This invention relates generally to the field of medical treatment of illnesses, and more specifically to devices and methods for remotely monitoring and outpatient triaging patients with contagious diseases.
When contagious (e.g., viral) illnesses spread rapidly within a region, healthcare resources in the region are likely be stretched, resulting in limits of medical treatment for patients. For example, as COVID-19 has spread within the U.S., guidelines from the Centers for Disease Control and Prevention (CDC) recommend patients with “flu-like” symptoms (fever/cough/dyspnea) to contact their local doctor. Unfortunately, it is not always easy to contact one's primary doctor, especially during a time when an exponential number of patients may simultaneously feel symptomatic and seek care. For example, phone lines may become overloaded and while patients are alternatively instructed to go to the emergency room. However, emergency rooms quickly become overwhelmed, and there are not enough ICU isolation units. As a result, many patients are unable to receive the medical attention and treatment that are required. Accordingly, there is a need for new and improved devices and methods to address these shortcomings.
In some variations, a method for remotely monitoring one or more patients may include, at one or more processors, receiving a transmission of one or more patient assessments of current health of each patient, determining a trending index for each patient based on a baseline medical risk of the patient, a social exposure risk of the patient, and at least one patient assessment for the patient; and triaging the one or more patients according to medical risk associated with the contagious disease based on the trending index. Each patient assessment may include, for example, an evaluation of at least one of: at least one symptom associated with a contagious disease and at least one vital sign associated with the contagious disease. The method may be used to remotely monitor a variety of patients, such as patients awaiting results of a test for the contagious disease, patients who have tested positive for the contagious disease, and/or patients associated with a person who has tested positive for the contagious disease (or suspected to be positive for the contagious disease).
Specifics of the patient assessment may vary depending on the type of contagious disease for which patients are being monitored. In some variations, the contagious disease may be a viral disease. The viral disease may, for example, affect the respiratory system. For example, the viral disease may be caused by a coronavirus (e.g., associated with Middle East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS), etc.), an influenza virus, etc. In one example variation, the contagious disease for which the patients are being monitored is COVID-19 (SARS-CoV-2). In some variations, the patient assessment may include an evaluation of at least one symptom selected from the group consisting of: fever, cough, dyspnea, fatigue, chills, myalgia, rhinorrhea, sore throat, nausea, vomiting, headache, abdominal pain, diarrhea, hemoptysis, chest congestion, and loss of smell and/or taste. Additionally or alternatively, the patient assessment may include an evaluation of at least one symptom selected from the group consisting of new onset chest pain, new onset back pain, and new onset walking difficulty. Furthermore, in some variations the patient assessment may include an evaluation of breathing difficulty during one or more specified activities. In some variations, the evaluation of at least one symptom may include a severity rating on a numerical scale.
Furthermore, in some variations the patient assessment may include an evaluation of at least one vital sign selected from the group consisting of resting oxygen saturation, and oxygen saturation immediately following mild activity (e.g., exercise), or both. For example, in some variations the patient assessment may additionally or alternatively include an evaluation the difference between oxygen saturation immediately following mild activity, and oxygen saturation measured at rest. The patient assessment may additionally or alternatively include other suitable vital signs, such as temperature and/or heart rate.
In some variations, the trending index may be based on an aggregation (e.g., sum) of a first risk score associated with baseline medical risk for the patient, a second risk score associated with social exposure risk for the patient, and a third risk score associated with at least one patient assessment for the patient. The first risk score may, for example, be quantified based on one or more characteristics selected from the group consisting of: age, sex, pregnancy, presence of a chronic medical condition, engagement in a chronic health-adverse behavior, and prescription of a specified medication.
The second risk score may, for example, be quantified based on one or more characteristics selected from the group consisting of: occupation as a healthcare worker, previous presence in a healthcare facility, previous presence in close proximity situation with other people, previous positive test for the contagious disease, association with a person who is suspected or confirmed as tested positive for the contagious disease, and association with a person exhibiting symptoms of the contagious disease. In some variations, the second risk score may be further quantified based on the patient having close contact with a person having one or more characteristics selected from the group consisting of: occupation as a healthcare worker (or essential worker or other occupation in a high-risk (e.g., public) environment), previous presence in a healthcare facility, previous presence in close proximity situation with other people, positive test for the contagious disease, a pending test result for the contagious disease, association with a person who is suspected or confirmed as tested positive for the contagious disease, and association with a person exhibiting symptoms of the contagious disease.
