage.
In an embodiment of the present invention, the decision response algorithms are responsive to the service level measures established by the site assessment module 130. In this embodiment, the algorithms adjust the response to fit the capabilities of the healthcare location.
As noted earlier, an aspect of the present invention is to standardize care and treatment across patient monitoring stations. This is effective in the present invention by providing decision support to caregivers as well as information concerning the latest care and practice standards for any given condition. Table 1 below is an exemplary list of a wide variety of conditions within the general categories of cardiovascular, endocrinology, general, gastrointestinal, hematology, infectious diseases, neurology, pharmacology, pulmonary, renal, surgery, toxicology, for which algorithms of care have been developed. As will be appreciated by those skilled in the art, the list in Table 1 is not exhaustive and other decision support algorithms may be developed for other conditions without departing from the scope of the present invention.







TABLE 1







Bradyarrhythmias diagnosis & treatment


Cardiogenic shock treatment


Cardio-pulmonary resuscitation treatment


Congestive heart failure diagnosis & treatment


Emergency cardiac pacing indications


Fluid resuscitation indications & treatment


Hypertensive crisis treatment


Implantable cardio-defibrillators indications


Intra-aortic balloon devices indications


Magnesium treatment


Treatment of hypotension


Myocardial infarction diagnosis & treatment


MI with left bundle branch block diagnosis


Pulmonary artery catheter indications


Permanent pacemakers indications


Pulmonary embolism diagnosis


Pulmonary embolism treatment


Supra-ventricular tachyarrhythmias diagnosis & treatments


Unstable angina diagnosis & treatment


Venous thromboembolism prophylaxis treatment


Venous thrombosis: diagnosis & treatment


Ventricular arrhythmias diagnosis & treatment


Adrenal insufficiency diagnosis and treatment


Diabetic ketoacidosis diagnosis and treatment


Hypercalcemia: diagnosis & treatment


Hyperglycemia: insulin treatment


Steroid replacement treatment


Thyroid disease diagnosis and treatment


End of life treatment decisions


Pressure ulcers treatment


Organ procurement indications


Antibiotic associated colitis diagnosis and treatment


Hepatic encephalopathy diagnosis and treatment


Hepatic failure diagnosis and treatment


Treatment of patients with ascites


Nutritional management


Acute pancreatitis diagnosis and treatment


Upper gastro-intestinal bleeding: stress prophylaxis treatment


Upper gastro-intestinal bleeding: non-variceal treatment


Upper gastro-intestinal bleeding: variceal treatment


Heparin treatment


Heparin-induced thrombocytopenia diagnosis and treatment


The bleeding patient diagnosis and treatment


Thrombocytopenia diagnosis and treatment


Thrombolytic treatment


Transfusion indications


Hematopoetic growth factor indications


Warfarin treatment


Acalculus cholecystitis diagnosis and treatment


Bloodstream infections diagnosis and treatment


Candiduria diagnosis and treatment


Catheter related septicemia diagnosis and treatment


Catheter replacement strategies


Endocarditis prophylaxis


Endocarditis diagnosis and treatment


Febrile neutropenia diagnosis and treatment


Fever of Unknown Origin diagnosis


HIV+ patient infections diagnosis and treatment


Meningitis diagnosis and treatment


Necrotizing soft tissue infections diagnosis and treatment


Non-infectious causes of fever diagnosis


Ophthalmic infections diagnosis and treatment


Pneumonia, community acquired diagnosis and treatment


Pneumonia, hospital acquired diagnosis and treatment


Septic shock diagnosis and treatment


Sinusitis diagnosis and treatment


Systemic Inflammatory Response Syndrome diagnosis and treatment


Transplant infection prophylaxis


Transplant-related infections diagnosis and treatment


Agitation, anxiety, depression & withdrawal treatment


Brain death diagnosis


Guillain-barre syndrome diagnosis and treatment


Intracerebral hemorrhage diagnosis and treatment


Myasthenia gravis diagnosis and treatment


Neuromuscular complications of critical illness diagnosis and treatment


Non-traumatic coma diagnosis


Sedation treatment


Status epilepticus diagnosis and treatment


Stroke diagnosis and treatment


Sub-arachnoid hemorrhage diagnosis and treatment


Aminoglycoside dosing and therapeutic monitoring


Amphotericin-b treatment


Analgesia treatment


Drug changes with renal dysfunction


Penicillin allergy diagnosis and treatment


Neuromuscular blocker treatment


Vancomycin treatment


Adult Respiratory Distress Syndrome: hemodynamic treatment


Adult Respiratory Distress Syndrome: steroid treatment


Adult Respiratory Distress Syndrome: ventilator treatment


Asthma diagnosis & treatment


Bronchodilator use in ventilator patients


