Providing continuous care across multiple care settings

Abstract

To provide a method of improving cares by transferring and treating information on a patient, specifically information related to risks of developing pressure ulcers when the patient is cared in a plurality of settings.SOLUTION: A method includes the steps of: deciding to transfer a patient from a first care setting to a second care setting; performing a first assessment of the patient in the first care setting; preparing a transfer record of the assessment; and transferring the transfer record with the patient to the second care setting.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - reference to related patent applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 587,337, filed on November 16, 2017, and U.S. Provisional Patent Application No. 62 / 693,810, filed on July 3, 2018. The entire contents of these applications are incorporated herein by reference.

[0002] The present disclosure provides a method for improving care by transferring and handling patient information, particularly information related to the risk of developing pressure ulcers, when a patient receives care in multiple environments.

Background Art

[0003] The skin is the largest organ in the human body. It is easily exposed to various types of damage and trauma. If the skin and its surrounding tissues cannot redistribute external pressure and mechanical forces, ulcers can form. For example, even for moderate pressure, such as the pressure on the back - side skin surface of a supine patient caused by the patient's body weight, continuous exposure over a long period can lead to pressure ulcers. In the presence of other injuries such as neuropathy and peripheral tissue weakness that may be induced by diabetes, even periodic exposure to moderate pressure and stress can lead to ulcers, such as foot ulcers.

[0004] Approximately 2.5 million people in the United States and an equivalent number in the EU develop pressure ulcers each year. In long - term emergency settings, up to 25% of elderly immobile patients develop pressure ulcers. Due to infections and other complications from pressure ulcers, approximately 60,000 patients in the United States die each year.

[0005] For both patients and society, it is desirable to detect tissue damage before skin breakdown occurs and intervene with appropriate treatment to avoid further deterioration of the underlying tissues. The average cost of treating pressure-induced injury is only $2,000 for the earliest visible signs (stage 1 ulcer), but this rises to $129,000 when the ulcer becomes deep enough to expose muscle or bone (stage 4 ulcer). Currently, patients typically receive general prophylaxis for pressure ulcers, which means that the prophylaxis is not targeted at any particular anatomical site. Patients only receive targeted local treatment for their ulcers after the pressure ulcer has reached a point where it can be identified by visual assessment. The current standard for detecting pressure ulcers is visual inspection, which is subjective, unreliable, untimely, and has low specificity. Therefore, even if a patient has skin inflammation and signs of ulcer development, they do not receive targeted local treatment for the developing ulcer. Instead, the inflammation will persist and develop into a full-blown ulcer.

[0006] In current practice, the risk of a patient developing pressure ulcers is independently assessed upon arrival at a new care environment. This lack of knowledge from the previous care environment can lead to a decline in the quality of care received in the new environment. [Overview of the project]

[0007] In one embodiment, the disclosure provides and includes a method for identifying and providing an appropriate level of pressure ulcer care to a patient based on multiple subcutaneous moisture (SEM) measurements. In one embodiment, the patient receives progressively more effective intervention for the pressure ulcer based on changes in SEM measurements. In another embodiment, the patient receives a lower-intensity intervention for the pressure ulcer based on changes in SEM measurements.

[0008] A method for providing continuous care to a patient while transferring between care environments, comprising the steps of: deciding to transfer the patient from a first care environment to a second care environment; performing a first assessment of the patient in the first care environment; creating a transfer record for the assessment; and transferring the transfer record along with the patient to the second care environment.

[0009] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient requiring treatment for pressure ulcers, comprising the steps of: evaluating a patient for pressure ulcer risk upon admission to a care facility, the evaluation step including performing a first group of subcutaneous moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first group of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a first intervention of level -0 if the first delta value does not exceed a first threshold; and administering a first intervention of level -N if the first delta value exceeds a first threshold, wherein N is an integer and N has a value of 1 or greater. In a further embodiment, the Disclosure provides and includes: performing a second set of SEM measurements on a patient at a first predetermined frequency corresponding to the level of intervention to be administered; calculating a second delta value from a portion of the second set of SEM measurements; determining whether the second delta value exceeds a second threshold; continuing to administer the first intervention if the second delta value does not exceed the second threshold; continuing to perform the set of SEM measurements at a first predetermined frequency if the second delta value does not exceed the second threshold; administering a second intervention of level-M if the second delta value exceeds the second threshold, wherein M is an integer and M is greater than N; and administering the second intervention of level-M if the second delta value exceeds the second threshold, wherein the set of SEM measurements corresponds to a second predetermined frequency corresponding to level-M. In a further embodiment, the Disclosure provides and includes determining whether a second delta value is less than a third threshold, administering a level-(N-1) intervention if the second delta value is less than the third threshold and the first intervention is not level-0, and performing multiple SEM measurements at predetermined frequencies corresponding to level-(N-1) if the second delta value is less than the third threshold.

[0010] In one embodiment, the present disclosure provides and includes a method for delaying the progression of pressure ulcer development in a patient in need thereof, comprising the steps of: identifying the current Level-K intervention received by the patient; performing multiple subcutaneous moisture (SEM) measurements of the patient; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a first threshold; continuing the current intervention if the delta value does not exceed the first threshold; continuing to perform multiple SEM measurements at a predetermined frequency corresponding to Level-K if the delta value does not exceed the first threshold; administering a new Level-N intervention if the delta value exceeds the first threshold, wherein N has a value greater than K; and performing multiple SEM measurements at a predetermined frequency corresponding to Level-N if the delta value exceeds the first threshold. In a further embodiment, the Disclosure provides and includes determining whether a delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and performing a number of SEM measurements at predetermined frequencies corresponding to level-L if the delta value is less than the second threshold.

[0011] In one embodiment, the Disclosure provides and includes a method for stratifying groups of patients in a nursing home based on pressure ulcer risk, the method comprising: taking multiple subcutaneous moisture (SEM) measurements for each patient; calculating a delta value from a portion of the multiple SEM measurements for each patient; determining whether each delta value exceeds any value in a set of thresholds corresponding to N care levels and assigning a care level to each patient; and reorganizing the groups of patients based on each of the care levels assigned to the patients.

[0012] In one embodiment, the Disclosure provides and includes a method for reducing the incidence of pressure ulcers in patients admitted to a nursing home, comprising the steps of: evaluating a patient for the risk of pressure ulcers upon admission to the nursing home; performing a first set of subcutaneous moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first set of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a first intervention of level -0 if the first delta value does not exceed a first threshold; and administering a level -N intervention if the first delta value exceeds a first threshold, wherein N is an integer and N has a value of 1 or greater.

[0013] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires the application of a protective cream to the heel of the patient, comprising the steps of: performing a plurality of subepidermal moisture (SEM) measurements on the heel of the patient; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying a protective cream to the heel of the patient if the delta value exceeds the threshold; and performing a plurality of SEM measurements every two hours if the delta value exceeds the threshold.

[0014] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires neuromuscular stimulation to the patient's heel, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's heel; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying neuromuscular stimulation to the patient's heel if the delta value exceeds the threshold; and performing multiple SEM measurements every hour if the delta value exceeds the threshold.

[0015] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires the application of a topical cream to the patient's heel, comprising the steps of: performing a plurality of subepidermal moisture (SEM) measurements on the patient's heel; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying the topical cream to the patient's heel if the delta value exceeds the threshold; and performing a plurality of SEM measurements every 30 minutes if the delta value exceeds the threshold.

[0016] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires the application of a protective cream to the patient's sacrum, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's sacrum; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying a protective cream to the patient's sacrum if the delta value exceeds the threshold; and performing multiple SEM measurements every 6 hours if the delta value exceeds the threshold.

[0017] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires neuromuscular stimulation of the patient's sacrum, comprising the steps of: performing multiple subcutaneous moisture (SEM) measurements on the patient's sacrum; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying neuromuscular stimulation to the patient's sacrum if the delta value exceeds the threshold; and performing multiple SEM measurements every four hours if the delta value exceeds the threshold.

[0018] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires the application of a topical cream to the patient's sacrum, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's sacrum; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying the topical cream to the patient's sacrum if the delta value exceeds the threshold; and performing multiple SEM measurements every two hours if the delta value exceeds the threshold. [Brief explanation of the drawing]

[0019] The patent or application file must include at least one drawing in color. A copy of the publication of the patent or application, including the color drawing, will be provided by the Japan Patent Office upon application and payment of the required fees.

[0020] The modes of disclosure described herein are described merely by reference to the accompanying drawings. By specifically referring to the detailed drawings, it is emphasized that the individual items illustrated are illustrative and intended for explanatory purposes of the modes of disclosure. In this regard, the specification and drawings will make it clear to those skilled in the art how the modes of disclosure may be implemented, whether considered individually or in combination.

[0021] [Figure 1] Figure 1 illustrates an example of the entire selection process for pressure ulcer treatment based on SEM values, from admission to discharge from a nursing care facility, in accordance with this disclosure.

[0022] [Figure 2A] Figure 2A is a sample of a visual assessment of healthy tissue in accordance with this disclosure.

[0023] [Figure 2B] Figure 2B is a plot of the mean values ​​of SEM measurements obtained in and around a healthy sacrum, in accordance with this disclosure.

