Just in Time Cardio Pulmonary Resuscitation Trial (JITCPR-T)
Primary Purpose
Cardiopulmonary Arrest With Successful Resuscitation, Educational Problems
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
AHA course
Sponsored by
About this trial
This is an interventional other trial for Cardiopulmonary Arrest With Successful Resuscitation focused on measuring Youtube, Video Education, Public Empowerment, CPR, AED
Eligibility Criteria
Inclusion Criteria: Employee of Gillette Stadium Exclusion Criteria: Age less than 18 years
Sites / Locations
- Gillette StadiumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Control
Just in time video
AHA Course
Arm Description
Assessment without training or video prompt
Assessment with JiT video available
Assessment after completion of CPR training course
Outcomes
Primary Outcome Measures
Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance)
Correct CPR will be measured by successful completion of all five of the following actions:
Calling for 9-1-1 (as measured by verbalizing action to examiner)
Calling for automated external defibrillator (as measured by verbalizing action to examiner)
Placing hand in correct position on manikin chest (as measured by examiner)
Compressing at a rate of 100-120 per minute (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
Compressing to a depth of at least 2 inches (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
Secondary Outcome Measures
CPR knowledge (Objective Knowledge)
Knowledge regarding CPR skills will be measured by an 8-question multiple choice assessment, based on the American Heart Association HeartSaver curriculum. The assessment will test participants' understanding of when to perform CPR on a victim and how to perform CPR correctly (e.g., hand placement, compression rate, and compression depth). The assessment will be scored as 1 point per correct answer, with a range of 0-8 points (higher score indicates better knowledge).
Change in willingness to respond (Subjective Preparedness)
Participants will complete pre/post 6-question assessments to determine the change in their likelihood and confidence in providing CPR in different situations. Items will be scored on a 5-point Likert-type scale (very unlikely to very likely) for likelihood to perform CPR (for a stranger, close relative for friend, or if requested by a trained professional and confidence in identifying cardiac arrest, performing CPR, and using an AED. Change in willingness to respond will be measured by examining the within-person change from pre and post assessments.
Full Information
NCT ID
NCT05983640
First Posted
April 12, 2023
Last Updated
August 7, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT05983640
Brief Title
Just in Time Cardio Pulmonary Resuscitation Trial
Acronym
JITCPR-T
Official Title
Just in Time Cardio Pulmonary Resuscitation Trial (JITCPR-T): Comparison of a Brief Video to Traditional CPR Training: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to the AHA Heartsaver® Course and no training (control) in ability to correctly perform CPR. The secondary objective is to assess skill retention 3-9 months after the AHA Heartsaver course with and without JiT Video use. The goal of this work is to study the effectiveness of this new JiT video to improve objective knowledge- and performance-based measures of effective OHCA response, as well as subjective ratings of preparedness and likeliness to respond, compared to the standard AHA Heartsaver® CPR AED Training course.
Detailed Description
The first responder phase of out-of-hospital cardiac arrest (OHCA) response is most often led by bystanders with limited resources and no medical training. Bystanders play a critical role in the initial measures of the cardiac arrest chain of survival-activation of emergency medical services (EMS), initiation of cardiopulmonary resuscitation (CPR), and administration of defibrillation when indicated. Early bystander response, early bystander CPR, and defibrillation in under 8 minutes are associated with increased survival to hospital discharge.
Despite the clear importance of early bystander response to OHCA, rates of bystander CPR remain low with only one-third of OHCA patients receiving bystander CPR. Lay people with CPR training are more likely to perform CPR than those without training. Prior studies comparing traditional in-person training programs for CPR versus technology-enabled self-instruction (TESI) formats have demonstrated superiority or equivalency of TESI to prepare lay bystanders in OHCA response. Shorter duration and more convenient access to TESI in light of these findings provide a promising opportunity to increase public preparedness to participate in OHCA management at greater scales and lower costs. However, CPR-specific skills and knowledge deteriorate within 3 to 6 months of initial training, and time, location, and duration have all been perceived as barriers to completing CPR training.
