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

Acute Respiratory Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322694
• Other study ID #: FACS
• Secondary ID: CRI-2021-02
• Status: Completed
• Start date: February 3, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1474
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Diarrhea
• Dysentery
• Emergencies
• Infections
• Respiratory Tract Infections

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Montréal	Montréal	Quebec
Canada	Hôpital Général Juif	Montréal	Quebec
Canada	CHU de Québec - Université Laval	Québec

Sponsors (3)

Lead Sponsor	Collaborator
Simon Berthelot	Meridian Bioscience, Inc., Ministère de l'Économie, de la Science et de l'Innovation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence proportion of ED returns	Incidence proportion of ED returns at 7 and 30 days after the initial visit.	30 days
Secondary	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
Secondary	Incidence of antibiotic prescribing	Incidence of antibiotic prescribing at initial visit and at 7 days (telephone follow-up).	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Incidence proportion of hospitalizations	Incidence proportion of hospitalizations at 7 and 30 days after the initial visit.	30 days
Secondary	Incidence proportion of deaths	Incidence proportion of deaths at 7 and 30 days after the initial visit.	30 days