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Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest (DISPATCH)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multifaceted intervention including 3 components
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Dispatcher, Cardiopulmonary Resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adults with nontraumatic, out-of-hospital cardiac arrest diagnosed during the emergency medical service call
  • Cardiac arrest located in urban area

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients under the law
  • Patients deprived of liberty by court ruling or administrative ruling
  • Traumatic cardiac arrest
  • CA occurring under the eyes of a professional emergency services patrol on duty
  • Cardiac arrest for which resuscitation seem unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, non-resuscitation personal directive…)

Sites / Locations

  • SAMU 80 - CHU Amiens Picardie
  • SAMU 74 - CH Annecy Genevois
  • SAMU 33 - CHU Hôpital Pellegrin
  • SAMU 01 - CH Fleyriat
  • SAMU 29 - CHRU La Cavale Blanche
  • SAMU 73 - Centre Hospitalier Métropôle Savoie
  • SAMU 21 - CHU Dijon
  • SAMU 38 - CHU Grenoble Alpes
  • Samu 85 - Chd Les Oudairies
  • SAMU 54 - CHU Nancy
  • SAMU 44 - Hôtel Dieu
  • SAMU 06 - CHU de Nice
  • SAMU 42 -CHU Saint-Etienne
  • SAMU 31 - CHU Toulouse
  • SAMU 26 - CH de Valence

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control Group

Test Group

Arm Description

Usual management of patients according to international guidelines. Protocols of call acceptance, phone advice and sending of emergency services are not modified

Multifaceted intervention Training using distance learning for medical regulation assistants to recognise cardiac arrest on phone Activation of the location-software application to send bystanders on cardiac arrest location before the arrival of emergency medical services (EMS) Motivation feed-back Volunteers will received feed-back regarding CPR initiated before EMS arrival and survival

Outcomes

Primary Outcome Measures

CPR initiated by bystanders before the arrival of first professionals rescuers
Proportion of patients who's received CPR initiated by bystander before EMS arrival.

Secondary Outcome Measures

Survival at 72h after out-of-hospital cardiac arrest
survival at 72h
Return of Spontaneous Circulation
Proportion of patients who's recovered a spontaneous circulation after CPR
Survival to hospital admission
Vital status at hospital admission
Survival to hospital discharge
Vital status at hospital discharge
Survival at 30 days
Vital status at 30 days
Neurological functional status CPC
As measured by Cerebral Performance Category (CPC) at hospital discharge and at 30 days Score less or equal to 2 will be considered as favorable neurological outcome
Neurological functional status mRS
As measured by modified Rankin Scale (mRS) at hospital discharge and at 30 days: modified Rankin Scale (mRS): 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead Score less or equal to 3 will be considered as favorable neurological outcome
First recorded rhythm
First recorded cardiac rhythm by EMS

