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ReCES 5x Manager

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The ReCES Manager is used to manage user security, licensing setup, global system settings for the ReCES suite, clinical research study definitions and field mappings to EMR/EHR fields that will be used to define study parameters. Virtually every aspect of the ReCES system is managed within the manager application. Except for database connection settings, SimProbe and ReCES Monitor use settings configured in the manager.

System Configuration:
Various system settings are managed here including information about where the patient diagnosis codes are stored in the NextGen® templates, how ReCES should identify valid order records if the user is using the NextGen® KBM template sets to process orders and default databaseconnection settings. User Management:

ReCES manages its own user security. There are no limits on the number of users that can be added to the ReCES system but the number of users that can be logged into and using the ReCES manager at once (concurrently) is limited to the number of user licenses purchased. Each user is linked to a valid NextGen® user id so that study management can be limited to licensed ReCES practices and access to NextGen® practices is limited to practices that the user is a member of and so changes to EMR/EHR data can be assigned to the correct NextGen® user id.Users can be granted administrator rights and specific add, edit delete rights for study management and candidate management. Access to specific studies can also be controlled.

Study Management:
The study definition is the core of the ReCES system. The SimProbe application uses information in the study definition to build the queries and evaluate the patient information for determination of eligibility. The flexibility of the study definition configuration allows for a very detailed evaluation of a patient's medical record and provides high probability candidates for study participation.

Study definitions consists of nine (10) sections:

• Study Master record - this is the master record for each study and contains information describing the study, priority level of the study, begin and end dates defining the timeframe for evaluation by ReCES, options to set active/inactive status, show/hide alerts, age, sex and race criteria and the practices the study is assigned to. It is also where the NextGen® Study Monitor login information is defined that allow monitors from the sponsor to log into NextGen® and review the enrolled patient's medical information.
• Study Locations - each study can be linked to one or more NextGen® locations so that patients are only evaluated at those locations assigned to the study.
• Study Parameters - study parameters are field level qualification criteria assigned to the study. The criteria is highly configurable and includes the ability to check text, date, numeric (integer) and decimal values with range checks for date and numeric/decimal fields and and wildcard matches for text fields. Parameters can be set to evaluate a minimum number of data points for evaluation as well as a maximum timeframe for the values or limit the evaluation to the current encounter.
• NextGen Lab Module Integration - Lab order and result evaluation parameters can be configured to access the NextGen Lab Module tables to verify orders and evaluate lab result criteria for qualifications.  This eliminates the need to post lab result data to template fields to allow result range evaluations.
• Parameter Groups - parameter groups allow the evaluation of a group of individual field level parameters as a group. Groups can be defined as inclusion/exclusion and configured as any (# of total # must be true), all (all must be true) or none (none can be true). Groups can also be configured to allow evaluation of different possible valid values for a field in situations where range and text matching are inadequate.
• Diagnosis Criteria - diagnosis assignments can be defined as any (diagnosed with at least one diagnosis in the list), all (diagnosed with all diagnoses in the list) or none (can be diagnosed with none in the list). Individual codes can be used as well as wildcard matches (i.e. 250* for all 250.## codes)
• Medication Criteria - medications can be defined as inclusion/exclusion. Medications are selected from the NextGen® medication table and any medication in the table can be selected. Search capabilities include brand, generic and category searches. Once the primary search is conducted, the results can be further filtered by name, dosage, category and form to narrow the list down to the required medications.
• Allergy Criteria - allergies can be defined as inclusion/exclusion. Allergies are selected from the NextGen® allergy table and any allergy in the table can be selected.
• Probe Alert - the probe alert text is the information that is presented to the provider from the SimProbe application when a patient qualifies as a candidate. The alert should contain descriptive information about the study, requirements that must be met that cannot be evaluated by ReCES and any other information that is relevant for qualification in the study. Alerts are not displayed for patients who are currently enrolled in a study, already flagged as a candidate for the study in question or are in the exclusion list.
• Visit Alert - the visit alert is information that is entered into research dedicated fields in an EMR template when a patient is enrolled into a study and flagged as a research participant. The text should contain descriptive information about the study and any special instructions for insuring continued enrollment. Other research associated fields are also set to help notify providers and staff on subsequent visits that this patient requires special attention because of their research participation status.
• Candidate Listing - the candidate list is a management sublevel to the study definition. It includes the list of candidates that have qualified for the study through the SimProbe evaluation and patients that have been added to the candidate list manually through evaluations or referrals outside of ReCES. There is a separate section below outlining the capabilities of the candidate management system.

