COVID-19 Watch + COVID-19 Pulse

NCT04581863 | Completed Results FDA Device

• 1 other identifier: 844043
• Study Type: interventional
• Target: 2,097
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly deteriorating at home, prevent viral spread during in-person visits; and minimize future surges in emergency departments (EDs). In addition, fingertip pulse oximeters 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, limited telemedicine access may be exacerbating observed disparities for Black and Latino patients. In our health system, Black and Latino patients used video-visits 15 percent less often than white patients. Text messaging and phone calls may improve healthcare access for communities of color, but the evidence for these telecommunication modalities to be effective and improve equity are limited. The University of Pennsylvania Health System (UPHS) developed and deployed COVID Watch to improve access to health care for COVID-19 patients who are self-isolating at home. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using a clinical algorithm to determine whether patients need an urgent escalation to a team of dedicated, on-call nurses within one hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. Patients can also trigger the algorithmic assessment independent of the scheduled messages. As of May 21, 2020, COVID Watch has managed 3,628 COVID-19 patients at home, of which 1,295 are confirmed COVID-19 positive; of these, 61 percent are Black or Latino, higher than the proportion of all UPHS COVID-19 positive patients that are Black or Latino (55 percent).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Difference in Days Alive and Out of Hospital

  Primary outcome will be reported for patients who are confirmed to be COVID positive. Outcomes include time-based and categorical clinical outcomes. Time-based measures will be assessed at 30 days and begin when a COVID-19 patient was tested (e.g., nasopharyngeal swab) in outpatient and ED settings, or starting at the time of discharge from the hospital if enrolled in COVID Watch as an inpatient. Staying safe and out of the hospital using Days Alive and Out of Hospital (DAOH) since the date of the positive COVID-19 test. Initial analyses will include in-hospital deaths. Deaths that occur outside the hospital in 2020 will be added to a follow up analysis when National Death Index (NDI) becomes available (est. January 2021)."

  30 days

Other Outcomes (15)

• Days Alive and Out of Hospital (DAOH) by Racial/Ethnic Subgroups Among COVID-19 Positive Patients

  30 days

• Self-reported Anxiety Among COVID-19 Positive Patients

  0, 7, and 14 days

• Self-perception of Confidence in Managing Illness Among COVID-19 Positive Patients

  0, 7, and 14 days

Study Arms (2)

COVID Watch

ACTIVE COMPARATOR

COVID Watch provides text-based assessments, two times a day for 14 days and escalates care to a nurse via telemedicine for any reported worsening of symptoms not severe enough to recommend going to the ED immediately. This service is provided free of charge to patients, a benefit to patients without insurance or established primary care. UPHS already offers a version of COVID Watch with pulse oximetry to patients with COVID-19 being discharged from the ED who meet specific criteria: a discharge pulse ox less than 95%, an infiltrate on chest x-ray, are or age of 60 years or older, or who are deemed by the ED clinician to have significant comorbid conditions.

Other: COVID Watch

PCORI Pulse

EXPERIMENTAL

This arm is COVID Watch + pulse oximeter device. Patients sent a pulse oximeter will be prompted twice daily to text their oxygen saturation level after walking in place for 1 minute. If the oxygen saturation is \>3% lower than than the baseline first O2 sat measurement, or if it falls below an absolute level of 90%, the patient will receive an immediate call from the same on-call RN's for COVID Watch and undergo the same triage protocol .

Device: pulse oximeter; Other: COVID Watch

Interventions

pulse oximeter DEVICE

Patients will be prompted twice daily to text their oxygen saturation level after walking in place for 1 minute. If the oxygen saturation is \>3% lower than than the baseline first O2 sat measurement, or if it falls below an absolute level of 90%, the patient will receive an immediate call from the same on-call RN's for COVID Watch and undergo the same triage protocol .

PCORI Pulse

COVID Watch OTHER

Enrolled patients receive text-based assessments, two times a day for 14 days and escalates care to a nurse via telemedicine for any reported worsening of symptoms not severe enough to recommend going to the ED immediately.

COVID Watch; PCORI Pulse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with suspected or confirmed COVID-19 started on COVID Watch as routine care via (1) outpatient COVID-19 testing or (2) who were tested for COVID-19 and discharged from the ED.

You may not qualify if:

• less than 18 years of age
• were provided a pulse oximeter upon discharge from the ED (available for distribution as usual care for patients with suspected COVID-19 being discharged from the ED with an ED pulse ox less than 95%, who have an infiltrate on chest x-ray, are greater than 60 years of age, or who are deemed by the ED clinician to have significant comorbid conditions).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mucio Delgado, MD, Principal Investigator
• Organization: University of Pennsylvania

mucio.delgado@pennmedicine.upenn.edu

215-746-8256

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 9, 2020
• Study Start: November 30, 2020
• Primary Completion: February 5, 2021
• Study Completion: May 31, 2022
• Last Updated: November 24, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-11

Locations

US (1)