method for providing continuity of care to a patient during transfer between care locations

专利摘要:
METHOD TO PROVIDE CONTINUITY OF CARE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE.The present disclosure provides methods for providing continuity of care to a patient during transfer between care settings. The method includes the decision steps to transfer a patient from a primary care setting to a second setting, conducting a first patient assessment in the first care setting, preparing an assessment transfer record and transferring the transfer record with the patient for the second service environment.
公开号:BR112020009676A2
申请号:R112020009676-8
申请日:2018-11-16
公开日:2020-10-13
发明作者:Martin Burns
申请人:Bruin Biometrics, Llc；
IPC主号:

专利说明:

[001] [001] This application claims the benefit of US Provisional Application 62 / 587,337, which was filed on November 16, 2017 and US Provisional Application 62 / 693,810, which was filed on July 3, 2018. The entire contents of these applications are incorporated here by reference. APPLICATION FIELD
[002] [002] This disclosure provides methods of transferring and manipulating patient information, in particular, information related to the risk of developing a pressure ulcer, to improve care when a patient receives care in various environments. FUNDAMENTALS
[003] [003] The skin is the largest organ in the human body. It is easily exposed to different types of damages and injuries. When the skin and its surrounding tissues cannot redistribute external pressure and mechanical forces, ulcers can occur. Prolonged continuous exposure to a still modest pressure, such as the pressure created by a patient's body weight in the supine position on the posterior surfaces of the skin, can lead to a pressure ulcer. In the presence of other damage, such as neuropathy and weakening of peripheral tissue that can be induced by diabetes, even periodic exposure to moderate levels of pressure and stress can lead to an ulcer, for example, a foot ulcer.
[004] [004] Pressure ulcers are developed by approximately 2.5 million people a year in the United States and an equivalent number in the European Union. In long-term and intensive care settings, up to 25% of elderly, immobile patients develop pressure ulcers. Approximately 60,000 patients in the US die each year from infections and other complications of pressure ulcers.
[005] [005] The detection of tissue damage before the skin breaks and intervention with appropriate therapy to prevent further deterioration of the underlying tissue is desirable not only for the patient, but for society. The average cost of treating pressure-induced damage at the first visible sign (a stage 1 ulcer) is only $ 2,000, but rises to $ 129,000 when the ulcer is deep enough to expose muscle or bone (a stage 4 ulcer). Currently, patients usually receive universal prevention of pressure ulcers, which means that prevention does not target any specific anatomical site. Patients receive only targeted and localized treatment of the ulcer after the development of the pressure ulcer, to the point that it can be identified by a visual assessment. The current standard for detecting pressure ulcers is visual inspection, which is subjective, unreliable, inopportune and lacks specificity. Therefore, even when a patient is experiencing skin inflammation, a precursor to the development of ulcers, he or she would not receive localized and targeted treatment for the developing ulcer. Instead, the inflammation would continue to turn into a complete ulcer.
[006] [006] In current practice, an independent assessment of the risk of a patient developing pressure ulcers on reaching the treatment site is performed. This lack of knowledge of the previous service environment can decrease the quality of care received in the new service environment. SUMMARY
[007] [007] In one aspect, the present disclosure provides and includes a method for identifying and providing an appropriate level of pressure ulcer treatment to a patient based on a plurality of subepidermal moisture (SEM) measurements. In one aspect, a patient receives increasingly effective pressure ulcer interventions based on changes in SEM measurements. In one aspect, a patient receives less intensive pressure ulcer interventions based on changes in SEM measurements.
[008] [008] A method to provide continuity of care to a patient during transfer between care locations, the method comprising the steps of: deciding to transfer a patient from a first care setting to a second care setting, conducting a first assessment of the patient in the first care setting, prepare a transfer record of the assessment and transfer the transfer record with the patient to the second care setting.
[009] [009] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of pressure ulcer treatment, the method comprising the steps of: assessing a patient for a pressure ulcer risk in a patient after admission to a care unit, where the assessment step comprises making a first plurality of Subepidermal Humidity (SEM) measurements on the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first delta value exceeds a first limit, administer a first level 0 intervention if the first delta value does not exceed the first limit and administer a first level N intervention if the first delta value exceeds the first limit, where N is a number integer and N has a value equal to or greater than 1. In an additional aspect, the present disclosure provides and includes performing a second plurality of SEM measurements in the pa aware of a first predetermined frequency corresponding to the level of intervention administered, calculate a second delta value of a portion of the second plurality of SEM measurements, determine whether the second delta value exceeds a second limit, continue to administer the first intervention if the second delta value do not exceed the second limit, continue to make a plurality of SEM measurements at the first predetermined frequency if the second delta value does not exceed the second limit, administer a second level M intervention if the second delta value exceeds the second limit, where M is an integer and M is greater than N and make a plurality of SEM measurements at a second predetermined frequency corresponding to level M if the second delta value exceeds the second limit. In yet an additional aspect, this disclosure provides and includes determining whether the second delta value is less than a third limit, administering a level intervention (N - 1) if the second delta value is less than the third limit and whether the first intervention is not level 0 and perform a plurality of SEM measurements at a predetermined frequency corresponding to the level (N - 1) if the second delta value is less than the third limit.
[0010] [0010] In one aspect, the present disclosure provides and includes a method for delaying the progression of pressure ulcer development in a patient in need of it, the method comprising the steps of: identifying a current K-level intervention received by the patient , make a plurality of subepidermal humidity (SEM) measurements on the patient, calculate a delta value from a portion of the plurality of SEM measurements, determine if the delta value exceeds a first limit, continue to administer the current intervention if the value delta does not exceed the first limit, continue to make a plurality of SEM measurements at a predetermined frequency corresponding to level K if the delta value does not exceed the first limit, administering a new level N intervention if the delta value exceeds the first limit, where N has a value greater than K and perform a plurality of SEM measurements at a predetermined frequency corresponding to the level N if the delta value exceeds see the first limit. In an additional aspect, the present disclosure provides and includes determining whether the delta value is less than a second limit, administering an L level intervention if the delta value is less than the second limit, where L has a non-negative value less than than K and make a plurality of SEM measurements at a predetermined frequency corresponding to the L level if the delta value is less than the second limit.
[0011] [0011] In one aspect, the present disclosure provides and includes a method of stratifying patient groups in a care unit based on the risk of pressure ulcer, the method comprising the steps of: making a plurality of subepidermal moisture measurements (SEM) in each of the patients, calculate a delta value from a part of the plurality of SEM measurements for each of the patients,
[0012] [0012] In one aspect, the present disclosure provides and includes a method to reduce the incidence of ulcer in patients admitted to a care unit, the method comprising the steps of: assessing a patient for a risk of pressure ulcer upon admission in a care unit, where the assessment step comprises making a first plurality of Subepidermal Humidity (SEM) measurements on the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first value delta exceeds a first limit, administer a first level 0 intervention if the first delta value does not exceed the first limit and administer a level N intervention if the first delta value exceeds the first limit, where N is an integer and N has a value equal to or greater than 1.
[0013] [0013] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a barrier cream on the patient's heel, the method comprising the steps of: making a plurality of subepidermal moisture measurements (SEM) on the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a cream barrier on the patient's heel, if the delta value exceeds the limit, and perform a plurality of SEM measurements every two hours, if the delta value exceeds the limit.
[0014] [0014] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of neuromuscular stimulation on the patient's heel, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) on the patient's heel, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer neuromuscular stimulation in the patient's heel if the delta value exceeds the limit and perform a plurality of SEM measurements every hour if the delta value exceeds the limit.
[0015] [0015] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a topical cream to the patient's heel, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) on the patient's heel, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a topical cream for patient's heel, if the delta value exceeds the limit, and perform a plurality of SEM measurements every half hour, if the delta value exceeds the limit.
[0016] [0016] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a barrier cream to the patient's sacrum, the method comprising the steps of: making a plurality of measurements of subepidermal moisture (SEM) in the patient's sacrum, calculate a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a cream of barrier in the patient's sacrum if the delta value exceeds the limit and perform a plurality of SEM measurements every six hours if the delta value exceeds the limit.
[0017] [0017] In one aspect, the present disclosure provides and includes a method to identify and treat a patient in need of applying neuromuscular stimulation to the patient's sacrum, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) in the patient's sacrum, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a neuromuscular stimulation in the patient's heel if the delta value exceeds the limit and perform a plurality of SEM measurements every four hours if the delta value exceeds the limit.
[0018] [0018] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a topical cream to the patient's sacrum, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) in the patient's sacrum, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a topical cream on the sacrum of the patient, if the delta value exceeds the limit, and make a plurality of SEM measurements every two hours, if the delta value exceeds the limit. BRIEF DESCRIPTION OF THE FIGURES
[0019] [0019] This patent or order file contains at least one drawing executed in color. Copies of that patent or patent application publication with colored drawings will be provided by the Office upon request and payment of the necessary fee.
[0020] [0020] The aspects of disclosure are described here, for example only, with reference to the attached drawings. With specific reference now to the drawings in detail, it should be noted that the particularities shown are by way of example and for the purpose of illustrative discussion of aspects of the disclosure. In this regard, the description and drawings, considered alone and together, make it evident to those skilled in the art how aspects of disclosure can be practiced.
[0021] [0021] Figure 1 shows an example of a general process for selecting a pressure ulcer treatment based on SEM values from admission to a care unit to discharge from the care unit, according to the present disclosure.
[0022] [0022] Figure 2A is a visual assessment of a healthy tissue sample according to the present disclosure.
[0023] [0023] Figure 2B is a graph of the averages of SEM measurements performed in each location and around a healthy sacrum, according to the present disclosure.