[0024] [Figure 3A] Figure 3A is a sample of the visual evaluation of damaged tissue according to the present disclosure.

[0025] [Figure 3B] Figure 3B is a plot of the average values of SEM measurements obtained at various locations in and around the damaged sacrum according to the present disclosure.

[0026] [Figure 4] Figure 4 is a diagram of a process for selecting and monitoring an intervention level based on the amount by which the delta value from SEM measurements exceeds a threshold according to the present disclosure.

[0027] [Figure 5] Figure 5 is an example of a matrix for workflow guidance for selecting a new intervention level using the current intervention level and a new delta value according to the present disclosure.

[0028] [Figure 6A] Figures 6A, 6B, and 6C show examples of the progression over time of delta values for a single patient at a single location where a pressure ulcer has developed according to the present disclosure. [Figure 6B] The same as above. [Figure 6C] The same as above.

[0029] [Figure 6D] Figure 6D is an example of a plot of the change over time of delta values for a single patient at a single location where a pressure ulcer has developed according to the present disclosure.

[0030] [Figure 7A] Figures 7A and 7B are examples of methods for mapping areas of tissue damage according to the present disclosure. [Figure 7B] The same as above.

[0031] [Figure 8A]Figure 8A shows an example of a currently recommended treatment decision-making pathway for preventing pressure ulcers in hospitalized patients, combining risk assessment and visual inspection.

[0032] [Figure 8B] Figure 8B shows an example of the current expanded treatment decision pathway for preventing pressure ulcers, as is currently implemented in some healthcare facilities.

[0033] [Figure 9] Figure 9 is an example flowchart illustrating how a SEM scanner may be used in a standalone pressure ulcer prevention procedure in accordance with this disclosure.

[0034] [Figure 10] Figure 10 is an example flowchart illustrating how a SEM scanner may be used to further improve the enlarged treatment decision pathway shown in Figure 8B, in accordance with this disclosure.

[0035] [Figure 11] Figure 11 illustrates the concept of providing continuous care across multiple care settings, in accordance with this disclosure. [Modes for carrying out the invention]

[0036] This specification is not intended to be a detailed catalog of all possible methods by which this disclosure may be implemented, or of all possible features that may be added to the current disclosure. For example, a feature described according to one embodiment may be incorporated into another embodiment, and a feature described according to a particular embodiment may be omitted from that embodiment. In other words, this disclosure is intended to mean that in some embodiments of this disclosure, any feature or combination of features expressed herein may be excluded or omitted. Furthermore, to those skilled in the art, several modifications and additions to the various embodiments suggested herein will become apparent in light of the current disclosure, but these will not deviate from the current disclosure. In other examples, well-known structures, interfaces, and processes are not described in detail so as not to unnecessarily obscure the invention. It is intended that nothing in this specification shall be construed as a disclaimer of any part of the full scope of the invention. Accordingly, the following description is intended to describe certain embodiments of some parts of this disclosure and is not intended to specify all of their order, combinations, and variations in their entirety.

[0037] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art in which this disclosure pertains. Technical terms used in the descriptions herein are intended solely to describe specific aspects or embodiments and are not intended to limit the disclosure.

[0038] All publications, patent applications, patents, and other references cited herein are invoked by reference in their entirety for teaching relating to the sentences and / or paragraphs in which they are referenced. References to the art used herein are intended to refer to the art as commonly understood in the art, including variations of that art or substitutions of equivalent art that would be apparent to those skilled in the art.

[0039] U.S. Patent Application No. 14 / 827,375 ("Application 375") discloses an apparatus for measuring subcutaneous capacitance using radio frequency (RF) energy with bipolar sensors, where subcutaneous capacitance corresponds to the water content of a target area of ​​a patient's skin. Application 375 also discloses arrays of bipolar sensors of various sizes.

[0040] U.S. Patent Application No. 15 / 134,110 discloses a subcutaneous moisture (SEM) measuring device similar to the device shown in Figure 3, which emits and receives a 32 kHz frequency RF signal via a single coaxial sensor, generates a bioimpedance signal, and then converts this signal into an SEM value.

[0041] U.S. Patent Applications No. 14 / 827,375 and No. 15 / 134,110 are both incorporated herein by reference in their entirety. However, the SEM values ​​of this application may be measured by any similar or equivalent apparatus or technique that would be apparent to those skilled in the art. For example, the apparatus for measuring the SEM values ​​of this application may be a wired device, a wireless device, or a system comprising various components communicating with one another.

[0042] Unless otherwise indicated in that context, the various features of the disclosure described herein are particularly intended to be used in any combination. Furthermore, the disclosure is also intended to exclude or omit any of the features or combinations of features expressed herein in some embodiments of this disclosure.

[0043] The methods disclosed herein include and comprise one or more steps or actions for achieving the described methods. The steps and / or actions of the methods may be interchangeable without departing from the scope of the disclosure. In other words, unless a particular order of steps or actions is required for proper operation of the embodiments, the order and / or use of any particular steps and / or actions may be modified without departing from the scope of the disclosure.

[0044] As used in the descriptions of this disclosure and the attached claims, the singular forms "a," "an," and "the" are also intended to include the plural forms unless otherwise explicitly stated in the context.

[0045] As used herein, “and / or” refers to and encompasses not only any and all possible combinations of one or more of the items listed in relation, but also, where it is interpreted as alternative (“or”), not combinations.

[0046] As used herein, the terms “about” and “approximately” mean, when referring to measured values ​​such as length, frequency, or SEM values, that a particular quantity may vary by ±20%, ±10%, ±5%, ±1%, ±0.5%, or ±0.1%.

[0047] In this specification, phrases such as "between X and Y" and "approximately between X and Y" must be interpreted as including X and Y. In this specification, phrases such as "approximately between X and Y" mean "approximately between X and approximately Y," and phrases such as "from approximately X to Y" mean "from approximately X to approximately Y."

[0048] As used herein, the terms “sub-epidermal moisture” or “SEM” refer to an increase in tissue fluid and local edema caused by vascular leakage and other changes that alter the underlying structure of damaged tissue in the presence of continuous pressure on the tissue, apoptosis, necrosis, and inflammatory processes.

[0049] As used herein, "patient" may refer to a human subject or an animal subject.

[0050] As used herein, "delta" refers to the calculated difference between two SEM values.

[0051] In this specification, the variables "K", "L", "M", and "N" are non-negative integers.

[0052] Figure 1 illustrates the entire process 100 for selecting pressure ulcer treatment based on SEM values ​​generated by SEM measurements performed using an SEM scanner in accordance with this disclosure, from admission to discharge from a care facility. In one embodiment, the care facility is selected from a group consisting of hospitals, assisted living facilities, residential care facilities, nursing homes, long-term care facilities, continuing care communities, and independent living communities. In another embodiment, the care facility may be the patient's home or another residence, in which case the “admission” step 102 is the patient’s initial assessment at home by a nurse or other caregiver. In one embodiment, the schedule and assessment intervals of interventions used in the home setting may differ from the corresponding interventions and intervals used in the hospital.

[0053] In one embodiment, in process 100, a newly admitted patient undergoes an admission assessment in step 104, which includes one or more of the following: a visual inspection of a portion of the patient's skin, completion of at least a portion of a risk assessment protocol that evaluates one or more of the following: nutrition, mobility, physical activity, physical fitness, and communication ability, and SEM measurements performed at one or more locations on the patient's skin. In one embodiment, the SEM measurements may include performing multiple SEM measurements at a single “location” on the patient’s skin. In one embodiment, the “location” is considered to be an area rather than a single point, such that the SEM measurements may be performed at spatially separated points within the scope of that location. For example, the “heel” location includes not only the medial, lateral, and posterior surfaces around the heel, but also the posterior portion of the sole of the foot.

[0054] In one embodiment, once the assessment step is complete, step 106 determines whether the patient is “deviant,” that is, whether the combination of results from the various elements of the assessment indicates that the patient has tissue damage that could lead to pressure ulcers or is at risk of developing such tissue damage. Each element of the assessment may have individual criteria for the level of risk, such as a scoring system with thresholds indicating unacceptable risk. In one embodiment, there exists a protocol that combines criteria to generate a composite parameter that can be used to select the level of intervention.

[0055] In one embodiment, if the patient is determined to be at an acceptable risk level, the process proceeds to step 108, which involves implementing the lowest level of intervention, which is expressed herein as "Level-Zero" or "Level-0". Proceeding to steps 110 through 112, the patient is re-evaluated in step 114 using at least the SEM measurement protocol, at a frequency or conversely, at time intervals associated with Level-0. The process then loops back to step 106 to evaluate the results of the SEM measurements performed in step 114.

[0056] In one embodiment, if the patient is determined to be deviant in step 106, the process then proceeds to step 122, which implements a higher level of intervention. In another embodiment, there is a defined hierarchy of intervention levels, where each level implements an intervention that is more effective than the next lower level. In yet another embodiment, each level also has a defined monitoring interval or frequency indicating how often a set of SEM measurements should be performed, with higher levels generally having shorter intervals. In this example, the process was defined by the hospital or other governing body to advance one level to intervention level-1 in this respect. In yet another embodiment, step 122 may implement intervention level-2 or higher. Here the process enters a new loop, which begins in step 130, where the patient is now monitored at a frequency of level-N, where N ranges from 1 to n, and n is the defined highest level of intervention and monitoring.

