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临床试验/NCT04806477
NCT04806477已完成不适用

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

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Number of final evaluation ICD 10-code diagnosis.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation

Active Comparator

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

干预措施: Telemedicine Consultation (Other)

Adult patients with respiratory tract symptom - telemedicine before face-to-face evaluation

Active Comparator

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

干预措施: Face-to-face Consultation (Other)

Adult patients with respiratory tract symptom - only face-to-face evaluation

Active Comparator

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

干预措施: Face-to-face Consultation (Other)

结局指标

主要结局

Number of final evaluation ICD 10-code diagnosis.

时间窗: 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).

次要结局

  • Rate of indication for complementary exams(up to 10 months)
  • Time of medical care(up to 10 months)
  • Type of requested exams(up to 10 months)
  • Type of Medical prescription(up to 10 months)
  • Type of proposed destination after completion of the service(up to 10 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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