In some variations, the third risk score may be quantified based at least in part on severity of a symptom or vital sign in a most recent patient assessment. Additionally or alternatively, the third risk score may be quantified based on change in severity of a symptom or vital sign between the most recent patient assessment and at least one prior patient assessment. In some variations, two separate risk scores may be quantified in the above scores as included as separate additional risk scores for inclusion in the trending index.
Furthermore, in some variations determining the trending index for each patient may further include aggregating a fourth risk score associated with number of days since onset of at least one symptom associated with the contagious disease.
A patient may be prompted to complete a patient assessment at programmed intervals (e.g., daily). In some variations, at least one patient may be prompted via a SMS text message comprising a hyperlink to an interactive online survey. Additionally or alternatively, at least one patient may be prompted over an automated phone system with at least one of a programmable voice service and a programmable text service. Furthermore, in some variations the method may include transmitting a programmed reminder to at least one patient to complete the patient assessment, in response to failing to receive the patient assessment from the at least one patient by a predetermined time. Additionally or alternatively, the method may include transmitting a programmed reminder to at least one designated contact of a patient in response to failing to receive the patient assessment from the patient by a predetermined time.
The method may further include communicating to one or more medical care practitioners patient data associated with the one or more patients. The communicated patient data may include at least one selected from the group consisting of: at least one patient assessment, at least one trending index, and the results of triaging the one or more patients according to medical risk associated with the contagious disease. Additionally or alternatively, the method may include communicating a programmed alert for at least one patient characterized as having a threshold medical risk associated with the contagious disease.
Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.
Various methods and systems for remotely monitoring and/or outpatient triaging patients with illnesses are described herein. Such methods and systems may, for example, be used to help monitor and manage patients who are at risk for contagious diseases, such as viral diseases.
For example, in view of the COVID-19 pandemic, health systems need an easy way to manage patients who are infected with or are otherwise at risk for COVID-19. For patients with COVID-19, symptoms such as fever and/or cough typically progress to breathing difficulty over time (e.g., on average, about 7 days after onset of symptoms). During this period, home isolation or quarantine may be typical, with patient symptoms, vital signs, etc. tracked to determine whether and when to safely escalate care of these patients (e.g., hospitalization). Similarly, persons who are suspected to have been exposed to someone with COVID-19 (e.g., close contact with someone who has tested positive for COVID-19 or is presumptive positive for COVID-19, who have arrived from a region with a high occurrence of COVID-19 within the population, etc.) may also be instructed to engage in home isolation or quarantine.
The methods and systems described herein may be used to remotely monitor and triage patients in this and similar scenarios, such as for health systems and regional health departments to manage infectious outbreaks. For example, the methods and systems described herein may be used to remotely monitor patients who have tested positive for a contagious disease, patients who are awaiting results of a test for an contagious disease, patients who are closely associated with (e.g., have close contact with, such as household contact or workplace contact) a person who has tested positive for the contagious disease or is otherwise suspected to potentially have the contagious disease, and/or patients who are recovering from the contagious disease (e.g., discharged from hospital). Patients under home monitoring/surveillance can be monitored and, if warranted, tested for the contagious disease, without going into traditional healthcare facilities where others could be exposed to the disease. Furthermore, those assessed to be at lower risk can continue to self-monitor at home, while those assessed with escalating changes in symptoms can be pre-identified to get hospital attention sooner. Patients with other contagious diseases (e.g., other viral diseases such as other coronavirus diseases (e.g., caused by viruses associated with Middle East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS), etc.), influenza, etc.) may similarly be monitored and/or managed.
Advantageously, the methods and systems described herein may allow medical teams to monitor their patients and assist with either home management or escalation of care, and/or provide alerts and/or other information to governmental health officials. The system may be programmed to automatically triage patients by risk level through a medically adopted protocol to be used by local medical teams to monitor and triage patients in the outpatient setting. By monitoring and triaging patients in the outpatient setting, this may advantageously relieve load on hospitals, clinics, and other in-person medical care institutions and free such institutions for more severe and critical cases requiring direct treatment. Accordingly, the devices and methods such as those described herein for remote monitoring and triaging may significantly increase the ability for healthcare systems to manage outbreaks of illnesses. Furthermore, the methods and systems described herein are designed to be convenient and easy-to-use, thereby improving patient compliance and improving the ability to accurately and promptly identify patients whose escalating illnesses warrant medical attention.
As shown in
As described in further detail below, the patient data may be provided through a reporting protocol performed by the patient as part of a regular (e.g., daily) assessment and include, for example, information relating to symptoms, vital signs, social exposure risk (e.g., activities that may increase the risk profile of the patient with respect to the contagious disease), and/or any other suitable information. Such patient data may be processed by the medical risk characterization system 130 to triage the one or more patients according to medical risk associated with the contagious disease based on the trending index, thereby identifying those patients who may be in more need of urgent medical attention. As described in further detail below, the patient data, the results of triaging, and/or the identities of patients in most need of urgent medical attention, etc. may be communicated to one or more medical care providers 140 who may act accordingly (e.g., contact patients, provide medical guidance or treatment, etc.). Patient data may additionally or alternatively be collected into patient reports and/or uploaded into suitable electronic health records. In some variations, the system 100 may be associated with a virtual clinic staffed by physicians and/or other medical care professionals. Additionally or alternatively, the system 100 may be associated with non-virtual (e.g., “brick-and-mortar”) medical institutions. Medical care teams at the virtual clinic and/or non-virtual medical institutions may use the system 100 to monitor patients and can “order” tests, prescribe or adjust medication and/or medical treatment (e.g., for a contagious disease associated with respiratory conditions, treatment with supplemental oxygen may be prescribed or adjusted), and/or provide other suitable medical guidance (e.g., bed rest), etc. as medically relevant and when available.
Patients may be selected or invited by a healthcare institution (e.g., medical care provider) to participate in remote monitoring. For example,
Once contacted by the remote monitoring system, a patient may complete an online or otherwise electronic form that is available through a suitable website, portal, mobile application, and the like. Through this form, the patient (or representative such as a family member, friend, medical care provider, etc.) may provide patient information (e.g., contact information, baseline risk information, social exposure risk information, an initial patient assessment of symptoms and/or vital signs, etc.) and/or complete one or more suitable telehealth consent forms. The information may then be reviewed by a licensed care provider to prescribe or order remote monitoring for the illness of interest (e.g., “flu-like” symptoms).
For example, a patient may receive an electronic message (e.g., email, SMS text message, etc.) with a hyperlink that, once selected, directs the patient to a patient account set-up form.
Additionally, as shown in
Furthermore, a patient enrolling in remote monitoring may provide social exposure risk information (e.g., travel history, known or potential contact with others who are ill or potentially ill, etc.), etc. Social exposure risk information for the patient may include, for example, occupation as a healthcare worker, previous presence in a healthcare facility, previous presence in close proximity situation with other people, previous positive test for the contagious disease, association with a person who is suspected or confirmed as tested positive for the contagious disease, and association with a person exhibiting symptoms of the contagious disease, etc. Additionally or alternatively, social exposure risk information may include whether the patient has had close contact with (e.g., lives with, works with, or otherwise had has close contact with) anyone who would be able to indicate occupation as a healthcare worker, previous presence in a healthcare facility, previous presence in close proximity situation with other people, previous positive test for the contagious disease, association with a person who is suspected or confirmed as tested positive for the contagious disease, and association with a person exhibiting symptoms of the contagious disease, etc. In some variations, appropriate consents may be obtained to enable use of this social exposure risk information to assist in contact tracing efforts to investigate and/or further mitigate outbreaks of the contagious disease.
An initial patient assessment may further be provided during patient enrollment. For example, the initial patient assessment may include an evaluation of presence and/or severity of one or more symptoms, date/time of onset of such symptoms, evaluation of one or more vital signs, etc.
In some variations, patient enrollment information may be obtained through an online form. Additionally or alternatively, patient enrollment information may be obtained over an automated phone interview (e.g., over an automated phone system with programmable voice and/or programmable text services). For example, patient enrollment may be performed in a manner similar to that described in U.S. patent application Ser. Nos. 16/664,434 and/or 62/955,223, each of which is hereby incorporated in its entirety by this reference.
In some variations, at least some information provided during patient enrollment may be used to automatically complete or partially complete other standard health forms, such as CDC's PUI form, thereby improving efficiency in providing crucial information to healthcare officials during events such as an outbreak.
Patient enrollment may also include providing the patient with one or more monitoring equipment such as a thermometer and/or pulse oximeter (e.g., if the patient does not already have one) for subsequent use in remote monitoring. Alternatively, patients may utilize personal equipment. Exemplary devices for use in monitoring and triaging systems and methods described herein as described in further detail in U.S. patent application Ser. Nos. 16/664,434 and/or 62/955,223 (incorporated by reference above).
