Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Other: Telemedicine Consultation
* Other: Face-to-face Consultation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation<br>We included adults (≥18 years of age) who had at least one acute symptom compatible with Respiratory Tract Infection (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) with or without symptoms related to the infection (fever ≥ 38oC, chills, sweating, myalgia) who have undergone telemedicine consultation before face-to-face evaluation | Other: Telemedicine Consultation<br>* Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.<br>Other: Face-to-face Consultation<br>* Direct face-to-face evaluation (without telemedicine consultation before).<br>|
| Active Comparator: Adult patients with respiratory tract symptom - only face-to-face evaluation<br>We included adults (≥18 years of age) who had at least one acute symptom compatible with Respiratory Tract Infection (sore throat, nasal obstruction, coryza, new or growing cough, sputum, hoarseness, dyspnea) with or without symptoms related to the infection (fever ≥ 38oC, chills, sweating, myalgia) who have undergone only face-to-face evaluation | Other: Face-to-face Consultation<br>* Direct face-to-face evaluation (without telemedicine consultation before).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of medical care | Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation. | up to 10 months | 
| 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 | 
| Type of requested exams | Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation. | up to 10 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Respiratory Tract Infections, Emergency Medical Services, Referral and Consultation, COVID-19