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Remote Patient Monitoring for Home Management of Coronavirus Disease 2019 in New York: A Cross-Sectional Observational Study

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Background

The coronavirus disease 2019 (COVID-19) global pandemic posed an unprecedented public health emergency, accounting for over 12 million cases worldwide.1 New York City rapidly became the viral epicenter in the United States with ∼214,061 COVID-19 cases, including 55,173 hospitalizations and 18,596 confirmed deaths as of July 6, 2020.2 With cases exponentially rising and straining health care systems both in New York City3 and worldwide, health authorities recommended that health institutions explore alternatives to face-to-face triage to avoid unnecessary health visits and prevent further spread of the disease.4

Considering that telemedicine has proven effective in managing chronic and respiratory diseases5,6 while lessening the burden on emergency departments (EDs),7–9 its integration with remote patient monitoring (RPM) became a compelling solution to use during the pandemic. RPM involves the asynchronous transmission of health care data between physically distant patients and health care providers to aid in clinical management9,10 and it has been shown to be a viable alternative to traditional in-person care in terms of hospital readmission and symptom detection.6,11,12 The value of using RPM to deliver care to patients during the COVID-19 pandemic was recently described,13 as it is low-cost, scalable, and has bidirectional features, which foster communication between patients and health care providers in an environment devoid of contamination.14 Moreover, RPM provides the opportunity for continuous clinical data collection from which future predictive models can be generated.

The Precision Recovery Program (PRP), an RPM initiative from the Mount Sinai Health System, was officially launched in mid-March 2020 to provide a high-intensity standard of care to patients who were reporting symptoms consistent with the COVID-19 infection. This study aimed to (1) depict demographic characteristics and symptom presentation in patients with suspected cases of COVID-19 who were enrolled in PRP and (2) assess RPM as a tool for delivering care to patients with confirmed or suspected COVID-19 diagnoses.

Methods

The Precision Recovery Program

Precision Recovery is a daily physiologic data and symptom tracking application completed via smart device. Following a physician evaluation (either in-person or virtually), patients were referred to the PRP if they were displaying symptoms consistent with COVID-19. PRP accepted referrals from eight hospitals within the Mount Sinai Health System (Mount Sinai Beth Israel, Mount Sinai Brooklyn, Mount Sinai Hospital, Mount Sinai Morningside, Mount Sinai Queens, Mount Sinai South Nassau, Mount Sinai West, Mount Sinai Union Square). Referring departments included Mount Sinai Health System’s Emergency Departments, Inpatient Units, Outpatient Clinics, and telehealth video urgent care service (Sinai Now). Patients were also able to self-refer by contacting PRP’s hotline advertised online (through social media, the Mount Sinai website, and e-mail blasts) and on the news.

As part of the referral process, pertinent medical information, including comorbidities, COVID-19 symptom presentation, COVID-19 test results, and patient discharge status, was provided. If RPM was deemed clinically indicated by the PRP licensed provider, patients were onboarded by a clinical coordinator. During onboarding, patients were verbally instructed to download on their smart devices two mobile applications: MyCap, Research Electronic Data Capture (REDCap), software’s mobile data entry tool (Vanderbilt University, TN) and Zoom (Zoom Video Communications, San Jose, CA), an online meeting platform. Patients were also provided with a virtual guide outlining procedures for software usage and data entry as well as contact information for technical support.

In addition, patients who were considered by their referring physician or PRP clinician to be at high risk of rapid respiratory deterioration were provided with a pulse oximeter. Criteria that indicated high risk for respiratory deterioration included the following: individuals with a medical history of severe respiratory or cardiovascular disease, individuals discharged from the inpatient setting with supplemental oxygen or those who had complex inpatient stays including those who required mechanical ventilation or acute respiratory failure, and patients with severe COVID-19 symptoms.

