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.
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.
Adam Cheng, MD contact
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital/KidSIM simulation center
Calgary, Alberta, T3B 6A8
Yiqun Lin, MD, info@kidsim.ca
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:
- Real time CPR feedback will not be available to all participants. Data will be collected for analysis only.
- 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.
- Conditions
- Cardiopulmonary Resuscitation
- 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 group | Role | What they receive |
|---|---|---|
| control | Active comparator | Annual BLS training Receives: Other: Longitudinal practice and real-time feedback |
| intervention | Experimental | Brief 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.
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)
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
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
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.
- First posted3 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Alberta Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiqun Lin, Alberta Children's Hospital
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 37265710Cheng 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 30951004Lin 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Training Program on CPR Quality of Pediatric Healthcare Providers: A Randomized Control Trial With Economic Evaluation
- ClinicalTrials.gov ID
- NCT02539238
- Acronym / sponsor ID
- REB14-1352
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- Medical Education, cardiopulmonary resuscitation, feedback, cost-effectiveness analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alberta Children's HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (estimated)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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:
- Real time CPR feedback will not be available to all participants. Data will be collected for analysis only.
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: Longitudinal practice and real-time feedbackAnnual BLS training |
| intervention | Experimental | Other: Longitudinal practice and real-time feedbackBrief CPR training dispersed over a year period of time with real-time feedback during working hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Paediatric Healthcare providers in the Emergency Department at Alberta Children's Hospital (nurses and physicians)
Key exclusion criteria (1 listed)
- Not Basic Life Support (BLS), Advanced Cardiovascular Life Support (ACLS), or Pediatric Advanced Life Support (PALS) certified within the past two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal practice and real-time feedbackBrief CPR practice distributed during working hours with real-time feedback | Other | control, intervention |
Primary outcome
Achieving "excellent CPR" at the end of the study (number and percentage)
Time frame: month 12
dichotomous variable based on chest compression depth, rate and recoil
3 secondary outcomes
Change of percentage of adequate compression depth from baseline (numeric, percent)
Time frame: month 3,6,9,12
Change of percentage of adequate compression rate from baseline (numeric, percent)
Time frame: month 3,6,9,12
Change of percentage of adequate compression recoil from baseline (numeric, percent)
Time frame: month 3,6,9,12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Derived from this study: PubMed 37265710Lin 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.
- Derived from this study: PubMed 30951004Cheng 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.
- Derived from this study: PubMed 29944894Lin 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.
- KidSIM Simulation Research ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Cheng, MD contact
1 site in 1 country: see every site and its status.
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.