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

Cardiopulmonary Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02539238
• Other study ID #: REB14-1352
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2015
• Last updated: September 2, 2015
• Start date: June 2015

Study information

• Verified date: August 2015
• Source: Alberta Children's Hospital
• Contact: Yiqun Lin, MD
• Phone: 5872160937
• Email: yiqlin[@]ucalgary.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board (University of Calgary)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation

Intervention

Other:
• Longitudinal practice and real-time feedback
Brief CPR practice distributed during working hours with real-time feedback

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital/KidSIM simulation center	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost (Canadian Dollar)	Cost of running both control and experimental educational program	month 12	No
Primary	Achieving "excellent CPR" at the end of the study (number and percentage)	dichotomous variable based on chest compression depth, rate and recoil	month 12	No
Secondary	Change of percentage of adequate compression depth from baseline (numeric, percent)	Percentage of chest compression with depth greater than 50 mm	month 3,6,9,12	No
Secondary	Change of percentage of adequate compression rate from baseline (numeric, percent)	Percentage of chest compression with rate between 100-120 per minute	month 3,6,9,12	No
Secondary	Change of percentage of adequate compression recoil from baseline (numeric, percent)	Percentage of chest compression with fully recoil between compressions	month 3,6,9,12	No

External Links

•   KidSIM Simulation Research Program