- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07776990
Effectiveness of a Communication Training Program in Improving the Handling of Calls for Suspected Cardiac Arrest at SAMU-Centre 15. (COM-ARM)
Effectiveness of a Communication Training Program in Improving the Handling of Calls for Suspected Cardiac Arrest at SAMU-Centre 15. A Multicenter, Randomized Controlled Stepped-Wedge Implementation Trial
Each year, France's emergency response services-the SAMU (15) and the fire department (18)-handle 31 million and 19 million calls, respectively. The effectiveness of this system depends on the call centers' ability to obtain location information, prioritize responses, assess the severity of each call, and dispatch appropriate emergency resources.
Cardiac arrest (CA) affects 40,000 people in France each year who call on this service. The survival rate decreases by 7 to 10% for every minute that elapses between cardiac arrest and the start of cardiopulmonary resuscitation (CPR). Early CPR performed by bystanders is associated with a survival rate 2-3 times higher than CPR initiated only after emergency responders arrive on the scene. CPR assisted by SAMU-Centre 15 dispatchers (T-CPR) is a way to provide CPR to patients before emergency responders arrive on the scene and is recommended as early as possible to improve survival. According to the American Heart Association (AHA) guidelines, the timing of the initiation of the chain of survival is considered high quality if T-CPR is initiated within 90 seconds.
Studies show that recognizing a cardiac arrest (CA) over the phone is often difficult for several reasons, including communication challenges, the caller's stress, and the presence of abnormal breathing.
Emergency medical dispatchers (EMDs) receive very little training on communication strategies, particularly those needed to optimally manage stressed and sometimes difficult callers. Interventions to improve communication have proven effective among healthcare professionals. These methods included face-to-face training, blended learning programs, simulation-based teamwork exercises, and communication techniques adapted from aviation. Standardized scripting systems have been shown to improve the speed of decision-making and the dispatch of emergency response teams. These scripts depend on the quality of the information provided by the caller and the caller's ability to communicate effectively with the EMD.
The objective of this study will be to evaluate the effect of a communication training program for Centre-15 emergency medical dispatchers on calls for cardiac arrest.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Guillaume Debaty, MD, PhD
- Numéro de téléphone: +334767634202
- E-mail: gdebaty@chu-grenoble.fr
Sauvegarde des contacts de l'étude
- Nom: Juliette Meyzenc
- Numéro de téléphone: +33476634256
- E-mail: jmeyzenc@chu-grenoble.fr
Lieux d'étude
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-
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Annecy, France
- Ch Annecy-Genevois
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Contact:
- Thierry Roupioz
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Bordeaux, France
- CHU Bordeaux
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Contact:
- Xavier Combes
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Chambéry, France
- CH Métropole Savoie- Chambéry
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Contact:
- Heidi Mampe Armstrong
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La Roche-sur-Yon, France
- CH Vendée
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Contact:
- Vincent Diot
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Lyon, France
- Hospices Civils de Lyon - HEH
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Contact:
- Florent Femy
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Nancy, France
- CHRU NANCY
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Contact:
- Tahar Chouihed
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Nantes, France
- CHU Nantes
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Contact:
- Simon Ribes
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Rennes, France
- Chu Rennes
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Contact:
- Paul-Georges Reuter
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Rouen, France
- CHU Rouen
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Contact:
- Mélanie Roussel
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Toulouse, France
- CHU Toulouse
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Contact:
- Vincent Bounes
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Out-of-hospital cardiac arrest of presumed medical origin in an adult patient diagnosed during the phone call to the 15 emergency dispatch center
Non Inclusion Criteria:
- Minor patients,
- Calls initially handled by another emergency call center or a healthcare professional,
- Calls regarding cardiac arrest for which CPR has already been initiated at the time the call is made to the 15 center,
- Obvious or known pregnancy at the time of enrollment.
- Persons protected under Articles L1121-6 and L1121-8 of the Public Health Code (CSP).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control
Standard patient care in accordance with international recommendations.
Local protocols for handling
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Expérimental: Experimental
A multifaceted initiative combining training for SAMU Emergency medical dispatchers on the use of a standardized protocol, training on barriers to the early recognition of cardiac arrest, communication training to optimize interactions with callers, and training on handling difficult calls.
