Clinical trial NCT06149819: Chest Pain Nurse Track
Official title: Nurse Pathway for the Diagnosis of Non-traumatic Chest Pain in the Emergency Department: Preliminary Pilot Study (Chest Pain Nurse Track)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
Keywords: non traumatic chest pain
Nurse
management
track
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a controlled, single centre, non-randomized, open-label interventional study evaluating the implementation of a nursing pathway management for chest pain. This study is an external comparison with a control group consisting of patients meeting the same eligibility criteria admitted to the Emergency Department over the same period and included prospectively with a 1:1 ratio. This design was chosen because of the difficulty of randomizing patients (few trained nurses) and the need to conduct a pivotal study.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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 :

1. 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.

   The patient will be enrolled either in the experimental (paramedical) or control (medical) group. 91 patients will be included in each group.

   Experimental (Intervention) group or (paramedical cohort) :

   The patient is 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.

   The nurse will manage the patient according to the standardized algorithm based on the recommendations. An emergency physician will be systematically involved in the management process for interpretation of electrocardiogram (EKG) and chest x-ray, during a positive diagnosis, a sign of gravity and finally at any time as soon as the nurse considers it necessary. In addition each patient will be systematically examined and reassessed by a physician during paramedical management to validate the clinical, therapeutic and discharges conclusions.

   Control group (or medical cohort) :

   Cohort of patients receiving usual medical care over the same period in the emergency department and meeting eligibility criteria. Patients in this group will be included prospectively after obtaining their consent, with a 1:1 ratio with sex and age correspondence +/- 5 years).

   An independent adjudication committee comprising at least one emergency physician and one cardiologist will be responsible for analyzing the medical records of all patients (included in the two groups) in order to determine compliance with diagnostic management. It will meet before each Data and Safety Monitoring Board (DSMB) meeting (at 20, 50 and 80%) and at the end of the study.

   Data and Safety Monitoring Board (DSMB)composed of a methodologist, a cardiologist and an emergency physician. The DSMB will be responsible for analyzing the compliance and safety of management in the experimental group at 20, 50 and 80% of enrollment and at the request of the sponsor if necessary. This committee will also analyze the one month outcome of the patients included. It will decide whether to prosecute or stop the study.
3. Phone call follow-up of patient after one month to collect data :

   * Intercurrent serious events : death, re-admission, myocardial infarction, serious AE
   * Assessment of patient satisfaction
   * Any additional examinations and consultations carried out.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG
timeFrame: 15 minutes
measure: Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department.
timeFrame: 30 days
measure: All-cause care consumption in each cohort at one month
timeFrame: 30 days
measure: Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort
timeFrame: 30 days
measure: Refusal rate of participation in the study in the paramedical cohort
timeFrame: 24 hours and 30 days
measure: Patient satisfaction assessed during discharge and at one month in both cohort
timeFrame: 24 hours and 30 days
measure: Assessment of quality of life during discharge and at one month in both cohort
timeFrame: 24 hours and 30 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: Emergency Department of University Hospital Grenoble
name: Damien VIGLINO
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department of University Hospital Grenoble
name: Florian BARRET, Bachelor
role: STUDY_DIRECTOR
affiliation: Emergency Department of University Hospital Grenoble
name: Karine FANJAS, Bachelor
role: STUDY_DIRECTOR
References: