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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Infection
• Intervention / Treatment: Other: Face-to-face Consultation; Other: Telemedicine Consultation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adult patients with acute gastrointestinal infection - telemedicine 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 undergone telemedicine consultation before face-to-face evaluation	Other: Face-to-face Consultation; Direct face-to-face evaluation (without telemedicine consultation before).; Other: Telemedicine Consultation; Brief telemedicine consultation, blindedto subsequent face-to-face evaluation.
Active Comparator: Adult patients with acute gastrointestinal infection - only 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	Other: Face-to-face Consultation; Direct face-to-face evaluation (without telemedicine consultation before).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of medical care	Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.	through study completion, an average of 1 year
Medical prescription	Comparison of medical prescription after completion of the service between telemedicine and face-to-face consultation.	through study completion, an average of 1 year
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.	through study completion, an average of 1 year
Rate of indication for complementary exams	Comparison of rate (porcentage) of indication for complementary exams between telemedicine and face-to-face consultation.	through study completion, an average of 1 year
Types of requested exams	Comparison of types of requested exams (porcentage) between telemedicine and face-to-face consultation.	through study completion, an average of 1 year
Guidelines follow-up	Comparison of guidelines follow-up (porcentage) between telemedicine and face-to-face consultation.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Diarrhea; Emergency Medical Services
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 36793220300000071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No