Bronchoscopy & thoracentesis indications


Chronic Obstructive Pulmonary Disease treatment


Chest X-ray indications


Noninvasive modes of ventilation indications


Endotracheal tubes & tracheotomy indications


Treatment of airway obstruction


Ventilator weaning


Acute renal failure: diagnosis and treatment


Dialysis indications


Diuretic treatment


Hyperkalemia: diagnosis & treatment


Hypernatremia: diagnosis & treatment


Hypokalemia: diagnosis & treatment


Hyponatremia: diagnosis & treatment


Oliguria diagnosis and treatment


Obstetrical complications and treatment


Dissecting aortic aneurysm diagnosis and treatment


Post-operative hypertension treatment


Post-operative myocardial ischemia (non-cardiac surgery) treatment


Diagnosis and treatment of arrhythmias after cardiac surgery


Diagnosis and treatment of post-operative bleeding


Post-operative management of abdominal


Post-operative management of open heart


Post-operative management of thoracotomy


Post-operative management of carotid


Wound healing treatment


Diagnosis and treatment of acetaminophen overdose


Diagnosis and treatment of anaphylaxis


Diagnosis and treatment of cocaine toxicity


Diagnosis and treatment of alcohol withdrawal


Diagnosis and treatment of hyperthermia


Diagnosis and treatment of latex allergy


Diagnosis and treatment of unknown poisoning


Diagnosis and treatment of abdominal compartment syndrome


Diagnosis and treatment of blunt abdominal injury


Diagnosis and treatment of blunt aortic injury


Diagnosis and treatment of blunt cardiac injury


Deep Venous Thrombosis prophylaxis treatments


Acid-base disturbance diagnosis and treatment


Electrolyte disturbance diagnosis and treatment


Severity adjustment calculation and outcome prediction


Ventilator treatment


Continuous renal replacement treatment


Infusion pump administration treatment


Fungal infection diagnosis and treatment


Viral infection diagnosis and treatment


Diagnosis and treatment of extremity compartment syndrome


Diagnosis and treatment of head injury


Diagnosis and treatment of hypothermia


Diagnosis and treatment of identification of cervical cord injury


Diagnosis and treatment of spinal cord injury


Diagnosis and treatment of open fractures


Diagnosis and treatment of penetrating abdominal injury


Diagnosis and treatment of penetrating chest injury


Admission criteria


Discharge criteria


Patient triage


Discharge planning









FIGS. 6A, B, C and 6D illustrate an application of a decision support algorithm for the diagnosis and treatment of acalculous cholecystitis to patient data according to an embodiment of the present invention. FIGS. 6A through 6D are exemplary only and are not limiting. As will be appreciated by those skilled in the art, decision support algorithms (DSAs) for other conditions may be implemented in the continued patient care software without departing from the scope of the present invention.
Referring to FIG. 6A, a datastore comprising patient data is accessed by the DSA 600 for data indicative of clinical infection. A determination is made whether the data is sufficient to determine whether the patient is clinically infected 602. If the data necessary to make the decision are not available, the system continues its monitoring 604 until data in the datastore indicates otherwise. Alternatively, an alert may be issued on a monitor at the command center although this is not a requirement for further tests to be ordered. Test that are ordered by the DSA are then performed on the patient to obtain the data required for the decision.
If the data are sufficient, a determination is made whether the patient meets criteria for a clinical infection as measured by elevated temperature and leukocystosis 606. In an embodiment of the present invention, the criteria are temperature great than 102 F, or a white blood cell count greater than 12,000. If the criteria for clinical infection are not met the system of the present invention goes back into its continuous monitoring mode 608. The process is then complete and the continuous monitoring of the present invention continues.
If the patient is clinically infected 606, the DSA accesses the patient data datastore and acquires data indicative of whether the patient has had a previous cholecystectomy 610. A determination is then made whether the data is sufficient to determine whether the patient has had a previous cholecsystectomy 612. If the data necessary to make the decision are not available, the DSA prompts the caregiver to find out this information 613. When the information is obtained it is put into the datastore. Notations of “incomplete data” are kept by the system so that treatment records and need for tests can be audited. This is accomplished by storing an “incomplete data” record 614.
