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Cardiopulmonary ResuscitationNCT02539238

Improving CPR Quality With Longitudinal Practice and Realtime Feedback - RCT With CEA

A study testing Longitudinal practice and real-time feedback in people with Cardiopulmonary Resuscitation, run by Alberta Children's Hospital at 1 site in Canada.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Objectives: The primary objective of this project is to assess whether the implementation of a new cardiopulmonary resuscitation (CPR) training program (longitudinal training with real-time feedback) can improve CPR quality of healthcare providers compared with traditional training method. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiopulmonary Resuscitation
What is being tested?
Longitudinal practice and real-time feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteCanada
Study dates
Jun 2015to Sep 2017
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Paediatric Healthcare providers in the Emergency Department at Alberta Children's Hospital (nurses and physicians)

Who cannot join

  • Not Basic Life Support (BLS), Advanced Cardiovascular Life Support (ACLS), or Pediatric Advanced Life Support (PALS) certified within the past two years

Trial locations and contacts

1 site in 1 country.

Yiqun Lin, MD contact

5872160937

yiqlin@ucalgary.ca

Canada1 site, 1 recruiting
  • Alberta Children's Hospital/KidSIM simulation center

    Calgary, Alberta, T3B 6A8

    Yiqun Lin, MD, info@kidsim.ca

    Recruiting

Other trials in Canada

About this study

Official title: The Effect of a New Training Program on CPR Quality of Pediatric Healthcare Providers: A Randomized Control Trial With Economic Evaluation

Objectives: The primary objective of this project is to assess whether the implementation of a new cardiopulmonary resuscitation (CPR) training program (longitudinal training with real-time feedback) can improve CPR quality of healthcare providers compared with traditional training method. The secondary objective is to identify whether the implementation of the new training program will result in cost-effectiveness.

Design: Randomized trial to compare new training program with tradition training method and cost-effectiveness alongside this trial

Read more

Participants and setting: Paediatric healthcare providers in Emergency Department at Alberta Children's Hospital. Subjects will be enrolled in either intervention (new training program) or control (traditional training program) by random.

Statistical analysis: Investigators will conduct chi-square test and independent t-test to compare the proportion of excellent CPR and 3 metrics of CPR quality of intervention group with control group at the end of 12-month interval. A multi-level logistic regression and linear regression models will be used to assess the effect of training method and time on proportion of excellent CPR and 3 metrics of CPR quality. Investigators will also conduct a full-economic evaluation in a health care system prospective. cost-effectiveness will be expressed as cost per increased CPR excellence according to incremental cost-effectiveness ratio (ICER). A one-way sensitivity analysis and a probabilistic sensitivity analysis will be conducted to deal with uncertainty in effects and costs.

Conclusion: The new CPR training program will serve as an example of competency-based psychomotor skill training program and help healthcare providers to improve quality of CPR, and potentially improve the survival of children with cardiac arrest. The results of the studies might provide evidence to inform and update in resuscitation education guideline to change the way of CPR training and improve the cost-effectiveness of CPR training program.

Read the detailed description

The study utilizes a randomized, paralleled study design.Paediatric healthcare providers (nurses and physicians) will be enrolled into one of two arms: (1) longitudinal just-in-time training with real-time feedback (intervention); or (2) Annual BLS recertification course (control).

Participants and Setting: The study will be conducted in the Emergency Department (ED) at Alberta Children's Hospital (ACH), a paediatric tertiary care and referral center in Calgary, Alberta, Canada. Annual BLS recertification courses are organized for healthcare providers in the emergency department every month and all healthcare providers in ED are scheduled to take the course once each year. The investigators will approach potential participants and seek consent from them during the course.

Intervention: longitudinal just-in-time training with real-time feedback The new CPR training curriculum (longitudinal just-in-time training with real-time feedback) provides on-demand CPR training opportunities in a longitudinal fashion with a continuous flow of practice, assessment, and feedback. Each CPR training station has a cart with an adult/paediatric sized CPR torso manikin and an infant manikin. The training unit also includes a real-time visual feedback device to provide quality of CPR feedback (depth, rate, and recoil of compressions) during compressions (referred to as real time feedback). At the end of each CPR practice event, the unit will provide summative feedback for the learner on the quality of CPR (depth, rate, recoil and overall quality). Health care providers in our study will have easy access to the training units, which will be located in the emergency department (ED) simulation lab. The instructional process consists of 2 parts, practice sessions and assessment sessions.

Each day, healthcare providers assigned to the ED resuscitation room for their clinical shift will practice CPR for 2 minutes with real-time feedback (if they are enrolled in the intervention arm of the study). Participants will do 2 minutes of continuous chest compressions while assuming that the patient is intubated. Training will take place in the ED simulation lab (located in the ED), a short 20-second walk from the resuscitation room. Providers will be encouraged to use the training unit each time they are on a resuscitation shift, but they will also have access to the training unit if they are not on a resuscitation shift. All health care providers in the intervention arm are recommended to attend practice sessions at least once a week, with no maximum for the number of times they are permitted to practice. After each practice session, participants will be presented with a quantitative summary of CPR performance (depth, rate, residual leaning force). Each training session will last approximately 3 minutes: 30 seconds for reviewing guidelines (short video), 2 minutes of CPR practice, 30 seconds for the participant to review their summative data. In order to encourage participants to practice, the investigators ask permission from ED administration to offer 5 minute protected time after hand-over of each shift and a research assistant will record times of practice for each participants enrolled in intervention group.

