Trial Outcomes & Findings for COVID-19 Watch + COVID-19 Pulse (NCT NCT04581863)
NCT ID: NCT04581863
Last Updated: 2023-11-24
Results Overview
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)."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2097 participants
Primary outcome timeframe
30 days
Results posted on
2023-11-24
Participant Flow
Participant milestones
| Measure |
COVID Watch
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.
COVID Watch: 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 + Pulse Oximeter
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 .
pulse oximeter: 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 .
COVID Watch: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
1041
|
1056
|
|
Overall Study
COMPLETED
|
1024
|
1025
|
|
Overall Study
NOT COMPLETED
|
17
|
31
|
Reasons for withdrawal
| Measure |
COVID Watch
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.
COVID Watch: 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 + Pulse Oximeter
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 .
pulse oximeter: 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 .
COVID Watch: 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.
|
|---|---|---|
|
Overall Study
Patients in alternate home program (e.g., home health care, inpatient rehab, etc.) were unenrolled.
|
17
|
31
|
Baseline Characteristics
COVID-19 Watch + COVID-19 Pulse
Baseline characteristics by cohort
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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.
|
Total
n=2049 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40 yo
|
35 Participants
n=5 Participants
|
364 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Age, Customized
40-49 yo
|
173 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Age, Customized
50-59 yo
|
198 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Age, Customized
60-69 yo
|
179 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Age, Customized
70 or older
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
611 Participants
n=5 Participants
|
607 Participants
n=7 Participants
|
1218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
413 Participants
n=5 Participants
|
418 Participants
n=7 Participants
|
831 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
63 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
347 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
697 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
499 Participants
n=5 Participants
|
495 Participants
n=7 Participants
|
994 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
115 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Hypertension
|
334 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
663 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Diabetes
|
156 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Hyperlipidemia
|
247 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
506 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Chronic heart failure
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Atrial fibrillation
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Cancer
|
103 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Chronic obstructive pulmonary disease
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Asthma
|
123 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Venous thromboembolism
|
29 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
Chronic kidney disease
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
History of transplant
|
31 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Pre-Existing Conditions, n (%)
History of substance use
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Insurance Coverage, n (%)
Blue Cross, Blue Shield, Commercial, or Managed Care
|
340 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
642 Participants
n=5 Participants
|
|
Insurance Coverage, n (%)
Medicaid or Managed Medicaid
|
125 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Insurance Coverage, n (%)
Medicare or Managed Medicare
|
137 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Insurance Coverage, n (%)
Other
|
422 Participants
n=5 Participants
|
422 Participants
n=7 Participants
|
844 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPrimary 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)."
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Difference in Days Alive and Out of Hospital
|
29.5 days
Standard Deviation 2.3
|
29.4 days
Standard Deviation 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThe mean number of days is per person. This data includes patients who presented to a health system hospital or any of 53 hospitals outside the health system captured in the regional health information exchange.
Outcome measures
| Measure |
COVID Watch
n=240 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=41 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
n=262 Participants
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
n=63 Participants
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
n=253 Participants
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
n=251 Participants
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
n=46 Participants
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
n=61 Participants
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Days Alive and Out of Hospital (DAOH) by Racial/Ethnic Subgroups Among COVID-19 Positive Patients
|
29.3 Days
Standard Deviation 2.6
|
29.4 Days
Standard Deviation 1.5
|
29.6 Days
Standard Deviation 2.4
|
29.6 Days
Standard Deviation 1.5
|
29.5 Days
Standard Deviation .4
|
29.3 Days
Standard Deviation 3.0
|
29.1 Days
Standard Deviation 4.0
|
29.3 Days
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 7, and 14 daysPatients were asked to rate their anxiety (1=very worried to 5=not at all worried) on Day 0, 7, and 14.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Self-reported Anxiety Among COVID-19 Positive Patients
0 days
|
2.9 score on a scale
Standard Deviation 1.3
|
2.8 score on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-reported Anxiety Among COVID-19 Positive Patients
7 days
|
2.3 score on a scale
Standard Deviation 1.3
|
2.3 score on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-reported Anxiety Among COVID-19 Positive Patients
14 days
|
2.0 score on a scale
Standard Deviation 1.2
|
2.0 score on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 7, and 14 daysPatients were asked to rate their confidence that they could manage their symptoms at home (1=not at all confident to 5=very confident) on Day 0, 7, and 14.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Self-perception of Confidence in Managing Illness Among COVID-19 Positive Patients
Day 0
|