If the data are sufficient, a determination is made whether the patient has had a previous cholecystectomy 616. If the patient has had a previous cholecystectomy, it is very unlikely that the patient has acalculous cholecystitis. Therefore the DSA has completed its analysis for acalculous cholecytitis and the continuous monitoring of the present invention continues for other possible etiologies of infection 618.
Referring to FIG. 6B, if the patient has not had a previous cholecystectomy, the DSA accesses the patient datastore and acquires data indicative of whether the patient has any of a set of risk factors 620. In another embodiment of the present invention, the risk factors comprise: 1) Prolonged intensive care unit (ICU) stay (defined as greater than six (6) days); 2) recent surgery within the last two weeks (particularly aortic cross clamp procedures); 3) hypotension (BP less than 90 mmHg); 4) positive end-expiratory pressure (PEEP) greater than ten (10) centimeters (cm); 5) transfusion greater than six (6) units of blood; 6) inability to use the gastrointestinal (GI) tract for nutrition; or 7) immunosuppresssion (AIDS, transplantation, or leukemia).
If the data are sufficient, a determination is made whether the patient has any of the risk factors 626. If the patient does not have any of the risk factors, the diagnostic process is then complete and the continuous monitoring of the present invention continues 628.
If the patient has any of the seven risk factors, the DSA accesses the patient data datastore and acquires data indicative of whether the patient has any of a set of symptoms 630 or abnormal laboratory values. A determination is made whether the data is sufficient to determine whether the patient has any of the symptoms 632 or abnormal laboratory values. If the data necessary to make the decision are not available, the DSA directs the order writing software 415 (see FIG. 4) to order the tests 633. Results are sent to the datastore. Notations of “incomplete data” are kept by the system so that treatment records and need for tests can be audited. This is accomplished by storing an “incomplete data” record 634. Alternatively, an alert may be issued on a monitor at the command center to check for right upper quadrant tenderness although this is not a requirement for further tests to be ordered. In another embodiment of the present invention, the symptoms comprise: right upper quadrant (RUQ) tenderness and the abnormal laboratory results comprising elevated alkaline phosphatase; elevated bilirubin; or elevated liver transaminases.
If the data are sufficient, a determination is made whether the patient has any of the symptoms 636 or abnormal laboratory values. If the patient does not have any of the symptoms or abnormal laboratory values, the DSA concludes that it is very unlikely that the patient has acalculous cholecystitis. The process is then complete and the continuous monitoring of the present invention continues 638.
Referring to FIG. 6C, if the patient has any of the symptoms or abnormal laboratory values, the DSA accesses the patient data datastore and acquires data indicative of whether alternative intra-abdominal infectious sources are more likely 640. A determination is made whether the data is sufficient to determine whether the other infectious sources are more likely 642. If the data necessary to make the decision are not available, the DSA prompts the user for a response as to whether other infectious causes are present and considered more likely 644. The user can then provide the requested information that can be considered by the system 646 for further analysis.
If the data are sufficient, a determination is made whether other sources of infection are more likely 646. Regardless of the outcome of this determination, the DSA accesses the patient datastore and acquires data indicative of whether the patient is sufficiently stable to be subjected to testing outside of the critical care environment 650. A determination is made whether the data are sufficient to determine whether the patient is stable to go outside of the critical care environment 652. If the data necessary to make the decision are not available, the DSA prompts the user for a response 654 and may direct the order writing software 415 (see FIG. 4) to order tests or procedures 653 that will assist in such a determination. An “incomplete data” record is also created 651. Test results are sent to the datastore. Notations of “incomplete data” are kept by the system so that treatment records and need for tests can be audited. This is accomplished by storing an “incomplete data” record 654. Alternatively, an alert may be issued on a monitor at the command center although this is not a requirement for further tests to be ordered.
Referring to FIG. 6D, if the data are sufficient, a determination is made whether the patient is sufficiently stable to be subjected to testing outside of the critical care environment 656.
