Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19 (RPM)

The GW Medical Faculty Associates recently launched a remote monitoring program for patients diagnosed with COVID-19. Patients are provided with a home pulse oximeter and thermometer. Participants complete daily surveys about their symptoms and vital signs and are escalated to receive phone calls and video visits if responses are abnormal.

Investigators would like to complete a study of the program to understand:

1. Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring
2. Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission
3. Patient satisfaction with program

Study Overview

• Status: Completed
• Conditions: Covid19; Infectious Disease; SARS-CoV Infection
• Intervention / Treatment: Other: Observational

Detailed Description

The SARS-CoV-2 that emerged in late 2019 has been noted to have a wide range of presentations, from asymptomatic and mild cases to those requiring intubation, ECMO, and critical care. As it is a novel pathogen, clinicians and scientists are only beginning understand when and who will require hospital-based resources such as oxygen, hospitalization, or ICU admission. The Medical Faculty Associates (MFA) COVID-19 Remote Monitoring Program (RPM) was developed to provide a daily touchpoint for patients during their COVID-19 course, including ready connection to paramedics and physicians when needed. The program was launched with the goal of identifying clinical decompensation early, maximizing available healthcare capacity, and minimizing nosocomial COVID-19 spread and healthcare worker exposure.

Investigators would like to perform analyses to test multiple hypotheses, including:

1. Patients discharged with a diagnosis of COVID-19 will be able to participate in a remote monitoring program.
2. A COVID-19 remote monitoring program will benefit patients.
3. Patients will be satisfied with their experience of a remote monitoring program and will have lower anxiety about their COVID-19 illness.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University, Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be all adults enrolled in the COVID-19 Remote Monitoring Program. The investigators anticipate this population to be similar to the GW University Hospital Emergency Department patient population.

Description

Inclusion Criteria:

• Laboratory-confirmed coronavirus infection
• Age >=18
• Primary language English or Spanish

Exclusion Criteria:

• Dementia
• Pregnant > 16 weeks gestation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient referred	Number of patients referred	1 year
Patients enrolled	Number of patients enrolled	1 year
Response Rate	Patients giving at least 50% response rate over 10 days	1 year
Flagged cases	Number of cases flagged for responses on survey	1 year
Telehealth	Number of cases escalated to telehealth	1 year
Patient program graduation	Number of patients who graduate from program	1 year
Patient unenrollment	Number of patients who unenrolled and for what reason	1 year

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Emergency Medicine; Remote Patient Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: IRB#NCR202520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No