After onboarding, patients were asked to complete a questionnaire that included information about their demographics and COVID-19 test results. They were then instructed to log their daily symptoms and physiologic data on MyCap and to participate in weekly video meetings with a licensed health care provider via Zoom for symptom tracking, clinical evaluation, and risk stratification. Patients unable to download Zoom dialed into their weekly meetings using the telephone. Patients unable to download MyCap received daily calls from their assigned PRP providers who manually entered their clinical and physiological data into REDCap.

Weekly meetings included a review of symptoms, pertinent clinical assessments, and patient education on home symptom management. If clinical deterioration was detected, the patient was escalated to a virtual triage visit with an on-call physician. Clinical elements that prompted a virtual triage with a physician included significant changes in symptom severity (two points on a five-point rating scale), new onset of chest pain or shortness of breath, and deterioration of physiological measures including hypoxemia (oxygen saturation <94%), tachycardia (heart rate >100 beats/min), tachypnea (>20 breaths/min), or any other clinical presentation as indicated by the PRP provider. Triage visits could also be initiated at the request of the patient.

All triage visits took place over video call or telephone and were performed by an on-call licensed physician. The PRP physician team included general practitioners, physiatrists, and neurosurgeons. Triage visits involved an assessment of the severity of illness and risk stratification. As a result of triage, based on physician’s clinical judgment, either ED visitation or at-home clinical management of symptoms was recommended. In the absence of escalation of symptoms, patients were contacted once a week through Zoom or telephone and had their symptoms continuously monitored (see Fig. 1 for the Precision Recovery workflow diagram).

Fig. 1.

Fig. 1. Precision recovery workflow diagram.

Study Design and Patients

This is a single-center, cross-sectional descriptive study reporting data collected from the PRP, operated out of an academic quaternary-care hospital in New York City during the COVID-19 pandemic and accepting referrals from eight hospitals within the Mount Sinai Health System. Retrospective approval for publication of these findings was provided by the Mount Sinai Program for Protection of Human Subjects (IRB 20-03315). Individuals were referred to PRP by a medical doctor if they had tested positive for COVID-19, or had presumptive diagnosis of COVID-19 based on the presentation of COVID-like symptoms. Patients who onboarded PRP between April 29 and May 12, 2020, and completed their onboarding questionnaires (including demographic, clinical, and physiologic data) were included in this analysis.

Data Collection and Outcome Measures

Data collection for this study included the following: self-reported demographic information, COVID-19 clinical data self-reported at PRP enrollment, and clinician-reported comorbidity data.

Data regarding medical comorbidities were collected from the patient’s electronic medical record (Epic System Corporation and PRISM). Comorbidity data included cardiovascular, chronic respiratory, immunosuppressive, kidney, chronic liver, metabolic, and thromboembolic disease. As part of clinical care, self-reported symptoms and physiologic data were entered into MyCap by patients and were retrieved from REDCap. Only PRP baseline self-reported data were retrieved for analysis in the current study. Self-reported demographic data included age, gender, time since symptom onset (days), and COVID-19 status. COVID-19 status reflected whether the patient had any form of a COVID-19 test and its corresponding results. Additional self-reported data included physiologic data, symptom presence, and symptom severity. Physiologic data included body temperature (°F), systolic and diastolic blood pressure (mmHg), heart rate (bpm), and oxygen saturation levels (%SpO2). Symptoms data included chest pain, dyspnea, tachypnea, difficulty concentrating, cyanosis, diarrhea, and anosmia. Children enrolled in the program had the questionnaires completed by their legal guardians. Symptom severity was collected on a four-point categorical scale, excluding dyspnea, which was collected on a five-point numerical scale.15

Data Analysis

Continuous variables were described using mean and standard deviation (SD), and categorical variables were described using number and percentage. For the purposes of data interpretation, symptom severity (excluding dyspnea) was translated into a four-point categorical scale of none, mild, moderate, and severe. We performed chi-square tests of independence to determine differences between COVID-19 test statuses for individual symptom presentation. To correct for multiple comparisons, we used the Benjamini–Hochberg procedure to adjust p-values.16 All statistical analyses were performed using SPSS (Statistical Package for the Social Sciences) version 25.0 software (IBM Corp.). The radar plot was generated with Microsoft Excel version 16.0 (Microsoft Corp.).

Results

Patient Demographics and Clinical Characteristics

One hundred twelve patients (n = 112) who were enrolled in PRP between April 29, 2020, and May 12, 2020, were included in this study. Seventy-two patients (64.3%) were referred from the Mount Sinai Health System: 24 (21.4%) from outpatient clinics (including departments of Cardiology, Emergency Medicine, Pulmonology, and Neurosurgery), 24 (21.4%) from inpatient units, 18 (16.1%) from EDs, and 6 (5.4%) from the telehealth urgent care service Sinai Now. Forty patients (35.7%) self-referred to the program. Ninety-three patients (83.0%) were able to download MyCap mobile application. For the remaining 17.0%, demographic, physiologic, and clinical data were collected via a Zoom or telephone call with a PRP clinician.

Patients were on average (SD) 49 (17.6) years old and 60.7% were female. Less than 64% of patients received a test for COVID-19. Among patients who reported their testing results, 44.6% tested positive, 17.9% tested negative, and 33.0% had an unknown COVID status (Table 1).

Table 1. Demographics and Baseline Characteristics
DEMOGRAPHIC VARIABLE N MEAN (SD)/%
Age (years) 112 48.7 (17.6)
 <20 2 1.8%
 20–30 15 13.5%
 31–40 25 22.5%
 41–50 18 16.2%
 51–60 19 17.1%
 61–70 16 14.4%
 >71 17 15.3%
Gender 112  
 Male 44 39.3%
 Female 68 60.7%
Date since symptom onset 104 27.9 (18.1)
 0–10 27 26.0%
 11–20 16 15.3%
 21–30 12 11.6%
 31–40 18 17.3%
 41–50 16 15.4%
 51–60 12 11.6%
 61–70 3 2.9%
Had a COVID-19 test 110  
 Yes 71 63.4%
 No 39 34.8%
COVID-19 test results 107  
 Positive 50 44.6%
 Negative 20 17.9%
 Unknown 37 33.0%

The most common pre-existing comorbidity identified was cardiovascular disease (39.8% of participants), of which hypertension (36.3%) was the most common diagnosis. Metabolic disease was identified in 37.2% of participants and in this category, hypercholesterolemia (26.5%) and diabetes (17.7%) were most frequently reported. Chronic respiratory disease was present in 13.3% of participants, of which asthma was the most prevalent (11.5%). Comorbidity data were unavailable for 20.4% of patients (Table 2).

Table 2. Participant Comorbidities
COMORBIDITIES TOTAL (N = 112), n (%)
Cancer 8 (7.1)
Cardiovascular disease 45 (39.8)
 Hypertension 41 (36.3)
 Congestive heart failure 3 (2.7)
 Dysrhythmia 7 (6.2)
 Coronary artery disease 6 (5.3)
 Stroke 3 (2.7)
Chronic respiratory disease 15 (13.3)
 Asthma 13 (11.5)
 Chronic obstructive pulmonary disease 3 (2.7)
 Sleep apnea 2 (1.8)
Immunosuppression 3 (2.7)
 Human immunodeficiency virus 1 (0.9)
 Organ transplant 0 (0)
 Other 2 (1.8)
Kidney disease 4 (3.5)
 Chronic 3 (2.7)
 End-stage 1 (0.9)
Chronic liver disease 4 (3.5)
 Cirrhosis 3 (2.7)
 Hepatitis B 0 (0)
 Hepatitis C 2 (1.8)
 Other 0 (0)
Metabolic disease 42 (37.2)
 Obesity (BMI 30–35) 4 (3.5)
 Morbid obesity (BMI >35) 10 (8.8)
 Prediabetes 6 (5.3)
 Diabetes 20 (17.7)
 High cholesterol 30 (26.5)
Thromboembolic disease 5 (4.4)
 Deep vein thrombosis 3 (2.7)
 Pulmonary embolism 3 (2.7)
Unavailable data 23 (20.4)

