Abstract:
A method and system for monitoring and managing a remote infusion regimen where a prescribed infusion regimen is provided and compared to subsequent infusion event data to determine if the data falls within predetermined parameters. If the data does not fall within predetermined parameters a monitoring technician, supportive caregiver, patient or some combination thereof are immediately notified so that corrective action may be taken.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    This invention is directed to a system and method that automates compliance of use of an infusion pump and more particularly a system and method that increases the probability that a prescribed infusion regimen is followed. 
         [0002]    Ambulatory pumps are used on patients that can actively ambulate, which presents unique challenges in the care and management of patients. Within a healthcare setting, patients on ambulatory pumps remain under observation which limits non-compliance opportunities. In the home or other alternate site locations it becomes difficult to monitor and enforce patient compliance with prescribed infusion protocols. Home infusion patients generally prefer to be home versus the hospital in many cases, but can become non-compliant with infusion plans due to the technical challenges of managing infusions, a desire to skip or terminate treatments, or inadvertent misses. 
         [0003]    Compliance with prescribed infusion plans is particularly important in the home setting as there is typically an expense associated with incorrectly followed infusion schedules. Antibiotics, the most ubiquitous home infusion medication class, are typically effective only if completed in a full protocol. The patient who feels better on day three or four and subsequently fails to complete a planned seven day infusion regimen will likely require a hospital re-admission, often through the Emergency Room, thereby negating the financial benefits and patient preference benefits of out-of-hospital infusion strategies. Such non-compliance becomes noteworthy not only to the patient but to the hospital as well as the payer/insurer, who generally supports alternate care strategies in order to avoid or truncate hospitalizations. Other medications delivered at home include medical necessities such as TPN, protein-derived therapeutics (which are typically very expensive), and oncolytics. All of these medications&#39; effectiveness are dictated by timely and complete compliance. Payers generally will continue to be very invested in paying for home infusions that are in fact correctly administered. Further, discharging hospitals are growing more invested in post-discharge patient outcomes through pay-for-performance incentives and re-admission metrics are growing in importance through accountable care evolution. 
         [0004]    In the past, compliance with home infusion plans has been loosely monitored through phone calls to patients or caregivers to ask about compliance. Further, compliance has been indirectly monitored through observation of appropriate re-order needs for IV medications and infusion supplies. Also, home nursing visits could be used to apply either of the two above techniques as well as ascertain probability of compliance based on patient condition. Finally, pump infusion and event history downloads can be used to note likely compliance. These techniques provide some guidance but do not offer a full perspective on patient compliance as phone inquiries can be misleading, medication inventory can be manipulated, home nurse visits may be infrequent, and pump activity downloads provide ex-post facto compliance datum but certainly are not timely enough to be actively useful. Therefore, a need exists in the art for a system and method that addresses these deficiencies. 
         [0005]    An objective of the present invention is to provide a system and method that fully automates compliance monitoring and management of an infusion pump regimen. 
         [0006]    Another objective of the present invention is to provide a system and method to link a prescribed infusion regiment to what is actually carried out by the home patient. 
         [0007]    A still further objective of the present invention is to provide a system and method that increases the probability that a patient follows a prescribed infusion regimen. 
         [0008]    Yet another objective of the present invention is to provide a system and method that increases the probability that an incomplete or incorrect regimen is addressed early in the non-compliance cycle. 
         [0009]    Still, another objective of the present invention is to provide a system and method that captures value for a patient, a payer, an alternate site caregiver, and a discharging hospital. 
         [0010]    One more objective of the present invention is to provide a system and method that increases motivation to use pumps for home infusions, whereby pumps can generally provide a safer means of controlled medication infusion than gravity infusions and provide a means by which to electronically capture the medication delivery details. 
         [0011]    These and other objectives will be apparent to one of ordinary skill in the art based upon the following written description, drawings, and claims. 
       SUMMARY OF THE INVENTION 
       [0012]    A system and method for monitoring and managing remote compliance with an infusion regimen includes a healthcare provider having a controller with a processing unit, a database and a display. The database includes a plurality of patient records that include prescribed infusion regimens and patient outcome data. A patient is provided medication, an infusion pump, and one or more infusion sets in order to perform an infusion event at a remote location. Upon completing an infusion event, infusion event data is captured and transmitted to the healthcare provider where the data is stored in the patient outcome data and compared to the prescribed infusion regimen to determine if the data is within predetermined parameters. Notification is then provided to a monitoring technician and the patient. 
         [0013]    Further, the anticipated infusion schedule is automatically monitored in order to trigger messaging or notification to the healthcare provider and/or patient in the event that appropriate infusion confirmation is not provided to match the infusion schedule within an appropriate time window. 
         [0014]    Alternatively, the prescribed infusion regimen is downloaded to the infusion pump. The infusion event data from an infusion event is captured and compared with anticipatory infusion event data within the pump. If successful, the patient and/or supportive caregiver are provided with a code which is transmitted to the healthcare provider. If not within predetermined parameters an alarm or other notification is provided to the patient and/or supportive caregiver. This alarm or notification can be transmitted automatically through cellular communications, internet communications, or other means. 