4.3 score on a scale
Standard Deviation 1.0
|
4.3 score on a scale
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-perception of Confidence in Managing Illness Among COVID-19 Positive Patients
Day 7
|
4.4 score on a scale
Standard Deviation 0.9
|
4.5 score on a scale
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-perception of Confidence in Managing Illness Among COVID-19 Positive Patients
Day 14
|
4.5 score on a scale
Standard Deviation 0.9
|
4.5 score on a scale
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 7, and 14 daysPatients were asked to rate how helpful these found the program (1=not at all helpful to 5=very helpful) on Day 0, 7, and 14.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Self-perception of Program Helpfulness in Managing Illness Among COVID-19 Positive Patients
Day 14
|
4.6 score on a scale
Standard Deviation 0.8
|
4.3 score on a scale
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-perception of Program Helpfulness in Managing Illness Among COVID-19 Positive Patients
Day 0
|
4.2 score on a scale
Standard Deviation 1.1
|
4.3 score on a scale
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-perception of Program Helpfulness in Managing Illness Among COVID-19 Positive Patients
Day 7
|
4.4 score on a scale
Standard Deviation 1.0
|
4.1 score on a scale
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThe count of participants encompasses all deaths in each arm. This data includes patients who presented to a health system hospital or any of 53 hospitals outside the health system captured in the regional health information exchange.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Mortality Among COVID-19 Positive Patients
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThe count of participants encompasses all deaths with respect to each arm and each race/ethnic group. This data includes patients who presented to a health system hospital or any of 53 hospitals outside the health system captured in the regional health information exchange.
Outcome measures
| Measure |
COVID Watch
n=240 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=41 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
n=262 Participants
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
n=63 Participants
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
n=253 Participants
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
n=251 Participants
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
n=46 Participants
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
n=61 Participants
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Mortality by Racial/Ethnic Subgroups Among COVID-19 Positive Patients
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThe mean number of visits/hospitalizations is per patient. Emergency and Hospitalizations include patients who presented to a health system hospital or any of 53 hospitals outside the health system captured in the regional health information exchange. Office visits are within the Penn health system and do not include patients who presented to any of 53 hospitals outside the Penn health system captured in the regional health information exchange.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Health Care Utilization (Outpatient, Emergency Department, and Inpatient Care)
ED Visits
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Health Care Utilization (Outpatient, Emergency Department, and Inpatient Care)
Hospitalizations
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Health Care Utilization (Outpatient, Emergency Department, and Inpatient Care)
Office Visits within the Health System
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.6
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThe mean number of visits/hospitalizations is per patient. This data includes patients who presented to a health system hospital or any of 53 hospitals outside the health system captured in the regional health information exchange. Office visits are within the Penn health system and do not include patients who presented to any of 53 hospitals outside the Penn health system captured in the regional health information exchange.
Outcome measures
| Measure |
COVID Watch
n=240 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=41 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
n=262 Participants
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
n=63 Participants
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
n=253 Participants
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
n=251 Participants
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
n=46 Participants
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
n=61 Participants
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Health Care Utilization (Outpatient, Emergency Department, and Inpatient Care) by Racial/Ethnic Subgroups Among COVID-19 Positive Patients
Hospitalizations
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.2
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
|
Health Care Utilization (Outpatient, Emergency Department, and Inpatient Care) by Racial/Ethnic Subgroups Among COVID-19 Positive Patients
ED Visits
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.5
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.0 Number of Visits/Hospitalizations
Standard Deviation 0.2
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.0 Number of Visits/Hospitalizations
Standard Deviation 0.2
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.0 Number of Visits/Hospitalizations
Standard Deviation 0.2
|
|
Health Care Utilization (Outpatient, Emergency Department, and Inpatient Care) by Racial/Ethnic Subgroups Among COVID-19 Positive Patients
Outpatient Office Visits
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.3
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.6
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.6
|
0.1 Number of Visits/Hospitalizations
Standard Deviation 0.6
|
0.2 Number of Visits/Hospitalizations
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysEscalations to a clinician represents the number of unique patients who escalated to a clinician one or more times throughout enrollment per their allocated study.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Remote Monitoring Escalations to Clinician
|
108 Participants
|
242 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysMean represents average clinician response time in minutes to escalations.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Timing of Remote Monitoring Escalations to Clinician
|
29.7 minutes
Standard Deviation 34.0
|
27.8 minutes
Standard Deviation 40.5
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: A single participant could be escalated multiple times.
