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Completed

NCT Number: NCT04806477

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

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.

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Key information

Conditions

Respiratory Tract Infections COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Abert Einstein

São Paulo, 05652-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine consultation

Other

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

Face-to-face consultation

Other

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

Primary outcomes

  1. Number of final evaluation ICD 10-code diagnosis.

    Time frame: up to 10 months

    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).

Secondary outcomes

  1. Time of medical care

    Time frame: up to 10 months

    Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.

  2. Rate of indication for complementary exams

    Time frame: up to 10 months

    Comparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation.

  3. Type of requested exams

    Time frame: up to 10 months

    Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation.

  4. Type of Medical prescription

    Time frame: up to 10 months

    Comparison of type of medical prescription after completion of the service between telemedicine and face-to-face consultation

  5. Type of proposed destination after completion of the service

    Time frame: up to 10 months

    Comparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2021
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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