[0057] In one embodiment, step 134 evaluates the patient's history to determine whether their symptoms have improved. If the patient's symptoms have improved, for example, as evidenced by a decrease in the delta value, the process then proceeds to step 142. In this example, step 142 continues the implementation of the current level of intervention, and the process loops through steps 140-130-132-134-142-140 until the delta value falls below a threshold. In one embodiment, the level of intervention can be reduced in step 142 based on the magnitude of the delta value as it begins to decrease.

[0058] In one embodiment, if no improvement is seen in the patient in step 134, the treatment proceeds to increasing the level of intervention in step 138, provided that the skin has not broken down, i.e., there is no open ulcer, in step 136. If there is an open ulcer, in step 144, a SEM scan is performed around the periphery of the open wound to map any signs of inflammation or other signs indicating the spread of the ulcer. The ulcer itself is treated in step 148, and this secondary loop 144-146-148-150 is continued until the wound closes, at which point the treatment returns to step 130.

[0059] In one embodiment, at any point in process 100, the patient is discharged, and the process proceeds to step 118, where the patient's condition at discharge or transfer is documented. In one embodiment, step 118 includes SEM measurements of the last set of locations on the patient's body. In one embodiment, these locations include areas that have not received intervention and areas that have not been previously identified as at risk. In one embodiment, this information is provided to the receiving caregiver. The patient is then discharged or transferred in step 120.

[0060] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient requiring treatment for pressure ulcers, comprising the steps of: evaluating the patient for pressure ulcer risk upon admission to a care facility, which includes performing a first group of subcutaneous moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first group of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a first intervention of level -0 if the first delta value does not exceed the first threshold; and administering a first intervention of level -N if the first delta value exceeds the first threshold, wherein N is an integer and N has a value of 1 or greater.

[0061] In one embodiment, the first multiple SEM measurements are performed at and around one or more anatomical sites selected from a group consisting of the sternum, sacrum, heel, scapula, elbow, ear, and other fleshy tissues of the patient. In another embodiment, the first multiple SEM measurements are divided into subgroups for analysis based on the general location where the measurements are performed. In another embodiment, the first multiple SEM measurements are performed at locations located in one or more concentric circles centered around the anatomical site. In yet another embodiment, the first multiple SEM measurements are performed at locations located on a straight line approximately equidistant from the anatomical site.

[0062] In one embodiment, the first delta value is determined by the difference between the maximum and minimum SEM values ​​from a first set of SEM measurements collected. In another embodiment, the first delta value is determined by the difference between the maximum SEM mean of measurements taken at a first location and the minimum SEM mean of measurements taken at a second location. In another embodiment, the first delta value is determined for a subset of a first set of SEM measurements, which are comprised of subgroups defined by the locations where the measurements were taken. In another embodiment, the average SEM value at a location is obtained from 2, 3, 4, 5, 6, 7, 8, 9, 10, or more SEM values ​​measured at that location. In yet another embodiment, the first delta value is determined by the difference between SEM values ​​derived from measurements taken at two symmetrical locations with respect to a certain centerline.

[0063] In some embodiments, the delta value may be calculated from multiple SEM measurements taken in multiple ways at a specific location or in the vicinity of a specific location. In some embodiments, the multiple SEM measurements are taken within a predetermined pattern on the skin, and the delta value is calculated by subtracting the SEM value associated with a predetermined location within the pattern from the maximum SEM value taken at other locations within the pattern. In some embodiments, the multiple SEM measurements are taken within a predetermined pattern on the skin, and the delta value is calculated by identifying the SEM value associated with a predetermined location within the pattern and subtracting the maximum SEM value that occurred at other locations within the pattern. In some embodiments, the average SEM value may be calculated from a set of SEM values ​​obtained from multiple SEM measurements at a single location, and a delta value calculated as the average value of the same set and the maximum difference between single SEM values. In some embodiments, the delta value may be calculated as the ratio of the maximum SEM value to the minimum SEM value within a set of SEM values.

[0064] In one aspect, the first threshold is approximately 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 embodiment, the first threshold may range from 0.1 to 8.0, for example, 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 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 embodiment, the first threshold can be increased or decreased by a factor or multiplier based on the values ​​provided herein. It will be understood that the threshold is not limited by design, but rather a person skilled in the art can select a predetermined value based on a given unit of the SEM. In one embodiment, the threshold of the present disclosure varies depending on a specific part of the patient's body in which the measurement is performed, or on one or more of the patient's characteristics, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0065] In one embodiment, N can range from 1 to 50, for example, 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 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, etc.

[0066] In one embodiment, N is determined by the amount by which the first delta value exceeds the first threshold. In another embodiment, the amount by which the delta value exceeds the threshold set at (N+1) is greater than the amount by which the delta value exceeds the threshold set at N. In yet another embodiment, the amount by which the delta value exceeds the threshold set at (N-1) is less than the amount by which the delta value exceeds the threshold set at N.

[0067] In one embodiment, Level-1 (N=1) intervention is applied to patients with delta values ​​that exceed the threshold by only 100% or less of the threshold, for example, delta values ​​that exceed the threshold by only 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less of the threshold.

[0068] In one aspect, Level-2 (N=2) intervention is applied to patients with delta values ​​that exceed the threshold by only 150% or less of the threshold, for example, delta values ​​that exceed the threshold by only 145%, 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less of the threshold.

[0069] In one aspect, Level-3 (N=3) intervention is defined as a delta value exceeding the threshold by only 200% or less of the threshold, for example, below 195%, 190%, 185%, 180%, 175%, 170%, 165%, 160%, 155%, 150%, 145%, 140%, 135%, 130%, 125%, and 120% of the threshold. This applies to patients with a delta value exceeding the threshold by only 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less.

[0070] In one aspect, Level-4 (N=4) intervention is defined as a delta value exceeding the threshold by 250% or less of the threshold, for example, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less. This applies to patients with a delta value exceeding the threshold by only 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less.

[0071] In one aspect, intervention at level -5 (N=5) is defined as a delta value exceeding the threshold by 300% or less of the threshold, for example, below 295%, 290%, 285%, 280%, 275%, 270%, 265%, 260%, 255%, 250%, 245%, 240%, 235%, 230%, 225%, 220%, 215%, 210%, 205%, 200%, 195%, 190%, 185%, 180%, 175%, and 170%. This applies to patients with a delta value exceeding the threshold by only 165%, 160%, 155%, 150%, 145%, 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less.

[0072] In one aspect, intervention at level -6 (N=6) is defined as a delta value exceeding the threshold only by 350% or less of the threshold, for example, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, and 195% or less of the threshold. This applies to patients with a delta value exceeding the threshold by only 190%, 185%, 180%, 175%, 170%, 165%, 160%, 155%, 150%, 145%, 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less.

[0073] In one aspect, Level-7 (N=7) intervention is defined as delta values ​​exceeding the threshold by 400% or less of the threshold, for example, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 3 25% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less , 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less This applies to patients with a delta value exceeding the threshold by only 215%, 210%, 205%, 200%, 195%, 190%, 185%, 180%, 175%, 170%, 165%, 160%, 155%, 150%, 145%, 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5%.

[0074] In one aspect, Level-8 (N=8) intervention is defined as a delta value exceeding the threshold only by 450% or less of the threshold, for example, 445% or less, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less. Below, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% Below, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less Lower, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less Lower, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less This applies to patients with a delta value exceeding the threshold by only 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less.

[0075] In one aspect, Level-9 (N=9) intervention is defined as a delta value exceeding the threshold by 500% or less of the threshold, for example, below 495%, 490%, 485%, 480%, 475%, 470%, 465%, 460%, 455%, 450%, 445%, 440%, 435%, 430%, 425%, 420%, 415%, 410%, 405%, and 4 00% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335 % or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less Lower, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 13 This applies to patients with a delta value exceeding the threshold by only 5% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less.

[0076] In one aspect, intervention at level -10 (N=10) is defined as a delta value exceeding the threshold only 550% or less of the threshold, e.g., 545% or less, 540% or less, 535% or less, 530% or less, 525% or less, 520% ​​or less, 515% or less, 510% or less, 505% or less, 500% or less, 495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less. % or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% Below, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 2 20% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less This applies to patients with a delta value exceeding the threshold by only 145%, 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less.

[0077] In one aspect, intervention at level -N is more effective than intervention at level -0. In another aspect, intervention at level -(N+1) is more effective than intervention at level -N. In one aspect, interventions at level-(N-1) are less effective than interventions at level-N.

[0078] In one embodiment, the evaluation step of this disclosure further includes performing a visual inspection. In one embodiment, the visual inspection is performed in accordance with the guidelines of the NPUAP (National Pressure Ulcer Advisory Panel).

[0079] In one embodiment, the steps evaluated in this disclosure further include performing a risk assessment. In one embodiment, 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] In one embodiment, the Disclosure further provides and includes: performing a second set of SEM measurements on a patient at a first predetermined frequency corresponding to the level of intervention to be administered; calculating a second delta value from a portion of the second set of SEM measurements; determining whether the second delta value exceeds a second threshold; continuing to administer the first intervention if the second delta value does not exceed the second threshold; continuing to perform the set of SEM measurements at a first predetermined frequency if the second delta value does not exceed the second threshold; administering a second intervention of level-M if the second delta value exceeds the second threshold, wherein M is an integer and M is greater than N; and performing a second set of SEM measurements at a second predetermined frequency corresponding to level-M if the second delta value exceeds the second threshold.

