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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04806477
Other study ID # 34172720400000071
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date November 1, 2020

Study information

Verified date March 2021
Source Hospital Israelita Albert Einstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized study that sought to analyze the diagnostic accuracy of the telemedicine consultation of patients suspected of respiratory tract infections during COVID-19 pandemic in comparison with the face-to-face evaluation at the emergency department.


Description:

Unicentric, prospective and randomized study performed between September and November 2020 with adult patients who sought care at emergency department. The inclusion criterion was the exhibition of any tract respiratory symptom. Patients older than 65 years, with chronic heart or lung diseases or immunosuppressed were excluded. Eligible patients were randomized 1:1 for a brief telemedicine consultation, blinded to subsequent face-to-face evaluation or direct face-to-face evaluation.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date November 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with at least one acute symptom compatible with RTI (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) in presence or absence of symptoms related to the infection (fever = 38oC, chills, sweating, myalgia) that motivated spontaneously face-to-face evaluation at the ED. Exclusion Criteria: - Patients with diagnosis of chronic respiratory diseases (chronic obstructive pulmonary disease, asthma and interstitial lung disease) - Patients with previous diagnosis of congestive heart failure, - Patients with HIV / AIDS - Patients with active cancer - Patients with type I diabetes mellitus - Patients in use of any immunosuppressant - Patients with chronic cough - Patiets that referral to emergency room after nursing triage.

Study Design


Intervention

Other:
Telemedicine Consultation
Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.
Face-to-face Consultation
Direct face-to-face evaluation (without telemedicine consultation before).

Locations

Country Name City State
Brazil Hospital Israelita Abert Einstein São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of final evaluation ICD 10-code diagnosis. All institutional Emergency Department or Telemedicine assessments involve filling out the final diagnosis on an International Classification of Diseases (ICD-10)-code basis in the electronic medical record before discharge to home or admission. For aggregation of most prevalent RTI with similar pathophysiologic characteristics, three diagnostic groups were defined, based on ICD 10 codes: RTI, including COVID-19 (B34.2, B34.9, B97.2, J00, J04, J06, J11, J20, J30, J39, U07.1); PT - Acute Pharyngotonsillitis (J02-J03.9) and AS - Acute Sinusitis (J01-J01.9). up to 10 months
Secondary Time of medical care Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation. up to 10 months
Secondary Rate of indication for complementary exams Comparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation. up to 10 months
Secondary Type of requested exams Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation. up to 10 months
Secondary Type of Medical prescription Comparison of type of medical prescription after completion of the service between telemedicine and face-to-face consultation up to 10 months
Secondary Type of proposed destination after completion of the service Comparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation. up to 10 months
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