CHU Grenoble Alpes
Grenoble, 38043, France
Location status: Recruiting
Location contact
Damien VIGLINO
CONTACT
NCT Number: NCT06149819
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Grenoble, 38043, France
Location status: Recruiting
Damien VIGLINO
CONTACT
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 :
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
trained nurses will take in charge non-traumatic chest pain patient according to the standardized algorithm based on the recommendations .
Time frame: 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.
Time frame: 15 minutes
Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG
Time frame: 30 days
Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department .
Time frame: 30 days
All-cause care consumption in each cohort at one month
Time frame: 30 days
Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort
Time frame: 24 hours and 30 days
Refusal rate of participation in the study in the paramedical cohort
Time frame: 24 hours and 30 days
Patient satisfaction assessed during discharge and at one month by a numerical scale in both cohort numbered from 1 to 10 : (Not satisfied patient would no longer accept a nurse's care - Completely satisfied patient would accept to be cared for again by a nurse)
Time frame: 24 hours and 30 days
Assessment of quality of life using EuroQol 5-dimension scale at discharge from emergency department and at one month in both cohort numbered from 0 to 100 : (the worst health you can imagine -the best health you can imagine)
Contact information is provided by the study sponsor or research team.
Damien VIGLINO, Pr MD PhD
CONTACT
Prudence MABIALA MAKELE, PhD
CONTACT
University Hospital, Grenoble
Other
Nurse Pathway for the Diagnosis of Non-traumatic Chest Pain in the Emergency Department: Preliminary Pilot Study (Chest Pain Nurse Track)
Acronym: CHESTNUT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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