If the patient is not sufficiently stable to be subjected to testing outside of the critical care environment (regardless of whether other sources of infection are indicated), the DSA issues a message comprising a recommendation that empiric antibiotic be considered and a bedside ultrasound be performed and the results communicated to the patient datastore 658. In still another embodiment of the present invention, the DSA directs the order writing software (see FIG. 4) to order the bedside ultrasound. The DSA accesses the test results and other patient data 662. If no other infectious etiologies are identified, no abnormalities of the gall-bladder are noted, and the patient is not improving, the DSA issues a message comprising a “provisional diagnosis of acalculous cholecystitis” and recommends an empiric cholecystectomy and systemic antibiotics 664. If no other infectious etiologies are identified, no abnormalities of the gall bladder are noted, and the patient is improving, the DSA issues a message comprising a recommendation to observe the patient 666.
If the patient is sufficiently stable to go outside of the critical care environment for a test and a determination was made that no other sources of infection were indicated (see FIG. 6C, 646), the DSA issues an order that empiric antibiotics be considered and a morphine sulfate Cholescintigraphy test be performed 668 and the results communicated to the datastore. In still another embodiment of the present invention, the DSA directs the order writing software 415 (see FIG. 4) to order the test.
A determination is made whether the results of the tests are normal 670. If the test indicates an abnormality, the DSA issues a message comprising a recommendation to consider a diagnosis of acalculous cholecystitis, administer systemic antibiotics and perform either a cholecystectomy or a percutaneous drainage 672. If the results are normal, acalculous cholecystitis is excluded 674. The process is then complete and the continuous monitoring of the present invention continues.
If the patient is sufficiently stable to go outside of the critical care environment for a test and a determination was made that other sources of infection were indicated (see FIG. 6C, 646), the DSA issues an order to consider empiric antibiotics and for an abdominal CT scan to be performed 680 and the results communicated to the datastore. In still another embodiment of the present invention, the DSA directs the order writing software 415 (see FIG. 4) to order the test.
The test results and other data are analyzed 682 and a determination is made whether other infection sources are indicated and whether the gall bladder is normal or if abnormalities are present that are not diagnostic 684. If other infectious etiologies are not apparent and the test: a) demonstrates abnormalities of the gall bladder but not diagnostic; or b) no gall-bladder abnormalities are noted, the DSA issues a report comprising a recommendation to maintain continued observation of the patient 686. The process is then complete and the continuous monitoring of the present invention continues. Alternatively, if other infectious etiologies are apparent, the DSA will make recommendations as to further diagnostics and treatments.
While the decision support algorithm described with reference to FIGS. 6A, B, C and 6D refers to a continuous monitoring “mode” of the present invention, this is not meant as a limitation. As previously described, embodiments of the present invention anticipate environments in which data is stored and evaluated on a “delayed” basis. The decision support algorithms described with reference to FIGS. 6A, B, C and 6D may be adapted to operate with delayed data without departing from the scope of the present invention.
Referring again to FIGS. 1 and 2, the remote command center comprises an A/V conferencing server 190. In an embodiment of the present invention, A/V conferencing server 190 acquires audio and video signals from patient monitoring station “A” and provides a terminal (not shown) access to these signals via external network access 195. In yet another embodiment of the present invention addition, a local terminal (not shown) operated by a “local visitation participant” or “LVP” and a remote terminal (not shown) operated by a “remote visitation participant” or “RVP” are bridged by A/V conferencing server 190 to provide audio and video signals from the patient monitoring station, the local terminal and the remote terminal available simultaneously to LVP and RVP. Additionally, a terminal user may control the position of camera 205. By way of illustration and not as a limitation, RVPs may be family members or other concerned parties while LVPs may be patients, nurses, doctors, family members or other concerned parties. This embodiment thus permits family members the capability to “virtually visit” other sick family members when a physical visit to a patient's location is not possible and/or desirable. The “virtual visit” further allows the possibility to see and speak with a care provider regarding a patient's care or related subjects without having to be physically located at the health care provider's location. The present invention also provides a means for the floor staff (i.e. those caregivers in the hospital at or near the patient's bedside) to instantly alert the command center of the conditions of patients who destabilize thereby allowing for more rapid response by those manning the command center.
