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

Completed

• Conditions: Acute Respiratory Infection; Acute Bacterial Diarrhea

• Registration Number: NCT05322694
• Lead Sponsor: Simon Berthelot

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-12
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1474

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.	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 Outcome Measures

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

Trial Locations

Locations (3)

Centre hospitalier universitaire de Montréal; 🇨🇦 Montréal, Quebec, Canada

Hôpital Général Juif; 🇨🇦 Montréal, Quebec, Canada

CHU de Québec - Université Laval; 🇨🇦 Québec, Canada