Field of the Invention

The present invention relates generally to systems, methods, and computer products for capturing and managing clinical patient data. More particularly, the present invention relates to systems and methods which enable healthcare providers to customize the capture of clinical data for electronic patient records.

Background to the Invention

Various products are available to healthcare providers to enable them to capture and manage increasingly detailed clinical data in the form of electronic patient records. These products vary from freeform paper notes through template based paper forms and software based computer systems. The simplest method for documenting clinical aspects of a patient visit are freeform paper notes, wherein the healthcare provider writes down what he or she regards as the relevant and significant details concerning the patient's history, symptoms and treatment protocol.

Another type of paper documentation involves template based paper forms. The templates are typically complaint-specific templates on which the healthcare provider indicates positive history or physical examination findings, and indicates pertinent negative findings by crossing out those words or sections which are not applicable. Such products can greatly reduce the time spent by the healthcare provider in documenting a patient visit resulting in cost savings and improved efficiency.

Paper based systems have the disadvantage that they can be difficult to search and store and can not be readily shared with other healthcare providers as required.

Software based systems offer healthcare providers the ability to document patient visits using systematic templates on a computer. Healthcare providers choose appropriate templates from a list of model templates for a particular encounter. It is difficult however, for software vendors to create general-purpose templates for capturing clinical data which will be applicable in all or a large number of situation types. When customized templates are

required by a healthcare provider, these must be individually programmed to meet the healthcare provider's particular requirements. Therefore, in most cases, healthcare providers have little direct control over the clinical data that is stored in the electronic patient record systems. It can also be difficult to relate data items appearing on a first form with the same data items appearing on a second form, to avoid duplicate input of a particular data item that happens to appear on multiple forms.

The discussion of the background to the invention included herein is included to explain the context of the invention. This is not to be taken as an admission that any of the material referred to were published, known or part of the common general knowledge as at the priority date of the claims.

Summary of the Invention

According to an aspect of the present invention, there is provided a system for customizing patient clinical data to be captured and stored in an electronic patient record database by a healthcare provider, the system including:

(a) a library defined by the healthcare provider, the library containing a plurality of clinical data items each corresponding to an element of clinical data to be captured for a patient;

(b) a clinical data item selection component to enable a user to nominate one or more clinical data items from the library to be captured for a particular patient or group of patients; and

(c) a template generating component for generating a template configured to capture clinical data corresponding to the healthcare provider nominated clinical data items.

In a preferred embodiment of the invention, the system further includes a design component for manipulating the layout of the clinical data items within the template. The design component may include an object component that provides a plurality of objects that can be added to or removed from the template, an aesthetic component for enhancing a visual appearance of the template, and/or a coding component that permits properties to be set for any objects added to the template.

Preferably, a plurality of clinical data items is associated in a clinical data group. This enables selection of a single item from the clinical data group to cause each other clinical data item in the group to be selected.

In another preferred form of the invention, the system includes links between certain events and one or more templates to cause entry of a particular event to prompt the system to automatically display a corresponding form for entry of clinical data. The links may be activated by any one or more of the following events: (a) start of a patient visit; (b) entry of a clinical data code corresponding to a particular diagnosis;

(c) initiation of a task associated with a service provided to the patient; or

(d) a user request for invoking a particular type of assessment or template. In yet another embodiment, the system includes filters between a template and one or more clinical data item values such that entry of a particular clinical data item value causes the system to automatically display a corresponding form for entry of further clinical data. The filters may be activated by any one or more of the following: (a) a patient's age and/or gender; (b) a reason for the patient's visit;

(c) a visit type;

(d) a specialty indicated by the patient's condition;

(e) a healthcare provider;

(f) a clinical event; (g) a service provided to the patient;

(h) a status of a service provided to the patient; or (i) an inventory item provided to the patient.

Preferably, the system further includes a normality setup component for assigning normality levels to the clinical data items. The system may also include a unit of measurement setup component for assigning valid units of measurement to the clinical data items.

In a preferred form of the invention, the system further includes a clinical data set component for assigning a valid data set to the clinical data items.