[0081] In one embodiment, the 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 1 hour, and at least once every 30 minutes.

[0082] In one embodiment, the second set of SEM measurements are performed according to paragraph 0061. In another embodiment, the second set of SEM measurements are performed at the same location where the first set of SEM measurements were performed. In another embodiment, the second set of SEM measurements are performed in part of the same location where the first set of SEM measurements were performed. In yet another embodiment, the second set of SEM measurements are performed in the vicinity of the location where the first set of SEM measurements were performed. In yet another embodiment, the second set of SEM measurements are performed at a different location from the location where the first set of SEM measurements were performed.

[0083] In one embodiment, the second delta value is determined by the difference between the maximum and minimum SEM values ​​from a second set of SEM measurements collected. In another embodiment, the second delta value is determined by the difference between the maximum SEM mean of measurements taken at the first location and the minimum SEM mean of measurements taken at the second location. In yet another embodiment, the second delta value is determined for a subset of the second set of SEM measurements, which are comprised of subgroups defined by the locations where they were taken.

[0084] In one aspect, the second threshold is approximately 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 embodiment, the second threshold may range from 0.1 to 8.0, for example, 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 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 embodiment, the second threshold can be increased or decreased by a factor or multiplier based on the values ​​provided herein. In one embodiment, the second threshold can be the same as the first threshold. In one embodiment, the second threshold can be greater than the first threshold. In one embodiment, the second threshold can be less than the first threshold.

[0085] In one aspect, M ranges from 2 to 50, for example, 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 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, etc.

[0086] In one embodiment, M is determined by the amount by which the second delta value exceeds the second threshold. In one embodiment, the amount by which the delta value exceeds the threshold set in (M+1) is greater than the amount by which the delta value exceeds the threshold set in M. In another embodiment, the amount by which the delta value exceeds the threshold set in (M-1) is less than the amount by which the delta value exceeds the threshold set in M.

[0087] In one embodiment, interventions at level M are selected according to paragraphs 0067 to 0076, with N replaced by M.

[0088] In one embodiment, the disclosure further provides and includes determining whether a second delta value is less than a third threshold, administering a level-(N-1) intervention if the second delta value is less than the third threshold and the first intervention is not level-0, and performing multiple SEM measurements at predetermined frequencies corresponding to level-(N-1) if the second delta value is less than the third threshold.

[0089] In one aspect, the third threshold is approximately 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 embodiment, the third threshold may range from 0.1 to 8.0, for example, 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 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 embodiment, the third threshold can be increased or decreased by a factor or multiplier based on the values ​​provided herein. In one embodiment, the third threshold can be the same as the second threshold. In one embodiment, the third threshold can be greater than the second threshold. In one embodiment, the third threshold can be less than the second threshold. In one embodiment, the third threshold can be the same as the first threshold. In one embodiment, the third threshold can be greater than the first threshold. In another embodiment, the third threshold can be less than the first threshold.

[0090] In one embodiment, the second delta value can be 0.1 to 99.5% of the third threshold, for example, 0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15% These include 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%, etc.

[0091] In one embodiment, the Disclosure provides and includes a method for slowing the progression of pressure ulcer development in a patient in need of this method, comprising the steps of: identifying the current Level-K intervention the patient has received; performing multiple subcutaneous moisture (SEM) measurements of the patient; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a first threshold; continuing the current intervention if the delta value does not exceed the first threshold; continuing to perform multiple SEM measurements at a predetermined frequency corresponding to Level-K if the delta value does not exceed the first threshold; and administering a new Level-N intervention if the delta value exceeds the first threshold, wherein N has a value greater than K; and administering the new Level-N intervention, wherein if the delta value exceeds the first threshold, N has a value greater than K; and performing multiple SEM measurements at a predetermined frequency corresponding to Level-N if the delta value exceeds the first threshold. In one embodiment, the patient in need of this method is a patient experiencing a change in care, a change in mobility, a change in nutrition, a change in sensory cognition, or a combination thereof. In one embodiment, the patient in need of this method is a patient who has developed an open ulcer. In one embodiment, the patients who require this are those whose open ulcers have healed. In another embodiment, the patients who require this are those undergoing surgery. In another embodiment, the patients who require this are those receiving spinal or sacral anesthesia during surgery. In yet another embodiment, the patients who require this are those undergoing surgery that lasts for four hours or longer, for example, five hours or more, six hours or more, seven hours or more, eight hours or more, nine hours or more, ten hours or more, eleven hours or more, or twelve hours or more. In some embodiments, surgical procedures may continue for more than one hour, for example, more than two hours, or more than three hours.

[0092] In one embodiment, multiple SEM measurements are performed according to paragraph 0061. In another embodiment, the delta value is determined according to paragraph 0062. In another embodiment, the first threshold is determined according to paragraph 0064.

[0093] In one aspect, K ranges from 2 to 50, for example, 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 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, etc.

[0094] In one embodiment, K is determined by the amount by which the delta value exceeds a threshold. In one embodiment, the amount by which the delta value exceeds the threshold set for (K+1) is greater than the amount by which the delta value exceeds the threshold set for K. In another embodiment, the amount by which the delta value exceeds the threshold set for (K-1) is less than the amount by which the delta value exceeds the threshold set for K.

[0095] In one embodiment, interventions at level K are selected according to paragraphs 0067 to 0076, with N replaced by K.

[0096] In one embodiment, the disclosure further provides and includes determining whether a delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and performing a number of SEM measurements at predetermined frequencies corresponding to level L if the delta value is less than the second threshold.

[0097] In one embodiment, the second threshold is determined according to paragraph 0084.

[0098] In one embodiment, 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 embodiment, L is K-1 if the delta value is between 90 and 99.5% of the second threshold, for example, between 90 and 95%, 91 and 96%, 92 and 97%, 93 and 98%, 94 and 99%, or between 95 and 99.5%, as long as K-1, for which L is 0, is not less than 0. In another embodiment, L is K-2 if the delta value is between 80 and 89.9% of the second threshold, for example, between 80 and 85%, 81 and 86%, 82 and 87%, 83 and 88%, 84 and 89%, or between 85 and 89.9%, as long as K-2, for which L is 0, is not less than 0. In one embodiment, L is K-3 if the delta value is between 70 and 79.9% of the second threshold, for example, between 70 and 75%, 71 and 76%, 72 and 77%, 73 and 78%, 74 and 79%, or 75 and 79.9%, and L is 0, unless K-3 is less than 0. In another embodiment, L is K-4 if the delta value is between 60 and 69.9% of the second threshold, for example, between 60 and 65%, 61 and 66%, 62 and 67%, 63 and 68%, 64 and 69%, or 65 and 69.9%, and L is 0, unless K-4 is less than 0. In one embodiment, L is K-5 if the delta value is between 50 and 59.9% of the second threshold, for example, between 50 and 55%, 51 and 56%, 52 and 57%, 53 and 58%, 54 and 59%, or 55 and 59.9%, unless K-5, which would result in L being 0, is not less than 0. In another embodiment, L is K-6 if the delta value is between 40 and 49.9% of the second threshold, for example, between 40 and 45%, 41 and 46%, 42 and 47%, 43 and 48%, 44 and 49%, or 45 and 49.9%, unless K-6, which would result in L being 0, is not less than 0.In one embodiment, L is K-7 if the delta value is between 30 and 39.9% of the second threshold, for example, between 30 and 35%, 31 and 36%, 32 and 37%, 33 and 38%, 34 and 39%, or 35 and 39.9%, unless K-7, which would result in L being 0, is not less than 0. In another embodiment, L is K-8 if the delta value is between 20 and 29.9% of the second threshold, for example, between 20 and 25%, 21 and 26%, 22 and 27%, 23 and 28%, 24 and 29%, or 25 and 29.9%, unless K-8, which would result in L being 0, is not less than 0. In one embodiment, L is K-9 if the delta value is between 10 and 19.9% ​​of the second threshold, for example, between 10 and 15%, 11 and 16%, 12 and 17%, 13 and 18%, 14 and 19%, or 15 and 19.9%, unless K-9, which would result in L being 0, is not less than 0. In another embodiment, L is K-10 if the delta value is between 0.1 and 9.9% of the second threshold, for example, between 0.1 and 5%, 1 and 6%, 2 and 7%, 3 and 8%, 4 and 9%, or 5 and 9.9%, unless K-10, which would result in L being 0, is not less than 0.

[0099] In one embodiment, the Disclosure provides and includes a method for stratifying groups of patients in a nursing home based on pressure ulcer risk, the method comprising: taking multiple subcutaneous moisture (SEM) measurements for each patient; calculating a delta value from a portion of the multiple SEM measurements for each patient; determining whether each delta value exceeds any value in a set of thresholds corresponding to N care levels and assigning a care level to each patient; and reorganizing the groups of patients based on each of the care levels assigned to the patients.

