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Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Gastrointestinal Infection Patients

Primary Purpose

Gastrointestinal Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemedicine Consultation
Face-to-face Consultation
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Infection focused on measuring Diarrhea, Telemedicine, Emergency Medical Services

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age> 18 years
  • Symptoms present less than 7 days.
  • Without the use of antibiotics in last 30 days prior to the onset of symptoms.
  • No trips abroad in the last 15 days prior to the onset of symptoms.
  • Presence of more than three episodes of watery diarrhea in the last 24 hours with or without symptoms related to the infection (fever 38oC, chills, sweating, myalgia, vomiting) that motivated / were looking for the Emergency Care Unit
  • Signature of informed consent form

Exclusion Criteria:

  • Return to the Emergency Care Unit due to maintenance or aggravation of the complaint
  • Age> 65 years
  • Diagnosis of chronic gastrointestinal diseases, gastritis with or without gastroesophageal reflux disease, previous diverticulitis, previous abdominal surgery, chronic colitis, inflammatory bowel diseases, food intolerances (gluten, lactose)
  • Previous diagnosis of congestive heart failure, HIV / AIDS, active cancer, type I diabetes mellitus, use of any immunosuppressant
  • Diarrhea chronic
  • Patient with emergency room criteria by the nursing evaluation of the triage.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Adult patients with acute gastrointestinal infection - telemedicine before face-to-face evaluation

    Adult patients with acute gastrointestinal infection - only face-to-face evaluation

    Arm Description

    Adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious) who have undergone telemedicine consultation before face-to-face evaluation

    Adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious) who have only face-to-face evaluation

    Outcomes

    Primary Outcome Measures

    Accuracy of telemedicine diagnosis of adult patients with symptoms compatible with acute gastrointestinal infection
    The patient will be evaluated by telemedicine and / or face-to-face consultation and at the end will receive the diagnosis, which will be assigned the ICD code. At the end, these ICDs will be grouped by the same clinical significance and will be compared between the two consultation methods (telemedicine versus face-to-face consultation).

    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 (porcentage) of indication for complementary exams between telemedicine and face-to-face consultation.
    Types of requested exams
    Comparison of types of requested exams (porcentage) between telemedicine and face-to-face consultation.
    Guidelines follow-up
    Comparison of guidelines follow-up (porcentage) between telemedicine and face-to-face consultation.
    Medical prescription
    Comparison of medical prescription after completion of the service between telemedicine and face-to-face consultation.
    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

    First Posted
    March 11, 2021
    Last Updated
    February 10, 2022
    Sponsor
    Hospital Israelita Albert Einstein
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04803435
    Brief Title
    Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Gastrointestinal Infection Patients
    Official Title
    Telemedicine Evaluation of Immunocompetent Adult Patients With Symptoms Suggestive of Acute Gastrointestinal Infection Compared With Face-to-face Medical Consultation in an Emergency Department: a Randomized Study of Diagnostic Accuracy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 20, 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    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
    Acute gastroenterocolitis (GECA) in healthy adults is a frequent cause of looking for medical care in emergency care units and most cases are aimed at etiology viral infection or food toxin, being generally self-limited with good prognosis and only need for treatment with behavioral measures and use of medications for relief symptomatic. Anamnesis is the main resource for the diagnosis and stratification of GECA severity and is infrequent alterations of physical examination and complementary examinations without association with symptoms of alert. Telemedicine has become a resource that allows easier and faster access to medical evaluation, with low cost and rational use of resources. Virtual emergency care is part of Hospital Israelita Albert Einstein (HIAE) institutional routine and there is a large number of consultations whose final diagnosis was GECA. It is not known whether the accuracy of diagnosis of GECA by telemedicine is not inferior to the diagnosis by face-to-face evaluation, considered the Golden pattern. The aim of the study is compare the diagnostic accuracy of GECA by telemedicine with that of face-to-face care. It is a prospective randomized study with a population of adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious). Patients whose screening will be excluded of nursing directed for immediate evaluation in the emergency room and patients with dysfunctions organisms or immunosuppression. Patients who accept and sign the informed consent form will be randomized into 2 groups: A) immediate face-to-face evaluation; B) evaluation initially by telemedicine and sequentially at face-to-face evaluation. In both cases, the ICD diagnostics will be compiled and grouped according to clinical significance and will be the primary outcome of the study. Service time, exams requested, guidelines, prescription and destination will also be analyzed. Patients and doctors who undergoing group B assessment will be blinded to the telemedicine assessment data.
    Detailed Description
    The face-to-face assessment will be carried out by the local UPA medical and assistance team and the assessment by telemedicine by the fixed medical team of the HIAE service responsible for urgency / emergency. Both in face-to-face evaluation, as well as telemedicine, clinical data, final diagnosis, destination, total time of care, guidance and prescription will be computed. In the face-to-face evaluation, complementary exams and medications received in situ were computed. Final diagnoses will receive nomenclature according to the International Statistical Classification of Diseases and Problems Health-Related - ICD 10 (institutional medical record requirement - Cerner) and will be grouped according to equivalence of syndromic diagnosis. The diagnosis of the face-to-face assessment is made according to protocols based on extensive medical literature and approved by the institutional clinical staff, being representative of current medical practice and will be considered the gold standard diagnosis. Patients evaluated by telemedicine will be blinded to the diagnosis, recommended destination, guidelines and prescription performed by the medical team. UPA doctors will be blind to the doctor's assessment telemedicine and telemedicine doctors will not have access to the data obtained in the screening.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Infection
    Keywords
    Diarrhea, Telemedicine, Emergency Medical Services

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adult patients with acute gastrointestinal infection - telemedicine before face-to-face evaluation
    Arm Type
    Active Comparator
    Arm Description
    Adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious) who have undergone telemedicine consultation before face-to-face evaluation
    Arm Title
    Adult patients with acute gastrointestinal infection - only face-to-face evaluation
    Arm Type
    Active Comparator
    Arm Description
    Adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious) who have only face-to-face evaluation
    Intervention Type
    Other
    Intervention Name(s)
    Telemedicine Consultation
    Intervention Description
    Brief telemedicine consultation, blindedto 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
    Accuracy of telemedicine diagnosis of adult patients with symptoms compatible with acute gastrointestinal infection
    Description
    The patient will be evaluated by telemedicine and / or face-to-face consultation and at the end will receive the diagnosis, which will be assigned the ICD code. At the end, these ICDs will be grouped by the same clinical significance and will be compared between the two consultation methods (telemedicine versus face-to-face consultation).
    Time Frame
    through study completion, an average of 1 year
    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
    through study completion, an average of 1 year
    Title
    Rate of indication for complementary exams
    Description
    Comparison of rate (porcentage) of indication for complementary exams between telemedicine and face-to-face consultation.
    Time Frame
    through study completion, an average of 1 year
    Title
    Types of requested exams
    Description
    Comparison of types of requested exams (porcentage) between telemedicine and face-to-face consultation.
    Time Frame
    through study completion, an average of 1 year
    Title
    Guidelines follow-up
    Description
    Comparison of guidelines follow-up (porcentage) between telemedicine and face-to-face consultation.
    Time Frame
    through study completion, an average of 1 year
    Title
    Medical prescription
    Description
    Comparison of medical prescription after completion of the service between telemedicine and face-to-face consultation.
    Time Frame
    through study completion, an average of 1 year
    Title
    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
    through study completion, an average of 1 year

    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: Age> 18 years Symptoms present less than 7 days. Without the use of antibiotics in last 30 days prior to the onset of symptoms. No trips abroad in the last 15 days prior to the onset of symptoms. Presence of more than three episodes of watery diarrhea in the last 24 hours with or without symptoms related to the infection (fever 38oC, chills, sweating, myalgia, vomiting) that motivated / were looking for the Emergency Care Unit Signature of informed consent form Exclusion Criteria: Return to the Emergency Care Unit due to maintenance or aggravation of the complaint Age> 65 years Diagnosis of chronic gastrointestinal diseases, gastritis with or without gastroesophageal reflux disease, previous diverticulitis, previous abdominal surgery, chronic colitis, inflammatory bowel diseases, food intolerances (gluten, lactose) Previous diagnosis of congestive heart failure, HIV / AIDS, active cancer, type I diabetes mellitus, use of any immunosuppressant Diarrhea chronic Patient with emergency room criteria by the nursing evaluation of the triage.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tarso AD Accorsi, MD, PhD
    Phone
    +55 11 2151 2773
    Email
    tarsoa@einstein.br
    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

    12. IPD Sharing Statement

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    Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Gastrointestinal Infection Patients

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