Symptom Reports and Severity

Of patients who responded, the most commonly reported symptoms included dyspnea (55.4%), anxiety (55.4%), and chest pain (42.9%). The least reported symptoms included difficulty concentrating (42.0%), tachypnea (41.1%), and headache (34.8%). Symptom presentation categorized by polymerase chain reaction COVID (PCR)-test status is presented in Figure 2. Differences in symptom presentation were not statistically significant (p > 0.05) between COVID-19 test statuses. On average, most patients categorically rated their symptoms as mild. Anxiety was ranked as the most severe symptom (9.8%), followed by difficulty concentrating (4.5%). Symptom presentation data and severity rankings can be found in Table 3.

Fig. 2.

Fig. 2. Symptom presentation by COVID-19 test status. COVID-19, coronavirus disease 2019.

Table 3. Symptom Report and Severity
SYMPTOM SEVERITY TOTAL (N = 112), n (%)
Chest pain
 None 62 (55.4)
 Mild 38 (33.9)
 Moderate 8 (7.1)
 Severe 2 (1.8)
 No response 2 (1.8)
Tachypnea
 None 63 (56.3)
 Mild 33 (29.5)
 Moderate 12 (10.7)
 Severe 1 (0.9)
 No response 3 (2.7)
Headache
 None 71 (63.4)
 Mild 21 (18.8)
 Moderate 16 (14.3)
 Severe 2 (1.8)
 No response 2 (1.8)
Difficulty concentrating
 None 61 (54.5)
 Mild 34 (30.4)
 Moderate 8 (7.1)
 Severe 5 (4.5)
 No response 4 (3.6)
Anxiety
 None 49 (43.8)
 Mild 36 (32.1)
 Moderate 15 (13.4)
 Severe 11 (9.8)
 No response 1 (0.9)
Dyspnea
 None 47 (42.0)
 Mild to moderate 26 (23.2)
 Moderate 27 (24.1)
 Moderate to severe 9 (8.0)
 Severe 0 (0)
 No response 3 (2.7)

Vital Statistics

Of 112 patients, 72.3% had thermometers, 32.1% had blood pressure cuffs, 45.5% had pulse oximeters, and 53.6% had a device that could measure heart rate (pulse oximeter or blood pressure cuff). Of the patients who had a device to report vital statistics, 100% reported body temperature, 88.9% reported blood pressure, 100% reported oxygen saturation levels, and 55% reported heart rate. Overall, 29% of participants reported blood pressure and 29% reported heart rate.

Patients reported an average body temperature of 98.3 (1.1)°F, oxygen saturation levels of 96.7 (1.9) % SpO2, blood pressure of 124.8 (17.9)/75.7(9.7) mmHg, and heart rate of 85.4 (14.4) beats/min. Of the individuals who reported SpO2 levels and heart rate, 27.5% indicated an oxygen saturation level below 96%, and 36.4% were tachycardic, respectively.

Triage and Outcomes

Within the cohort of 112 patients reported in this study, 20 patients were triaged over the course of their participation in PRP and the total number of triage calls was 45. Eleven patients were triaged more than once. Of the 20 patients triaged, 6 were referred to the ED, while 14 were recommended to remain home and continue with symptom monitoring. Of the six patients who received a recommendation to go to the ED, all (100%) complied and three were subsequently admitted to the hospital. Nineteen triaged patients have been discharged from the program and one patient passed away.

Discussion

Recently, numerous studies have reported on inpatient COVID-19 symptom presentation in New York City cohorts.17–20 However, fewer studies are focusing on mild to moderate symptom presentation, as well as clinical aspects of early disease onset. Detailed documentation of these cases is crucial, given emerging long-tail symptom presentation data in cohorts that initially exhibited only mild to moderate symptoms.21

Our data show that among the 112 patients studied, dyspnea, anxiety, and chest pain were the most commonly reported symptoms. Most symptoms were rated as mild, while anxiety was most commonly rated as severe, supporting an increased demand for mental health and counseling services during the COVID-19 pandemic.22–24 Average vital signs analysis revealed unremarkable results in terms of temperature, blood pressure, and blood oxygen saturation. Of the 53.6% of individuals who had a device with which to measure heart rate (i.e., blood pressure cuff or pulse oximeter), 36.4% were tachycardic (>90 bpm),25 while the rest were within the range of normality. Considering the utility of heart rate in predicting poor outcomes in influenza-like illnesses and viral syndromes, groups are harnessing wearable health technology to surveil acute infections.26

There was no statistically significant difference in symptom presentation between individuals with different PCR-test statuses, highlighting an important emerging issue about ensuring adequate care coordination for COVID-19 patients regardless of PCR-test status. Considering both the high false-negative rate of the PCR-test27 and general low availability of the testing,28 it is essential that all individuals have access to health care that is subsidized by the government or insurance.

Current traditional telehealth strategies, such as physician video visits, often consist of patient evaluations for immediate need of hospital services. If there is no urgent need for hospitalization, patients are advised to perform standard management of flu-like symptoms and to contact the telehealth urgent care services or present to the ED if symptoms worsen. However, given the levels of anxiety that are experienced by patients displaying COVID-19 symptoms,29 which can be further enhanced by an unknown PCR-test status, there is great uncertainty around the question of “how sick is sick enough” for an individual to seek emergency services. Implementing and utilizing an RPM system to manage COVID-19 cases are preferable to traditional care delivery models because RPM allows for daily monitoring of symptoms, reduces the use of limited hospital resources, improves access to care, and lessens the transmission of COVID-19.7,30

The challenges faced during the implementation of PRP align with previously documented challenges surrounding telehealth. These difficulties include educating providers and patients in how to use the virtual technology,31 training providers in the collection and interpretation of results,32,33 insurance coverage,34 and data quality, safety, and accountability concerns.33,35 In addition, we noted irregular data entry among patients as less than one-third of the patient population provided vital statistics for heart rate, systolic blood pressure, and diastolic blood pressure. This heterogeneity among which questions patients chose to answer resulted from the ability for patients to skip questions within the app. Although having this option available is known to ultimately increase overall compliance to app-based data entry, it can introduce the possibility for skewed results if subgroup analysis is not performed. Also, medical history was not available for 20% of our patient population, which limits our demographic depiction. However, as long as there is a well-managed history of regular symptom-reporting for each patient, most COVID-19 patients can be effectively managed remotely with advice on symptom management.

Conclusions

Our study was able to depict demographic characteristics and symptom presentation in COVID-19 patients with mild symptoms enrolled in an RPM program, as well as add to current literature supporting RPM as a valuable tool for delivering care to COVID-19 patients.

The COVID-19 outbreak has highlighted a need for comprehensive telemedicine services to be adopted by hospitals and health systems worldwide. We believe that a condition-specific RPM service is the optimal telemedicine standard of care for COVID-19, as it has the potential to further our knowledge about COVID-19. Furthermore, we recommend that health care providers utilize services to deliver care to all patients presenting with COVID-19 symptoms regardless of PCR-test status.

Acknowledgments

We acknowledge the frontline health care workers who are caring for acutely ill COVID-19 patients during this health care crisis.

Authors’ Contributions

L.T., C.K., J.T., M.C., and D.P. contributed to the study concept and design, data collection, and article preparation. E.B., S.D., S.B., and L.N. performed data analysis and interpretation, and article preparation. All authors read and approved the final version.

Disclosure Statement

No competing financial interests exist.

Funding Information

This article was supported by the New York State SCIRB-IDEA grant (C34459GG) for M.C. and D.P.

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