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

May 16, 2023 updated by: University Hospital, Grenoble

Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2481

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • SAMU 80 - CHU Amiens Picardie
      • Annecy, France, 74370
        • SAMU 74 - CH Annecy Genevois
      • Bordeaux, France, 33076
        • SAMU 33 - CHU Hôpital Pellegrin
      • Bourg en bresse, France, 01012
        • SAMU 01 - CH Fleyriat
      • Brest, France, 29609
        • SAMU 29 - CHRU La Cavale Blanche
      • Chambéry, France, 73011
        • SAMU 73 - Centre Hospitalier Métropôle Savoie
      • Dijon, France, 21000
        • SAMU 21 - CHU Dijon
      • Grenoble, France, 38043
        • SAMU 38 - CHU Grenoble Alpes
      • La Roche-sur-Yon, France, 85025
        • Samu 85 - Chd Les Oudairies
      • Nancy, France, 54000
        • SAMU 54 - CHU Nancy
      • Nantes, France
        • SAMU 44 - Hôtel Dieu
      • Nice, France, 06001
        • SAMU 06 - CHU de Nice
      • Saint-Étienne, France, 42270
        • SAMU 42 -CHU Saint-Etienne
      • Toulouse, France, 31000
        • SAMU 31 - CHU Toulouse
      • Valence, France, 26953
        • SAMU 26 - CH de Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Usual management of patients according to international guidelines. Protocols of call acceptance, phone advice and sending of emergency services are not modified
Other: Test Group

Multifaceted intervention

  1. Training using distance learning for medical regulation assistants to recognise cardiac arrest on phone
  2. Activation of the location-software application to send bystanders on cardiac arrest location before the arrival of emergency medical services (EMS)
  3. Motivation feed-back Volunteers will received feed-back regarding CPR initiated before EMS arrival and survival
Other: Multifaceted intervention including 3 components
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CPR initiated by bystanders before the arrival of first professionals rescuers
Time Frame: Day 0
Proportion of patients who's received CPR initiated by bystander before EMS arrival.
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival to hospital discharge
Time Frame: up to 30 days
Vital status at hospital discharge
up to 30 days
Survival at 30 days
Time Frame: 30 days
Vital status at 30 days
30 days
Survival at 72h after out-of-hospital cardiac arrest
Time Frame: 72 hours
survival at 72h
72 hours
Return of Spontaneous Circulation
Time Frame: Day 0
Proportion of patients who's recovered a spontaneous circulation after CPR
Day 0
Survival to hospital admission
Time Frame: Day 0
Vital status at hospital admission
Day 0
Neurological functional status CPC
Time Frame: up to 30 days
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
up to 30 days
Neurological functional status mRS
Time Frame: 30 days

As measured by modified Rankin Scale (mRS) at hospital discharge and at 30 days:

modified Rankin Scale (mRS): 0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead Score less or equal to 3 will be considered as favorable neurological outcome
30 days
First recorded rhythm
Time Frame: 30 min
First recorded cardiac rhythm by EMS
30 min

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bystander's CPR quality
Time Frame: Day 0
Evaluation of CPR quality performed by bystanders on a 4 points scale. CPR quality will be assessed by first professional rescuers on scene.
Day 0
Confirmation of cardiac arrest
Time Frame: Days 0
The dispatcher CA's recognition will be confirmed by EMS on scene
Days 0
Automated External Defibrillator initiated before EMS arrival
Time Frame: Day 0
Proportion of patients who's benefit to a automated external defibrillator before the EMS arrivals
Day 0
CPR initiation by witness without dispatcher Telephone-CPR
Time Frame: Day 0
Evaluation of the proportion of patients with CPR initiated before EMS arrival without dispatcher Telephone-CPR
Day 0
CPR initiation by witness with Telephone-CPR
Time Frame: Day 0
Evaluation of CPR initiated before EMS arrival following Telephone-CPR
Day 0
CPR initiation by app-activated bystanders
Time Frame: Day 0
Evaluation of CPR initiated by bystanders, who are activated by the geo-localization application
Day 0
Proportion of cardiac arrest correctly identified after dispatch
Time Frame: 24 months
Assessment of the evolution in CA recognition after the e-learning training
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Monique Sorentino, Chu Grenoble Alpes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DISPATCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol will be submitted for publication. IPD will be shared with other researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrest

Clinical Trials on Multifaceted intervention including 3 components

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings