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Completed

NCT Number: NCT05322694

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Montréal, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Acute Respiratory Infections :

Inclusion criteria

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

Exclusion criteria

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

Acute infectious diarrhea :

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.

    Time frame: 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 outcomes

  1. Incidence proportion of ED returns

    Time frame: 30 days

    Incidence proportion of ED returns at 7 and 30 days after the initial visit.

  2. Incidence of prescribing antiviral medication

    Time frame: 7 days

    Incidence of prescribing antiviral medication (e.g., oseltamivir) at the initial ED visit and at 7 days (telephone follow-up).

  3. Incidence of antibiotic prescribing

    Time frame: 7 days

    Incidence of antibiotic prescribing at initial visit and at 7 days (telephone follow-up).

  4. Incidence of intensive care unit admission

    Time frame: 30 days

    Incidence of intensive care unit admission at 30 days (obtained from provincial administrative database on hospital admissions).

  5. Mean costs of care of the initial ED visit from a health system perspective

    Time frame: 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).

  6. Mean costs of the disease from the patient perspective

    Time frame: 7 days

    Mean 7-day costs from the patient perspective (obtained from the Cost for Patient Questionnaire - the CoPaQ- administered at telephone follow-up).

  7. Length of stay in the ED

    Time frame: 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).

  8. Incidence proportion of hospitalizations

    Time frame: 30 days

    Incidence proportion of hospitalizations at 7 and 30 days after the initial visit.

  9. Incidence proportion of deaths

    Time frame: 30 days

    Incidence proportion of deaths at 7 and 30 days after the initial visit.

Sponsors and collaborators

Lead sponsor

Simon Berthelot

Other

Collaborators

  • Meridian Bioscience, Inc.
  • Ministère de l'Économie, de la Science et de l'Innovation

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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