[0100] In one embodiment, the Disclosure provides and includes a method for reducing the incidence of pressure ulcers in patients admitted to a nursing home, the method comprising the steps of: evaluating a patient for the risk of pressure ulcers upon admission to the nursing home, the evaluation step including performing a first group of subcutaneous moisture (SEM) measurements of the patient; calculating a first delta value from a portion of the first group of SEM measurements; determining whether the first delta value exceeds a first threshold; administering a first intervention of level -0 if the first delta value does not exceed a first threshold; and administering a first intervention of level -N if the first delta value exceeds a first threshold, wherein N is an integer and N has a value of 1 or greater. In one aspect, the incidence of ulcers among patients in nursing care facilities decreases 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 1000.

[0101] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient who requires the application of a protective cream to the patient's heel, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's heel; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying a protective cream to the patient's heel if the delta value exceeds the threshold; and performing multiple SEM measurements every two hours if the delta value exceeds the threshold. In one embodiment, the multiple SEM measurements are performed at least once every hour or at least once every 30 minutes if the delta value exceeds the threshold.

[0102] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient who requires neuromuscular stimulation of the patient's heel, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's heel; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying neuromuscular stimulation to the patient's heel if the delta value exceeds the threshold; and performing multiple SEM measurements every hour if the delta value exceeds the threshold. In one embodiment, the multiple SEM measurements are performed at least once every 30 minutes if the delta value exceeds the threshold.

[0103] In one embodiment, the present disclosure provides and includes a method for identifying and treating a patient who requires the application of a topical cream to the patient's heel, comprising the steps of: performing a plurality of subepidermal moisture (SEM) measurements on the patient's heel; calculating a delta value from a portion of the plurality of SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying the topical cream to the patient's heel if the delta value exceeds the threshold; and performing a plurality of SEM measurements every 30 minutes if the delta value exceeds the threshold.

[0104] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient who requires the application of a protective cream to the patient's sacrum, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's sacrum; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying a protective cream to the patient's sacrum if the delta value exceeds the threshold; and performing multiple SEM measurements every 6 hours if the delta value exceeds the threshold. In one embodiment, the multiple SEM measurements are performed at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, or at least once every 30 minutes if the delta value exceeds the threshold.

[0105] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient who requires neuromuscular stimulation of the patient's sacrum, comprising the steps of: performing multiple subepidermal water (SEM) measurements on the patient's sacrum; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying neuromuscular stimulation to the patient's sacrum if the delta value exceeds the threshold; and performing multiple SEM measurements every 4 hours if the delta value exceeds the threshold. In one embodiment, the multiple SEM measurements are performed at least once every 3 hours, at least once every 2 hours, at least once every 1 hour, or at least once every 30 minutes if the delta value exceeds the threshold.

[0106] In one embodiment, the Disclosure provides and includes a method for identifying and treating a patient who requires the application of a topical cream to the patient's sacrum, comprising the steps of: performing multiple subepidermal moisture (SEM) measurements on the patient's sacrum; calculating a delta value from a portion of the multiple SEM measurements; determining whether the delta value exceeds a threshold corresponding to level N, where N is 2 or greater; applying the topical cream to the patient's sacrum if the delta value exceeds the threshold; and performing multiple SEM measurements every two hours if the delta value exceeds the threshold. In one embodiment, the multiple SEM measurements are performed at least once every hour or at least once every 30 minutes if the delta value exceeds the threshold.

[0107] In one embodiment, the method of this disclosure is performed using the apparatus disclosed in U.S. Patent Applications No. 14 / 827,375 and No. 15 / 134,110. In one embodiment, the water content is equivalent to an SEM value on a predetermined scale. In one embodiment, the predetermined scale may range from 0 to 20, for example, 0 to 1, 0 to 2, 0 to 3, 0 to 4, 0 to 5, 0 to 6, 0 to 7, 0 to 8, 0 to 9, 0 to 10, 0 to 11, 0 to 12, 0 to 13, 0 to 14, 0 to 15, 0 to 16, 0 to 17, 0 to 18, 0 to 19, etc. In one embodiment, the predetermined scale can be increased or decreased by a factor or multiplier based on the values ​​provided herein.

[0108] In one embodiment, the disclosure further provides and includes providing targeted treatment to an anatomical site in a patient identified as injured by a combination of visual assessment and SEM scan measurement. In one embodiment, the targeted treatment is provided to a site prone to pressure ulcers, selected from the group consisting of the toes, heels, sacrum, spine, elbows, scapulae, occipital region, and ischial tuberosity. In one embodiment, the targeted treatment is simultaneously provided to a second site prone to pressure ulcers, selected from the group consisting of the toes, heels, sacrum, spine, elbows, scapulae, occipital region, and ischial tuberosity. In one embodiment, the first site receiving targeted treatment is known to cause the development of pressure ulcers at the second site.

[0109] This disclosure is illustrated by the following embodiments. The embodiments expressed herein illustrate some aspects of this disclosure, but should not be construed in any way as limiting the scope of this disclosure. [Examples]

[0110] Example 1: Intervention level for treating pressure ulcers on the heel

[0111] Subjects identified as being at risk of pressure ulcers on the heels were treated according to the following scheme:

[0112] [Table 1]

[0113] Example 2: Intervention level for treating pressure ulcers in the sacrum

[0114] Subjects identified as being at risk of pressure ulcers in the sacrum were treated according to the following scheme:

[0115] [Table 2]

[0116] Example 3: Identification of patients requiring Level-0 intervention in the sacrum

[0117] The patient underwent multiple SEM measurements on and around the bony prominence of the sacrum using a device capable of performing SEM measurements. Before performing the measurements, surface moisture and material were removed from the patient's skin surface. The electrodes of the device were applied to the patient's skin with sufficient pressure, ensuring complete contact for approximately one second, to obtain each SEM measurement.

[0118] SEM measurements were performed along a straight line crossing the patient's sacrum. Multiple measurements were taken at a given measurement site. Figure 2A shows a sample of visual assessment of healthy tissue. Figure 2B shows corresponding plots of the mean values ​​of SEM measurements taken at each site. A threshold of 0.5 was selected. The delta value was calculated as the difference between the maximum mean SEM value and the minimum mean SEM value, and this was determined to be less than 0.5. Because the SEM delta value was below the threshold, the patient was identified as requiring level -0 intervention. Therefore, the patient was placed on a standard mattress and repositioned every 24 hours.

[0119] Further SEM measurements were performed every 24 hours until discharge. There was no change in the intervention level.

[0120] Example 4: Identification of patients requiring level-n intervention in the sacrum

[0121] The patient underwent multiple SEM measurements performed along a straight line transverse the sacrum, following the same procedure as described in Example 3.

[0122] Figure 3A shows a sample of the visual assessment of the damaged tissue. Figure 3B shows the corresponding plots of the mean values ​​of the SEM measurements taken at each location. A threshold of 0.5 was selected. The delta value was calculated as the difference between the maximum mean SEM value and the minimum mean SEM value, and was defined as greater than 0.5. Because the SEM delta value was more than 200% above the threshold, the patient was identified as requiring a level-8 intervention. Therefore, the patient was placed on a silicone pad and monitored every hour until a SEM delta value less than 170% above the threshold was observed, at which point the patient was switched to a level-7 intervention.

[0123] Example 5: Example of the process for selecting intervention and monitoring levels

[0124] Figure 4 illustrates process 400, which selects the level of intervention and monitoring based on the amount by which the delta value derived from SEM measurements exceeds a threshold. Here, in step 402, the caregiver performed multiple SEM measurements using an SEM scanner at a location on the patient's skin, generating one SEM value for each measurement. In step 404, a delta value "Δ" was calculated using some of these SEM values. The delta value was calculated by subtracting the minimum SEM value generated from the multiple SEM measurements from the maximum SEM value.

[0125] In step 406, the calculated delta value was compared to the threshold "T". If the delta value was below the threshold, step 408 was performed, and the caregiver waited until a monitoring interval related to the current care level occurred, and then the SEM measurement was repeated in step 402. If the delta value was greater than the threshold, the amount by which the delta value exceeded the threshold was compared to a cascading series of different values.

[0126] In some cases, the delta value was positive, and the comparison was performed by subtracting a threshold from the delta value, which resulted in a positive difference, and then a determination was made in step 410 as to whether this difference exceeded the first difference D1. If this difference was less than D1, the process proceeded to step 412, and then to step 414, where interventions and measurement intervals, each related to level -N+1, were implemented. In this embodiment, N was a value greater than or equal to zero.

[0127] In some cases, for example, if the SEM measurement at the center of the data in Figure 3B is subtracted from the average of the SEM values ​​from the leftmost to the rightmost location in Figure 3B, the delta value will be negative. In that case, the differences Dl and D2 passing through Dn were chosen to have negative values, which would have different absolute values ​​from the corresponding differences D1 and D2 passing through Dn used for a positive delta value. Alternatively, the comparison in steps 410, 420, and 430 was changed from "≧" to "≦" as shown in Figure 4.