Patient data may be received in one or more suitable manners. For example, in some variations, the remote monitoring system may include an interactive survey that may prompt a patient (or a user associated with the patient) to complete and submit a patient assessment. The survey may, for example, be an online survey accessible over the Internet, a survey integrated in a mobile application executed in a user computing device (e.g., smartphone or tablet), or the like. In some variations, as shown in
Accordingly, to complete a patient assessment, the patient may complete an online survey.
In some variations, the survey may further prompt the patient to answer one or more questions relating to at least one symptom associated with the contagious disease for which the patient is being monitored. For example,
In some variations, the system may further prompt the patient to indicate severity of one or more of the indicated symptoms. For example, as shown in
It should be understood that additional GUIs may be included in the online survey to gather any changes or updates to other patient data, such as baseline medical risk information (e.g., new chronic medical conditions or medications, or indication that the patient is newly pregnant) and/or social exposure risk (e.g., recent visits to hospital, test results, close contact exposure to other person(s) at risk for the contagious disease, etc.). At least some information may additionally or alternatively be automatically pulled from the patient's medical record for consideration by the remote monitoring system (e.g., new positive test for the contagious disease).
Once the online survey is completed, the survey may provide a confirmation screen (e.g., GUI 1000 as shown in
While
For example, as shown in
For example, through the automated phone system, the patient may be prompted to provide patient information, including one or more bodily metrics.
Patient responses during the assessment are transcribed and processed by the remote monitoring system. For example, information that the patient has recited over a telephone call may be transcribed into text, parsed, and analyzed. Additional methods of analysis are described in further detail in U.S. patent application Ser. Nos. 16/664,434 and/or 62/955,223 (incorporated by reference above). It should be understood that similar to that described above, additional questions may be asked via the automated phone system to gather any changes or updates to other patient data, such as baseline medical risk information (e.g., new chronic medical conditions or medications, or indication that the patient is newly pregnant) and/or social exposure risk (e.g., recent visits to hospital, test results, close contact exposure to other person(s) at risk for the contagious disease, etc.). At least some information may additionally or alternatively be automatically pulled from the patient's medical record for consideration by the remote monitoring system (e.g., new positive test for the contagious disease).
In some variations, the provided patient information may be compared to protocols (e.g., CDC medical protocol) to trigger appropriate follow-up questions. The follow-up questions may be identified and asked in real-time or substantially real-time during completion of the patient assessment during completion of the online survey or phone assessment, and/or may be identified and/or asked after the completion of the online survey or phone assessment during a separate contact with the patient. Based on the patient information provided, disease progression may be identified at the patient level and triaged to appropriate personnel (e.g., heath system providers and county health officials).
As described above, in addition to collecting vitals and symptoms regularly (e.g., daily, twice daily), a remote monitoring service may collect baseline information from patients at intake to help with risk stratification (e.g., patients who are elderly with chronic conditions and exposure history are at higher risk than younger patients without comorbidities) for triaging purposes.
In some variations, a triaging protocol may incorporate a “trending index” that may be generated to triage or rank all patients by potential medical risk. For example, a trending index can be reviewed and adopted by medical providers who are interested in remotely monitoring their patients at risk for the contagious disease of interest. In some variations, the trending index may be based at least in part on baseline medical risk, social exposure risk, and/or patient assessment (e.g., vital signs, symptoms). Additionally or alternatively, a triaging protocol may allow medical teams (or public health organizations) to sort patients based on characteristics such as age, comorbidity risk, social/exposure history, as well as symptoms/vitals and/or other suitable information.
In some variations, a triaging protocol may additionally or alternatively be based at least in part on a machine learning model (e.g., neural network algorithm) that has been trained using patient data obtained for patients who have been confirmed positive for the contagious disease. In other words, in addition or as an alternative to utilizing a trending index such as that described below, medical risk for patients may be predicted (e.g., by a learning module 138 as shown in
As shown in Table 1, an exemplary trending index may incorporate multiple risk scores associated with different characteristics of the patient. For example, in some variations an exemplary trending index may be based on at least one risk score associated with each of multiple risk factor categories: baseline medical risk (e.g., age, chronic medical conditions), social exposure risk, at least one patient assessment (e.g., daily symptoms, vital signs), and/or days since first symptoms appeared. For example, a risk score may be based in part on raw points associated with individual aspects of baseline medical risk, social exposure risk, symptoms, vital signs, etc. In some variations, a risk score may be normalized for a risk factor category or subcategory based on a respective normalization value (e.g., normalization value of 15 for age). Additionally or alternatively, a risk score for a particular risk factor category may be capped at a respective maximum value as shown in the below Tables 2-5. The normalization value and the maximum value for a particular risk factor category may be equal. In some variations, a trending index may be the sum (or other suitable formula) of scores of risk scores for the risk factor categories. Furthermore, in some variations, the relative contribution of a risk factor category may be adjusted based on a respective weighting factor.