[0024] [0024] Figure 3A is a visual assessment of a damaged tissue sample according to the present disclosure.
[0025] [0025] Figure 3B is a graph of the averages of SEM measurements made at each location in and around a damaged sacrum, according to the present disclosure.
[0026] [0026] Figure 4 is an illustration of a process for selecting an intervention and monitoring level based on the amount by which a delta value derived from SEM measurements exceeds a threshold value according to the present disclosure.
[0027] [0027] Figure 5 is an example of a workflow guidance matrix in which the current level of intervention and the new delta value are used to select the new level of intervention in accordance with this disclosure.
[0028] [0028] Figures 6A, 6B and 6C represent an example of progression over time from a delta value for a single patient to a single location where a pressure ulcer develops in accordance with the present disclosure.
[0029] [0029] Figure 6D is an example of a graph of a change in the delta value over time for a single patient in a single location where a pressure ulcer develops in accordance with the present disclosure.
[0030] [0030] Figures 7A and 7B are examples of methods for mapping areas of tissue damage, according to the present disclosure.
[0031] [0031] Figure 8A is an example of a treatment decision route currently recommended for the prevention of pressure ulcers in hospitalized patients, using a combination of risk assessment and visual assessment.
[0032] [0032] Figure 8B is an example of a current increased treatment decision path for the prevention of pressure ulcers, as currently implemented in some health units.
[0033] [0033] Figure 9 is an example flow chart of how an SEM scanner can be used in an independent process to avoid pressure ulcers, according to the present disclosure.
[0034] [0034] Figure 10 is an example flow chart of how a SEM Scanner can be used as a complement to further improve the expanded treatment decision path of Figure 8B, according to the present disclosure.
[0035] [0035] Figure 11 illustrates the concept of providing continuity of service in various service environments, in accordance with this disclosure. DETAILED DESCRIPTION
[0036] [0036] This description is not intended to be a detailed catalog of all the different ways in which the disclosure can be implemented or all the features that can be added to the present disclosure. For example, the features illustrated in relation to one modality can be incorporated into other modalities and the features illustrated in relation to a specific modality can be excluded from that modality. Thus, the disclosure contemplates that, in some disclosure modalities, any characteristic or combination of characteristics established in this document can be excluded or omitted. In addition, numerous variations and additions to the various modalities suggested here will be evident to those skilled in the art in the light of the present disclosure, which do not depart from the present disclosure. In other cases, known structures, interfaces and processes have not been shown in detail so as not to unnecessarily obscure the invention. It is intended that no part of this specification is interpreted to affect a denial of any part of the full scope of the invention. Therefore, the following descriptions are intended to illustrate some particular forms of disclosure, and not to exhaustively specify all permutations, combinations and variations thereof.
[0037] [0037] Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as commonly understood by one versed in the technique to which this disclosure belongs. The terminology used in describing the disclosure in this document is intended to describe only particular aspects or modalities and is not intended to limit the disclosure.
[0038] [0038] All publications, patent applications, patents and other references cited here are incorporated by reference in their entirety for the teachings relevant to the sentence and / or paragraph in which the reference is presented. References to the techniques employed herein are intended to refer to techniques as commonly understood in the art, including variations in techniques or substitutions of equivalent techniques that would be evident to one skilled in the art.
[0039] [0039] US patent application serial number 14 / 827,375 ("application 375") discloses an apparatus that uses radiofrequency (RF) energy to measure sub-epidermal capacitance using a bipolar sensor, where the sub-epidermal capacitance corresponds to moisture content of the target region of a patient's skin. Order 375 also discloses an arrangement of these bipolar sensors of various sizes.
[0040] [0040] US Patent Application series 15 / 134,110 discloses an apparatus for measuring subepidermal moisture (SEM) similar to the device shown in Figure 3, in which the device emits and receives an RF signal at a frequency of 32 kHz through of a single coaxial sensor and generates a bioimpedance signal and then converts that signal to a SEM value.
[0041] [0041] US patent application serial number, both 14 / 827,375 and 15 / 134,110, are hereby incorporated by reference in their entirety. However, the SEM values of this application can be measured by any similar or equivalent devices or techniques that would be evident to one skilled in the art. For example, a device that measures the SEM values of this order can be a wired device, a wireless device, or a system that comprises several components communicating with each other.
[0042] [0042] Unless the context indicates otherwise, it is specifically intended that the various characteristics of the disclosure described herein can be used in any combination. Furthermore, the present disclosure also contemplates that, in some disclosure modalities, any characteristic or combination of characteristics established in this document can be excluded or omitted.
[0043] [0043] The methods disclosed herein include and comprise one or more steps or actions to achieve the described method. The steps and / or actions of the method can be exchanged with each other without departing from the scope of this disclosure. In other words, unless a specific order of steps or actions is necessary for the proper operation of the modality, the order and / or the use of specific steps and / or actions can be modified without departing from the scope of this disclosure.
[0044] [0044] As used in the disclosure description and in the appended claims, the singular forms "one", "one" and "the" also intend to include plural forms,
[0045] [0045] As used here, "and / or" refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as a lack of combinations when interpreted alternatively ("or").
[0046] [0046] The terms “about” and “approximately”, as used here, when referring to a measurable value, such as length, frequency or SEM value, etc., should cover variations of ± 20%, ± 10%, ± 5 %, ± 1%, ± 0.5% or up to ± 0.1% of the specified quantity.
[0047] [0047] As used here, phrases like "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used here, phrases like "between about X and Y" mean "between about X and about Y "and phrases like" about X to Y "mean" about X to about Y ".
[0048] [0048] As used here, the term "subepidermal moisture" or "SEM" refers to the increase in tissue fluid and local edema caused by vascular leakage and other changes that modify the underlying structure of damaged tissue in the presence of continuous pressure in the tissue apoptosis, necrosis and inflammatory process.
[0049] [0049] As used here, a "patient" can be a human or animal individual.
[0050] [0050] As used here, “delta” refers to a difference calculated between two SEM values.
[0051] [0051] As used in this document, the variables “K”, “L”, “M” and “N” are non-negative integers.
[0052] [0052] Figure 1 represents a general process 100 for selecting a pressure ulcer treatment based on the SEM values produced from the SEM measurements made using a SEM scanner in accordance with this disclosure, since admission to a medical unit. service until discharge from the service unit. In one aspect, a care unit is selected from the group consisting of a hospital, an assisted living unit, a residential care unit, a nursing home, a long-term care unit, a long-term care community and a independent community. In one aspect, a care unit can be a patient's home or other home, after which the “admit” step 102 will be a first assessment of a patient in your home by a nurse or other caregiver. In one respect, the schedule of interventions and assessment intervals used in a home setting may differ from the interventions and corresponding intervals used in a hospital.
[0053] [0053] In one aspect, in case 100, a newly admitted patient receives an intake assessment in step 104 that includes one or more of a visual examination of a part of the patient's skin, completion of at least a portion of a risk assessment protocol that assesses one or more of nutrition, mobility, physical activity, physical strength and communication skills and SEM measurements performed at one or more locations on the patient's skin. In one aspect, SEM measurements can include performing a plurality of SEM measurements at a single "location" on the patient's skin. In one respect, “location” is considered to be an area and not a single point, so SEM measurements can be made at spatially separate points within the location. For example, a location of the "heel" includes the medial, lateral and posterior surfaces around the heel, as well as the posterior portion of the sole of the foot.
[0054] [0054] In one aspect, once the evaluation stage is completed, in step 106 a determination is made as to whether the patient is "deviated", that is, whether the combination of the results of the various elements of the evaluation indicates that the patient has or you run the risk of developing tissue damage that can lead to a pressure ulcer. Each element of the assessment can have an individual criterion for the level of risk, for example, a scoring system with a threshold value that indicates an unacceptable risk. In one aspect, there is a protocol to combine the criteria to generate a composite parameter that can be used to select an intervention level.
[0055] [0055] In one aspect, if it is determined that the patient is at an acceptable level of risk, the process branches out to step 108, which implements the lowest level of intervention, referred to here as "level zero" or "level 0" . Advancing in steps 110 and 112, the patient will be reassessed using at least the SEM measurement protocol in step 114 at a frequency or inversely over a time interval associated with level 0. Process 100 then returns to step 106 to evaluate the results SEM measurements made in step 114.
[0056] [0056] In one aspect, if the patient is determined in step 106 as deviated, the process branches out in step 122, which implies a higher level of intervention. In one respect, there is a defined hierarchy of intervention levels, with each level implementing intervention more effectively than the next lower level. In one respect, each level also has a defined monitoring interval or frequency, indicating how often a set of SEM measurements should be taken, where higher levels will generally have shorter intervals. In this example, the process has been defined by the hospital, or another management organization, to advance a level to a level 1 intervention at this point. In another aspect, step 122 can implement a level 2 or higher level of intervention. The process now enters a new cycle, starting at step 130, where the patient will be monitored at a frequency of level N, where N is in the range of 1 to n, with n being the highest defined level of intervention and monitoring.
[0057] [0057] In one aspect, in step 134, the patient's history is assessed to determine whether his condition is improving. If the patient's condition is improving, for example, as evidenced by a decreasing delta value, the process branches to step 142. In this example, step 142 continues to implement the current level of intervention and the process runs through step 140 until steps 130-132-134-142-140 until the delta value falls below the limit. In one aspect, the level of intervention can be reduced in step 142 based on the magnitude of the delta value, as the delta value tends downward.