[0128] Example 6: Workflow Guidance Matrix

[0129] Figure 5 shows an example of a workflow guidance matrix 500 for selecting a new intervention level 506 using the current intervention level 502 and a new delta value 504. Here, the caregiver monitored the patient's symptoms by performing multiple SEM measurements periodically at one or more locations on the patient's skin. At the time of these measurements, the patient received care associated with a certain level of intervention and monitoring. In this example, level-0 (zero) is associated with patients who were not considered to be at significant risk of developing pressure ulcers. Higher levels of intervention and monitoring were identified by intervention stages ranked according to, for example, cost, difficulty of implementation, or other parameters identified by the care facility. When caregivers were performing a new set of SEM measurements, they examined this matrix by identifying the row for the current intervention level 502, the delta value was determined from the most recent set of SEM measurements 504, and the intervention level in cell 506 where row 502 and column 504 intersected was identified. Caregivers were able to consider the current intervention level and delta value when selecting a level of intervention for the next time interval, as well as the identified intervention level.

[0130] In some cases, the values ​​for the new intervention levels in cell 506 were similar across rows. In some cases, the values ​​for the new intervention levels in adjacent cells 506 differed by only one level or more. In some cases, the values ​​for the new intervention levels in adjacent cells 506 were identical across adjacent cells.

[0131] Example 7: Progression of tissue conditions leading to pressure ulcers

[0132] Figures 6A, 6B, and 6C illustrate explanatory, non-limiting examples of the temporal progression of tissue conditions leading to pressure ulcers. Figure 6A shows a cross-section of healthy tissue 600, including the stratum corneum 602 and healthy cells 604 in the epidermis / dermis. The cross-section shows the SEM scanner's central electrode 606 and toroidal electrode 608 in contact with the stratum corneum 602. An explanatory representation of the SEM scanner's high-sensitivity region is shown as an elliptical region 610. This region 610 has a sensitivity depth. In some cases, the sensitivity depth is in the range of 0.14 to 0.16 inches. In some cases, the sensitivity depth is less than 0.16 inches.

[0133] Figure 6B shows a descriptive cross-section of slightly damaged tissue 620. Cellular damage, for example resulting from prolonged exposure to low levels of pressure, is affecting the tissue. Without being limited by theory, some cells 622 rupture, releasing fluid contents into the intercellular spaces 624. Alternatively, also without being limited by theory, an inflammatory response causes fluid to move into the intercellular spaces 624. This damage is not visible on the skin surface.

[0134] Figure 6C is a descriptive cross-section 640 of a more advanced level of injury. Without being limited by theory, here the tissue is such that the cells 622 rupture in large numbers, which can result in small mechanical structures that transmit the continuously applied pressure. As the thickness of the tissue decreases, the bone 642 here comes closer to the skin surface. The ruptured cells 622 and the intercellular spaces 624 are compressed, and fluid 644 is pushed out of the local tissue, as indicated by arrow 646.

[0135] Figure 6D is a descriptive plot of delta values ​​for one patient at a single site where a pressure ulcer developed.660 SEM values ​​were measured by a SEM scanner. Delta values ​​were generated from a set of SEM measurements taken at incremental time. Point 672 represents the measurement at time = zero, where all SEM values ​​are baseline values ​​associated with healthy tissue, and the delta value is zero. At time t1, another set of SEM measurements were taken, and the associated delta value is shown at point 674. This delta value was below the threshold662 and therefore did not indicate significant subsurface damage.

[0136] At time t2, the damage had progressed, with a delta value of 676 greater than the threshold of 662, indicating significant damage. This damage was still not visible on the skin. Nevertheless, a delta value greater than the threshold of 662 indicated that there was cellular damage at a depth shallower than the sensitivity depth of the SEM scanner.

[0137] At time t3, although the damage continued, the intercellular fluid volume decreased due to mechanical extrusion as shown in Figure 6C. This resulted in a decrease in the SEM values ​​obtained across the damaged area, which reduced the calculated delta value of 678 because the SEM values ​​of the healthy tissue remained almost the same as those during the previous measurements.

[0138] At time t4, the injury had progressed to the point where it was visible on the skin surface, as shown in Figure 3A. In some cases, time t4 may occur before one or both of t2 and t3. In some cases, time t4 may occur after time t3 and before t5, after the delta value has reached zero again along curve 670. Arrow 665 indicates that the injury remained visible after time t4. In some cases, the tissue may be considered a "stage 1" pressure ulcer after time t4.

[0139] At time t5, the damage had progressed to the point where sufficient fluid had been squeezed out of the local tissue, where the SEM value of a certain measurement performed across the damaged area was lower than that of healthy tissue. As shown in Figure 3B, this resulted in a negative delta value of 680. In some cases, a negative delta indicates severe tissue damage. In other cases, a negative delta would indicate necrosis of a portion of the tissue at the location of the lowest SEM value.

[0140] Example 8: Method for mapping areas of potential damage I

[0141] Figure 7A shows an example of a method for mapping the areas of potential damage. Damaged 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 still not healthy tissue. The skin covering all of these areas had a similar appearance and texture and did not indicate subsurface damage. A series of dashed circles 740, 742, 744, 746, 748, and 750 show an example of a set of locations where SEM measurements were performed. SEM measurements performed at locations 740, 742, and 750 generally produced SEM values ​​associated with healthy tissue, which are identified as "H" in this example. SEM measurements performed at locations 744 and 748 generally produced SEM values ​​"J" that were slightly greater than H. SEM measurements performed at location 746 generally produced SEM values ​​"P" that were greater than J. All of these measurements were assumed to have been performed at a single "location" on the patient's body, for example, the sacrum, even if the individual locations were spatially dispersed across this location. For this set of SEM values, the delta was defined as the difference between the highest SEM value, likely occurring at location 746, and the lowest SEM value, likely occurring at one of locations 740, 742, and 750, within the range of this set. If the delta was greater than the threshold "T", this indicated significant damage at that location. The exact location of the greatest damage was likely close to measurement location 746, which produced the highest SEM value.

[0142] Example 9: Method for mapping areas of potential damage II

[0143] Figure 7B shows a second example of mapping the area of ​​potential damage. In this embodiment, the approximate location of the greatest damage was known by first applying the method shown in Figure 7A, for example. The intent of this method was to determine the extent of the damage by mapping the boundary between area 710 and area 720. For simplicity, the SEM values ​​obtained from measurements within 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 location 760, which was known to be the approximate location of the greatest damage. Subsequent measurements were performed at locations 762, 764, 766, and 768, in the order shown by path 780. The SEM value obtained at location 764 was slightly larger than the SEM values ​​obtained at locations 762 and 766, indicating that location 764 was partially within the area 720, while locations 762 and 766 were entirely within the less damaged area 710. The boundary could be approximated by interpolation between the various measurement locations. For example, the SEM value obtained at location 770 was large enough to suggest that it was entirely within the area 720, and therefore did not help in identifying the boundary between areas 710 and 720. Thus, the subsequent location 772 was entirely away from the starting location 760. In this embodiment, since location 760 is entirely within the area 710, the boundary between areas 710 and 720 could be interpolated as being between locations 770 and 772. The SEM value obtained from the measurement at location 774 was similar to the SEM value from location 770, and therefore it was sufficient to identify the boundary as outside location 774 without performing another measurement at a location corresponding to location 772.

[0144] This set of measurements makes it possible to create a map of a specific level of damage, for example, area 720. By repeating this mapping process at regular time intervals, it becomes possible to obtain indications that area 720 is expanding, which may indicate that it is appropriate to increase the level of intervention, or that area 720 is shrinking, which may indicate that the current level of intervention is enabling the damage to heal.

[0145] Example 10: Treatment decision pathway for patient stratification and provision of appropriate treatment

[0146] Figure 8A outlines the currently recommended treatment decision-making pathway for preventing pressure ulcers in hospitalized patients, as presented in the National Institute for Health and Care Excellence (NICE) clinical guidelines, Pressure ulcers: prevention and management, published on April 23, 2014. The guidelines recommend performing a risk analysis for all patients admitted to care facilities who present with one or more risk factors, such as significantly limited mobility, significant sensory loss, past or present pressure ulcers, malnutrition, inability to reposition independently, or significant cognitive impairment. Risk assessment is typically performed using a scoring checklist, such as the Braden Scale, to assess the severity of specific risk factors.

[0147] Once the risk assessment is complete, patients are identified as (i) at low risk of developing pressure ulcers, (ii) at risk of developing pressure ulcers, or (iii) at high risk of developing pressure ulcers. Patients are classified according to their risk level and undergo various procedural treatments and visual assessments.

[0148] All patients are potentially at risk of developing pressure ulcers. They are more likely to occur in people who are seriously ill or who have neurological disorders, motor impairments, nutritional deficiencies, poor posture, or deformities.

[0149] Pressure ulcers are classified into stages 1 through 4, with stage 1 being the mildest. The NPUAP (National Pressure Ulcer Advisory Committee) defines a "stage 1" ulcer as intact skin with localized, non-blanchable erythema. "Blanchable" means that all redness of the tissue is lost upon pressure, while "non-blanchable" tissue remains red upon pressure due to the presence of red blood cells outside the blood vessels (extravascular migration). In some patients, blanching erythema or changes in sensation, body temperature, or firmness may precede any visible changes.

[0150] Visual skin assessment (VSA) is the current method for identifying pressure ulcers. Trained healthcare professionals visually and tactilely evaluate the appearance of the skin, looking for redness, tissue firmness, tissue temperature, or moisture content.