As an example variation, for monitoring COVID-19, baseline medical risk and daily symptoms/vitals factors may be individually scored as shown in Tables 2-7. However, it should be understood that in other variations (for COVID-19, for other contagious diseases, etc.), other suitable points and ranges may be used.
Table 2 illustrates example points associated with different age ranges, and Table 3 illustrates example points associated with different baseline medical risks. To the extent that either females or males may be at greater risk for a particular contagious disease, baseline risk points may similarly be associated with the patient's sex.
Table 4 illustrates example points associated with different social exposure risk. In some variations, questions relating to recent foreign and/or domestic travel (marked with * in Table 4), may be customized based on factors such as the estimated incubation period, and/or estimated current degree of community spread, etc. of the particular contagious disease for which patients are being monitored. More points may, for example, be associated with regions associated with higher levels of travel notice (e.g., by the CDC) or based on otherwise known incidence of the disease. For example, recent travel to an epicenter region may be associated with +5 points, recent travel to a region with a Level 3 travel notice may be associated with +4 points, recent travel to a region with a Level 2 travel notice may be associated with +3 points, recent travel to another region known to have a developing outbreak may be associated with +2 points, etc. In some variations, questions relating to recent travel may be appropriate in instances where there is not yet known community transmission of the disease in a region where the patient is located. Such questions relating to recent travel may be omitted in instances where travel is not an important risk factor (e.g., in instances where there is known widespread community transmission of the contagious disease in a region where the patient in located).
In some variations, the triaging protocol (e.g., trending index) may assess aspects of the regular (e.g., daily) patient assessment in a static manner (e.g., incorporating patient data from the most recent patient assessment), or in a dynamic manner (e.g., incorporating change in patient data relative to one or more previous patient assessments). Table 5 illustrates example points associated with vitals and symptoms from a patient assessment assessed in a static manner for COVID-19, while Table 6 illustrates example points associated with vitals and symptoms from a patient assessment assessed in a dynamic manner for COVID-19.
Table 7 illustrates example points associated with days since first cardinal symptoms appeared for COVID-19. Accordingly, assessment of this risk category may incorporate patient data received from the patient over multiple patient assessments over time.
In some variations, a group of patients (e.g., within a city, set of cities, county, state, etc., and/or within a group of patients associated with a healthcare institution or medical care provider) being monitored may be triaged based on their trending index scores. In some variations, patient data for a group of patients may be communicated via a dashboard or other suitable summary report interface, where the group of patients may be summarized (e.g., ranked) and/or information about an individual patient's health status may be accessed in an individual patient report. The communicated patient data displayed in the summary report (or communicated in any suitable manner) may include, for example, at least one patient assessment (e.g., symptoms, vital signs), testing status for the contagious disease, at least one trending index, and/or the results of triaging the one or more patients according to medical risk associated with the contagious disease.
For example,
As described above in some variations, individual patients may be selected for more detailed review. For example,
In some variations, the remote monitoring system may communicate a programmed alert for at least one patient characterized as having a threshold medical risk associated with the contagious disease (e.g., a threshold trending index value). The programmed alert may, for example, be communicated through emphasizing on the summary report (e.g., dashboard) of any patients who are characterized as having a threshold medical risk associated with the contagious disease. Such highlighting may appear as color-coding, enlarged or capitalized font, location of the patient listing (e.g., ranked position on a group list), etc. As another example, the programmed alert may be communicated by providing an alert notification (e.g., through a secondary dialog box, contact to the medical care provider such as via email, SMS text message, or phone call, etc.) for individual patients or a group of patients characterized as having threshold medical risk.
The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practice the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed; obviously, many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to explain the principles of the invention and its practical applications, they thereby enable others skilled in the art to utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the following claims and their equivalents define the scope of the invention.
This application claims priority to U.S. Patent Application Ser. No. 62/989,492 filed Mar. 13, 2020, which is incorporated herein in its entirety by this reference.
Number | Date | Country | |
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62989492 | Mar 2020 | US |