[0058] [0058] In one aspect, if the patient does not show improvement in step 134, the process branches to an increase in the level of intervention in step 138, as long as the skin is not broken, that is, an open ulcer has not developed , in step 136. If an open ulcer develops, the SEM scan will now be performed around the periphery of the open wound in step 144 to map the inflammation or other precursor indication of the spread of the ulcer. The ulcer itself is treated in step 148 and this secondary cycle 144-146-148-150 continues until the wound closes, after which the process returns to step 130.
[0059] [0059] In one aspect, at any time in process 100, patient discharge branches to step 118, where the patient's condition after discharge or transfer is documented. In one aspect, step 118 comprises a final set of SEM measurements at one or more locations on the patient's body. In one respect, these sites include areas that were not receiving an intervention and have not been previously identified as at risk. In one aspect, this information is provided to the receiving caregiver. The patient is then unloaded or transferred in step 120.
[0060] [0060] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of pressure ulcer treatment, the method comprising the steps of: assessing a patient for a risk of pressure ulcer in a patient after admission to a care unit, where the assessment step comprises making a first plurality of Subepidermal Humidity (SEM) measurements on the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first delta value exceeds a first limit, administer a first level 0 intervention if the first delta value does not exceed the first limit and administer a first level N intervention if the first delta value exceeds the first limit, where N is a number integer and N has a value equal to or greater than 1.
[0061] [0061] In one aspect, a first plurality of SEM measurements is performed at one or more anatomical sites selected from the group consisting of a sternum, sacrum, heel, scapula, elbow, ear and other fleshy tissues. a patient. In one aspect, a first plurality of SEM measurements is separated into subgroups for analysis based on the general location at which a measurement is taken. In one aspect, a first plurality of SEM measurements is performed at sites located in one or more concentric circles centered around an anatomical site. In one aspect, a first plurality of SEM measurements is made at locations located in a straight line approximately equidistant from an anatomical site.
[0062] [0062] In one aspect, a first delta value is determined by the difference between the maximum SEM value and the minimum SEM value of the first plurality of SEM measurements collected. In one respect, a first delta value is determined by the difference between the maximum SEM average of measurements taken at one location and the minimum SEM average of measurements taken at a second location. In one aspect, a first delta value is determined for a portion of a first plurality of SEM measurements made from a subgroup, as defined by the location taken. In one respect, an average SEM value at a location is obtained from two, three, four, five, six, seven, eight, nine, ten, or more than ten SEM values measured at that location. In one aspect, a first delta value is determined by the difference between the SEM values obtained from measurements made at two bisymetric locations in relation to a central line.
[0063] [0063] In one aspect, a delta value can be calculated from a plurality of SEM measurements taken at a given location, or close to a specific location, in a plurality of methods. In one aspect, a plurality of SEM measurements are made in a predetermined pattern on the skin and the delta value is calculated by subtracting the SEM value associated with a predetermined position within the pattern from the highest SEM value made in the other positions in the pattern. In one respect,
[0064] [0064] In one aspect, a first limit can be 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0 , 75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 , 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3 , 0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2 , 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5 , 5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7 , 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4 or 7.5. In one respect, a first limit can range from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0 or 4.0 to 4.5. In one aspect, a first limit can be scaled by a factor or a multiple based on the values provided here. It will be understood that a limit is not limited by the project, but one skilled in the art would be able to choose a predetermined value based on a given SEM unit. In one respect, the limits of the present disclosure vary according to the specific portion of a patient's body on which measurements are being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnic group and other physical characteristics or medical conditions.
[0065] [0065] In one aspect, N ranges from 1 to 50, such as 1 to 2, from 1 to 3, from 1 to 4, from 1 to 5, from 1 to 6, from 1 to 7, from 1 to 8, from 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40 or 1 to 45.
[0066] [0066] In one aspect, N is determined by the amount by which the first delta value exceeds the first limit. In one aspect, the amount by which a delta value exceeds an established limit for (N + 1) is greater than the amount by which a delta value exceeds an established limit for N. In one aspect, the amount by which a delta value exceeds a limit established for (Nl) is less than the value by which a delta value exceeds a limit established for N.
[0067] [0067] In one aspect, a level 1 intervention (N = l) is applied to a patient with a delta value that exceeds the limit by no more than 100% of the limit value, such as no more than 95%, no more than 90% no more than 85%, no more than 80%, no more than 75%, no more than 70%, no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than more than 45%, no more than 40%, no more than 35%, no more than 30%, no more than 25%, no more than 20%, no more than 15%, no more than 10% or less than 5% of the limit value.
[0068] [0068] In one aspect, a level 2 intervention (N = 2) is applied to a patient with a delta value that exceeds the limit by no more than 150% of the limit value, such as no more than 145%, no more than 140% no more than 135%, no more than 130%, no more than 125%, no more than 120%, no more than 115%, no more than 110%, no more than 100%, no more than 95%, no more than more than 90%, no more than 85%, no more than 80%, no more than 75%, no more than 70%, no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than 45%, no more than 40%, no more than 35%, no more than 30%, no more than 25%, no more than 20%, no more than 15%, no more than 10% or not more than 5% of the limit value.
[0069] [0069] In one aspect, a level 3 intervention (N = 3) is applied to a patient with a delta value that exceeds the limit by no more than 200% of the limit value, such as no more than 195%, no more than 190%, no more than 185%, no more than 180%, no more than 175%, no more than 170%, no more than 165%, no more than 160%, no more than 155%, no more than 150% , no more than 145%, no more than 140%, no more than 135%, no more than 130%, no more than 125%, no more than 120%, no more than 115%, no more than 110%, no more than 100%, no more than 95%, no more than 90%, no more than 85%, no more than 80%, no more than 75%, no more than 70%, no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than 45%, no more than 40%, no more than 35%, no more than 30%, no more than 25%, no more than 20% , not more than more than 15%, not more than 10% or more than 5% of the limit value.
[0070] [0070] In one aspect, a level 4 intervention (N = 4) is applied to a patient with a delta value that exceeds the limit by no more than 250% of the limit value, such as no more than 245%, no more than 240% no more than 235%, no more than 230%, no more than 225%, no more than 220%, no more than 215%, no more than 210%, no more than 205%, no more than 200%, no more than 195%, no more than 190%, no more than 185%, no more than 180%, no more than 175%, no more than 170%, no more than 165%, no more than 160%, no more that 155%, no more than 150%,
[0071] [0071] In one aspect, a level 5 intervention (N = 5) is applied to a patient with a delta value that exceeds the limit by no more than 300% of the limit value, such as no more than 295%, no more than 290% no more than 285%, no more than 280%, no more than 275%, no more than 270%, no more than 265%, no more than 260%, no more than 255%, no more than 250%, no more than 245%, no more than 240%, no more than 235%, no more than 230%, no more than 225%, no more than 220%, no more than 215%, no more than 210%, no more than 205%, no more than 200%, no more than 195%, no more than 190%, no more than 185%, no more than 180%, no more than 175%, no more than 170%, no more than 165 % no more than 160%, no more than 155%, no more than 150%, no more than 145%, no more than 140%, no more than 135%, no more than 130%, no more than 125%, no more than 120%, no more than 115%, no more than 110%, no more than 100%, no more than 95%, no more than 90%, no more than 85%, no more than 80%, no more than 75%, no more s that 70%, no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than 45%, no more than 40%, no more than 35%, no more than 30%, no more than 25%, no more than 20%, no more than 15%, no more than 10% or more than 5% of the limit value.
[0072] [0072] In one aspect, a level 6 intervention (N = 6) is applied to a patient with a delta value that exceeds the limit by no more than 350% of the limit value, such as no more than 345%, no more than 340%, no more than 335%, no more than 330%, no more than 325%, no more than 320%, no more than 315%, no more than 310%, no more than 305%, no more than 300% , no more than 295%, no more than 290%, no more than 285%, no more than 280%, no more than 275%, no more than 270%, no more than 265%, no more than 260%, no more than 255%, no more than 250%, no more than 245%, no more than 240%, no more than 235%, no more than 230%, no more than 225%, no more than 220%, no more than 215%, no more than 210%, no more than 205%, no more than 200%, no more than 195%, no more than 190%, no more than 185%, no more than 180%, no more than 175% , no more than 170%, no more than 165%, no more than 160%, no more than 155%, no more than 150%, no more than 145%, no more than 140%, no more than 135%, no more than 130%, no more than 125%, no more than 120%, no more than 115%, no more than 110%, no more than 100%, no more than 95% no more than 90%, no more than 85%, no more than 80%, no more than 75%, no more than 70%, no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than 45%, no more than 40%, not more than 35%, not more than 30%, not more than 25%, not more than 20%, not more than 15%, not more than 10% or not more than 5% of the limit value.
[0073] [0073] In one aspect, a level 7 intervention (N = 7) is applied to a patient with a delta value that exceeds the limit by no more than 400% of the limit value, such as no more than 395%, no more than 390%, no more than 385%, no more than 380%, no more than 375%, no more than 370%, no more than 365%, no more than 360%, no more than 355%, no more than 350% ,
[0074] [0074] In one aspect, a level 8 intervention (N = 8) is applied to a patient with a delta value that exceeds the limit by no more than 450% of the limit value, such as no more than 445%, no more than 440% no more than 435%, no more than 430%, no more than 425%, no more than 420%, no more than 415%, no more than 410%, no more than 405%, no more than 400%, no more than 395%, no more than 390%, no more than 385%, no more than 380%, no more than 375%, no more than 370%, no more than 365%, no more than 360%, no more than 355%, no more than 350%, no more than 345%, no more than 340%, no more than 335%, no more than 330%, no more than 325%, no more than 320%, no more than 315% no more than 310%, no more than 305%, no more than 300%, no more than 295%, no more than 290%, no more than 285%, no more than 280%, no more than 275% , no more than more than 270%, no more than 265%, no more than 260%, no more than 255%, no more than 250%, no more than 245%, no more than 240%, no more than 235% , no more than 230%, no more than 225%, no more than 220%, no more than 215%, no more than 210%, no more than 205%, no more than 200% no more than 195%, no more than 190%, no more than 185%, no more than 180%, no more than 175%, no more than 170%, no more than 165%, no more than 160%, no more than 155%, no more than 150%, no more than 145%, no more than 140%, no more than 135%, no more than 130%, no more than 125%, no more than 120%, no more than 115%, no more than 110% , no more than 100%, no more than 95%, no more than 90%, no more than 85%, no more than 80%, no more than 75%, no more than 70% no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than 45%, no more than 40%, no more than 35%, no more than 30%, no more than more than 25%, no more than 20%, no more than 15%, no more than 10% or more than 5% of the limit value.
