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

NCT04806477 | Completed

• 1 other identifier: 34172720400000071
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

Telemedicine; Respiratory Tract Infections; Emergency Medical Services; Referral and Consultation; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time of medical care

  up to 10 months

• Rate of indication for complementary exams

  up to 10 months

• Type of requested exams

  up to 10 months

• Type of Medical prescription

  up to 10 months

• Type of proposed destination after completion of the service

  up to 10 months

Study Arms (2)

Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation

ACTIVE COMPARATOR

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; Other: Face-to-face Consultation

Adult patients with respiratory tract symptom - only face-to-face evaluation

ACTIVE COMPARATOR

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

Interventions

Telemedicine Consultation OTHER

Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.

Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation

Face-to-face Consultation OTHER

Direct face-to-face evaluation (without telemedicine consultation before).

Adult patients with respiratory tract symptom - only face-to-face evaluation; Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Abert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35649057 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; COVID-19

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Eduardo HS Cordioli, MD

  Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: September 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)