Assessment sessions will be built into the instruction framework of the intervention. The assessment session will be given at baseline and every 3 months over the course of one year. Assessment sessions will be run in the same setting as practice sessions. Subjects in will be expected to complete assessment sessions at baseline, 3, 6, 9, and 12 months intervals. Each participant will have protected time (after weekly rounds) for assessment sessions. During the assessment sessions:

  1. Real time CPR feedback will not be available to all participants. Data will be collected for analysis only.
  2. Participants will be presented with the quantitative summary of CPR performance only, if enrolled in the intervention arm.

Study Design: At the beginning of the study, both groups will undergo annual Basic Life Support (BLS) recertification training to ensure good CPR skill acquisition at baseline. All participants who provide consent will be recruited and randomized into one of the 2 study arms. The nurse educator, who is not a member of study group, will generate allocation sequence with an online random number generator. Given the attributes of the study, we will not be able to blind the participants or investigators.

Participants in both arms will be assessed after BLS recertification course as baseline assessment. The baseline assessment includes a CPR competency test and demographic information . Participants randomized to the intervention arm will participate in longitudinal just-in-time training with real-time feedback program as described above. Participants randomized to the control arm will undergo the current standard program of annual BLS recertification but will not participate in the interventional training program during the course of the year. Quantitative measures of CPR quality (compression depth, rate, recoil and overall performance) will be captured for all assessment sessions (in both intervention and control arm) at 3,6,9 and 12 months. For the control group, a second recertification course will be conducted at 1 year, after which CPR performance will be assessed in the same way. In order to ensure compliance, course instructors will send a reminder email to all participants for assessment, and they will be given some protected time (i.e. academic half day) for participating assessment sessions. The assessment sessions will take place in the Emergency Department simulation lab at Alberta Children's Hospital. Control group participants will be advised not to use the training unit for intervention group for CPR practice during the course of the study.

Being tested
Longitudinal practice and real-time feedback
Keywords
Medical Education, cardiopulmonary resuscitation, feedback, cost-effectiveness analysis

What participants receive

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

  • Longitudinal practice and real-time feedbackOther

    Brief CPR practice distributed during working hours with real-time feedback

Study groups in NCT02539238
Study groupRoleWhat they receive
controlActive comparatorAnnual BLS training
Receives: Other: Longitudinal practice and real-time feedback
interventionExperimentalBrief CPR training dispersed over a year period of time with real-time feedback during working hour
Receives: Other: Longitudinal practice and real-time feedback

What is being measured

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

  1. Achieving "excellent CPR" at the end of the study (number and percentage)

    dichotomous variable based on chest compression depth, rate and recoil

    Measured: month 12

Secondary outcomes (3)
  1. Change of percentage of adequate compression depth from baseline (numeric, percent)

    Percentage of chest compression with depth greater than 50 mm

    Measured: month 3,6,9,12

  2. Change of percentage of adequate compression rate from baseline (numeric, percent)

    Percentage of chest compression with rate between 100-120 per minute

    Measured: month 3,6,9,12

  3. Change of percentage of adequate compression recoil from baseline (numeric, percent)

    Percentage of chest compression with fully recoil between compressions

    Measured: month 3,6,9,12

Timeline

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

  1. First posted3 Sep 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionSep 2017 (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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539238
Sponsor's protocol ID
REB14-1352
Status last verified
Aug 2015
First submitted
23 Aug 2015
Last updated
3 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Lin Y, Savage T, Gravel G, Davidson J, Tofil N, Duff J, Cheng A. Who is the real team leader? Comparing leadership performance of the team leader and CPR Coach during simulated cardiac arrest. Resusc Plus. 2023 May 24;14:100400. doi: 10.1016/j.resplu.2023.100400. eCollection 2023 Jun.

    PubMed 37265710
  • Cheng A, Kessler D, Lin Y, Tofil NM, Hunt EA, Davidson J, Chatfield J, Duff JP; International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE) CPR Investigators. Influence of Cardiopulmonary Resuscitation Coaching and Provider Role on Perception of Cardiopulmonary Resuscitation Quality During Simulated Pediatric Cardiac Arrest. Pediatr Crit Care Med. 2019 Apr;20(4):e191-e198. doi: 10.1097/PCC.0000000000001871.

    PubMed 30951004
  • Lin Y, Cheng A, Grant VJ, Currie GR, Hecker KG. Improving CPR quality with distributed practice and real-time feedback in pediatric healthcare providers - A randomized controlled trial. Resuscitation. 2018 Sep;130:6-12. doi: 10.1016/j.resuscitation.2018.06.025. Epub 2018 Jun 23.

    PubMed 29944894

Questions about this trial

What is this clinical trial studying?

A study testing Longitudinal practice and real-time feedback in people with Cardiopulmonary Resuscitation, run by Alberta Children's Hospital at 1 site in Canada.

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 3 Sep 2015. 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 Canada. 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 Yiqun Lin, MD (5872160937, yiqlin@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achieving "excellent CPR" at the end of the study (number and percentage) (time frame: month 12). 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 NCT02539238, which also lists 3 linked publications.

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 3 Sep 2015.

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