[0151] If a patient is identified as being at low risk of developing pressure ulcers, they are simply monitored for changes in their clinical condition, such as undergoing surgery, worsening of an underlying condition, or changes in mobility. Patients who use a wheelchair for extended periods or are seated may be given a high-performance foam cushion or equivalent pressure-relieving cushion. If there are no changes in their clinical condition, low-risk patients will not be re-evaluated under this set of guidance and will remain on the same treatment and evaluation route until they are discharged from the care facility.

[0152] If a patient is identified as being at risk of developing pressure ulcers, they will be scheduled for repositioning, or "changing their position," every six hours. If the patient is wheelchair-bound or seated for extended periods, as is the case with low-risk patients, a high-performance foam cushion may be provided. No other monitoring or interventions are recommended in the NICE guidelines.

[0153] High-risk patients will be given a high-performance foam mattress as a preventative measure, a high-performance cushion if they use a wheelchair or sit for extended periods, and their position will be changed every four hours. Patients will receive daily VSA (Various Systemic Assessment) of all areas of their body. If areas with persistent erythema are found, appropriate intervention will be implemented, and these areas will be re-examined with VSA every two hours. Areas without persistent erythema will be re-examined with VSA daily. An individualized care plan will be developed for each high-risk patient.

[0154] This flowchart shows that the majority of caregivers spend their time with high-risk patients. While this may be appropriate, patients at risk may remain unmonitored and may develop stage 1 ulcers before symptoms are observed by caregivers. Furthermore, a consequence of relying on VSA to detect problems is that patients may develop stage 1 ulcers before interventions are selected or implemented. By the time the injury progresses to stage 1, the skin is likely to have broken down and become a stage 2 ulcer despite interventions. Clearly, earlier identification of tissue damage is necessary so that interventions can prevent subepidermal damage from progressing to and beyond stage 1.

[0155] Figure 8B shows an example of the current expanded treatment decision pathway for pressure ulcer prevention, as implemented in some healthcare facilities. This expanded pathway adds a monitoring step to both the high-risk and low-risk pathways. Low-risk patients undergo weekly risk assessments, such as a Braden Scale assessment. Patients identified as high-risk in the initial assessment are given a high-performance foam mattress as a preventative measure and are assessed daily using a VSA. A care plan is developed for monitoring and treatment of these high-risk patients. For high-risk patients, there are no changes to their care.

[0156] The expanded plan has the advantage of providing basic monitoring for all patients regarding pressure ulcers. However, the additional steps require more time, either by adding staff or placing an additional burden on existing staff. The care route in Figure 8B is superior to the recommended care route in Figure 8A, but it requires more resources and is still plagued by the limitation that patients will inevitably develop stage 1 ulcers before the injury can be identified by VSA.

[0157] Various hospitals and nursing care facilities use a range of risk classifications, ranging from two categories (low risk and high risk) to four or more classifications, including "very high risk" in addition to the classifications shown in Figure 8B. Patients are assigned to one of these classifications based on the results of their initial risk assessment.

[0158] Figure 9 is an example flowchart illustrating how a SEM scanner may be used in a standalone pressure ulcer prevention procedure according to this disclosure. All incoming patients undergo a complete SEM scanner assessment of all selected body locations for monitoring. These selected locations may include areas recommended in the SEM scanner's Instructions for Use (IFU), such as the sacrum and both heels. Further locations may be identified by the hospital and integrated into hospital practices. Multiple SEM measurements are taken at and around each location on the body, spaced apart from each other; this is generally referred to as taking multiple measurements at a location on the body. The SEM scanner calculates a “delta” value for each location from the set of measurements taken at and around that location. The delta value is then compared to one or more thresholds to classify the patient. In this embodiment, patients are assigned to one of two risk classifications: low risk and high risk.

[0159] In one embodiment, the clinician performs SEM scans of body locations identified as potentially having damage in the initial SEM scan during a first time interval. The clinician also performs SEM scans of all other body locations selected for monitoring during a second time interval that is longer than the first. In one embodiment, the values ​​of the first and second time intervals vary depending on the risk classification to which the patient is assigned. For example, high-risk patients may have a first time interval of 4 hours and a second time interval of 1 day, while patients with some risk may have a first time interval of 1 day and a second time interval of 1 week. In one embodiment, the time intervals may not be strictly based on time but may be event-based, such as when there is a change in personnel or a shift change. Generally, body locations with high delta values ​​are scanned more frequently than other body locations that are monitored but had normal delta values ​​in previous SEM scans.

[0160] In one embodiment, the interval at which SEM scans are performed is determined by the delta value from the previous SEM scan. For example, if the delta value of a body location in a previous SEM scan was greater than or equal to a first threshold, the SEM scan of that body location is performed at a first time interval. On the other hand, if the delta value of the previous SEM scan of that body location was greater than or equal to a second threshold (which is greater than the first threshold), the SEM scan is performed at a second time interval, which is shorter than the first time interval.

[0161] In this embodiment, low-risk patients undergo weekly SEM scans of all body locations selected for monitoring. This is a small effort that provides basic protection even for the healthiest patients, as weekly SEM scans are likely to detect tissue damage before it becomes visible on VSA.

[0162] In the current care pathways shown in Figures 8A and 8B, patients who would be identified as high-risk would receive specialized care based on the location of their body exhibiting a delta value above the threshold. For example, if the sacrum has a delta value above the threshold, the patient would be repositioned every six hours and receive daily SEM scans of the sacrum and weekly SEM scans of other body locations.

[0163] Figure 10 is an example flowchart illustrating how a SEM scanner may be used to further improve the expanded treatment decision pathway of Figure 8B in accordance with this disclosure. Patients admitted to the facility undergo both risk assessment and SEM scanning of all body locations identified in the hospital for monitoring, and the patient's assignment to a risk classification is based partly on the risk assessment and partly on the SEM scan results. An initial delta value greater than a threshold indicates that potential injury is present at that body location. In one embodiment, the assignment is based solely on the largest initial delta value found during the initial SEM scan.

[0164] For example, the decision of whether to perform an intervention such as repositioning the patient at the first interval is currently based on VSA and risk assessment, even though it is uncertain whether there is early-stage subcutaneous damage. In some embodiments, the decision to perform an intervention on a specific body part or a standard intervention such as a high-performance mattress is based on the delta value revealed at that site in the SEM scan. If the delta value is below a predetermined threshold, no intervention is necessary. If the delta value is greater than the predetermined threshold, then an intervention is selected and performed, partly based on the location of the body and partly based on the delta value of that location. The predetermined threshold for selecting and performing an intervention may be greater than or less than the threshold for determining whether there is potential damage at that location of the body.

[0165] The cost comparison of care pathways in Figures 8A, 8B, 9, and 10 highlights one of the advantages of monitoring patients using SEM scanners. Note that the costs cited herein are for patients who do not have or have not yet developed pressure ulcers, in which case the expected treatment cost rises to $2,000 for stage 1 ulcers.

[0166] The baseline for this comparison is the expanded current practice in Figure 8B, which represents the current “best practice” for hospitals striving to reduce the incidence of pressure ulcers. Providing care through low-risk care pathways is expected to cost an average of $26 per patient over an average length of hospital stay of 5.6 days, care for patients at risk is expected to cost an average of $121, and care for high-risk patients is expected to cost $165. All care pathways rely on VSA to detect pressure ulcers and, otherwise, rely on implementing interventions based on “typical” patient progression rather than the symptoms of a specific patient.

[0167] As shown in Figure 10, integrating a SEM scanner into the current “best practice” workflow does not reduce the cost of any part of the care pathway, as no work elements are eliminated. The benefit lies in the ability to detect tissue damage at an early stage with minimal incremental cost. The incremental cost of adding an SEM scan to a no-risk care pathway is $2, raising the cost from approximately $26 to $28. The expected cost of caring for a risk patient who does not have a high delta value on the SEM scan, i.e., does not have subepidermal tissue damage, also increases by only $2. However, if a risk patient is found to have a high delta value on the SEM scan, the patient moves up to the high-risk category, where the expected care cost rises from $165 to $169. While this may appear to be an additional cost at first glance, it represents a higher level of protection provided to the risk patient.

[0168] Figure 9 illustrates an example workflow that relies solely on a SEM scanner for patient monitoring and does not involve conventional VSA. The expected cost of preventive care for low-risk patients is $4, compared to $28 for the integrated low-risk care pathway in Figure 10. For at-risk patients, who simply fall into a different classification than the SEM scanner care pathway in Figure 9, the expected cost is $97, compared to $123 to $169 for at-risk and high-risk patients in the integrated care pathway in Figure 10.

[0169] Figure 11 illustrates the concept of providing continuous care across multiple care settings in accordance with this disclosure. This example shows a care route 1100 for a patient to be cared for sequentially across multiple care settings, starting from a home care setting 1110. A decision is made to transfer the patient to hospital 1150, where the patient will initially be admitted to a medical / surgical (med / surg) unit 1120. After receiving care in the med / surg unit 1120 for a period of time, the patient is transferred to a long-term care unit 1130 within the same hospital 1150. After further treatment, the patient is discharged from hospital 1150 to a nursing care facility 1140. Although not shown in Figure 11, the care route 1100 is not limited to the combination of procedures and care environments in this sample. For example, the care route 1100 may also involve discharging the patient and returning them to a home care environment.

