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

Respiratory Tract Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806477
• Other study ID #: 34172720400000071
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: March 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

Other:
• Telemedicine Consultation
Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.
• Face-to-face Consultation
Direct face-to-face evaluation (without telemedicine consultation before).

Locations

Country	Name	City	State
Brazil	Hospital Israelita Abert Einstein	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time of medical care	Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.	up to 10 months
Secondary	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
Secondary	Type of requested exams	Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation.	up to 10 months
Secondary	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
Secondary	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