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Cardiopulmonary Arrest With Successful ResuscitationJITCPR-TNCT05983640

Just in Time Cardio Pulmonary Resuscitation Trial

A study testing Video and AHA course in people with Cardiopulmonary Arrest With Successful Resuscitation and Educational Problems, run by Brigham and Women's Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Video and AHA course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
27 Mar 2023to 1 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Employee of Gillette Stadium

Who cannot join

  • Age less than 18 years

Trial locations and contacts

1 site in 1 country.

Eric Goralnick, MD, MS contact

(617) 525-8495

egoralnick@bwh.harvard.edu

United States1 site, 1 recruiting
  • Gillette Stadium

    Foxborough, Massachusetts, 02035

    Recruiting

Other trials in United States

About this study

Official title: Just in Time Cardio Pulmonary Resuscitation Trial (JITCPR-T): Comparison of a Brief Video to Traditional CPR Training: a Randomized Controlled Trial

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.

Read the 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.

Being tested
Video, AHA course
Keywords
Youtube, Video Education, Public Empowerment, CPR, AED

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VideoOther

    Just in time training video on hands only CPR

  • AHA courseOther

    AHA Heartsaver CPR course

Study groups in NCT05983640
Study groupRoleWhat they receive
ControlNo interventionAssessment without training or video prompt
Just in time videoExperimentalAssessment with JiT video available
Receives: Other: Video
AHA CourseActive comparatorAssessment after completion of CPR training course
Receives: Other: AHA course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance)

    Correct CPR will be measured by successful completion of all five of the following actions:

    1. Calling for 9-1-1 (as measured by verbalizing action to examiner)
    2. Calling for automated external defibrillator (as measured by verbalizing action to examiner)
    3. Placing hand in correct position on manikin chest (as measured by examiner)
    4. Compressing at a rate of 100-120 per minute (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
    5. Compressing to a depth of at least 2 inches (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)

    Measured: Measured within 2 hours of randomization, during the intervention

Secondary outcomes (2)
  1. 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).

    Measured: Measured immediately after skill evaluation completion

  2. 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.

    Measured: Measured within 1 hour before and immediately after skill evaluation completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start27 Mar 2023
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, three arm, parallel, open-label trial
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983640
Sponsor's protocol ID
2023P000222
Acronym
JITCPR-T
Status last verified
Aug 2023
First submitted
12 Apr 2023
Last updated
9 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goldberg SA, Cash RE, Peters GA, Jiang D, O'Brien C, Hasdianda MA, Eberl EM, Salerno KJ, Lees J, Kaithamattam J, Tom J, Panchal AR, Goralnick E. Evaluating video-supported layperson CPR compared to a standard training course: A randomized controlled trial. Resusc Plus. 2024 Dec 6;20:100835. doi: 10.1016/j.resplu.2024.100835. eCollection 2024 Dec.

    PubMed 39717499

Questions about this trial

What is this clinical trial studying?

A study testing Video and AHA course in people with Cardiopulmonary Arrest With Successful Resuscitation and Educational Problems, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eric Goralnick, MD, MS ((617) 525-8495, egoralnick@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance) (time frame: Measured within 2 hours of randomization, during the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05983640, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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