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

• Sponsor: Simon Berthelot (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05322694
• Collaborator: Meridian Bioscience, Inc. (Industry), Ministère de l'Économie, de la Science et de l'Innovation (Other)
• Enrollment: 670
• Locations: 3
• Anticipated Duration (Months): 10.9
• Patients Per Site: 223.3
• Patients Per Site Per Month: 20.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Infection; Acute Bacterial Diarrhea

Study Design

• Study Type: Observational
• Anticipated Enrollment: 670 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Feb 3, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Incidence proportion of ED returns [30 days]

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

2. 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).

3. Incidence of antibiotic prescribing [7 days]

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

4. 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).

5. 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).

6. 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).

7. 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).

8. Incidence proportion of hospitalizations [30 days]

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

9. Incidence proportion of deaths [30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Pharyngeal pain and/or iv. Nasal congestion and/or v. Rhinorrhea and/or vi. Agueusia and/or vii. Anosmia;

1. A triage score of 3 (30 minutes), 4 (60 minutes) or 5 (120 minutes) on the Canadian Triage and Acuity Scale (CTAS);

2. Triaged by the ED nurse and managed according to standard ED care protocols;

3. Resident of Québec;

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire de Montréal	Montréal	Quebec	Canada	H2X 0A9
2	Hôpital Général Juif	Montréal	Quebec	Canada	H3T 1E2
3	CHU de Québec - Université Laval	Québec		Canada	G1V 4G2

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Simon Berthelot, Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté de médecine de l'Université Laval, CHU de Quebec-Universite Laval
• ClinicalTrials.gov Identifier: NCT05322694
• Other Study ID Numbers: FACS; CRI-2021-02
• First Posted: Apr 12, 2022
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Dysentery; Emergencies; Diarrhea

Study Results

No Results Posted as of Apr 21, 2022