Nurse Pathway for the Diagnosis of Non-traumatic Chest Pain in the Emergency Department: Preliminary Pilot Study (Chest Pain Nurse Track)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care.
研究概览
简要总结
Chest pain is a commonly encountered presentation in the emergency department (ED), with an incidence ranging from 5 to 12%. Chest pain has a wide range of aetiologies from the mildest to the most severe. In benign forms these pains can be musculoskeletal, psychogenic or even indeterminate (>60% depending on the place of recruitment). Coronary aetiology represents 12 to 25% of severe forms.
The management of chest pain in the emergency department is part of the daily life of nurses. According to the french 2020 Nurse Reception Organizer (IOA) guidelines, a nurse who has been trained for this role is required to "triage" (severity grade and orientation) patients presenting for this reason. The presence of specialized nurses in the management of chest pain allows faster initial management.
To date, no study has been conducted to assess the diagnostic and treatment performance of a nursing pathway for the management of patients presenting with acute chest pain regardless of the suspected diagnosis and not only acute coronary syndrome.
详细描述
The main objective of this interventional study is to evaluate the diagnostic safety of a nursing pathway for the management of patients presenting with chest pain in the emergency department compared with usual medical care.
This study is an external comparison with a control group consisting of patients meeting the eligibility criteria admitted to the Emergency Department over the same period and included prospectively with a 1:1 ratio.
The study will be conducted in three phases :
- Training volunteer emergency department nurses (11) : the course will cover all aspects of management of non-traumatic chest pain (physiopathology, from diagnosis to treatment).
For the selection of nurses, these criteria will need to be met : minimum of five years of practice in the profession with at least three years in emergency department ; the nurse must have had the training as a Nurse Reception Organizer and have received specific training in accordance with the study protocol. 2. Enrollment of 182 patients admitted to the emergency department for non-traumatic chest pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Admission to emergency department (ED) for non-traumatic Chest Pain
- •Affiliation to the French social security system
- •Written informed consent must be obtained
- •For women of childbearing age: effective contraception in place for at least 3 months. The absence of pregnancy should be confirmed by a negative urine test without delaying the start of the management including the realization of Electrocardiogram (EKG/ECG).
排除标准
- •Suspected alcohol, drug or toxic intoxication
- •Chest pain with associated neurological signs
- •Patient with pacemaker or defibrillator
- •Patient in vital distress requiring immediate medical intervention
- •Patient admitted with a previously established aetiological diagnosis
- •Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
- •Pregnant or breast-feeding patients
- •Subject under administrative or judicial control, under protection
研究组 & 干预措施
Intervention (paramedical)
The patients will be cared for by one of the specially trained nurses based on a previously established allocation per day. A nurse will be able to take in charge several patients successively included on the same day, in accordance with the actual practice of organized intra-hospital sector and according to the standardized algorithm based on the recommendations.
The DSMB will analyzed the compliance and safety of the management in this group at 20, 50 and 50% of enrollment and at the request of the sponsor if necessary.
An adjudication committee will determine compliance with diagnostic management in the two groups.
干预措施: Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain (Other)
Control (medical)
In this group the patients will received usual medical care over the same period in the emergency department and meeting eligibility criteria. Patients will be included prospectively after obtaining their consent, with a 1:1 ratio with sex and age correspondence +/- 5 years).
An adjudication committee will determine compliance with diagnostic management in the two groups.
结局指标
主要结局
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care.
时间窗: 30 days
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care after adjudication by an expert committee.
次要结局
- Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG(15 minutes)
- Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort(30 days)
- Patient satisfaction assessed during discharge and at one month in both cohort(24 hours and 30 days)
- All-cause care consumption in each cohort at one month(30 days)
- Assessment of quality of life during discharge and at one month in both cohort(24 hours and 30 days)
- Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department.(30 days)
- Refusal rate of participation in the study in the paramedical cohort(24 hours and 30 days)