Clinical trial NCT05322694: Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Infection
Acute Bacterial Diarrhea
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Meridian Bioscience, Inc.
name: Ministère de l'Économie, de la Science et de l'Innovation
First posted: 2022-04-12
Enrollment: 1474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.
timeFrame: 30 days
Secondary outcomes:
measure: Incidence proportion of ED returns
timeFrame: 30 days
measure: Incidence of prescribing antiviral medication
timeFrame: 7 days
measure: Incidence of antibiotic prescribing
timeFrame: 7 days
measure: Incidence of intensive care unit admission
timeFrame: 30 days
measure: Mean costs of care of the initial ED visit from a health system perspective
timeFrame: 30 days
measure: Mean costs of the disease from the patient perspective
timeFrame: 7 days
measure: Length of stay in the ED
timeFrame: Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours)
measure: Incidence proportion of hospitalizations
timeFrame: 30 days
measure: Incidence proportion of deaths
timeFrame: 30 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier universitaire de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Hôpital Général Juif
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
Study officials:
References: