Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-03 @ 4:25 PM
Study NCT ID:
NCT05322694
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2022-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasopharyngeal swab samples and rectal swab samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1474}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.', 'timeFrame': '30 days', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Incidence proportion of ED returns', 'timeFrame': '30 days', 'description': 'Incidence proportion of ED returns at 7 and 30 days after the initial visit.'}, {'measure': 'Incidence of prescribing antiviral medication', 'timeFrame': '7 days', 'description': 'Incidence of prescribing antiviral medication (e.g., oseltamivir) at the initial ED visit and at 7 days (telephone follow-up).'}, {'measure': 'Incidence of antibiotic prescribing', 'timeFrame': '7 days', 'description': 'Incidence of antibiotic prescribing at initial visit and at 7 days (telephone follow-up).'}, {'measure': 'Incidence of intensive care unit admission', 'timeFrame': '30 days', 'description': 'Incidence of intensive care unit admission at 30 days (obtained from provincial administrative database on hospital admissions).'}, {'measure': 'Mean costs of care of the initial ED visit from a health system perspective', 'timeFrame': '30 days', 'description': '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).'}, {'measure': 'Mean costs of the disease from the patient perspective', 'timeFrame': '7 days', 'description': 'Mean 7-day costs from the patient perspective (obtained from the Cost for Patient Questionnaire - the CoPaQ- administered at telephone follow-up).'}, {'measure': 'Length of stay in the ED', 'timeFrame': 'Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours)', 'description': 'Length of stay in the ED on the initial visit (electronic medical records).'}, {'measure': 'Incidence proportion of hospitalizations', 'timeFrame': '30 days', 'description': 'Incidence proportion of hospitalizations at 7 and 30 days after the initial visit.'}, {'measure': 'Incidence proportion of deaths', 'timeFrame': '30 days', 'description': 'Incidence proportion of deaths at 7 and 30 days after the initial visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Infection', 'Acute Bacterial Diarrhea']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Acute Respiratory Infections :\n\nInclusion Criteria:\n\n1. 18 years of age or older;\n2. Able to consent to the study;\n3. Reachable by phone;\n4. Consent to be reached directly by phone;\n5. 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;\n6. A triage score of 3 (30 minutes), 4 (60 minutes) or 5 (120 minutes) on the Canadian Triage and Acuity Scale (CTAS);\n7. Triaged by the ED nurse and managed according to standard ED care protocols;\n8. Resident of Québec;\n9. Holder of a Québec health insurance number.\n\nExclusion Criteria:\n\n1. Cognitive impairment that prevents the patient from reliably answering the risk stratification tool or research questions;\n2. Resident of a long-term care facility;\n3. Refusal of nasopharyngeal swab.\n\nAcute infectious diarrhea :\n\nInclusion Criteria:\n\n1. 18 years of age or older;\n2. Able to consent to the study;\n3. Reachable by phone;\n4. Consent to be reached directly by phone;\n5. At least three loose or liquid stools over a 24-hour period and for 10 days or less;\n6. A triage score of 3 (30 minutes), 4 (60 minutes) or 5 (120 minutes) on the Canadian Triage and Acuity Scale (CTAS);\n7. Triaged by the ED nurse and managed according to standard ED care protocols;\n8. Resident of Québec.\n9. Holder of a Québec health insurance number.\n\nExclusion Criteria:\n\n1. Known neutropenia (\\<500 neutrophils);\n2. Active inflammatory bowel disease;\n3. Anorectal pathology;\n4. Recent colonic surgery (\\< 6 months);\n5. Cognitive impairment preventing the patient from reliably answering the risk stratification tool or research questions;\n6. Resident of a long-term care facility;\n7. Refusal of the rectal swab.'}, 'identificationModule': {'nctId': 'NCT05322694', 'briefTitle': 'Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'FACS'}, 'secondaryIdInfos': [{'id': 'CRI-2021-02', 'type': 'OTHER', 'domain': 'CHU de Québec - Université Laval'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute respiratory infections', 'description': '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.\n\nImmediately 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.'}, {'label': 'Acute infectious diarrhea', 'description': '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.\n\nImmediately 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier universitaire de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Général Juif', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'country': 'Canada', 'facility': 'CHU de Québec - Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simon Berthelot', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meridian Bioscience, Inc.', 'class': 'INDUSTRY'}, {'name': "Ministère de l'Économie, de la Science et de l'Innovation", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté de médecine de l'Université Laval", 'investigatorFullName': 'Simon Berthelot', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}