According to another aspect of the present invention, there is provided a method for capturing and storing customized patient clinical data in an electronic patient record database, the method including the following steps:

(a) a healthcare provider defining a library, the library including a plurality of clinical data items each corresponding to an element of clinical data to be captured for a patient;

(b) a user consulting the library and selecting one or more clinical data items from the library to be captured for a particular patient or group of patients; and

(c) generating a template configured to capture clinical data corresponding to the selected clinical data items.

In a preferred embodiment of the invention, the method further includes the step of manipulating the layout of the clinical data items within the template to achieve a desired template appearance. The step of manipulating the layout of the template may include adding or removing one or more objects from the template, enhancing a visual appearance of the template and/or setting properties for the objects added to the template.

Preferably, the method further includes the step of associating a plurality of clinical data items in a clinical data group such that selection of a single item from the group causes each other item in the group to be selected. In another preferred form of the invention, the method further includes the step of linking certain events with one or more templates such that entry of a particular event causes a corresponding form for entry of clinical data to be automatically displayed. The linkage of certain events with the templates may be based on any one or more of the following events: (a) start of a patient visit;

(b) entry of a clinical data code corresponding to a particular diagnosis;

(c) initiation of a task associated with a service provided to the patient; or

(d) a user request for a particular type of assessment or template.

In yet another preferred embodiment, the method further includes the step of applying a filter between a template and one or more clinical data item values and one or more templates such that entry of a particular clinical data item value causes a corresponding form to be displayed for entry of further clinical data. The filters may be activated by any one or more of the following: (a) a patient's age and/or gender;

(b) a reason for the patient's visit;

(c) a visit type;

(d) a specialty indicated by the patient's condition;

(e) a healthcare provider; (f) a clinical event;

(g) a service provided to the patient;

(h) a status of a service provided to the patient; or

(i) an inventory item provided to the patient.

Preferably, the method further includes the step of assigning normality levels to the clinical data items.

The method may further include the step of assigning valid units of measurement to the clinical data items.

In a preferred form of the invention, the method further includes the step of assigning a valid data set to the clinical data items.

Brief Description of the Drawings

The invention will now be described in further detail by reference to the attached drawings illustrating example forms of the invention. It is to be understood that the particularity of the drawings does not supersede the generality of the preceding description of the invention. In the drawings:

Figure 1 is a schematic diagram of the main system components according to an embodiment of the present invention.

Figure 2 is a screen view of a clinical data setup functionality used to define the library of clinical data items and/or groups. Figure 3 is a screen view of clinical data item text setup facility.

Figure 4 is a screen view of an example of a defined clinical data group.

Figure 5 is a screen view showing an example of a series of user defined templates stored in the system.

Figure 6 is a screen view showing a list of clinical data items available for selection.

Figure 7 is a screen view showing a screen design component according to an embodiment of the present invention.

Figure 8 is a database schema showing the links between various system components.

Figure 9 is a screen view showing an example of a clinical data set comprising a number of clinical data set elements.

Figure 10 is a flowchart giving a summary for creating a clinical data template.

Detailed Description

Referring firstly to Figure 1 , the system of the present invention allows healthcare providers to customize the patient clinical data that they wish to capture and store within their electronic patient record database. The system includes access to a library stored in a database. The library is defined by the healthcare provider to include a plurality of clinical data items, each corresponding to an element of clinical data that the healthcare provider wishes to capture for a patient record.

The plurality of clinical data items may include a series of standard clinical data items (e.g. age, weight, height, blood pressure, etc) which are predefined by the system. The system enables the healthcare provider to add to this series of predefined standard clinical data items, any other clinical data items which may be particular to the healthcare provider. This enables each healthcare provider to extend the library to include any clinical data items which may be of interest to that particular organisation. Accordingly, the healthcare provider defines the library of clinical data items, which are available for use by the physicians arid other healthcare professionals (hereinafter referred to as users) that practice within a particular healthcare provider organisation.

Users employ a clinical data item selection component to nominate one or more clinical . data items from the healthcare provider defined library. This enables each user to determine the clinical data which is pertinent to their examination of the patient and which they wish to store in their electronic patient record database. Different combinations of clinical data items may be defined for a particular patient or group of patients or may be standardized across the entire healthcare provider organisation.