[0075] [0075] In one aspect, a level 9 intervention (N = 9) is applied to a patient with a delta value that exceeds the limit by no more than 500% of the limit value, such as no more than 495%, no more than 490% no more than 485%, no more than 480%, no more than 475%, no more than 470%, no more than 465%, no more than 460%, no more than 455%, no more than 450%, no more than 445%, no more than 440%, no more than 435%, no more than 430%, no more than 425%, no more than 420%, no more than
[0076] [0076] In one aspect, an IO level intervention (N = 10) is applied to a patient with a delta value that exceeds the limit by no more than 550% of the limit value, such as no more than 545%, no more than 540%, no more than 535%, no more than 530%, no more than 525%, no more than 520%, no more than 515%, no more than 510%, no more than 505%, no more than 500% , no more than more than 495%, no more than 490%, no more than 485%, no more than 480%, no more than 475%, no more than 470%, no more than 465%, no more than 460% , no more than 455%, no more than 450%, no more than 445%, no more than 440%, no more than 435%, no more than 430%, no more than 425%, no more than 420%, no more than 415% no more than 410%, no more than 405%, no more than 400%, no more than 395%, no more than 390%, no more than 385%, no more than 380%, no more than 375 %, no more than more than 370%, no more than 365%, no more than 360%, no more than 355%, no more than 350%, no more than 345%, no more 340%, no more than 335% , not more than 330%, no more than 325%, no more than 320%, no more than 315%, no more than 310%, no more than 305%, no more than 300%, no more than 295%, no more than 290%, no more than 285%, no more than 280%, no more than 275%, no more than 270%, no more than 265%, no more than 260%, no more than 255%, no more than 250% , no more than 245%, no more than 240%, no more than 235%, no more than 230%, no more than 225%, no more than 220%, no more than 215%, no more than 210% , no more than 205%, no more than 200%, no more than 195%, no more than 190%, no more than 185%, no more than 180%, no more than 175%, no more than 170%, no more than 165%, no more than 160%, no more than 155%, no more than 150%, no more than 145%, no more than 140%, no more than 135%, no more than 130%, no more than 125%, no more than 120%, no more than 115%, no more than 110%, no more than 100%, no more than 95%, no more than 90%, no more than 85%, no more than 80%, no more than 75%, no more than 70%, no more than 65%, no more than 60%, no more than 55%, no more than 50%, no more than 45%, no more than
[0077] [0077] In one aspect, a level N intervention is more effective than a level 0 intervention. In one aspect, a level (N + 1) intervention is more effective than a level N intervention. In one aspect, a level intervention (Nl) is less effective than a level N intervention.
[0078] [0078] In one aspect, the evaluation stage of the present disclosure also includes performing a visual evaluation. In one aspect, visual assessment is performed according to the guidelines of the National Pressure Ulcer Advisory Panel (NPUAP).
[0079] [0079] In one aspect, the evaluation stage of the present disclosure also includes the performance of a risk assessment. In one aspect, the risk assessment is performed according to a test selected from the group consisting of the Braden Scale, the Gosnell Scale, the Norton Scale and the Waterlow Scale.
[0080] [0080] In one aspect, the present disclosure provides and further includes performing a second plurality of SEM measurements on the patient at a first predetermined frequency corresponding to the level of intervention administered, calculating a second delta value of a portion of the second plurality of SEM measurements , determine if the second delta value exceeds a second limit, continue to administer the first intervention if the second delta value does not exceed the second limit, continue to make a plurality of SEM measurements at the first predetermined frequency if the second delta value does not exceed the second limit, administer a second intervention at level M if the second delta value exceeds the second limit, where M is an integer and M is greater than N and make a plurality of SEM measurements at a second predetermined frequency corresponding to level M if the second delta value exceeds the second limit.
[0081] [0081] In one aspect, a predetermined frequency is selected from the group consisting of at least once every 72 hours, at least once every 48 hours, at least once every 24 hours, at least once every 12 hours, at least once every 8 hours, at least once every 6 hours, at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour and at least once every half hour.
[0082] [0082] In one aspect, a second plurality of SEM measurements is performed according to [0061]. In one aspect, a second plurality of SEM measurements is performed at the same locations as a first plurality of SEM measurements was performed. In one aspect, a second plurality of SEM measurements is made at some of the same locations where a first plurality of SEM measurements has been taken. In one aspect, a second plurality of SEM measurements is taken close to the locations where a first plurality of SEM measurements was taken. In one aspect, a second plurality of SEM measurements is made at different locations than where a first plurality of SEM measurements was taken.
[0083] [0083] In one aspect, a second delta value is determined by the difference between the maximum SEM value and the minimum SEM value of the second plurality of SEM measurements collected. In one respect, a second delta value is determined by the difference between the maximum SEM average of measurements taken at one location and the minimum SEM average of measurements taken at a second location. In one aspect, a second delta value is determined for a portion of a second plurality of SEM measurements made from a subgroup, as defined by the location taken.
[0084] [0084] In one aspect, a second limit can be 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0 , 75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 , 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3 , 0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2 , 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5 , 5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7 , 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4 or 7.5. In one respect, a second limit can range from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0 or 4.0 to 4.5. In one aspect, a second limit can be scaled by a factor or a multiple based on the values provided here. In one respect, a second limit can be the same as a first limit. In one aspect, a second limit can be greater than a first limit. In one aspect, a second limit can be less than a first limit.
[0085] [0085] In one aspect, M ranges from 2 to 50, like 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40 or 2 to 45.
[0086] [0086] In one aspect, M is determined by the amount by which the second delta value exceeds the second limit. In one aspect, the amount by which a delta value exceeds an established limit for (M + 1) is greater than the amount by which a delta value exceeds an established limit for M. In one aspect, the amount by which a delta value exceeds a limit established for (Ml) is less than the value by which a delta value exceeds a limit established for M.
[0087] [0087] In one aspect, an intervention at level M is chosen according to [0067] to [0076], replacing N with M.
[0088] [0088] Still in one aspect, the present disclosure provides and also includes determining whether the second delta value is less than a third limit, administering a level intervention (N - 1) if the second delta value is less than the third limit and if the first intervention is not level 0 and perform a plurality of SEM measurements at a predetermined frequency corresponding to the level (N - I) if the second delta value is less than the third limit.
[0089] [0089] In one aspect, a third limit can be 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0 , 75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 , 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3 , 0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2 , 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5 , 5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7 , 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4 or 7.5. In one respect, a third limit can vary from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0 or 4.0 to 4.5. In one aspect, a third limit can be scaled by a factor or a multiple based on the values provided here. In one respect, a third limit can be the same as a second limit. In one aspect, a third limit can be greater than a second limit. In one aspect, a third limit can be less than a second limit. In one respect, a third limit can be the same as a first limit. In one respect, a third limit can be greater than a first limit. In one aspect, a third limit can be less than a first limit.
[0090] [0090] In one aspect, a second delta value can be 0.1-99.5% of the third limit, such as 0.1-1%, 0.1-5%, 1-5%, 5-15%, 10-20%, 15-25%, 20-30%, 25-35%, 30-40%, 35-45%, 40-50%, 0.1-25%, 15-35%, 25-50 %, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70 -80%, 75% -85%, 80-90%, 85-95%, 90-99.5%, 65-85% or 75-99.5% of the third limit.
[0091] [0091] In one aspect, the present disclosure provides and includes a method to delay the progression of pressure ulcer development in a patient in need of it, the method comprising the steps of: identifying a current K-level intervention received by the patient , make a plurality of subepidermal humidity (SEM) measurements on the patient, calculate a delta value from a portion of the plurality of SEM measurements, determine if the delta value exceeds a first limit, continue to administer the current intervention if the value delta does not exceed the first limit, continue to make a plurality of SEM measurements at a predetermined frequency corresponding to level K if the delta value does not exceed the first limit, administering a new level N intervention if the delta value exceeds the first limit, where N has a value greater than K and perform a plurality of SEM measurements at a predetermined frequency corresponding to the level N if the delta value exceeds see the first limit. In one aspect, a patient in need is a patient experiencing a change in care, a change in mobility, a change in nutrition, a change in sensory perception or a combination of these. In one aspect, a patient in need of it is a patient who has developed an open ulcer. In one aspect, a patient in need of it is a patient who has recovered from an open ulcer. In one aspect, a patient in need of it is a patient who receives surgery. In one aspect, a patient in need of it is a patient who receives spinal painkillers or sacral painkillers during surgery. In one aspect, a patient in need of it is a patient who receives surgery for a duration of four or more hours, such as five or more hours, six or more hours, seven or more hours, eight or more hours, eight or more hours, nine or more hours, ten or more hours, eleven or more hours or twelve or more hours. In one aspect, a surgery lasts for one or more hours, such as two or more hours or three or more hours.
