Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea

NCT05322694 | Completed

• 2 other identifiers: FACSCRI-2021-02
• Study Type: observational
• Target: 1,474
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Respiratory Infection; Acute Bacterial Diarrhea

Outcome Measures

Primary Outcomes (1)

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

  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).

  30 days

Secondary Outcomes (9)

• Incidence proportion of ED returns

  30 days

• Incidence of prescribing antiviral medication

  7 days

• Incidence of antibiotic prescribing

  7 days

• Incidence of intensive care unit admission

  30 days

• Mean costs of care of the initial ED visit from a health system perspective

  30 days

Study Arms (2)

Acute respiratory infections

Participants will be recruited according to their symptoms when presenting to the emergency room. They can be included either in the acute respiratory infection group or acute infectious diarrhea group or both. Immediately after triage, eligible patients will be approached by research personnel (nurse or other professional authorized to perform the sampling and techniques required for the study) and enrolled after consent has been obtained. Once the study procedures are completed, participants will follow the care pathway that they would normally follow without the research project. The results of the clinical decision rule (molecular test and risk stratification tool) will not be disclosed to the treating team or the patient.

Acute infectious diarrhea

Participants will be recruited according to their symptoms when presenting to the emergency room. They can be included either in the acute respiratory infection group or acute infectious diarrhea group or both. Immediately after triage, eligible patients will be approached by research personnel (nurse or other professional authorized to perform the sampling and techniques required for the study) and enrolled after consent has been obtained. Once the study procedures are completed, participants will follow the care pathway that they would normally follow without the research project. The results of the clinical decision rule (molecular test and risk stratification tool) will not be disclosed to the treating team or the patient.

Eligibility Criteria

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

Study Population

Participants will be recruited according to their symptoms when presenting to the ED. They can be included in the acute respiratory infection group, the acute infectious diarrhea group or both.

You may qualify if:

• 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.

You may not qualify if:

• 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 :
• 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;
• 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.
• Known neutropenia (\<500 neutrophils);
• Active inflammatory bowel disease;

Sponsors & Collaborators

• Simon Berthelot: lead
• Meridian Bioscience, Inc.: collaborator
• Ministère de l'Économie, de la Science et de l'Innovation: collaborator

Study Sites (3)

Centre hospitalier universitaire de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Hôpital Général Juif

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Québec - Université Laval

Québec, G1V 4G2, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab samples and rectal swab samples

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté de médecine de l'Université Laval

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 12, 2022
• Study Start: February 3, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

CA (3)