Clinical trial NCT04806477: Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.
Official title: Randomized Trial of Diagnostic Accuracy of Medical Evaluation by Telemedicine Compared to Face-to-face Medical Evaluation in an Emergency Care Unit in Immunocompetent Adult Patients With Symptoms Suggestive of Acute Airway Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: Telemedicine
Respiratory Tract Infections
Emergency Medical Services
Referral and Consultation
COVID-19
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of final evaluation ICD 10-code diagnosis.
timeFrame: up to 10 months
Secondary outcomes:
measure: Time of medical care
timeFrame: up to 10 months
measure: Rate of indication for complementary exams
timeFrame: up to 10 months
measure: Type of requested exams
timeFrame: up to 10 months
measure: Type of Medical prescription
timeFrame: up to 10 months
measure: Type of proposed destination after completion of the service
timeFrame: up to 10 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Abert Einstein
state: SP
Study officials:
affiliation: Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
name: Eduardo HS Cordioli, MD
role: STUDY_DIRECTOR
References:
citation: Accorsi TAD, Moreira FT, Pedrotti CHS, Amicis K, Correia RFV, Morbeck RA, Medeiros FF, Souza JL Jr, Cordioli E. Telemedicine diagnosis of acute respiratory tract infection patients is not inferior to face-to-face consultation: a randomized trial. Einstein (Sao Paulo). 2022 May 27;20:eAO6800. doi: 10.31744/einstein_journal/2022AO6800. eCollection 2022.