[0092] [0092] In one aspect, a plurality of SEM measurements is performed according to [0061]. In one aspect, a delta value is determined according to [0062]. In one aspect, a first limit is determined according to [0064].
[0093] [0093] In one aspect, K ranges from 2 to 50, like 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40 or 2 to 45.
[0094] [0094] In one aspect, K is determined by the amount by which the delta value exceeds the limit. In one aspect, the amount by which a delta value exceeds an established limit for (K + 1) is greater than the amount by which a delta value exceeds an established limit for K. In one aspect, the amount by which a delta value exceeds a limit established for (K - l) is less than the value by which a delta value exceeds a limit established for K.
[0095] [0095] In one aspect, a K-level intervention is chosen according to [0067] to [0076], replacing N with K.
[0096] [0096] In one aspect, the present disclosure provides and also includes determining whether the delta value is less than a second limit, administering an L-level intervention if the delta value is less than the second limit, where L has a value not negative value less than K and make a plurality of SEM measurements at a predetermined frequency corresponding to level L if the delta value is less than the second limit.
[0097] [0097] In one aspect, a second limit is determined according to [0084].
[0098] [0098] In one aspect, L can be K-1, K-2, K-3, K-4, K-5, K-6, K-7, K-8, K-9 or K-10. In one aspect, L is K- 1 if a delta value is 90-99.5% of the second limit, such as 90-95%, 91-96%, 92-97%, 93-98%, 94-99% or 95-99.5% of the second limit, unless K-1 is less than 0, in which case L would be 0. In one aspect, L is K-2 if a delta value is 80-89.9% of the second limit, such as 80-85%, 81-86%, 82-87%, 83-88%, 84-89%, or 85-89.9% of the second limit, unless K-2 is less than 0, in this case L would be 0. In one aspect, L is K-3 if a delta value is 70-79.9% of the second limit, such as 70-75%, 71-76%, 72-77%, 73-78% , 74-79%, or 75-79.9% of the second limit, unless K-3 is less than 0, in which case L would be 0. In one aspect, L is K-4 if a delta value is 60- 69.9% of the second limit, such as 60-65%, 61-66%, 62-67%, 63-
[0099] [0099] In one aspect, the present disclosure provides and includes a method of stratifying patient groups in a care unit based on the risk of pressure ulcer, the method comprising the steps of: making a plurality of subepidermal moisture measurements (SEM) in each patient, calculate a delta value from a part of the plurality of SEM measures for each patient, determine whether each delta value exceeds any values in a set of threshold values corresponding to levels of care N and assign a level of care to each of the patients, reorganizing the group of patients based on each of the levels of care assigned to the patient.
[00100] [00100] In one aspect, the present disclosure provides and includes a method to reduce the incidence of ulcer in patients admitted to a care unit, the method comprising the steps of: assessing a patient for a risk of pressure ulcer upon admission in a care unit, where the assessment step comprises making a first plurality of Subepidermal Humidity (SEM) measurements on the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first value delta exceeds a first limit, administer a first level 0 intervention if the first delta value does not exceed the first limit and administer a first level N intervention if the first delta value exceeds the first limit, where N is an integer and N has a value equal to or greater than 1. In one aspect, the incidence of ulcers in patients in the care unit is reduced to less than 1 in 100, less than 1 in 200 , less than 1 in 300, less than 1 in 400, less than 1 in 500, less than 1 in 600, less than 1 in 700, less than 1 in 800, less than 1 in 900 or less than 1 in 1,000.
[00101] [00101] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a barrier cream to the patient's heel, the method comprising the steps of: making a plurality of measurements of subepidermal moisture (SEM) on the patient's heel, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a cream of barrier on the patient's heel if the delta value exceeds the limit and perform a plurality of SEM measurements every two hours if the delta value exceeds the limit. In one aspect, a plurality of SEM measurements are made at least once every hour or at least once every half hour if the delta value exceeds the limit.
[00102] [00102] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of neuromuscular stimulation on the patient's heel, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) on the patient's heel, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer neuromuscular stimulation in the patient's heel if the delta value exceeds the limit and perform a plurality of SEM measurements every hour if the delta value exceeds the limit. In one aspect, a plurality of SEM measurements are made at least once every half hour if the delta value exceeds the limit.
[00103] [00103] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a topical cream to the patient's heel, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) on the patient's heel, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a topical cream on the patient's heel, if the delta value exceeds the limit, and perform a plurality of SEM measurements every half hour, if the delta value exceeds the limit.
[00104] [00104] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a barrier cream to the patient's sacrum, the method comprising the steps of: making a plurality of subepidermal moisture measurements (SEM) in the patient's sacrum, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a cream of barrier in the patient's sacrum, if the delta value exceeds the limit, and perform a plurality of SEM measurements every six hours, if the delta value exceeds the limit. In one respect, a plurality of SEM measurements are taken at least once every four hours, at least once every three hours, at least once every two hours, at least once an hour, or at least once every half hour, if the delta value exceeds the limit.
[00105] [00105] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying neuromuscular stimulation to the patient's sacrum, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) in the patient's sacrum, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a neuromuscular stimulation in the sacrum of the patient if the delta value exceeds the limit and make a plurality of SEM measurements every four hours if the delta value exceeds the limit. In one respect, a plurality of SEM measurements are made at least once every three hours, at least once every two hours, at least once an hour, or at least once every half hour if the value delta exceeds the limit.
[00106] [00106] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient in need of applying a topical cream to the patient's sacrum, the method comprising the steps of: making a plurality of subepidermal moisture measurements ( SEM) in the patient's sacrum, calculate a delta value from a portion of the plurality of SEM measurements, determine whether the delta value exceeds a limit corresponding to the N level, where N is greater than or equal to 2, administer a topical cream on the sacrum of the patient, if the delta value exceeds the limit, and make a plurality of SEM measurements every two hours, if the delta value exceeds the limit. In one aspect, a plurality of SEM measurements are made at least once an hour or at least once every half hour if the delta value exceeds the limit.
[00107] [00107] In one aspect, the methods of the present disclosure are performed using the devices disclosed in the ET.S. Applications nº 14 / 827,375 and 15 / 134,110. In one aspect, the moisture content is equivalent to the SEM value on a predetermined scale. In one respect, a predetermined scale can range from 0 to 20, such as from 0 to 1, from 0 to 2, from 0 to 3, from 0 to 4, from 0 to 5, from 0 to 6, from 0 to 7, from 0 to 8, from 0 to 9, from 0 to 10, from 0 to 11, from 0 to 12, from 0 to 13, from 0 to 14, from 0 to 15, from 0 to 16, from 0 to 17, from 0 to 18, from 0 to 19. In one aspect, a predetermined scale can be scaled by a factor or a multiple based on the values provided here.
[00108] [00108] In one aspect, the present disclosure further provides and includes providing targeted treatment to an anatomical site of a patient identified as damaged by a combination of a visual assessment and SEM scan measurements. In one aspect, a treatment is provided directed to a common site for pressure ulcers selected from the group consisting of: fingers, heels, sacrum, spine, elbows, shoulder blades, occipitals and ischial tuberosity. In one aspect, a targeted treatment is provided simultaneously to a second common site for pressure ulcers selected from the group consisting of: toes, heels, sacrum, spine, elbows, shoulder blades, occiput and ischial tuberosity. In one aspect, a first site that receives targeted treatment is known to cause a pressure ulcer to develop in a second site.
[00109] [00109] The present disclosure is illustrated by the following examples. The examples presented here illustrate various aspects of the present disclosure, but should not be construed as limiting the scope of the present disclosure in any way.
[00110] [00110] The individuals identified as at risk for pressure ulcers in the heel were treated according to the following scheme: TABLE 1. EXAMPLE OF INTERVENTION SCHEME FOR THE TREATMENT OF
[00111] [00111] The individuals identified as at risk for pressure ulcers in the sacrum were treated according to the following scheme: TABLE 2: EXAMPLE OF INTERVENTION REGIME FOR TREATMENT OF
[00112] [00112] A patient underwent several SEM measurements at the bony prominence of the sacrum and around it using a device capable of measuring SEM measurements. Before taking measurements, surface moisture and matter above the patient's skin surface were removed. An electrode of the device was applied to the patient's skin with sufficient pressure to ensure complete contact for approximately one second to obtain each SEM measurement.
[00113] [00113] SEM measurements were performed in a straight line through a patient's sacrum. Several measurements were made at a given measurement location. Figure 2A is a visual assessment of a healthy tissue sample. Figure 2B is a corresponding graph of the averages of SEM measurements taken at each location. A limit of 0.5 was chosen. A delta value was calculated as the difference between the maximum mean SEM value and the minimum mean SEM value, which was determined to be less than 0.5. As the delta SEM value was below the limit value, the patient was identified as needing a level 0 intervention. Consequently, the patient was placed on a conventional mattress and turned over every 24 hours.
[00114] [00114] Additional SEM measurements were performed every 24 hours until discharge. There was no change in the level of intervention. Example 4: Identification of a patient who needs a level n intervention in the sacrum
[00115] [00115] A patient was subjected to several SEM measurements performed in a straight line through the sacrum, according to the same procedure described in Example 3.