Patients were asked after an escalation to a clinician how they would have self-managed their COVID symptoms if not for the COVID Watch program (A. Gone to ER, B. Contacted my doctor, C. Stayed at home, or D. Other).
Outcome measures
| Measure |
COVID Watch
n=172 Escalations
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.
COVID Watch: 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 + Pulse Oximeter
n=366 Escalations
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Self-Reported Symptom Self-Management Among COVID-19 Positive Patients
"Gone to the ER"
|
28 Escalations
|
49 Escalations
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-Reported Symptom Self-Management Among COVID-19 Positive Patients
"Contacted my doctor"
|
43 Escalations
|
111 Escalations
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-Reported Symptom Self-Management Among COVID-19 Positive Patients
"Stayed at home"
|
24 Escalations
|
68 Escalations
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-Reported Symptom Self-Management Among COVID-19 Positive Patients
"Other"
|
1 Escalations
|
18 Escalations
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Self-Reported Symptom Self-Management Among COVID-19 Positive Patients
Missing Responses
|
76 Escalations
|
120 Escalations
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: The control arm was not given pulse oximeters for SpO2 to be measured as per study design.
SpO2 denotes peripheral capillary oxygen saturation. This is the number of days between when patients were enrolled to when they initiated the pulse oximetry. This only applies to the COVID Watch + Pulse Oximeter patients.
Outcome measures
| Measure |
COVID Watch
n=1025 Participants
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.
COVID Watch: 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 + Pulse Oximeter
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Days Between Program Enrollment and Home Pulse Oximetry Initiation
|
2.4 Days
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysDays from enrollment to ED return visit includes patients who presented to any of 53 hospitals outside the health system captured in the regional health information exchange. ED denotes Emergency Department. Days from enrollment to ED return visit in Penn Health System does not include patients who presented to any of 53 hospitals outside the health system captured in the regional health information exchange. ED denotes Emergency Department.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Timing of Initial Presentation of Covid-19 Positive Patients Who Returned to Emergency Department
Days from enrollment to ED return visit
|
10.0 Days
Standard Deviation 7.5
|
9.1 Days
Standard Deviation 7.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Timing of Initial Presentation of Covid-19 Positive Patients Who Returned to Emergency Department
Days from enrollment to ED return visit in Penn Health System
|
10.1 Days
Standard Deviation 7.5
|
9.0 Days
Standard Deviation 7.2
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysLowest recorded oxygen saturation percentage does not include patients who presented to any of 53 hospitals outside the health system captured in the regional health information exchange. ED denotes Emergency Department.
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Severity of Initial Presentation of Covid-19 Positive Patients Who Returned to Emergency Department as Measured by Oxygen Saturation
|
96.9 Oxygen Saturation (%)
Standard Deviation 1.9
|
94.9 Oxygen Saturation (%)
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysTotal escalations represent number of total escalations, including multiple from same patient. Clinical recommendations, including referrals, followed an pre-specified clinical protocol
Outcome measures
| Measure |
COVID Watch
n=1024 Participants
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.
COVID Watch: 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 + Pulse Oximeter
n=1025 Participants
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 .
pulse oximeter: 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 .
COVID Watch: 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 Positive White Patients - Control
White patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Control
Other/Unknown (Asian, etc.) patients enrolled in the Control arm who had a positive COVID-19 diagnosis.
|
COVID Positive Black Patients - Intervention
Black patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive White Patients - Intervention
White patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Hispanic Patients - Intervention
Hispanic patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
COVID Positive Other/Unknown Patients - Intervention
Other/Unknown patients enrolled in the Intervention arm who had a positive COVID-19 diagnosis.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Subsequent Emergency Department Referrals
|
10 referrals
|
13 referrals
|
—
|
—
|
—
|
—
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—
|
—
|
Adverse Events
COVID Watch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
COVID Watch + Pulse Oximeter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mucio Delgado, MD, Principal Investigator
University of Pennsylvania
Phone: 215-746-8256
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place