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