[00116] [00116] Figure 3 A is a visual evaluation sample of the damaged tissue. Figure 3B is a corresponding graph of the averages of SEM measurements taken at each location. A limit of 0.5 was chosen. A delta value was calculated as the difference between the maximum mean SEM value and the minimum mean SEM value, which was determined to be above 0.5. As the delta SEM value was more than 200% above the limit value, the patient was identified as in need of a level 8 intervention. Consequently, the patient was placed on a silicone pad and monitored every hour, until a value of SEM delta less than 170% of the limit value was observed, at which point the patient moved to a level 7 intervention. Example 5: Example of process to select an intervention and monitoring level
[00117] [00117] Figure 4 is an illustration of a process 400 for selecting an intervention and monitoring level based on the amount by which a delta value derived from SEM measurements exceeds a threshold value. Here, a caregiver made a plurality of SEM measurements at a location on a patient's skin using an SEM scanner in step 402, where each measurement generated an SEM value. Using a portion of these SEM values, a delta “D” value was calculated in step 404. The delta value was calculated by subtracting the smallest SEM value from the largest SEM value generated from the plurality of SEM measurements.
[00118] [00118] The calculated delta value was compared to a “T” limit value in step 406. If the delta value is less than or equal to the limit value, step 408 was performed and the caregiver waited until the monitoring interval associated with the level current service time, then repeated the SEM measurements in step 402. If the delta value is greater than the limit value, the amount by which the delta value exceeded the limit value was compared to a cascade series of difference values.
[00119] [00119] In some cases, the delta value was positive and the comparison performed by subtracting the limit value from the delta value, which produced a positive difference, and then a determination was made as to whether the difference exceeded the first difference Dl in step 410. If the difference was less than Dl, the process branched to step 412 and then to step 414 to implement an intervention and measurement interval, respectively, associated with the N + 1 level. In this example, N had a value of zero or greater.
[00120] [00120] In some cases, the delta value was negative, for example, if the SEM measurement at the central position of the data in Figure 3B is subtracted from an average of the SEM values from the leftmost and rightmost locations in Figure 3B. In this case, the differences D1, D2 to Dn were selected to have negative values that could have different absolute values from the corresponding difference values Dl, D2 to Dn used for a positive delta value. Alternatively, the comparisons in steps 410, 420 and 430 were changed to "<" instead of ">" shown in Figure 4. Example 6: Workflow orientation matrix
[00121] [00121] Figure 5 is an example of a workflow guidance matrix 500 where the current intervention level 502 and the new delta value are 504 used to select the new intervention level 506. Here, a caregiver monitors the condition of a patient periodically by making multiple SEM measurements at one or more locations on the patient's skin. At the time of these measures, the patient received care associated with a level of intervention and monitoring. In this example, level 0 (zero) was associated with a patient who was not considered to be at significant risk of developing pressure ulcers. Higher levels of intervention and monitoring were identified with the gradations of intervention classified, for example, according to cost, difficulty of implementation or other parameter identified by the service unit. When a caregiver was taking a new set of SEM measurements, they consulted this matrix identifying the line of the current level of intervention 502, the delta value determined from the last set of SEM 504 measures and identified the level of intervention in cell 506 at the intersection line 502 and column 504. The caregiver can consider the level of intervention identified, the current level of intervention and the delta value when selecting an intervention level for the next period of time.
[00122] [00122] In some cases, the values of the new levels of intervention in the 506 cells were similar from one line to another. In some cases, the values of the new intervention levels in the adjacent 506 cells differed on a single level or on more than one level. In some cases, the values of the new levels of intervention in the adjacent cells 506 were the same in the adjacent cells. Example 7: Progression of tissue condition leading to pressure ulcer
[00123] [00123] Figures 6A, 6B and 6C represent a non-limiting illustrative example of a progression over time of the condition of the tissue that leads to a pressure ulcer. Figure 6A shows a cross section of healthy tissue 600, including stratum corneum 602 and healthy cells 604 in the epidermis / dermis. The central electrode 606 and toroidal electrode 608 of a SEM scanner are shown in cross section in contact with the stratum corneum 602. An illustrative indication of the sensitive region of the SEM Scanner is shown as the oval region
[00124] [00124] Figure 6B is an illustrative cross section of slightly damaged tissue 620. Cell damage, for example, resulting from long-term application of low level pressure, has affected the tissue. Without being bound by theory, some of the 622 cells ruptured, releasing fluid content into an intercellular space 624. Alternatively, and without being bound by theory, an inflammatory reaction caused the fluid to migrate to the intercellular space 624. This damage it is not visible on the skin surface.
[00125] [00125] Figure 6C is an illustrative 640 cross section of a more advanced damage level. Without being bound by theory, the tissue is now mostly 622 ruptured cells, which may provide little mechanical structure to withstand continuous applied pressure. The thickness of the tissue is reduced, with bone 642 now closer to the surface of the skin. The disrupted cells 622 and the intercellular space 624 are compressed, expelling fluid 644 out of the local tissue, as indicated by arrows 646.
[00126] [00126] Figure 6D shows an illustrative 660 graph of a delta value for a single patient in a single location where a pressure ulcer develops. SEM values were measured by an SEM scanner. A delta value was generated from sets of SEM measurements performed in incremental times. Point 672 was a measure of time = zero, where all SEM values had a baseline value associated with healthy tissue and the delta value is zero. At time tl, another set of SEM measurements was made and the associated delta value was indicated at point 674. This delta value was below the 662 limit and, therefore, there was no indication of significant surface damage.
[00127] [00127] At time t2, the damage progressed and the delta value 676 was greater than the 662 limit, indicating that there was significant damage. This damage was not yet visible on the skin. However, a delta value greater than the 662 limit indicated that there was cell damage at a depth less than the sensitive depth of the SEM scanner.
[00128] [00128] At time t3, the damage continued, but the amount of fluid in the intercellular space decreased due to mechanical expulsion, as illustrated in Figure 6C. This reduced the SEM value obtained on the damaged area, which reduced the calculated delta value 678, as the SEM value of healthy tissue remained almost the same as in previous measurements.
[00129] [00129] At time t4, the damage progressed to the point where it was visible on the skin surface, as shown in Figure 3 A. In some cases, time t4 can occur before one or both of t2 and t3. In some cases, time t4 may occur after the delta value has reached zero again along curve 670 after time t3 and before t5. Arrow 665 indicates that after time t4, the damage remained visible. In some cases, the tissue can be considered a “stage 1” pressure ulcer after time t4.
[00130] [00130] At time t5, the damage progressed to the point that enough liquid was expelled from the local tissue so that the SEM value of a measurement taken on the damaged area was less than the SEM value of healthy tissue. This resulted in the delta 680 being negative, as shown in Figure 3B. In some cases, the negative delta indicates that the tissue is seriously damaged. In some cases, the negative delta indicates that a portion of the tissue at the site of the lowest SEM value is necrotic. Example 8: Method of mapping an area with possible damage I
[00131] [00131] Figure 7A is an example of a method of mapping an area with possible damage. The damage area 700 was surrounded by healthy tissue 708. The central area 730 was significantly damaged. The first surrounding area 720 was less damaged and the second surrounding area 710 was less damaged, but it has not yet been healthy tissue. The skin in all of these areas had the same appearance and texture, with no indication of damage to the subsurface. The series of dashed line circles 740, 742, 744, 746, 748 and 750 indicates a set of sample locations where SEM measurements were performed. SEM measurements performed at sites 740, 742 and 750 generally produced an SEM value associated with healthy tissue, identified in this example as "H". SEM measurements performed at locations 744 and 748 generally produced a SEM “J” value slightly higher than H. An SEM measurement performed at location 746 generally produced a SEM “P” value greater than J. All of these measurements were considered to be taken in a single “location” in the patient's body, for example, the sacrum, even though the individual locations were spatially dispersed over that location. For this set of SEM values, the delta was the difference between the highest SEM value, which probably occurred at site 746, and the lowest SEM value, which probably occurred at one of sites 740, 742 and 750, within that set. If the delta is greater than a “T” limit value, this indicates that there is significant damage there. The exact location of the greatest damage was probably close to the 746 measurement location, where the highest SEM value was produced. Example 9: Method of mapping an area with possible damage II
[00132] [00132] Figure 7B shows a second example of mapping an area with possible damage. In this example, the approximate location of the greatest damage was known, for example, from the previous application of the method illustrated in Figure 7A. The intention of this method was to map the boundary between area 710 and area 720 to determine the extent of the damage. For simplicity, the SEM values produced by measurements in each area were the same and the SEM values increased from area 710 to area 720 and then to area 730. The first SEM measurement was performed at site 760, which was known as be the approximate location of the greatest damage. Subsequent measurements were made at sites 762, 764, 766 and 768 in the order indicated by path 780. The SEM value produced at site 764 was slightly higher than the SEM values produced at sites 762 and 766, indicating that the site
[00133] [00133] This set of measurements allowed the creation of a map of a certain level of damage, for example, area 720. Repeating this mapping process at regular intervals would provide an indication of whether area 720 is growing, which may indicate that an increased level of intervention is appropriate, or decreasing, which may indicate that the current level of intervention is allowing the damage to recover. Example 10: Treatment decision path for stratifying patients and providing appropriate treatments
[00134] [00134] Figure 8A summarizes a treatment decision path currently recommended for the prevention of pressure ulcers in hospitalized patients, as presented by the National Institute of Excellence in Health and Care (NICE) in its clinical guidelines Pressure ulcers:
[00135] [00135] After completing the risk assessment, the patient is identified as (i) at low risk of developing pressure ulcer, (ii) at risk of developing pressure ulcer or (iii) at high risk of developing pressure ulcer . Depending on the classification of the level of risk that the patient has, the patient undergoes different treatment sequences and evaluation by visual evaluation.
[00136] [00136] All patients are potentially at risk of developing a pressure ulcer. They are more likely to occur in people who are seriously ill or have neurological problems, impaired mobility, impaired nutrition, poor posture or deformity.