When each command center person logs onto the system of the present invention, a background service is started. This service subscribes to an emergency alert server that is connected to a video server. As noted earlier, the video server provides video feed from each beside to the command center as needed. Emergency message are passed from the bedside through the video server to the command center. As the emergency alert server receives a message from a video server, it sends a message to all of the subscribed services in the command center. This notification alerts the command center users by means of a “pop-up” alert window at the users' workstation that an emergency condition exists at the bed calling for the alert, and that the floor caregiver has requested immediate backup.
To facilitate the emergency call capability of the present invention, in addition to the various network connections of a more automated type, an emergency “call button” is provided at each critical care location. This could by or near each bed, at a nurse's station, at a mobile care bed or any location where the patient may be located. When pressed, the call button causes a message to be sent to the emergency alert server at the command center that a patient emergency has occurred.
The present invention comprises a video/audio server (Axis 2401) dedicated to each critical care location. A button activation mechanism and associated wiring is provided to allow the call button to be positioned in the room at a location convenient to the caregiver calling for command center backup.
Currently each video server can support up to 16 call buttons by using combinations of the four inputs to signify one alarm in a 4-bit binary pattern although this is not meant as a limitation. A typical installation would use one button or perhaps two (e.g. two beds per room) per video server.
A software interrupt event handler is configured on the video server to respond to activation of the emergency call button.
The emergency alert server comprises a web service called for sending emergency alert signals that is placed in service at system startup. When called, emergency alert web service responds with an acknowledgement message (e.g. “Alert Received”). The emergency alert web service identifies the ward and bed directly from the IP address (unique to each video server) and input number it was passed. It then sends a message to all subscribing clients identifying the emergency condition, the ward, and bed.
When a user logs into a workstation at the command center a user alert service subscribes to the emergency alert server and waits for any emergency message in the background. Upon receiving an emergency message, the service will popup a window with the message on top of the desktop and stay there until the user dismisses or acknowledges the alert. The user alert service the loads video assessment module to allow the command center to view the bed with the emergency.
In another embodiment of the present invention, a critical care hospital bed comprises monitoring instruments linked to a wireless network. This serves the needs of those patients who are transported from one location to another (either internal to a hospital or to other hospitals or diagnostic centers) for testing, procedures or other reasons. In this embodiment, monitoring continues using typical monitoring means that have been described above which include, without limitation, physiological monitoring equipment, video monitoring equipment and an emergency call button, all of which transmit their signals in a wireless fashion so that movement of the patient bed does not interrupt the transmission of information.
A telecommunications network for remote patient monitoring has now been illustrated. It will be apparent to those skilled in the art that other variations of the present invention are possible without departing from the scope of the invention as disclosed. For example, one can envision different ratios of remote command center to patient monitoring stations. Certain types of decision support algorithms would be used by intensivists, other types of remote monitoring of not only patient monitoring stations but other types of hospital functions as well as industrial functions where critical expertise is in limited supply but where that expertise must be applied to ongoing processes. In such cases a system such as that described can be employed to monitor processes and to provide standardized interventions across a number of locations and operations. Further, any reference to claim elements in the singular, for example, using the articles “a,” “an,” or “the” is not to be construed as limiting the element to the singular.

