跳至主要内容
临床试验/NCT02539238
NCT02539238Unknown不适用

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

Alberta Children's Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
Achieving "excellent CPR" at the end of the study (number and percentage)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: month 12

dichotomous variable based on chest compression depth, rate and recoil

次要结局

  • Change of percentage of adequate compression recoil from baseline (numeric, percent)(month 3,6,9,12)
  • Change of percentage of adequate compression depth from baseline (numeric, percent)(month 3,6,9,12)
  • Change of percentage of adequate compression rate from baseline (numeric, percent)(month 3,6,9,12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yiqun Lin

MD, MHSc, PhD candidate, Simulation Fellow

Alberta Children's Hospital

研究点 (2)

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