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

NCT ID: NCT04806477

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2020-11-01

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Telemedicine Consultation

Intervention Type: OTHER

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

Face-to-face Consultation

Intervention Type: OTHER

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

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

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

Group Type: ACTIVE_COMPARATOR

Face-to-face Consultation

Intervention Type: OTHER

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

Interventions

Telemedicine Consultation

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

Intervention Type: OTHER

Face-to-face Consultation

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo HS Cordioli, MD

Role: STUDY_DIRECTOR

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

Locations

Hospital Israelita Abert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35649057 (View on PubMed)

Other Identifiers

34172720400000071

Identifier Type: -

Identifier Source: org_study_id