## Claims

1. A rules-based patient care system comprising:
a telecommunications network;
monitoring stations comprising monitoring equipment, wherein the monitoring equipment comprises instructions for monitoring data elements from geographically dispersed hospitalized patients and for sending the monitored data elements to a remote command center via the telecommunications network, wherein the remote command center comprises instructions for:
receiving the monitored data elements from the geographically dispersed hospitalized patients;
accessing patient data elements indicative of a medical condition associated with each of the geographically dispersed hospitalized patients;
establishing patient-specific rules associated with each of the geographically dispersed hospitalized patients; and
applying the patient-specific rules continuously using a rules engine, wherein the rules engine comprises instructions for:
selecting data elements from the monitored data elements and the patient data elements associated with a hospitalized patient;
applying a patient-specific rule in an automated fashion to the selected data elements to produce an output indicative of a change in the medical condition of the patient; and
utilizing the output to determine in an automated fashion 24 hours per day 7 days per week if intervention is warranted; and


a patient rules generator connected to the telecommunications network, wherein the patient rules generator comprises instructions for:
creating the patient-specific rule;
acquiring rules performance measures indicative of the ability of the patient-specific rule to predict the change in the condition of the patient; and
determining from the rules performance measures whether to revise the patient-specific rule.

2. The system of claim 1, wherein the patient-specific rule comprises an algorithm.

3. The system of claim 1, wherein the selected data elements comprise a physiological data element of the patient and a clinical data element of the patient.

4. The system of claim 1, wherein the selected data elements comprise a physiological data element of the patient and a medication data element of the patient.

5. The system of claim 1, wherein the selected data elements comprise a physiological data element of the patient and a laboratory data element of the patient.

6. The system of claim 1, wherein the selected data elements comprise a clinical data element of the patient and a laboratory data element of the patient.

7. The system of claim 1, wherein the selected data elements comprise a physiological data element of the patient and another physiological data element of the patient.

8. The system of claim 1, wherein the selected data elements comprise at least two data elements of the patient selected from the group consisting of a physiological data element, a clinical data element of the patient, a medication data element of the patient, and a laboratory data element of the patient.

9. The system of claim 1, wherein intervention comprises issuing a patient intervention order.

10. The system of claim 9, wherein the patient intervention order comprises a patient release order.

11. The system of claim 1, wherein patient data elements are selected from the group consisting of physiological data elements and clinical data elements.

12. The system of claim 1, wherein the output indicative of the change in the medical condition of the patient comprises an output indicative of improvement of the condition of the patient.

13. The system of claim 1, wherein the output indicative of the change in the medical condition of the patient comprises an output indicative of degradation of the condition of the patient.

14. The system of claim 1, wherein the rules performance measures are derived from information provided by health care providers.

15. The system of claim 1, wherein the patient rules generator further comprises instructions for:
accessing historical data, wherein the historical data comprises other patient data elements for a plurality of other patients and wherein the patient data elements of another patient are associated with an outcome of the other patient;
applying multivariate analyses to the historical data to produce a result that relates the other patient data elements, the patient-specific rule, and the other patient outcomes; and
generating a rules performance measure by comparing the result to the patient-specific rule.

16. The system of claim 15, wherein the patient rules generator further comprises instructions for generating a new rule from the result.