Other aspects of study management include:

• Preliminary Candidate Search - The primary functionality of ReCES and SimProbe is to evaluate patient information for study participation during the encounter. Subsequently, once a study becomes active, SimProbe begins adding qualified candidates from that point forward. Preliminary searches evaluate demographic, diagnosis and medication parameters either ad hoc or from an associated defined study to allow scans of the entire patient database to find initial patients that may qualify before encounter scanning is implemented.  Results of preliminary searches linked to an existing study can be imported into the linked study's candidate list.  Preliminary searches can also be used as a tool to determine potential study participation success based on your patient population.  If the search is linked to an existing study definition and the study has field level parameters defined, the preliminary search can be configured to evaluate the field level parameters so that the preliminary search can be as detailed for your entire patient population as a SimProbe scan is for a single patient.
• Exclusion List - The exclusion list contains the patients that have opted out of a particular study or research participations altogether. These patients are not evaluated by ReCES on subsequent visits for the specified study or any study based on their exclusion status. This eliminates irrelevant alerts from SimProbe for these patients. Patients can also be added to the exclusion list manually.
• Record Type - A study can be defined as a Research or Alert type. Research would be the normal record type defined, but a record defined as an alert functions an alert mechanism only. In this case, the parameters are evaluated normally, but if the patient qualifies, a different style of alert window is displayed and no patient information is stored in the candidate list. This type of alert is useful in cases where you may have special education classes or or other programs in place that require some specific criteria for inclusion and need to alert the provider about a particular patient's eligibility so participation can be discussed with the patient during the visit.
• Saved Grid Views - Almost every table grid in ReCES allows for full customization of the columns (fields) displayed, column arrangement, column grouping, sorting and filtering. The study, candidate and candidate status lists allow the user to save these customizations so they can easily be recalled later. Users can also set default views for these screens so they are formatted to their requirements each time they log in to ReCES. Views can be saved public so other users can have access to the grid configuration.
• Visual Reports - Visual reports will print the grid exactly as it is displayed on screen honoring any display configuration and filtering criteria applied to the grid. Screens that have this capability will have a printer icon in the toolbar which launches the report designer along with a preview of the visual report. The report can be additionally modified via the report designer before being printed and report modifications can be saved and recalled later for future reports.

Candidate Management:
The ability to manage and track the status of candidates that ReCES has referred is an integral part of the ReCES system.

Candidate management capabilities include:

• Study Priority Management - The fact that ReCES may refer candidates for multiple studies complicates candidate management since there are likely to be different coordinators managing several different studies. ReCES allows for the prioritization of studies to be set so that the most urgent studies get evaluated first but when patients qualify for multiple studies, usually of the same type, problems can arise when two or more coordinators contact the patient for participation in different studies. Candidate management reduces the chances of this happening by sub-prioritizing candidates that are in multiple candidate lists based on the original priority of the studies. A candidate for the highest priority study that they qualify for is flagged as a primary candidate for that study and secondary for the rest. Coordinators can set their default candidate list views to show only primary candidates. When they log in, the only candidates they see listed are the ones flagged as primary for that study. They can toggle this filter on or off to see the rest of the candidates or filter the list on any other field criteria required. This functionality provides a visual cue to the coordinators of the candidates they should be working with and helps avoid patient and coordinator frustration.
• Patient Status Tracking - The candidate status screen allows each stage of the qualification process to be documented. There are six (6) primary evaluation stages: Initial Review, Provider/PI Approval, Patient Contact, Screen Appointment Scheduled, Enrollment, Randomization. Each stage has multiple result/reason values and date and time stamps of when and who documented the stage, comments about the stage and other information as it pertains to each stage. There is also a contact history kept that documents the type of contact, when and who was involved and a comment section. The candidate status screen can be used to quickly get a synopsis of how candidates are progressing and to make sure that candidates are not being overlooked. The candidate status screen is fully configurable and grid views can be saved and recalled.
• Detailed Qualification Values - When ReCES refers a candidate, the data extracted from the EMR during evaluation by SimProbe is stored along with the candidate. These values can be reviewed from the candidate listing by expanding the candidate record to display the field evaluated, the criteria and the actual value of the field in question. This makes it convenient for reviewing the candidates without having to open the EMR and lookup the value for each field separately.
• Automatic Updates to EMR - ReCES makes use of the user inclusion list in NextGen® to segregate enrolled patient charts from the rest of the patient population. Each study has a NextGen® Research Monitor user associated with it. The Monitor user is a NextGen® user that has been added to a special Monitor group in the EMR that only has view privileges to patient charts. When a patient is enrolled in a study through ReCES, the EMR patient is automatically added to the inclusion list for the specified NextGen® user id of the assigned Research Monitor. When the monitor is on site and needs to review charts for patients enrolled in their studies, they can login to NextGen® using the monitor login information and review their patient's charts. When the patient completes or is withdrawn from the study, the EMR patient is removed from the inclusion list when their status changes in ReCES.
• Automatic Enrollment Status Checking and Notification - ReCES can be configured so that SimProbe will check the enrollment status of a patient during an encounter.  If the patient is enrolled in a study, a pop-up alert with information about the study and the research contact associated with the study is displayed.  Also, ReCES can be configured to send a NextGen workflow  task to the research contact as well as an SMS text message to the contact's cell phone notifying them that an enroilled patient is being seen.
• Automatic Enrollment Violation Checking and Notification - In addition to enrolled patient visit notifications, ReCES can be configured to check the patient's chart for exclusion medications during an encounter.  If the patient is prescribed any medications listed in the enrolled study exclusion medications list, a pop-up alert with a list of the exclusion medications found, information about the study and the research contact associated with the study is displayed.  As with enrolled visit notifications, ReCES can be configured to send a NextGen workflow task to the research contact as well as an SMS text message to the  contact's cell phone notifying them that there has been an enrollment medication violation for the patient.

If you need additional information or would like to schedule an online demonstration, please contact us via the contact information on the Contacting Simbiote page and we will be in contact with you as soon as possible.