[00137] [00137] Pressure ulcers are categorized as stage 1 to stage 4, with stage 1 being the lowest condition. The National Pressure Ulcer Advisory Panel (NPUAP) defined a “stage 1” ulcer as intact skin with a localized area of unbleachable erythema, where “bleachable” indicates that the tissue loses all redness when pressed and “unbleachable” the tissue remains red when pressed due to the presence of red blood cells outside the blood vessels (leakage). In some patients, blanching erythema or changes in sensation, temperature or firmness may precede visual changes.
[00138] [00138] Visual skin assessment (VSA) is the current method of identifying pressure ulcers. A trained health professional assesses the appearance of the skin, both visual and tactile, looking for redness or variations in the firmness, temperature or moisture of the tissue.
[00139] [00139] If a patient is identified as having a low risk of developing a pressure ulcer, he is simply monitored for a change in clinical status, such as surgery, worsening of an underlying condition or change in mobility. A patient using a wheelchair or sitting for extended periods may receive a high specification foam pad or equivalent pressure distribution pad. If there is no change in clinical status, a low-risk patient will not be reevaluated according to this set of guidelines and will remain on the same path of treatment and evaluation until discharge from the care unit.
[00140] [00140] If a patient is identified as being at risk of developing a pressure ulcer, he will be programmed to be turned or "rotated" every 6 hours. As with the low risk patient, a high specification foam pad can be provided if the patient uses a wheelchair or sits for extended periods. No other monitoring or intervention is recommended by the NICE guidelines.
[00141] [00141] A high risk patient receives a high specification foam mattress as a preventive measure,
[00142] [00142] It can be seen in this flowchart that most of the time spent by caregivers will be in high-risk patients. While this may be appropriate, it leaves patients at risk without monitoring and they can develop a stage 1 ulcer before the condition is observed by a caregiver. In addition, the consequence of relying on VSA to detect a problem necessarily means that patients will develop a stage 1 ulcer before an intervention is selected or implemented. When the damage progresses to stage 1, the skin is likely to break and become an ulcer in stage 2, despite the intervention. There is a clear need to identify tissue damage earlier, so that interventions can prevent the progression of subepidermal damage to stage 1 and beyond.
[00143] [00143] Figure 8B is an example of a current increased treatment decision path for the prevention of pressure ulcers, as currently implemented in some health units. The increased path adds monitoring steps to both risk and low risk paths. A low-risk patient received a weekly risk assessment, for example, completion of the Braden Scale assessment.
[00144] [00144] The augmented plan has the benefit of providing basic monitoring of all patients for pressure ulcers. Additional steps require additional time, however, adding staff or further burdening existing staff. Although it is superior to the recommended service in Figure 8A, the service in Figure 8B requires more resources and still suffers from the limitation that a patient needs to develop a stage 1 ulcer before the VSA identifies the damage.
[00145] [00145] Several hospitals and care units use different numbers of risk categories, ranging from two categories, low risk and risk, to four or more categories, adding categories such as "very high risk" to the categories in the example in Figure 8B. Patients are assigned to the various categories based on the results of the initial risk assessment.
[00146] [00146] Figure 9 is an example flow chart of how an SEM scanner can be used in an independent process to prevent pressure ulcers, according to the present disclosure. Every patient received receives a complete SEM scanner assessment of all body locations selected for monitoring. These selected locations may include areas recommended in the SEM Scanner Instructions (IFE1), such as the sacrum and heels. Additional locations can be identified by the hospital and integrated into its internal practice. Multiple SEM measurements are taken at and around each location on the body in positions that are separate from each other, although this is generally referred to as taking multiple measurements at the body location. The SEM scanner calculates a “delta” value for each location from the set of measurements taken at and around the location. The delta value is then compared to one or more limit values to categorize a patient. In this example, the patient is assigned to one of two risk categories: low risk and risk.
[00147] [00147] In one aspect, the doctor will perform an SEM scan of a location on the body identified as having possible damage in the initial SEM scan in a first interval of time. The doctor will also perform an SEM scan of all other locations on the body selected for monitoring in a second time interval greater than the first time interval. In one respect, the values of the first and second time intervals are different, depending on the risk category to which the patient was assigned. For example, a high-risk patient will have a first time slot of 4 hours and a second time slot of 1 day, while a patient at risk will have a first time slot of 1 day and a second time slot of 1 week. . In one respect, the time interval can be based on events, for example, with a change in the responsible team or with a shift change, rather than strictly based on time. In general, sites on the body that have high delta values are scanned more often than other sites on the body that are monitored, but with normal delta values on previous SEM scans.
[00148] [00148] In one aspect, the interval at which an SEM scan is performed is determined by the delta values of the previous SEM scan. For example, an SEM scan of a body location that has a delta value greater than or equal to a first threshold in a previous SEM scan is performed in a first time interval, while an SEM scan is performed in a second time interval more shorter than the first time interval in which the previous SEM scan of a body location had a delta value greater than or equal to a second upper limit than the first limit.
[00149] [00149] In this example, low-risk patients receive a SEM scan weekly of all body sites selected for monitoring. This is a small effort that provides basic protection for even the healthiest patients, since a weekly SEM scan is likely to detect tissue damage before it becomes visible to the VSA.
[00150] [00150] Patients at risk, which will include patients who would be identified as high risk in the current treatment routes of figures 8 A and 8B, will receive specialized care based on the location of the body that has a delta value above a limit. For example, if the site of the sacrum has a delta value above a limit, the patient will be repositioned every 6 hours and will receive a SEM scan of the sacrum every day and an SEM scan of the other body sites every week.
[00151] [00151] Figure 10 is an example flow chart of how a SEM Scanner can be used as a complement to further improve the expanded treatment decision path of Figure 8B, according to the present disclosure. A received patient receives a risk assessment and SEM check of all body sites identified by the hospital for monitoring and a patient's assignment to a risk category is based partly on the risk assessment and partly on the results of the SEM check. An initial delta value that is greater than a threshold is an indication that there is possible damage to that location on the body. In one aspect, the assignment is based only on the largest initial delta value found during the initial SEM scan.
[00152] [00152] The decision to implement an intervention, for example, turning the patient over in a first interval, is currently based on the VSA and the risk assessment, despite the uncertainty as to whether there is damage in the initial stage below the skin. In one aspect, the decision to implement an intervention for a specific location on the body or a general intervention, such as a high specification mattress, is based on the delta value found for that site in the SEM scan. If the delta value is less than a predetermined limit, no intervention is necessary. If the delta value is greater than the predetermined limit, an intervention will be selected and implemented based partly on the location of the body and partly on the delta value for that location on the body. The predetermined limit for selecting or implementing an intervention can be greater or less than the limit for determining whether there is possible damage to the body site.
[00153] [00153] A comparison of the costs of the service routes of figures 8 A, 8B, 9 and 10 reveal one of the benefits of using the SEM scanner to monitor patients. Note that the costs quoted here are for patients who do not have or develop pressure ulcers; in this case, the estimated cost of treatment jumps to $ 2,000 for a stage 1 ulcer.
[00154] [00154] The baseline for this comparison is the current expanded practice in Figure 8B, which represents a current “best practice” for hospitals looking to reduce the incidence rate of pressure ulcers. Low risk care pathway is expected to cost an average of $ 26 per patient for an average hospital stay of 5.6 days, it is estimated that care for a patient at risk costs an average of $ 121 and a patient for high risk should cost $ 165. All routes of care depend on a VSA to detect a pressure ulcer and, otherwise, are implementing interventions based on the “typical” progression of the patient, rather than the specific condition of the patient.
[00155] [00155] The integration of the SEM scanner into the current “best practices” workflow, as shown in Figure 10, does not reduce the cost of any of the service routes, as no work elements are being eliminated. The benefit lies in the ability to detect tissue damage at an earlier stage at minimal incremental cost. The incremental cost of adding an SEM scan to the risk-free care pathway is $ 2, increasing the cost from approximately $ 26 to $ 28. The expected cost of care for a patient at risk who does not have a high SEM delta value, or that is, it has no sub-epidermal damage to the tissue, it is also increased by just $ 2. However, if a patient at risk has a high SEM scan delta value, he will be scaled into the high risk category, where the expected cost of treatment increases from $ 165 to $ 169. Although this may seem like an additional cost at first, it represents an increase in the level of protection provided to patients at risk.
[00156] [00156] Figure 9 represents an example of a workflow that relies only on a SEM scanner to monitor patients and forgo routine VSA. The expected cost of preventive care for a low-risk patient is $ 4, compared to the cost of $ 28 for the integrated low-risk care path in Figure 10. For a patient at risk, which is the only other category for the path for SEM scanner service in Figure 9, the expected cost is $ 97, compared to costs from $ 123 to $ 169 for patients at risk and high risk of integrated care path of Figure
[00157] [00157] Figure 11 illustrates the concept of providing continuity of care in various service environments, in accordance with this disclosure. This example shows an 1100 care pathway for a patient being cared for sequentially in a plurality of care settings, from an 1110 home care setting. A decision is made to transfer the patient to an 1150 hospital, where the patient is initially admitted to a 1120 medical / surgical unit. After receiving care at the 1120 medical / surgical unit for some time, the patient is transferred to a 1130 long-term care unit within the same hospital 1150. After additional treatment, the patient he is discharged from hospital 1150 to a qualified nursing unit 1140. Although not shown in Figure 11, the 1100 service route is not limited to this sample sequence and combination of care settings. For example, the 1100 service route may also involve a patient being discharged back to the home care setting.
