Back to resultsDiagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.
Primary Purpose
Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Telemedicine Consultation
Face-to-face Consultation
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Tract Infections focused on measuring Telemedicine, Respiratory Tract Infections, Emergency Medical Services, Referral and Consultation, COVID-19
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.
Sites / Locations
- Hospital Israelita Abert Einstein
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation
Adult patients with respiratory tract symptom - only face-to-face evaluation
Arm Description
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
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Time of medical care
Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.
Rate of indication for complementary exams
Comparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation.
Type of requested exams
Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation.
Type of Medical prescription
Comparison 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 service
Comparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation.
Full Information
NCT ID
NCT04806477
First Posted
March 11, 2021
Last Updated
August 25, 2021
Sponsor
Hospital Israelita Albert Einstein
1. Study Identification
Unique Protocol Identification Number
NCT04806477
Brief Title
Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
Telemedicine, Respiratory Tract Infections, Emergency Medical Services, Referral and Consultation, COVID-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Adult patients with respiratory tract symptom - only face-to-face evaluation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Telemedicine Consultation
Intervention Description
Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.
Intervention Type
Other
Intervention Name(s)
Face-to-face Consultation
Intervention Description
Direct face-to-face evaluation (without telemedicine consultation before).
Primary Outcome Measure Information:
Title
Number of final evaluation ICD 10-code diagnosis.
Description
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).
Time Frame
up to 10 months
Secondary Outcome Measure Information:
Title
Time of medical care
Description
Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.
Time Frame
up to 10 months
Title
Rate of indication for complementary exams
Description
Comparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation.
Time Frame
up to 10 months
Title
Type of requested exams
Description
Comparison of type of requested exams (porcentage) between telemedicine and face-to-face consultation.
Time Frame
up to 10 months
Title
Type of Medical prescription
Description
Comparison of type of medical prescription after completion of the service between telemedicine and face-to-face consultation
Time Frame
up to 10 months
Title
Type of proposed destination after completion of the service
Description
Comparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation.
Time Frame
up to 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo HS Cordioli, MD
Organizational Affiliation
Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Israelita Abert Einstein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05652-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35649057
Citation
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.
Results Reference
derived
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Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.
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