- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Guillaume Debaty, MD, PhD
- 전화번호: +334767634202
- 이메일: gdebaty@chu-grenoble.fr
연구 연락처 백업
- 이름: Juliette Meyzenc
- 전화번호: +33476634256
- 이메일: jmeyzenc@chu-grenoble.fr
연구 장소
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Annecy, 프랑스
- Ch Annecy-Genevois
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연락하다:
- Thierry Roupioz
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Bordeaux, 프랑스
- CHU Bordeaux
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연락하다:
- Xavier Combes
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Chambéry, 프랑스
- CH Métropole Savoie- Chambéry
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연락하다:
- Heidi Mampe Armstrong
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La Roche-sur-Yon, 프랑스
- CH Vendée
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연락하다:
- Vincent Diot
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Lyon, 프랑스
- Hospices Civils de Lyon - HEH
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연락하다:
- Florent Femy
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Nancy, 프랑스
- CHRU NANCY
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연락하다:
- Tahar Chouihed
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Nantes, 프랑스
- CHU Nantes
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연락하다:
- Simon Ribes
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Rennes, 프랑스
- Chu Rennes
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연락하다:
- Paul-Georges Reuter
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Rouen, 프랑스
- CHU Rouen
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연락하다:
- Mélanie Roussel
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Toulouse, 프랑스
- CHU Toulouse
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연락하다:
- Vincent Bounes
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control
Standard patient care in accordance with international recommendations.
Local protocols for handling
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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,
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Survival with good neurological outcome at 30 days
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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,
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Monique Sorrentino, CHU Grenoble Alpes
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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