[00158] [00158] In one aspect, a "record" or central database 1160 is established to aggregate data from all care settings, as well as the patient's condition at the time of transfer between care settings.
[00159] [00159] While in each service environment, for example, the home care environment 1120, health information related to the patient is recorded and transferred to database 1160 in a data record 1112. Health information may include the results of examinations or tests, observations, measurements, treatments, the implementation of interventions designed to prevent the development of pressure ulcers, diet notes and other records related to the patient's condition and treatment. A service environment data record can include one or more patient identifiers, a data element from the nutrition information group, an implemented intervention, a risk assessment, a visual skin assessment, an assistance plan, a note medical, simple event, a vital sign, a "health measure" such as redness of the skin or an indication of mobility or a measure of cognition, a body weight and a laboratory result and a date / time associated with the data element. Data records may vary in structure and content. A data record reported to the database may contain one of the more than the following data elements: a) a patient identifier b) a transaction date c) a unit identifier d) a transaction location e) nutritional information f) an implemented intervention g) a risk assessment h) a visual assessment of the skin i) a care plan j) a medical note (diagnosis, order, prescription, test request, procedure, treatment etc.) k) test results , procedure or treatment l) an event m) a vital sign n) a body weight o) a laboratory result
[00160] [00160] When a patient is transferred between the care environment, for example, from the home care environment 1110 to the medical / surgical care environment 1120, a transfer record 1114 is created and reported to the 1160 database. The transfer information on risks and health information related to pressure ulcers will improve the care provided in the new care environment. In one aspect, the transfer record 1114 comprises an assessment of the patient carried out at the “de” clinic after the decision to transfer the patient. In one aspect, the assessment comprises an SEM scan of at least one location on the body, where the SEM scan comprises a plurality of SEM values measured at a single body location and the calculation of a delta value from the plurality of values WITHOUT. In one respect, the transfer record contains a history of past SEM values and / or delta values while in the “from” service environment. In one aspect, the transfer record contains one or more of a VS A, a risk analysis and other health data. A transfer record can contain one of the following more than one of the following data elements: a) a patient identifier b) a date / time of the transaction (date and time, time zone or Greenwich Mean Time) c) a type of transaction (pre- admit, admit, transfer, discharge etc.) d) a “To” location e) a “From” location f) an installation / unit identifier g) a risk assessment h) a visual skin assessment i) a photograph of a body location
[00161] [00161] A patient can periodically move from a primary care setting, for example, a home care setting 1110, to an advanced care setting, for example, a long-term acute care unit 1130, where the patient will go through a “care episode” by doctors or other qualified professionals. Data records of assessments and care provided in the advanced care setting are reported to the 1160 database. After moving from the 1130 long-term intensive care setting to the 1110 home setting, record the data containing care instructions, prescriptions and other guidelines for care in the home environment 1110.
[00162] [00162] With the data from the entire 1100 service route aggregated in the 1160 database, it is possible to consult the 1160 database to retrieve the delta values observed over time for a specific patient in various care environments and various episodes service.
[00163] [00163] In one aspect, a consultation is structured to determine whether a patient's monitoring and / or treatment instructions are being followed.
[00164] [00164] In one aspect, a consultation is structured to determine whether a patient's treatment is effective.
[00165] [00165] In one aspect, a consultation is structured to determine whether a patient's result is related to one or more of the data elements reported to the 1160 database.
[00166] [00166] In one aspect, a consultation is structured to recover one or more health measures, together with delta values, to assess possible links between the recovered health measures and the development of a pressure ulcer or other results (development of other health problems. Delta values are plotted against the measurement date / time to form a time history of delta values for a location on the body. In one aspect, the treated values are analyzed to determine one or more of a slope, an acceleration, a curve shape and associated characteristics and an intercept time for a selected threshold value In one aspect, these analytical results can be used to implement the methods and processes of figures 1 and 4.
[00167] [00167] From the foregoing, it will be understood that the present disclosure can be incorporated in several ways, which include, but are not limited to the following:
[00168] [00168] Although the present disclosure has been described with reference to particular aspects, it will be understood by those skilled in the art that various changes can be made and equivalents can be used in place of elements of the same without departing from the scope of the disclosure.
In addition, many modifications can be made to a particular situation or material to the disclosure teachings without departing from the scope of the disclosure.
Therefore, it is intended that the disclosure is not limited to the particular aspects disclosed, but that the disclosure includes all aspects that fall within the scope and spirit of the attached claims.

权利要求:
Claims (20)
[1]
1. “METHOD TO PROVIDE CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF ATTENDANCE ”, characterized by the method consisting of the steps of: deciding to transfer a patient from a first care environment to a second environment, performing a first patient assessment in the first care environment, preparing a transfer record of the assessment, and transfer the transfer record with the patient to the second care setting.
[2]
2. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 1, characterized in that the first assessment includes the performance of a subepidermal humidity (SEM) scan of at least one location on the patient's body.
[3]
3. “METHOD TO PROVIDE CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN SERVICE PLACES ”, according to claim 2, characterized in that the SEM scan comprises a plurality of measurements of a SEM value at the body location and calculation of a delta value from the plurality of SEM values .
[4]
4. “METHOD TO PROVIDE CONTINUITY OF
ATTENDANCE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF ATTENDANCE ”, according to claim 3, characterized by still comprising the steps of: performing a plurality of SEM exams of the patient at different times while in the first service, and recording the delta values of each of the respective SEM scans, in which the decision to transfer the patient is partially based on the delta values recorded during the first visit.
[5]
5. “METHOD TO PROVIDE CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 4, characterized in that the transfer record comprises the delta values of a portion of the plurality of SEM scans of the patient performed at different times while in the first care environment.
[6]
6. “METHOD TO PROVIDE CONTINUITY OF
ATTENDANCE TO A PATIENT DURING TRANSFER BETWEEN ATTENDANCE PLACES ”, according to claim 2, characterized in that the SEM scan is performed at all locations on the body identified for monitoring.
[7]
7. “METHOD TO PROVIDE CONTINUITY OF
CARE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 1, characterized in that the first assessment comprises at least one of the patient's risk assessment, a visual assessment of the skin of at least one location of the patient's body and an image of at least one minus one location on the body.
[8]
8. “METHOD TO PROVIDE CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 1, characterized in that the transfer record comprises, at least, one of a type of transaction, a date / time of the transaction, a place“ for ”and a “from” location.
[9]
9. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 1, characterized by also comprising the steps of: performing a first SEM scan of at least one location on the patient's body while in the first care environment , in which the first SEM scan comprises a plurality of measurements of a SEM value at the body location and calculates a first delta value from the plurality of SEM values, create a first data record comprising the first delta value, report the first record data to a database and report the transfer record to the database.
[10]
10. “METHOD TO PROVIDE CONTINUITY OF
CARE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 9, characterized by: the first data record comprises a patient identifier and a first date / time when the first SEM scan was performed, and the record transfer includes the patient's identifier and a second date / time when the first assessment was performed.
[11]
11. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 10, characterized by further comprising the steps of: performing a SEM scan of at least one location on the patient's body and calculating a second delta value while in the second care environment, creating a second data record comprising the patient identifier, the second delta value and a third date / time at which the second SEM scan was performed, and reporting the second data record to a database.
[12]
12. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 11, characterized by additionally understanding the steps of: consulting the database to retrieve part of the data records that comprise the delta values of at least a location on the patient's body.
[13]
13. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 12, characterized by also comprising the steps of: formatting the recovered delta values in order of date / time and displaying the formatted delta values.
[14]
14. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 10, characterized by still comprising the steps of: creating an additional data record that includes the patient identifier, a data element of the group of nutritional information, an implemented intervention, a risk assessment, a visual assessment of the skin, a care plan, a medical certificate, a lean event, a vital sign, a body weight and a laboratory result and a date / time associated with the data element, and report the record of additional data to the database.
[15]
15. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 13, characterized in that the formatted delta values are displayed in the form of a curve.
[16]
16. “METHOD TO PROVIDE CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 15, characterized by also comprising the step of analyzing the recovered delta values to determine one or more of a slope, an acceleration, a curve shape and associated particularities and an intercept time for a selected threshold value.
[17]
17. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 16, characterized in that the acceleration is determined by the rate of variation of the slope of the curve.
[18]
18. “METHOD FOR PROVIDING CONTINUITY OF
ATTENDANCE TO A PATIENT DURING TRANSFER BETWEEN ATTENDANCE PLACES ”, according to claim 16, characterized by the decision to transfer the patient partially based on one or more of inclination, acceleration, curve shape and associated particularities and interception time of a selected threshold value.
[19]
19. “METHOD FOR PROVIDING CONTINUITY OF
SERVICE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF SERVICE ”, according to claim 11, characterized by also comprising the steps of: performing a SEM scan of at least one location on the patient's body and calculating a third delta value while in the third care environment, create a third data record comprising the patient identifier, the third delta value and a fourth date / time at which the third SEM scan was performed, and report the third data record to a database.
[20]
20. “METHOD FOR PROVIDING CONTINUITY OF
ATTENDANCE TO A PATIENT DURING TRANSFER BETWEEN PLACES OF ATTENDANCE ”, according to claim 19, characterized by also understanding the steps of consulting the database to retrieve the delta values observed over time for a specific patient in various care environments and several service episodes.

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法律状态:
2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201762587337P| true| 2017-11-16|2017-11-16|

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US62/587,337|2017-11-16|

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US201862693810P| true| 2018-07-03|2018-07-03|

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US62/693,810|2018-07-03|

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PCT/US2018/061497|WO2019099812A1|2017-11-16|2018-11-16|Providing a continuity of care across multiple care settings|

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