The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to the AHA Heartsaver® CPR AED Training Course and no training (control) in ability to correctly perform CPR. The secondary objectives are the evaluation participate interaction with the JiT video and to assess skill retention 3-9 months after the AHA Heartsaver course with and without JiT Video use. The goal of this work is to study the effectiveness of this new JiT video to improve objective knowledge- and performance-based measures of effective OHCA response, as well as subjective ratings of preparedness and likeliness to respond, compared to the standard AHA Heartsaver® CPR AED Training course.
This is a prospective, randomized, three arm, open-label trial will two rounds of data collection. In the first round, participants will be randomized to one of three arms (no training, AHA course, JiT video) and assessed on CPR skills and knowledge. All participants will then be exposed to the other conditions (completion of the AHA Heartsaver® CPR AED Training course and viewing of the JiT video). During the second round, approximately 3-12 months later, the investigators will test the effectiveness of the JiT video at prompting correct CPR skills after previous training versus no prompting.
Specific aim 1: Determine the efficacy of an abbreviated JiT video-based curriculum in achieving competence in CPR by lay-persons as compared to individuals trained by the AHA Heartsaver® CPR AED Training course.
Hypothesis 1: Participants in the abbreviated JiT video-based curriculum will have no difference in measures of objective knowledge, objective performance, and subjective preparedness to administer CPR compared to participants in the in-person AHA Heartsaver® CPR AED Training course, but superior results compared to controls.
Specific aim 2: Determine how participants interact with a JiT CPR education video during a simulated cardiac arrest. This is an exploratory, qualitative aim.
Specific aim 3: Determine retention of CPR skills using the abbreviated JiT video between 3-12 months after initial training, as compared to retention from the AHA Heartsaver® CPR AED Training course alone without a refresher.
Hypothesis 3: Participants who view the abbreviated JiT video during reassessment will have no differences in measures of objective knowledge, objective performance, and subjective preparedness to administer CPR compared to those without the video 3-12 months after initial training, but superior results compared to controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest With Successful Resuscitation, Educational Problems
Keywords
Youtube, Video Education, Public Empowerment, CPR, AED
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, three arm, parallel, open-label trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment without training or video prompt
Arm Title
Just in time video
Arm Type
Experimental
Arm Description
Assessment with JiT video available
Arm Title
AHA Course
Arm Type
Active Comparator
Arm Description
Assessment after completion of CPR training course
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
Just in time training video on hands only CPR
Intervention Type
Other
Intervention Name(s)
AHA course
Intervention Description
AHA Heartsaver CPR course
Primary Outcome Measure Information:
Title
Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance)
Description
Correct CPR will be measured by successful completion of all five of the following actions:
Calling for 9-1-1 (as measured by verbalizing action to examiner)
Calling for automated external defibrillator (as measured by verbalizing action to examiner)
Placing hand in correct position on manikin chest (as measured by examiner)
Compressing at a rate of 100-120 per minute (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
Compressing to a depth of at least 2 inches (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
Time Frame
Measured within 2 hours of randomization, during the intervention
Secondary Outcome Measure Information:
Title
CPR knowledge (Objective Knowledge)
Description
Knowledge regarding CPR skills will be measured by an 8-question multiple choice assessment, based on the American Heart Association HeartSaver curriculum. The assessment will test participants' understanding of when to perform CPR on a victim and how to perform CPR correctly (e.g., hand placement, compression rate, and compression depth). The assessment will be scored as 1 point per correct answer, with a range of 0-8 points (higher score indicates better knowledge).
Time Frame
Measured immediately after skill evaluation completion
Title
Change in willingness to respond (Subjective Preparedness)
Description
Participants will complete pre/post 6-question assessments to determine the change in their likelihood and confidence in providing CPR in different situations. Items will be scored on a 5-point Likert-type scale (very unlikely to very likely) for likelihood to perform CPR (for a stranger, close relative for friend, or if requested by a trained professional and confidence in identifying cardiac arrest, performing CPR, and using an AED. Change in willingness to respond will be measured by examining the within-person change from pre and post assessments.
Time Frame
Measured within 1 hour before and immediately after skill evaluation completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Employee of Gillette Stadium
Exclusion Criteria:
Age less than 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Goralnick, MD, MS
Phone
(617) 525-8495
Email
egoralnick@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Goralnick, MD, MS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gillette Stadium
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Just in Time Cardio Pulmonary Resuscitation Trial
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