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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,474
- 试验地点
- 3
- 主要终点
- 7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
7- and 30-day combined incidence of ED returns, hospitalizations, and deaths.
时间窗: 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).
次要结局
- Incidence proportion of ED returns(30 days)
- Incidence of intensive care unit admission(30 days)
- Mean costs of the disease from the patient perspective(7 days)
- Incidence proportion of hospitalizations(30 days)
- Incidence of prescribing antiviral medication(7 days)
- Incidence of antibiotic prescribing(7 days)
- Mean costs of care of the initial ED visit from a health system perspective(30 days)
- Incidence proportion of deaths(30 days)
- Length of stay in the ED(Measured from ED arrival to ED discharge on the initial visit (maximum 120 hours))
研究者
Simon Berthelot
Emergency Physician, CHU de Québec-Université Laval; Associate Professor, Faculté de médecine de l'Université Laval
CHU de Quebec-Universite Laval