17. The system of claim 16, wherein the patient rules generator further comprises instructions for testing the new rule against the historical data.

18. The system of claim 1, wherein the system further comprises a site assessment module, wherein the site assessment module further comprises instructions for:
receiving site assessment data, wherein the site assessment data are indicative of the capability of a health care location to provide diagnostic and treatment services to patients;
determining from the site assessment data service level measures indicative of a capability of the health care location to provide diagnostic and treatment services to patients; and

wherein the rules generator further comprises instructions for:
receiving service level measures;
creating the patient-specific rule consistent with the service level measures.

19. The system of claim 18, wherein the site assessment module further comprises instructions for:
prompting a user for the site assessment data; and
determining the service level measures based on the user response.

20. The system of claim 18, wherein the health care location is associated with a site assessment code and the site assessment module further comprises instructions for:
acquiring the site assessment code associated with the patient care management system; and
determining the service level measures at least in part based on the site assessment code.

21. The system of claim 18, wherein the service level measures comprise:
an inventory of available monitoring data elements;
an inventory of available diagnostic services;
an inventory of available surgical treatment services; and
an inventory of available laboratory services.

22. The system of claim 1, wherein the network is selected from the group consisting of a wired network, a wireless network, a satellite network, a public switched telephone network, an IP network, a packet switched network, a cell phone network, a cable network, and a coax network, a hybrid fiber coax network.

23. The system of claim 1, wherein the patient is located at a health care location that is remote from the remote command center.

24. The system of claim 23, wherein the health care location is selected from the group consisting of a hospital, a nursing home, a mobile health care facility, a space-based health care facility, a residence, an emergency room, an intensive care unit, a field health care facility, an operating room, and a step-down unit.

25. The system of claim 1, wherein the remote command center further comprises:
an external network interface, wherein the external network interface comprises instructions for connecting to an external network; and
instructions for providing a health care provider access to the remote command center via the external network.

26. The system of claim 25, wherein the external network is selected from the group consisting of a wired network, a wireless network, a cable network, a fiber optic network, and the Internet.

27. The system of claim 25, wherein the health care provider is selected from the group consisting of a physician, a nurse, a clinician, a diagnostician, and a intensivist.

28. The system of claim 25, wherein the remote command center further comprises instructions for sending the health care provider the alert if the patient-specific rule for the hospitalized patient has been contravened.

29. A method for managing the care of a patient:
receiving at a remote command center monitored data elements from geographically dispersed hospitalized patients via a telecommunications network;
accessing patient data elements indicative of a medical condition associated with each of the geographically dispersed hospitalized patients;
establishing patient-specific rules associated with each of the geographically dispersed hospitalized patients;
selecting data elements from the monitored data elements associated with the hospitalized patient and the patient data elements associated with the hospitalized patient;
applying the patient-specific rule associated with the hospitalized patient continuously to the selected patient data elements to produce an output indicative of a change in the medical condition of the patient;
utilizing the output to determine in an automated fashion 24 hours per day 7 days per week if intervention is warranted;
acquiring rules performance measures indicative of the ability of the patient-specific rule to predict the change in the condition of the patient; and
determining from the rules performance measures whether to revise the patient-specific rule.

30. The method for managing the care of a patient of claim 29, wherein the patient-specific rule comprises an algorithm.

31. The method for managing the care of a patient of claim 29, wherein the selected data elements comprise a physiological data element of the patient and a clinical data element of the patient.

32. The method for managing the care of a patient of claim 29, wherein the selected data elements comprise a physiological data element of the patient and a medication data element of the patient.

33. The method for managing the care of a patient of claim 29, wherein the selected data elements comprise a physiological data element of the patient and a laboratory data element of the patient.

34. The method for managing the care of a patient of claim 29, wherein the selected data elements comprise a clinical data element of the patient and a laboratory data element of the patient.

35. The method for managing the care of a patient of claim 29, wherein the selected data elements comprise a physiological data element of the patient and another physiological data element of the patient.

