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

NCT ID: NCT05322694

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1474 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2023-03-31

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

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. 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 :

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role: collaborator

Ministère de l'Économie, de la Science et de l'Innovation

UNKNOWN

Sponsor Role: collaborator

Simon Berthelot

OTHER

Sponsor Role: lead

Responsible Party

Simon Berthelot

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

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Centre hospitalier universitaire de Montréal

Montreal, Quebec, Canada

Hôpital Général Juif

Montreal, Quebec, Canada

CHU de Québec - Université Laval

Québec, , Canada

Countries

Canada

Other Identifiers

CRI-2021-02

Identifier Type: OTHER

Identifier Source: secondary_id

FACS

Identifier Type: -

Identifier Source: org_study_id