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

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.

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Infection; Acute Bacterial Diarrhea

• Study Type: Observational
• Enrollment (Actual): 1474

Contacts and Locations

• Study Contact: Name: Simon Berthelot, MD MSc FRCPC; Phone Number: 70553 418-525-4444; Email: simon.berthelot@fmed.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G2
    • CHU de Québec - Université Laval
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier Universitaire de Montréal
    • Montréal, Quebec, Canada, H3T 1E2
      • Hôpital Général Juif

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Acute Respiratory Infections :

Inclusion Criteria:

1. 18 years of age or older;
2. Able to consent to the study;
3. Reachable by phone;
4. Consent to be reached directly by phone;
5. 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;
6. A triage score of 3 (30 minutes), 4 (60 minutes) or 5 (120 minutes) on the Canadian Triage and Acuity Scale (CTAS);
7. Triaged by the ED nurse and managed according to standard ED care protocols;
8. Resident of Québec;
9. Holder of a Québec health insurance number.

Exclusion Criteria:

1. Cognitive impairment that prevents the patient from reliably answering the risk stratification tool or research questions;
2. Resident of a long-term care facility;
3. Refusal of nasopharyngeal swab.

Acute infectious diarrhea :

Inclusion Criteria:

1. 18 years of age or older;
2. Able to consent to the study;
3. Reachable by phone;
4. Consent to be reached directly by phone;
5. At least three loose or liquid stools over a 24-hour period and for 10 days or less;
6. A triage score of 3 (30 minutes), 4 (60 minutes) or 5 (120 minutes) on the Canadian Triage and Acuity Scale (CTAS);
7. Triaged by the ED nurse and managed according to standard ED care protocols;
8. Resident of Québec.
9. Holder of a Québec health insurance number.

Exclusion Criteria:

1. Known neutropenia (<500 neutrophils);
2. Active inflammatory bowel disease;
3. Anorectal pathology;
4. Recent colonic surgery (< 6 months);
5. Cognitive impairment preventing the patient from reliably answering the risk stratification tool or research questions;
6. Resident of a long-term care facility;
7. Refusal of the rectal swab.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence proportion of ED returns	Incidence proportion of ED returns at 7 and 30 days after the initial visit.	30 days
Incidence of prescribing antiviral medication	Incidence of prescribing antiviral medication (e.g., oseltamivir) at the initial ED visit and at 7 days (telephone follow-up).	7 days
Incidence of antibiotic prescribing	Incidence of antibiotic prescribing at initial visit and at 7 days (telephone follow-up).	7 days
Incidence of intensive care unit admission	Incidence of intensive care unit admission at 30 days (obtained from provincial administrative database on hospital admissions).	30 days
Mean costs of care of the initial ED visit from a health system perspective	Mean costs of the initial ED visit from a health system perspective estimated using time-driven activity-based costing (data obtained from initial visit data collection, electronic medical records and provincial physician billing database).	30 days
Mean costs of the disease from the patient perspective	Mean 7-day costs from the patient perspective (obtained from the Cost for Patient Questionnaire - the CoPaQ- administered at telephone follow-up).	7 days
Length of stay in the ED	Length of stay in the ED on the initial visit (electronic medical records).	Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours)
Incidence proportion of hospitalizations	Incidence proportion of hospitalizations at 7 and 30 days after the initial visit.	30 days
Incidence proportion of deaths	Incidence proportion of deaths at 7 and 30 days after the initial visit.	30 days

Collaborators and Investigators

• Sponsor: Simon Berthelot
• Collaborators: Meridian Bioscience, Inc.; Ministère de l'Économie, de la Science et de l'Innovation

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Emergencies; Infections; Communicable Diseases; Diarrhea; Respiratory Tract Infections; Dysentery
• Other Study ID Numbers: FACS; CRI-2021-02 (Other Identifier: CHU de Québec - Université Laval)

Drug and device information, study documents

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