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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04806477
Enrollment
98
Registered
2021-03-19
Start date
2020-09-01
Completion date
2020-11-01
Last updated
2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infections

Keywords

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

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.

Interventions

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

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

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of final evaluation ICD 10-code diagnosis.up to 10 monthsAll 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

MeasureTime frameDescription
Time of medical careup to 10 monthsComparison of time (minutes) of medical care between telemedicine and face-to-face consultation.
Rate of indication for complementary examsup to 10 monthsComparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation.
Type of requested examsup to 10 monthsComparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation.
Type of Medical prescriptionup to 10 monthsComparison of type of medical prescription after completion of the service between telemedicine and face-to-face consultation
Type of proposed destination after completion of the serviceup to 10 monthsComparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026