         [0015]    Alternatively, the prescribed infusion regimen is downloaded to the infusion pump. The infusion event data from an infusion event is captured and compared with anticipatory infusion event data within the pump. If the infusion schedule is not followed, the patient and/or supportive caregiver are messaged to initiate the infusion or to facilitate communication between the patient and caregiver. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a schematic view of a system for managing and monitoring a remote infusion regimen; 
           [0017]      FIG. 2  is a flow diagram of a method for managing and monitoring a remote infusion regimen; and 
           [0018]      FIG. 3  is a flow diagram of a method for managing and monitoring a remote infusion regimen. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0019]    Referring to the Figures a system and method of monitoring and managing a remote infusion regimen  10  includes a monitoring healthcare provider  12  such as a discharging hospital, having a controller  14  with a processing unit  16 , a database  18 , and a display  20 . The database  18  includes a plurality of patient records  22  and therapeutic approaches  24 . Included in the patient record  22  is personal information  26  related to the patient  28 , an infusion regimen  30  that has been prescribed by the healthcare facility  12 , and patient outcome data  32 . 
         [0020]    Once the patient  28  has been prescribed an infusion regimen  30 , which may consist of one or many infusions, the patient  28  is discharged from the healthcare facility  12 . Medications  34 , an infusion pump  36 , and one or more pump tubing infusion sets  38  are provided to the patient  28  for remote use in the patient&#39;s home or other remote location  40 . A monitoring clinician  41  such as a nurse, case manager or similar healthcare technician visits the remote location to train infusion techniques to the patient and/or a supportive caregiver  42  which includes a friend, a family member, or other individual who will initiate an infusion event  44 . With each infusion event  44 , infusion event data  46  is captured by an electronic device  48  connected to the infusion pump  36 . Infusion event data includes, but is not limited to, start time, end time, medication, flow rate events, alarms, and the like. Infusion event data  46  may also include infusion set disconnections from the bag or patient. The electronic device  48  includes a cellular telephone, Wi-Fi, cable, modem link or the like and any combination of the above. In one embodiment, the electronic device  48  includes a processing unit  50 , and a database  52 . The electronic device may be separate from the infusion pumps or could be integrated within the infusion pump. 
         [0021]    Once the infusion event data  46  is captured in real time, the data  46  is transmitted from the electronic device  48 , via an electronic network, to the controller  14 , where the data  46  is stored in the patient outcome data  32  in the patient record  22 . The infusion event data  46  may also be stored on the database  52  of electronic device  48  or transferred to the patient record  22  in packets or through post infusion events. 
         [0022]    The transmitted infusion event data  46  is compared by the processing unit  16  to the prescribed infusion regimen  30  to determine if the infusion event  44  is in compliance with the prescribed infusion regimen  30 . The results of the comparison are stored in the patient record  22  and shown on display  20 . The display  20  may show information related to a single patient record  22 , or may provide an on-screen triage of multiple home patients for a dashboard-type snapshot of infusion activity. 
         [0023]    In addition, if no infusion event data  46  is transmitted within a predetermined time period, this information is recorded in the patient record  22  and shown on display  22 . 
         [0024]    If the comparison of the infusion event data  46  with the prescribed infusion regimen  30  is not within pre-established parameters or if no infusion data  46  has been transmitted within a predetermined time period, the monitoring technician  41  is notified automatically by the controller  14  either through the display  20 , or a communication to the monitoring technician&#39;s electronic device  53  such as by e-mail or text message. In addition, the patient  28  and/or supportive caregiver  42  may also be notified by the controller  14  via the electronic network by a communication to the electronic device  48 . Further, the prescribed infusion regimen would be monitored automatically to identify missed infusions or incomplete infusions (i.e., those started but not successfully completed) or highly problematic infusions consisting of numerous alarms or inconsistencies. Upon notification, a skipped infusion or truncated regimen is immediately known, providing the opportunity to notify the patient  28 , send out a nurse  41 , or respond in another manner. 
         [0025]    In addition to notification, the controller automatically generates a report on patient compliance against an approved prescribed regimen or clinical pathway for the payer, hospital, caregiver, and physician. The transmitted infusion event data  46  may also be tied to a billing system  54  for the healthcare provider  12  to ensure charge capture, and may be linked to the electronic device  55  of a manufacturer  56  to allow for development of improved pump usage statistics. Also, the patient record  22  has an interface  58  to capture orders from computerized physician order entry (CPOE) and/or pharmacy systems and an interface  60  for the electronic medical record (EMR) to log therapies. 
         [0026]    In an alternative embodiment, the prescribed infusion regimen  30  is downloaded and stored in an electronic device  59  that includes a communication engine, wireless card or the like that is within the infusion pump  36  and the monitoring technician  41  is provided remote access through an electronic network to the infusion event data  46  that is stored on a database  61  within pump  36 . Also, the pump would be provided with one or more predetermined codes  62  that are provided to the patient  28  and/or the supportive caregiver  42  upon completion of a successful infusion event  44  which is then provided to the monitoring technician  41  either through the electronic network such as by e-mail or through a telephone call. The monitoring technician has access to the predetermined code  62  which is stored in the patient record  22  and can monitor the remote infusion event  44  when the code is received. 
         [0027]    In addition, the infusion event data  46  is compared to anticipated infusion data  64  that is stored on the infusion pump  36 , with subsequent infusion event data  46  download or exception reporting to the patient record  22  or other caregiver-accessible database  52 . When the infusion event data is not within pre-established parameters of prescribed or anticipated infusion regimens an on-pump alarm  66  is activated. Thus, patients  28  are notified immediately if they are not performing infusions within the allotted time, at appropriate start times, or the like. 
         [0028]    Accordingly, a method and system of monitoring and managing the compliance of a remote infusion regimen has been disclosed that at the very least, meets the stated objectives.