The nominated clinical data items are automatically assembled into one or more templates which form the basis for data entry forms which will be used to capture patient clinical data during patient visits. A template generating component generates a template which is configured to capture clinical data

corresponding to the clinical data items and/or clinical data groups nominated by the user. User defined templates are stored in the database.

The system further provides a design component or screen designer to enable the healthcare provider to manipulate the layout of the clinical data items in the template to achieve a desired look and feel for the resulting clinical data entry forms.

The user defined templates are generated using a number of setup utilities. The healthcare provider nominates the clinical data items and/or clinical data groups to determine the clinical data that they wish to capture and store in their system and assign properties and attributes to the clinical data.

The logical flow of the template can be manipulated using embedded scripting. For example, fields can be turned on or off in response to opening the form, entering data or certain data values, or may be invoked by clicking a button. The template can be configured to change dynamically in response to various triggers. An example, of the functionality provided by the embedded scripting is to automatically calculate a body mass index (BMI) when a patient's weight and height is entered into a form. The relevant scripting can be defined in one of a number of scripting languages including DelphiScript, EnableScript, JavaScript, PerlScript, PythonScript and VBScript. The system generates a template with links to the clinical data items. A user then utilises forms based on the templates generated during the set-up phase to input and modify clinical data stored in a particular patient's electronic patient record. Any clinical data entered using the clinical data forms may be displayed in the clinical data form on screen, in text form, or sent directly other output means such as a printer.

On a user confirming the template, the system will create or update an SQL view of the clinical data capture in the template. This creates a virtual table enabling users to query or report on the data using any third party product, in much the same way as if the table had been independently programmed. Referring now to Figure 2, clinical data items make up the smallest building blocks of the clinical data templates. Clinical data items are classed as being of a particular type. The range of clinical data item types is system defined and influences the defaults and parameter settings that need to be defined for the item. For example, if the clinical data item is a "numeric range"

type, then the minimum and maximum values need to be defined for the item as well as a default value. The clinical data types can be selected from one of the following system defined types:

Boolean Item Clinical Code Multimedia

Coded Values Numeric

Date Numeric Range

Date & Time Quantity

Derived Formula Quantity Range Drug Code Ratio

Duration Reason for Visit

Free Text Service

General Code Specialty

Generic Drug Time HCO URL

HCP

The clinical data items are usually represented as the different data entry fields on the clinical data forms. The value of each clinical data item is stored in the electronic patient record in the database. The same clinical data item may be used on a number of different templates but will only appear on a single form once. Clinical data items may be added or modified at any time, by selecting the item to be added from the library, or by selecting an existing clinical data item and modifying its description, normality, default remarks, or the like.

Clinical data items may also be specified as free form text items as shown in Figure 3. Free form text items may be prepopulated with commonly used items, i.e. selected from a drop down menu, or can be entered as free form text.

It is also possible to define clinical data items so that a previously stored value for a particular clinical data item, e.g. from the most recent patient visit, is copied to the template selected for the patient's next visit. This avoids the need for users to re-enter values for clinical data items which are unlikely to vary over time, e.g. height, sex, etc.

A number of clinical data items may be associated in a clinical data group. Clinical data items that are associated in such a group are typically those clinical data items that are likely to be completed together, for example,

blood pressure typically comprises two clinical data items, systolic blood pressure and diastolic blood pressure. Figure 4 shows an example of a defined clinical data group relating to the location of an injury on a patient. An advantage of associating clinical data items in a clinical data group is that selection of a single item from a group will cause each other item in the group to be selected simultaneously. Clinical data groups can be added or modified at any time. Modification of existing clinical data groups may involve adding a clinical data item or removing a clinical data item from the group.

The template generated by the system provides the basis of the forms that the healthcare provider completes when capturing patient clinical data for storage in the electronic patient record database. The template includes clinical data items and/or clinical data groups. An example of a series of predefined templates is shown in Figure 5. Templates can be added, removed and/or modified at any time. To add clinical data items to a template, the template is selected by the user and one or more clinical data items from the library in the available list are selected as shown in Figure 6. By double clicking on the selected clinical data item, the clinical data item is added to the selected items panel that are to appear on the template.