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a multifaceted initiative combining training for SAMU-Centre 15 emergency medical dispatchers (EMDs) on the use of a standardized script, training on barriers to the early recognition of cardiac arrest, communication training to optimize the relationship with the caller, and training on handling difficult calls
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The effect of a multifaceted training intervention for SAMU-Centre 15 emergency medical technicians on the proportion of patients with out-of-hospital cardiac arrest of medical origin who receive early T-RCP within 90 seconds of the call being answered,
Délai: Baseline
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The p-roportion of out-of-hospital cardiac arrests of medical origin for which T-RCP guidance is initiated within 90 seconds of the EMD answering the call will be calculated by the time to initiation of T-CPR (defined as the time elapsed between the SAMU-Centre 15 operator answering the call and the first time the operator verbally provides cardiopulmonary resuscitation instructions to the caller) The criterion will be considered met when this time is 90 seconds or less.
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Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Survival with good neurological outcome at 30 days
Délai: 30 days
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Favorable neurological outcome at 30 days : Neurological outcome will be assessed by a physician using: - the Cerebral Performance Category (CPC) scale CPC 1 : Good Cerbral Performance -> CPC 5: Brain Death |
30 days
|
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Survival with good neurological outcome at 30 days
Délai: 30 days
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Favorable neurological outcome at 30 days : Neurological outcome will be assessed by a physician using: - the modified Rankin scale Scores: 0: No Symptoms -> 5: Severe disability |
30 days
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Return of Spontaneous Circulation (ROSC)
Délai: perioperatively/periprocedurally (during the CPR)
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ROSC: defined by a clinical assessment of vital signs, including the presence of a palpable pulse or blood pressure
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perioperatively/periprocedurally (during the CPR)
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The proportion of patients admitted alive, discharged alive from the hospital, and alive at 30 days
Délai: Day 0, day of discharge of the hospital and 30 days
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Survival at hospital admission, discharge, and at 30 days
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Day 0, day of discharge of the hospital and 30 days
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The initial heart rate recorded
Délai: Baseline
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The initial heart rhythm recorded by a physician based on an analysis of the first heart rhythm recorded after the arrival of emergency medical personnel
|
Baseline
|
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Proportion of recognized cardiac arrests
Délai: Baseline
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Percentage of calls for suspected cardiac arrest (CA) out of the total number of calls received for confirmed cardiac arrest (upon the arrival of emergency responders at the scene).
|
Baseline
|
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Proportion of CAs recognized in calls for recognizable CAs
Délai: Baseline
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Percentage of calls for CAs identified relative to the number of calls received for identifiable CAs
|
Baseline
|
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Proportion of CA calls receiving CPR guidance,
Délai: Baseline
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Percentage of calls receiving advice from T-RCP
|
Baseline
|
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Proportion of CA calls in which the caller agrees to begin CPR for all CAs
Délai: Baseline
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Percentage of calls for CAs where the caller agrees to begin CPR for all CAs
|
Baseline
|
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Time to recognize a cardiac arrest
Délai: Baseline
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Timeframe for the EMS to recognize the CA.
|
Baseline
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Time to obtain location information
Délai: Baseline
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Time between answering the call and obtaining precise location information
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Baseline
|
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Percentage of cardiac arrests recognized within 60 seconds
Délai: Baseline
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Percentage of calls for CA recognized in less than 60 seconds, based on "recognizable" calls
|
Baseline
|
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Percentage of cardiac arrests recognized within 90 seconds
Délai: Baseline
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Percentage of calls for CA recognized in less than 90 seconds, based on "recognizable" calls
|
Baseline
|
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Time to begin CPR instructions
Délai: Baseline
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Timeframe for Initiating CPR instructions
|
Baseline
|
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Percentage of calls where CPR instructions begin within 150 seconds
Délai: Baseline
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The proportion of out-of-hospital cardiac arrests of medical origin for which T-RCP guidance is initiated within 150 seconds of the EMD answering the call is defined by the time to initiation of T-CPR
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Baseline
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Quality of communication by the EMD
Délai: Immediately after the procedure
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Call quality between the EMD and the caller: The evaluation will be conducted in accordance with the recommendations published by the Haute Autorité de Santé (HAS) [85], which include guidelines for conducting interviews with callers and communication protocols.
An assessment of compliance with the decision-making algorithms will also be included.
The evaluation will be carried out by experts during a blinded review of the trial period.
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Immediately after the procedure
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Impact on service quality
Délai: Day of inclusion
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Impact analysis on Center 15 by evaluating the QS30
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Day of inclusion
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Monique Sorrentino, CHU Grenoble Alpes
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 38RC22.0037
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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