Full Information

First Posted
July 19, 2018
Last Updated
May 16, 2023
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03633370
Brief Title
Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest
Acronym
DISPATCH
Official Title
Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cardiac arrest (CA) early recognition is essential in order to rapidly activate emergency services and for bystanders to begin cardiopulmonary resuscitation (CPR). As soon as a call is received, EMS dispatchers should try to identify CA. This may be difficult, in a context of stress and distress of the person calling. Yet, it is vital for bystanders to initiate CPR. Survival can be multiplied by 2 to 4 if the bystanders initiate a CPR before the arrival of the emergency medical services. This work aim to assess a multifaceted intervention combining 3 elements to improve the initial phone recognition of CA and raise the number of patients benefiting from CPR before EMS arrival on scene. The first element is a dispatcher training to the early phone recognition of CA. This training will be based on the concept of active teaching, favouring the interactive work of learners in particular by listening to real dispatch recordings. It will be completed by continuing education with a distance teaching platform including the systematic listening of recorded CA calls. The second element is based on the deployment of a software aiming to notify CA thanks to mobile phones. This system interfaced to a control software enables to request the participation of CPR-trained volunteers automatically. The volunteers have to be located in the patient's surroundings. The deployment of this mobile application will rely on first-aid volunteers, health personal and any trained volunteers willing to participate. A randomized control study in one city area proved the efficiency of a similar software to improve the proportion of CPR by bystanders. The third element consists in a motivational feedback. A weekly overview of the management and the outcomes of patients who suffered CA will be broadcast to all the responders and volunteers in the mobile application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac Arrest, Dispatcher, Cardiopulmonary Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A Stepped Wedge Cluster Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2481 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual management of patients according to international guidelines. Protocols of call acceptance, phone advice and sending of emergency services are not modified
Arm Title
Test Group
Arm Type
Other
Arm Description
Multifaceted intervention Training using distance learning for medical regulation assistants to recognise cardiac arrest on phone Activation of the location-software application to send bystanders on cardiac arrest location before the arrival of emergency medical services (EMS) Motivation feed-back Volunteers will received feed-back regarding CPR initiated before EMS arrival and survival
Intervention Type
Other
Intervention Name(s)
Multifaceted intervention including 3 components
Intervention Description
Multifaceted intervention including Dispatcher training to improve cardiac phone recognition, mobile application to send bystanders on cardiac arrest location before first professionals rescuers and motivational support for volunteer bystanders
Primary Outcome Measure Information:
Title
CPR initiated by bystanders before the arrival of first professionals rescuers
Description
Proportion of patients who's received CPR initiated by bystander before EMS arrival.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Survival at 72h after out-of-hospital cardiac arrest
Description
survival at 72h
Time Frame
72 hours
Title
Return of Spontaneous Circulation
Description
Proportion of patients who's recovered a spontaneous circulation after CPR
Time Frame
Day 0
Title
Survival to hospital admission
Description
Vital status at hospital admission
Time Frame
Day 0
Title
Survival to hospital discharge
Description
Vital status at hospital discharge
Time Frame
up to 30 days
Title
Survival at 30 days
Description
Vital status at 30 days
Time Frame
30 days
Title
Neurological functional status CPC
Description
As measured by Cerebral Performance Category (CPC) at hospital discharge and at 30 days Score less or equal to 2 will be considered as favorable neurological outcome
Time Frame
up to 30 days
Title
Neurological functional status mRS
Description
As measured by modified Rankin Scale (mRS) at hospital discharge and at 30 days: modified Rankin Scale (mRS): 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead Score less or equal to 3 will be considered as favorable neurological outcome
Time Frame
30 days
Title
First recorded rhythm
Description
First recorded cardiac rhythm by EMS
Time Frame
30 min
Other Pre-specified Outcome Measures:
Title
Bystander's CPR quality
Description
Evaluation of CPR quality performed by bystanders on a 4 points scale. CPR quality will be assessed by first professional rescuers on scene.
Time Frame
Day 0
Title
Confirmation of cardiac arrest
Description
The dispatcher CA's recognition will be confirmed by EMS on scene
Time Frame
Days 0
Title
Automated External Defibrillator initiated before EMS arrival
Description
Proportion of patients who's benefit to a automated external defibrillator before the EMS arrivals
Time Frame
Day 0
Title
CPR initiation by witness without dispatcher Telephone-CPR
Description
Evaluation of the proportion of patients with CPR initiated before EMS arrival without dispatcher Telephone-CPR
Time Frame
Day 0
Title
CPR initiation by witness with Telephone-CPR
Description
Evaluation of CPR initiated before EMS arrival following Telephone-CPR
Time Frame
Day 0
Title
CPR initiation by app-activated bystanders
Description
Evaluation of CPR initiated by bystanders, who are activated by the geo-localization application
Time Frame
Day 0
Title
Proportion of cardiac arrest correctly identified after dispatch
Description
Assessment of the evolution in CA recognition after the e-learning training
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adults with nontraumatic, out-of-hospital cardiac arrest diagnosed during the emergency medical service call Cardiac arrest located in urban area Exclusion Criteria: Pregnant or breastfeeding women Patients under the law Patients deprived of liberty by court ruling or administrative ruling Traumatic cardiac arrest CA occurring under the eyes of a professional emergency services patrol on duty Cardiac arrest for which resuscitation seem unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, non-resuscitation personal directive…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Sorentino
Organizational Affiliation
CHU Grenoble Alpes
Official's Role
Study Director
Facility Information:
Facility Name
SAMU 80 - CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
SAMU 74 - CH Annecy Genevois
City
Annecy
ZIP/Postal Code
74370
Country
France
Facility Name
SAMU 33 - CHU Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
SAMU 01 - CH Fleyriat
City
Bourg en bresse
ZIP/Postal Code
01012
Country
France
Facility Name
SAMU 29 - CHRU La Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
SAMU 73 - Centre Hospitalier Métropôle Savoie
City
Chambéry
ZIP/Postal Code
73011
Country
France
Facility Name
SAMU 21 - CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
SAMU 38 - CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Samu 85 - Chd Les Oudairies
City
La Roche-sur-Yon
ZIP/Postal Code
85025
Country
France
Facility Name
SAMU 54 - CHU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
SAMU 44 - Hôtel Dieu
City
Nantes
Country
France
Facility Name
SAMU 06 - CHU de Nice
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
SAMU 42 -CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42270
Country
France
Facility Name
SAMU 31 - CHU Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
SAMU 26 - CH de Valence
City
Valence
ZIP/Postal Code
26953
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol will be submitted for publication. IPD will be shared with other researcher.

Learn more about this trial

Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest

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