Once the healthcare provider has nominated the clinical data items and/or groups that are to appear on the template, it is possible to manipulate the look and feel of the template. Referring now to Figure 7, the design component of the system provides the tools required to manipulate the template layout. When a template is initially created, the system arranges each of the selected items in a sequence number order. The screen designer permits the healthcare provider to alter the position of the fields on the template, by dragging and dropping objects in the desired position. The screen designer further enables the healthcare provider to add or remove further components or objects to or from the template, such as captions, page controls (i.e., dividing the template into a number of pages accessible via tabs), insertion of search engines, and enables the tab order of the fields in the form to be set.

For complex clinical data item types, such as for example, clinical codes, healthcare providers (HCP) and the like, the system is configured to create an appropriate data entry field with an associated lookup or search button. For example, if a clinical code is selected, then the form will include a data entry

field to capture the clinical code and description of the clinical code, as well as a search button to automatically launch a full clinical code search function. The system also automatically checks that manually entered clinical codes or other complex clinical data items are valid. Figure 8 shows a database schema showing the links between various system components.

The system also includes a normality setup component for assigning normality levels to the various clinical data items. The normality levels define the norm or expected range of values for the clinical data items. The normality levels may comprise a series of ranges corresponding to e.g. normal, abnormal, severely abnormal, and the like.

The system may also include a unit of measurement setup component for assigning valid units of measurement to the clinical data items. For example, a clinical data item corresponding to dispensed quantities may allow users to enter values in terms of TABLETS, CAPSLUES, CAPLETS. As described previously in relation to complex objects, the system is configured to automatically create two fields, one for the quantity and one for associated unit of measure. Both the quantity and the associated unit of measure can be selected form a drop down menu. A clinical data set setup component can be used to assign valid data sets to the clinical data items. Referring now to Figure 9, the clinical data set called "Blood Groups" can be defined to contain the following data set elements: A Positive B Positive AB Positive

O Positive A Negative B Negative AB Negative O Negative

Unknown

Where the clinical data set is predefined as in the illustrated example, the elements are typically selected from a drop down menu when completing a form.

The system further includes links between the healthcare provider defined templates and certain events such that entry of a particular event causes the system to automatically display a corresponding form for entry of clinical data. These links are activated in response to events such as the start of a patient visit; entry of a clinical data code corresponding to a particular diagnosis; initiation of a task associated with a service; or, a user invoking a particular type of assessment or template. For example, a particular form may need to be completed when reporting radiology results. Therefore, this form is automatically displayed when radiology results are entered into the system. When such an event triggers display of a particular form, a filter operates to display only those forms which are relevant to a clinical value provided for that particular event. If no form is relevant to the entered value, then no form will be displayed. For example, if a user is ordering a chest xray, the system should display a form which prompts the user to ask the patient whether they are pregnant. However, this form is clearly only relevant to female patients of a restricted age group. Such filters may be activated by one or more of the following: a patient's age and/or gender; a reason for the patient's visit; a visit type (e.g. inpatient or outpatient); a specialty indicated by the patient's condition (e.g. cardiology, oncology, etc); a healthcare provider; a clinical event (e.g. road trauma, stroke, etc); a service provided to the patient (e.g. CT scan, xray, etc); a status of a service provided to the patient; or, an inventory item provided to the patient.

Referring now to Figure 10, the flowchart provides a summary of the steps, to be undertaken in creating a healthcare provider defined clinical data template.

The system of the present invention enables the user to import and export these templates, and any associated items between systems. This functionality enables the user defined templates to be shared between organisations. The system enables clinical data to be captured by the user defined forms for export in a user defined format using XSL, CSS and XML, and resulting in a HTML display.

An advantage of the present invention, is the ability for healthcare providers to customize the clinical data templates used to capture clinical patient data to be stored in their own system enables the healthcare provider to

determine the types of data that they wish to store rather than making do with the default clinical data items selected by the software vendor. The system of the present invention enables healthcare providers to quickly and easily customize their own systems without requiring individual programming of new or modified clinical data templates.

It is to be understood that various additions, alterations and/or modifications may be made to the parts previously described without departing from the ambit of the invention.