- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Guillaume Debaty, MD, PhD
- Telefonní číslo: +334767634202
- E-mail: gdebaty@chu-grenoble.fr
Studijní záloha kontaktů
- Jméno: Juliette Meyzenc
- Telefonní číslo: +33476634256
- E-mail: jmeyzenc@chu-grenoble.fr
Studijní místa
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Annecy, Francie
- Ch Annecy-Genevois
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Kontakt:
- Thierry Roupioz
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Bordeaux, Francie
- CHU Bordeaux
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Kontakt:
- Xavier Combes
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Chambéry, Francie
- CH Métropole Savoie- Chambéry
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Kontakt:
- Heidi Mampe Armstrong
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La Roche-sur-Yon, Francie
- CH Vendée
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Kontakt:
- Vincent Diot
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Lyon, Francie
- Hospices Civils de Lyon - HEH
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Kontakt:
- Florent Femy
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Nancy, Francie
- CHRU NANCY
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Kontakt:
- Tahar Chouihed
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Nantes, Francie
- CHU Nantes
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Kontakt:
- Simon Ribes
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Rennes, Francie
- Chu Rennes
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Kontakt:
- Paul-Georges Reuter
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Rouen, Francie
- CHU Rouen
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Kontakt:
- Mélanie Roussel
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Toulouse, Francie
- CHU Toulouse
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Kontakt:
- Vincent Bounes
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Control
Standard patient care in accordance with international recommendations.
Local protocols for handling
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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,
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Survival with good neurological outcome at 30 days
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Baseline
|
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Proportion of recognized cardiac arrests
Časové okno: 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).
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Baseline
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Proportion of CAs recognized in calls for recognizable CAs
Časové okno: Baseline
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Percentage of calls for CAs identified relative to the number of calls received for identifiable CAs
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Baseline
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Proportion of CA calls receiving CPR guidance,
Časové okno: Baseline
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Percentage of calls receiving advice from T-RCP
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Baseline
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Proportion of CA calls in which the caller agrees to begin CPR for all CAs
Časové okno: Baseline
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Percentage of calls for CAs where the caller agrees to begin CPR for all CAs
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Baseline
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Time to recognize a cardiac arrest
Časové okno: Baseline
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Timeframe for the EMS to recognize the CA.
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Baseline
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Time to obtain location information
Časové okno: 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
Časové okno: Baseline
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Percentage of calls for CA recognized in less than 60 seconds, based on "recognizable" calls
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Baseline
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Percentage of cardiac arrests recognized within 90 seconds
Časové okno: Baseline
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Percentage of calls for CA recognized in less than 90 seconds, based on "recognizable" calls
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Baseline
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Time to begin CPR instructions
Časové okno: Baseline
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Timeframe for Initiating CPR instructions
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Baseline
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Percentage of calls where CPR instructions begin within 150 seconds
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Monique Sorrentino, CHU Grenoble Alpes
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 38RC22.0037
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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