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Clinical Trials/NCT05322694
NCT05322694
Completed
Not Applicable

Multicenter Prospective Cohort Study to Derive and Validate Clinical Decision Rules in Emergency Department Triage to Improve the Care Pathway for Patients With Acute Respiratory Infection or Acute Infectious Diarrhea.

Simon Berthelot3 sites in 1 country1,474 target enrollmentFebruary 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Infection
Sponsor
Simon Berthelot
Enrollment
1474
Locations
3
Primary Endpoint
7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Acute respiratory infections (such as influenza-like illness and upper respiratory tract infection) and acute infectious diarrhea are, for the most part, conditions that do not require medical management or specific treatment. Depending on the level of their transmission in the community, however, these diseases place significant clinical and financial burden on the healthcare system, particularly on emergency departments (ED). The investigators propose a prospective multicenter cohort study with which they aim to validate clinical decision rules combining 1) rapid molecular tests and 2) risk stratification tools to identify patients at low risk for complications related to acute respiratory infection and acute infectious diarrhea. The use of these clinical decision rules by nurses in ED triage could allow low-risk patients to be sent directly home for self-treatment without having to see the emergency physician. By eliminating the need for physician assessment, paraclinical testing and prolonged waiting in the ED, these triage-based clinical decision rules could provide a new, safe care pathway for acute respiratory infections and acute infectious diarrhea, reducing the burden on the patient, the healthcare system, and society.

Registry
clinicaltrials.gov
Start Date
February 3, 2022
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Simon Berthelot
Responsible Party
Sponsor Investigator
Principal Investigator

Simon Berthelot

Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté de médecine de l'Université Laval

CHU de Quebec-Universite Laval

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older;
  • Able to consent to the study;
  • Reachable by phone;
  • Consent to be reached directly by phone;
  • At least one of the following respiratory symptoms consistent with an acute respiratory infection for 10 days or less, i. Cough and/or ii. Purulent sputum and/or iii. Pharyngeal pain and/or iv. Nasal congestion and/or v. Rhinorrhea and/or vi. Agueusia and/or vii. Anosmia;
  • A triage score of 3 (30 minutes), 4 (60 minutes) or 5 (120 minutes) on the Canadian Triage and Acuity Scale (CTAS);
  • Triaged by the ED nurse and managed according to standard ED care protocols;
  • Resident of Québec;
  • Holder of a Québec health insurance number.

Exclusion Criteria

  • Cognitive impairment that prevents the patient from reliably answering the risk stratification tool or research questions;
  • Resident of a long-term care facility;
  • Refusal of nasopharyngeal swab.
  • Acute infectious diarrhea :
  • Inclusion Criteria:
  • 18 years of age or older;
  • Able to consent to the study;
  • Reachable by phone;
  • Consent to be reached directly by phone;
  • At least three loose or liquid stools over a 24-hour period and for 10 days or less;

Outcomes

Primary Outcomes

7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.

Time Frame: 30 days

Combined proportion incidence at 7 and 30 days after the initial visit of ED returns, hospitalizations and deaths related to acute respiratory infection or acute infectious diarrhea (obtained from provincial administrative databases).

Secondary Outcomes

  • Incidence proportion of ED returns(30 days)
  • Incidence of intensive care unit admission(30 days)
  • Mean costs of the disease from the patient perspective(7 days)
  • Incidence proportion of hospitalizations(30 days)
  • Incidence of prescribing antiviral medication(7 days)
  • Incidence of antibiotic prescribing(7 days)
  • Mean costs of care of the initial ED visit from a health system perspective(30 days)
  • Incidence proportion of deaths(30 days)
  • Length of stay in the ED(Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours))

Study Sites (3)

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