[0170] In one embodiment, a central "registry" or database 1160 is established to collect data not only from all care environments but also from the patient's condition as they move between care environments.

[0171] For example, in a home care environment 1120, while in each care environment, health information about the patient is recorded in the data recorder 1112 and transferred to the database 1160. Health information may include the results of examinations or tests, observations, measurements, treatments, the implementation of interventions intended to prevent the development of pressure ulcers, dietary records, and other records concerning the patient's symptoms and treatments. Data records from the care environment may include the patient's identifying name and one or more data elements from a group of data elements such as nutritional information, interventions performed, risk assessments, visual skin assessments, care plans, physician's notes, lean events, vital signs, "health measures" such as indicators of skin redness or mobility or cognitive scales, weight, and laboratory results, along with the date / time associated with the data elements. The structure and content of the data records may vary. Data records reported to the database may contain one or more of the following data elements: a) Patient identification name b) Transaction date c) Facility identification name d) Location of the transaction e) Nutritional information f) Interventions implemented g) Risk assessment h) Visual skin evaluation i) Care plan j) Doctor's notes (diagnosis, instructions, prescriptions, requests for tests, procedures, treatment, etc.) k) Results of examinations, procedures, or treatments l) Event m) Signs of life n) Body weight o) Results from the laboratory

[0172] For example, when transferring a patient between care environments, such as from a home care environment 1110 to a med / surg care environment 1120, a transfer record 1114 is created and reported to the database 1160. Transferring information on risks and health information related to pressure ulcers will improve the care provided in the new care environment. In one embodiment, the transfer record 1114 includes an assessment of the patient performed at the “original” care site after the decision to transfer the patient was made. In one embodiment, this assessment includes a SEM scan of at least one body location, the SEM scan includes multiple SEM values ​​measured at a single body location and the calculation of a delta value from the multiple SEM values. In one embodiment, the transfer record includes a history of previous SEM values ​​and / or delta values ​​while in the “original” care environment. In one embodiment, the transfer record includes one or more of VSA, risk analysis, and other health data. The transfer record may include one of the following data elements: a) Patient identification name b) Transaction date / time (date and time, time zone or Greenwich Mean Time) c) Transaction type (before admission, upon admission, upon transfer, upon discharge, etc.) d) The location of the "transfer destination" e) The location of the "original transfer destination" f) Identification name of facility / unit g) Risk assessment h) Visual skin evaluation i) Photographs of body parts

[0173] Patients may periodically move from a primary care environment, such as a home care environment 1110, to a higher-level care environment, such as a long-term acute care unit 1130, where they will receive "care episodes" from physicians or other specialists. Data records of assessments and care provided in the higher-level care environment are reported to a database 1160. Upon discharge from the long-term acute care environment 1130 to the home environment 1110, the data records include care instructions, prescriptions, and other guidance for care in the home environment 1110.

[0174] The data collected in database 1160 from the entire care pathway 1100 makes it possible to query database 1160 to search for delta values ​​observed over time for a particular patient across multiple care environments and various care episodes.

[0175] In one embodiment, the query is configured to determine whether instructions from patient monitoring and / or treatment are continuing.

[0176] In one embodiment, the inquiry is configured to determine whether the treatment of the patient is effective or not.

[0177] In one embodiment, the query is configured to determine whether the patient's result is related to one or more of the data elements reported in the database 1160.

[0178] In one embodiment, the query is configured to search for one or more health measures in addition to delta values, and to assess possible connections between the searched health measures and the development of pressure ulcers or other outcomes (the progression of other health conditions). These delta values ​​are plotted against the date / time of measurement to form a time history of delta values ​​for a particular body location. In one embodiment, the delta values ​​are analyzed to determine one or more of the following: slope, acceleration, curve shape and associated characteristics, and time-to-intercept for a selected threshold. In one embodiment, these analytical results can be used to implement the methods and processes shown in Figures 1 and 4.

[0179] From the preceding description, it will be understood that this disclosure can be implemented by a variety of methods, including but not limited to the following:

[0180] While this disclosure has been described in relation to specific embodiments, those skilled in the art will understand that various modifications may be made, and components may be replaced with equivalents, without departing from the scope of this disclosure. Furthermore, many variations may be made for specific circumstances or materials to the teachings of this disclosure without departing from the scope of this disclosure. Thus, this disclosure is not limited to the specific embodiments disclosed, but is intended to include all embodiments that fall within the scope and spirit of the appended claims.

Claims

1. A system for identifying interventions for a patient during transfer between care environments, (a) A SEM scanner configured to perform subcutaneous moisture (SEM) measurement; (b) A processor electronically connected to the SEM scanner and configured to receive SEM measurements; and (c) Non-transient computer-readable media, including instructions electronically connected to and stored in the processor. Includes, When the aforementioned medium is executed on the processor, the following steps are taken: (i) The step of receiving a request to transfer the patient from the primary care environment to the secondary care environment; (ii) Steps to identify current interventions; (iii) A step of performing a first assessment of the patient in a first care setting, the first assessment comprising performing multiple subcutaneous moisture (SEM) measurements at at least one location on the patient's body; (iv) A step of calculating a delta value from the plurality of subepidermal moisture (SEM) measurements, wherein the delta value is determined by the difference between the maximum SEM value and the minimum SEM value obtained from the first plurality of SEM measurements; (v) A step of identifying a second intervention based on the delta value, wherein if the delta value exceeds a threshold, the second intervention is different from the current intervention, and if the delta value does not exceed a threshold, the second intervention is the same as the current intervention; (vi) A step of outputting a recommendation for the patient to be transferred to a second care environment, based at least in part on a plurality of SEM measurements recorded in the first care environment; (vii) After outputting recommendations to identify a second care environment, the step of creating a transfer record for transfer to the second care environment; and (viiii) Steps to transmit the transfer record along with the aforementioned patient to the second care environment. The system, including instructions to further perform the following.

2. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: A step of receiving delta values ​​from multiple SEM scans of the patient at different times in a first care environment, and A step of recording the delta value from each of the SEM scans. Includes instructions to perform further actions, The system according to claim 1, wherein the recommendation for the transfer of the patient to a second care environment is based in part on a delta value recorded in the first care environment.

3. The system according to claim 2, wherein the transfer record includes the delta values ​​from a portion of the plurality of SEM scans of the patient taken at different times while in the first care environment.

4. The system according to claim 1, wherein SEM scans are obtained at all locations of the body identified for monitoring.

5. The system according to claim 1, wherein the first evaluation further comprises at least one of the patient's risk assessment, a visual skin assessment of the patient's at least one body location, and an image of the at least one body location.

6. The system according to claim 1, wherein the transfer record includes at least one of the following: the type of transaction, the date / time of the transaction, the location of the "destination," and the location of the "source."

7. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The step of receiving a first SEM scan of at least one body location of the patient while in the first care environment, wherein the first SEM scan includes taking a plurality of SEM values ​​at the body location and calculating a first delta value from the plurality of SEM values, The steps include creating a first data record that includes the first delta value, The steps include reporting the first data record to the database, The system according to claim 1, further comprising the step of reporting the transfer record to the database.

8. The first data record includes the patient's identification name and the first date / time when the first SEM scan was performed. The system according to claim 7, wherein the transfer record also includes the patient's identification name and a second date / time when the first evaluation was performed.

9. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The steps include: receiving an SEM scan of at least one location of the patient's body while in the second care environment and calculating a second delta value; A step of creating a second data record including the patient's identification name, the second delta value, and a third date / time when the second SEM scan was performed. The system according to claim 8, further comprising the step of reporting the second record to a database.

10. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The system according to claim 9, further comprising the step of querying the database to retrieve a portion of the data record including the delta value of the at least one body location of the patient.

11. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The steps include formatting the searched delta values ​​in the order of date / time, and The system according to claim 10, further comprising the step of displaying a formalized delta value.

12. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The steps include creating a further data record that includes the patient's identifying name and data elements from a group of data elements such as nutritional information, interventions performed, risk assessment, visual skin assessment, care plan, physician's notes, events, vital signs, weight, and laboratory results, and the date / time associated with the data elements. The system according to claim 8, further comprising the step of reporting the aforementioned further data recording to the database.

13. The system according to claim 11, wherein the formalized delta value is displayed in the form of a curve.

14. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The system according to claim 13, further comprising the step of analyzing the retrieved delta values ​​to determine one or more of the slope, acceleration, curve shape and associated characteristics, and intercepts with respect to a selected threshold of time.

15. The system according to claim 14, wherein acceleration is determined by the rate of change of the slope of the curve.

16. The system according to claim 14, wherein the recommendation for identifying a second care environment is in part based on one or more of the inclination, acceleration, curve shape and associated characteristics, and a selected threshold intercept with respect to time.

17. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The steps include: receiving a third SEM scan of the patient's at least one body location while in the third care environment and calculating a third delta value; A step of creating a third data record including the patient's identification name, the three delta values, and the fourth date / time when the third SEM scan was performed. The system according to claim 9, further comprising the step of reporting the third data record to a database.

18. When a non-transient computer-readable medium, which includes instructions electronically connected to and stored in the processor, is executed on the processor, the following steps are taken: The system according to claim 17, further comprising the step of querying the database to retrieve delta values ​​observed over time for a particular patient across multiple care environments and various care episodes.

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