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

NCT04803435 | Unknown

• 1 other identifier: 36793220300000071
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Infection

Keywords

Diarrhea; Telemedicine; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• 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).

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Time of medical care

  through study completion, an average of 1 year

• Rate of indication for complementary exams

  through study completion, an average of 1 year

• Types of requested exams

  through study completion, an average of 1 year

• Guidelines follow-up

  through study completion, an average of 1 year

• Medical prescription

  through study completion, an average of 1 year

Study Arms (2)

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

ACTIVE COMPARATOR

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

Other: Telemedicine Consultation; Other: Face-to-face Consultation

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

ACTIVE COMPARATOR

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

Other: Face-to-face Consultation

Interventions

Telemedicine Consultation OTHER

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

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

Face-to-face Consultation OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo HS Cordioli, MD

  Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil

  STUDY DIRECTOR

Central Study Contacts

Tarso AD Accorsi, MD, PhD

CONTACT

+55 11 2151 2773; tarsoa@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: February 20, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2021-03