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The PulsePoint Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT01746290
Recruitment Status : Withdrawn (The intervention (PulsePoint application) could not be implemented in Toronto as planned)
First Posted : December 10, 2012
Last Update Posted : November 26, 2015
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Steven Brooks, Queen's University

Study Description
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Brief Summary:
"Sudden cardiac arrest" occurs when someone's heart stops beating unexpectedly. Each year, more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve survival: Call 911,start chest compressions and apply a defibrillator. Together, these actions can increase survival by up to 800%. The problem is that bystanders to cardiac arrest only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3 of every 100 cardiac arrest cases. There are many people in the community who are trained and willing to provide help for cardiac arrest victims such as off-duty paramedics, fire fighters, nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of these people is nearby, but unaware of the emergency. The PulsePoint smartphone application enables these people to be notified by the local emergency 911 service when there is a cardiac arrest near to them. It can be freely downloaded to several common types of smartphones. When there is a cardiac arrest emergency, all nearby PulsePoint users are sent an alert from the 911 service. When the phones receive the alert, they ring, vibrate and display a text message saying "CPR NEEDED". The user's current location and the exact location of the cardiac arrest are then displayed on a map. Nearby public access AEDs are also indicated on the map. The smartphone users can then go to provide chest compressions and use an AED while paramedics are on their way. A video at www.pulsepoint.org shows how this works. The objective of the investigators is to measure whether the PulsePoint smartphone application increases bystander CPR or AED use for victims of cardiac arrest outside the hospital. This project will happen in the City of Toronto. The investigators have a plan to get as many people as possible to download the application, focusing on health care professionals who know CPR. The investigators will set up a webpage that helps people download the software to their phone. The investigators will randomize 911 calls to have a PulsePoint alert sent or not. The investigators will use statistical analysis to measure whether sending an alert to a smartphone increases the chances of bystander resuscitation.

Condition or disease Intervention/treatment Phase
Out-of-hospital Cardiac Arrest Other: PulsePoint notification Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The PulsePoint Smartphone Application: Recruiting Bystanders to Provide Basic Life Support for Victims of Out-of-Hospital Cardiac Arrest
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PulsePoint notification
Conventional Emergency Dispatch PLUS The PulsePoint notification. In the event of a potential cardiac arrest identified by 911call-takers, data will be automatically pushed to PulsePoint smartphone application users within very close proximity to the emergency. This will be done in parallel with normal emergency dispatch of paramedics and fire fighters to the scene of the emergency. The activation radius around the emergency is somewhat variable, depending on phone signal strength, climate conditions and whether the phone is inside or outside, but is approximately 200-500 meters.
 Other: PulsePoint notification
When the smartphone receives the alert data, the phone alarms with auditory, tactile (vibration) and visual stimuli (Figure 1). After acknowledgement of the alert by the user, the application presents a map and text information to direct the user to the exact location of the emergency. Using local AED registry data, the application can also reveal exact AED locations in the vicinity of the emergency
No Intervention: Usual Care
Patients randomized to the control arm will receive conventional emergency medical dispatching procedures but no PulsePoint notification will be sent to nearby PulsePoint users.


Outcome Measures
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Primary Outcome Measures :
  1. Bystander Resuscitation [ Time Frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes ]
    Bystander Resuscitation is defined as the occurrence of a bystander performing cardiopulmonary resuscitation or applying an automated external defibrillator to the chest of the subject prior to the arrival of professional rescuers


Secondary Outcome Measures :
  1. Bystander CPR [ Time Frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes ]
    The performance of cardiopulmonary resuscitation by a bystander to cardiac arrest prior to arrival of professional rescuers

  2. Bystander AED use [ Time Frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes ]
    The use of an automated external defibrillator by a bystander prior to the arrival of professional rescuers. Automated external defibrillator use is defined as the application of the electrical pads of the machine to the chest of the victim.

  3. Bystander AED shock [ Time Frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes ]
    The occurrence of a bystander applying an automated external defibrillator and then applying a defibrillatory shock to the chest of the victim

  4. Return of Spontaneous Circulation [ Time Frame: Patients are followed until death or discharge from the hospital, an expected average 30 days ]
    Return of spontaneous circulation, defined as any palpable pulse or measureable blood pressure.

  5. Survival to hospital discharge [ Time Frame: Patients are followed until death or discharge from hospital, an expected average of 30 days ]
    Survival of a patient to the point of discharge from the acute care hospital. Discharge may be to a residence or long term care facility.

  6. Survival to hospital discharge with good functional outcome [ Time Frame: Patients are followed unitl death or discharge from hospital, an expected average of 30 days ]
    The occurrence of a patient surviving to hospital discharge with a Modified Rankin Score of 0, 1 or 2.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with 911 calls assigned MPDS code 09-E-01 (Suspected atraumatic cardiac arrest not breathing), and 09-E-02 (Suspected cardiac arrest, not breathing normally),
  2. Out-of-hospital cardiac arrest as defined within the ROC Epistry Database

Exclusion Criteria:

  1. Trauma (including burns) associated with cardiac arrest
  2. Cardiac arrests occurring in prisons, etc
  3. Patients not treated by paramedics because of a DNR order or signs of obvious death as per Ontario provincial paramedic medical directives (e.g. decapitation, decomposition, rigour mortis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746290


Locations
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Canada, Ontario
Toronto Emergency Medical Services
Toronto, Ontario, Canada, M3H 5R9
Sponsors and Collaborators
Queen's University
Heart and Stroke Foundation of Ontario
Investigators
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Principal Investigator: Steven C Brooks, MD MHSc Queen's University
More Information
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Responsible Party: Dr. Steven Brooks, Clinician-Scientist, Queen's University
ClinicalTrials.gov Identifier: NCT01746290    
Other Study ID Numbers: 228304
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Keywords provided by Dr. Steven Brooks, Queen's University:
Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases