Randomized Trial of Adding Pulse Oximetry to an Automated Text-messaging Program for Remotely Monitoring Patients at Home With COVID-19

Most (80-90%) COVID-19 positive patients are asked to self-isolate at home because they do not qualify for home care or inpatient admission. Alternatives to in-person care are urgently needed to: (1) manage an unpredictable clinical course; (2) identify and intercept patients rapidly deteriorating at home, (3) prevent viral spread during in-person visits; and (4) triage symptoms to minimize surges to emergency departments (EDs). In addition, fingertip pulse oximeters ("pulse oximetry") have been proposed to improve in-home early detection of respiratory deteriorations but are untested and the operational infrastructure to support large-scale monitoring is limited. While telemedicine has been widely adopted during the pandemic as an alternative to conventional outpatient care, worse COVID-19 outcomes observed among Black and Latino patients may be due, in part, to worse telemedicine access for these socially and medically disadvantaged groups.

To improve in-home monitoring and health care access for patients with suspected or confirmed COVID-19, the health innovation team at University of Pennsylvania Health System ("UPHS") developed COVID Watch, a free of charge, 24/7, automated, text message-based, home monitoring program across UPHS' large geographic catchment area. This study will answer the question, "How does the addition of pulse oximetry affect clinical outcomes for COVID-19 patients?"

COVID Watch was first implemented on March 24, 2020 and has enrolled 3,628 patients through May 21, 2020 of which 1,295 were COVID-19 positive. Understanding the effect of COVID Watch with and without pulse oximetry on Black and Latino patients is important because communities of color have had disproportionately higher rates of COVID-19 morbidity and mortality nationally, and locally in Pennsylvania, ranking 5th total deaths, and New Jersey, ranking 2nd. Symptom monitoring apps and programs are commercially available. However, COVID Watch is uniquely embedded into its host healthcare system, UPHS. Patients are enrolled using the electronic medical record (EMR), escalations are addressed by UPHS nurses, and they are referred to UPHS-based telemedicine, primary care, and social services when appropriate. COVID Watch is a scalable operational platform for monitoring patients with home pulse oximetry readings. Whether remote monitoring with or without pulse oximetry helps COVID-19 patients stay safe at home is an urgent, patient-centered question. Finally, with COVID-19 surges projected in late 2020, health systems will need to be prepared with evidence-based strategies for managing more COVID-19 patients at home.

COVID Watch (https://covidwatch.waytohealth.org/) is powered by UPHS' NIH-funded research and operational texting platform (www.waytohealth.org), integrated with UPHS' EMR. Since hypoxemia is the primary driver of admission and fatality among COVID-19 patients, the investigators focused the algorithm on shortness of breath, our closest approximation for concerning hypoxemia. Given the rapid and unpredictable decompensation of COVID-19 patients, patients receive clinical support 24 hours/day, 7 days/week. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using an algorithm to determine whether patients need an urgent escalation to a team of dedicated nurses within 1 hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. At each level patients' clinical needs are either managed with self-care advice, prescriptions, or a referral to the ED. The majority of COVID Watch patients (83.7%) have been enrolled by outpatient providers conducting telephone and video visits; 8.7% and 7.6% have been enrolled at ED and inpatient discharge, respectively. The program is available at all six of UPHS's hospitals and EDs, and all 530 affiliated ambulatory settings using the EMR. Any clinical staff member (e.g., RN, physician, medical assistants) logged on to the EMR is able to enroll patients. Patients can also trigger the algorithmic assessment independent of the scheduled messages. Patients only continue the intervention if they are agreeable ("opt-out") and can stop anytime. Patients are scheduled to be in COVID Watch for 14 days, with the option to extend to 21 days if interested. A Spanish-language version of COVID Watch was made available to patients on May 18, 2020, with nurses using translation lines to communicate with patients.

COVID Watch engagement is high. To date, nearly 80% of enrolled patients have engaged with the program, defined as responding to scheduled text messages at least once every two days. RNs have managed over 600 calls with a mean response time (median) of 25 minutes (11 minutes). Of the calls, 37% were asked to continue to monitor at home, 41% were scheduled for an urgent follow-up telemedicine visit, and 9% were sent to the ED for emergent evaluation.