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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Other: Telemedicine Consultation; Other: Face-to-face Consultation

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05652-900
      • Hospital Israelita Abert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Other: Telemedicine Consultation; Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.; Other: Face-to-face Consultation; Direct face-to-face evaluation (without telemedicine consultation before).
ACTIVE_COMPARATOR: 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	Other: Face-to-face Consultation; Direct face-to-face evaluation (without telemedicine consultation before).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (ACTUAL): March 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; COVID-19; Emergency Medical Services; Respiratory Tract Infections; Referral and Consultation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 34172720400000071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No