36. The method for managing the care of a patient of claim 29, wherein the selected data elements comprise at least two data elements of the patient selected from the group consisting of a physiological data element, a clinical data element of the patient, a medication data element of the patient, and a laboratory data element of the patient.

37. The method for managing the care of a patient of claim 29, wherein utilizing the output to determine if intervention is warranted comprises utilizing the output to determine whether to issue a patient intervention order.

38. The method for managing the care of a patient of claim 29, wherein utilizing the output to determine if intervention is warranted comprises utilizing the output to determine whether to issue a patient release order.

39. The method for managing the care of a patient of claim 29, wherein the patient data elements are selected from the group consisting of physiological data elements and clinical data elements.

40. The method for managing the care of a patient of claim 29, wherein the output indicative of the change in the medical condition of the patient comprises data indicative of improvement of the condition of the patient.

41. The method for managing the care of a patient of claim 29, wherein the output indicative of the change in the medical condition of the patient comprise data indicative of degradation of the condition of the patient.

42. The method for managing the care of a patient of claim 29, wherein acquiring rules performance measures indicative of the ability of the patient-specific rule to predict the change in the condition of the patient comprises deriving rules performance measures from information provided by health care providers.

43. The method for managing the care of a patient of claim 29, wherein acquiring rules performance measures indicative of the ability of the patient-specific rule to predict the change in the condition of the patient comprises:
accessing historical data, wherein the historical data comprises other patient data elements for a plurality of other patients and wherein the patient data elements of an other patient are associated with an outcome of the other patient;
applying multivariate analyses to historical data to produce a result that relates the other patient data elements, the patient-specific rule, and the other patient outcomes; and
generating a rules performance measure by comparing the result to the patient-specific rule.

44. The method for managing the care of a patient of claim 43 further comprising generating a new rule from the result.

45. The method for managing the care of a patient of claim 44 further comprising testing the new rule against the historical data.

46. The method for managing the care of a patient of claim 29 further comprising:
receiving site assessment data, wherein the site assessment data are indicative of the capability of a health care location to provide diagnostic and treatment services to patients;
determining from the site assessment data service level measures of the health care location indicative of a capability of the health care location to provide diagnostic and treatment services to patients; and
and wherein creating the patient-specific rule further comprises creating the patient-specific rule consistent with the service level measures.

47. The method for managing the care of a patient of claim 46 further comprising:
prompting a user for the site assessment data; and
determining the service level measures based on the user response.

48. The method for managing the care of a patient of claim 46, wherein the health care location is associated with a site assessment code and the method further comprises:
acquiring the site assessment code associated with the health care location; and
determining the service level measures at least in part based on the site assessment code.

49. The method for managing the care of a patient of claim 40, wherein the service level measures comprise:
an inventory of available monitoring data elements;
an inventory of available diagnostic services;
an inventory of available surgical treatment services; and
an inventory of available laboratory services.

50. The method for managing the care of a patient of claim 29, wherein the patient is located at a health care location that is remote from the command center.

51. The method for managing the care of a patient of claim 50, wherein the health care location is selected from the group consisting of a hospital, a nursing home, a mobile health care facility, a space-based health care facility, a residence, an emergency room, an intensive care unit, a field health care facility, an operating room, and a step-down unit.

52. The method for managing the care of a patient of claim 29 further comprising:
interfacing with an external network; and
providing a health care provider access to the remote command center via the external network.

53. The method for managing the care of a patient of claim 52, wherein the external network is selected from the group consisting of a wired network, a wireless network, a cable network, a fiber optic network, and the Internet.

54. The method for managing the care of a patient of claim 52, wherein the health care provider is selected from the group consisting of a physician, a nurse, a clinician, a diagnostician, and a intensivist.

55. The method for managing the care of a patient of claim 52 further comprising sending the health care provider the alert if the patient-specific rule for the hospitalized patient has been contravened.