Acute Respiratory InfectionNCT05322694
Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea
An observational study of Acute Respiratory Infection and Acute Bacterial Diarrhea, run by Simon Berthelot at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Infection, Acute Bacterial Diarrhea
- How many people
- 1,474 participants
- Where
- 3 sitesCanada
- Study dates
- 3 Feb 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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);
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- Triaged by the ED nurse and managed according to standard ED care protocols;
- Resident of Québec;
- Holder of a Québec health insurance number.
- 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.
Who cannot join
- 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 :
- Known neutropenia (<500 neutrophils);
- Active inflammatory bowel disease;
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- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre hospitalier universitaire de Montréal
Montreal, Quebec, H2X 0A9
Hôpital Général Juif
Montreal, Quebec, H3T 1E2
CHU de Québec - Université Laval
Québec, G1V 4G2
About this study
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.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (9)
Incidence proportion of ED returns
Incidence proportion of ED returns at 7 and 30 days after the initial visit.
Measured: 30 days
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).
Measured: 7 days
Incidence of antibiotic prescribing
Incidence of antibiotic prescribing at initial visit and at 7 days (telephone follow-up).
Measured: 7 days
Incidence of intensive care unit admission
Incidence of intensive care unit admission at 30 days (obtained from provincial administrative database on hospital admissions).
Measured: 30 days
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).
Measured: 30 days
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).
Measured: 7 days
Length of stay in the ED
Length of stay in the ED on the initial visit (electronic medical records).
Measured: Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours)
Incidence proportion of hospitalizations
Incidence proportion of hospitalizations at 7 and 30 days after the initial visit.
Measured: 30 days
Incidence proportion of deaths
Incidence proportion of deaths at 7 and 30 days after the initial visit.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start3 Feb 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Berthelot
- Sponsor type
- University, hospital or other
- Collaborators
- Meridian Bioscience, Inc., Ministère de l'Économie, de la Science et de l'Innovation
- Responsible party
- Sponsor-investigator, Simon Berthelot, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322694
- Sponsor's protocol ID
- FACS
- Other IDs
- CRI-2021-02
- Status last verified
- May 2023
- First submitted
- 17 Mar 2022
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05322694
- Acronym / sponsor ID
- FACS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,474 participants (actual)
- Lead sponsor
- Simon BerthelotUniversity, hospital or other
- Collaborators
- Meridian Bioscience, Inc., Ministère de l'Économie, de la Science et de l'Innovation
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
- Known neutropenia (<500 neutrophils);
- Active inflammatory bowel disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
9 secondary outcomes
Incidence proportion of ED returns
Time frame: 30 days
Incidence of prescribing antiviral medication
Time frame: 7 days
Incidence of antibiotic prescribing
Time frame: 7 days
Incidence of intensive care unit admission
Time frame: 30 days
Mean costs of care of the initial ED visit from a health system perspective
Time frame: 30 days
Mean costs of the disease from the patient perspective
Time frame: 7 days
Length of stay in the ED
Time frame: Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours)
Incidence proportion of hospitalizations
Time frame: 30 days
Incidence proportion of deaths
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infection and Acute Bacterial Diarrhea, run by Simon Berthelot at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7- and 30-day combined incidence of ED returns, hospitalizations, and deaths. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.