Simulation Training for Tracheostomy Care in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new simulation training program for caregivers of children with tracheostomies (a tube in the neck to assist with breathing). The goal is to determine if this realistic practice can help caregivers manage emergencies at home, potentially reducing hospital visits. Participants will be divided into groups: one receiving standard education, another using high-tech simulation, and a third with simpler simulation. Caregivers new to caring for a child with a tracheostomy, especially those being discharged from intensive care for the first time, might be suitable candidates. As an unphased trial, this study offers caregivers the chance to gain valuable skills that could enhance their confidence and effectiveness in emergencies.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that this simulation training is safe for tracheostomy care in children?
Research has shown that simulation-based training is safe and well-tolerated. Studies have found that using life-like dolls in training helps caregivers practice real-life situations without risking patient safety. These practice sessions often include scenarios like a tube coming loose or equipment malfunctioning, allowing caregivers to respond without facing actual emergencies.
Typically, no negative events are linked to this type of training. The goal is to improve skills and confidence in handling critical situations, not to endanger participants. Overall, simulation training effectively prepares caregivers for real-world challenges.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative ways to improve tracheostomy care training for caregivers of children. Unlike traditional education methods, which rely on basic instructions and demonstrations, this trial introduces a highly realistic simulation using advanced mannequins and audiovisual devices to mimic real-life emergencies. This immersive training aims to better prepare caregivers for unexpected situations, potentially enhancing their confidence and competence in managing tracheostomies at home. Additionally, the use of both high-fidelity and low-fidelity simulations allows researchers to compare the effectiveness of different training intensities, providing valuable insights that could revolutionize caregiver education in the future.
What evidence suggests that this simulation training is effective for tracheostomy care in children?
Research has shown that learning through practice can significantly boost caregivers' confidence and skills in managing tracheostomy emergencies. In this trial, participants in the active study group will engage in highly realistic simulation training, using a tracheostomy mannequin and audiovisual devices to mimic emergent clinical situations. Caregivers who participated in similar practice training reported feeling more satisfied and better prepared for home emergencies. Specifically, another study found that realistic practice scenarios enhanced caregivers' competence, leading to improved patient outcomes. These findings suggest that practice training, like the simulation training in this trial, could effectively prepare caregivers for real-life tracheostomy situations.34678
Who Is on the Research Team?
Jennifer Henningfeld, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
This trial is for caregivers who are looking after a child with a tracheostomy being discharged from the NICU/PICU for the first time. It includes 30 patients and their 60 caregivers, who must be able to read and speak English. Caregivers with experience caring for a child with a tracheostomy in the last 10 years cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Education and Simulation Training
Caregivers undergo bedside education, classroom-based skills class, and simulation training (high-fidelity or low-fidelity) to prepare for discharge.
Independent Care Sessions
Caregivers demonstrate practical skills needed for home care, repeating sessions until all skills are passed.
Follow-up
Participants are monitored for safety and effectiveness after discharge, including surveys and performance assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Simulation
Trial Overview
The study is testing a simulation program designed to help caregivers manage emergencies related to children dependent on tracheostomies and home ventilators. The goal is to see if realistic training can reduce hospital visits by improving understanding of potential clinical situations.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
In addition to the current state of education, the active study group will undergo highly realistic simulation. This involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers will complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.
No intervention, the same as the current state of education. Caregivers will still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.
In addition to the current state of education, the active control will undergo low-fidelity simulation that approximates the highly realistic clinical scenarios except with the use of a low-fidelity doll equipped with a tracheostomy and without the audiovisual inputs. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Children's Wisconsin
Collaborator
Children's Hospital and Health System Foundation, Wisconsin
Collaborator
Citations
1.
aao-hnsfjournals.onlinelibrary.wiley.com
aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.1276Outcomes of Children With Tracheostomy Before and After ...
“When in doubt, change it out”: a case-based simulation for pediatric residents caring for hospitalized tracheostomy-dependent children.
Assessing and enhancing pediatric residents' knowledge and ...
This study assessed pediatric residents' tracheostomy care skills, found they were limited, and showed a workshop significantly increased their ...
3.
publications.aap.org
publications.aap.org/hospitalpediatrics/article/14/4/251/196909/Sim-Based-Home-Tracheostomy-Care-A-Mixed-MethodsSim-Based Home Tracheostomy Care: A Mixed Methods ...
To assess effects of a Simulation-Based Discharge Education Program (SDP) on long-term caregiver-reported satisfaction and to compare clinical outcomes.
Simulation Training in the Pediatric Tracheostomy and ...
The investigators will develop, refine and pilot a highly-realistic simulation program that will allow caregivers opportunities to manage critical ...
Efficacy of Simulation for Caregivers of Children With a ...
This study aimed to show simulation improves confidence and competence in caregivers of children with a tracheostomy and examined the impact on patient ...
Pediatric Tracheostomy Care Simulation: Real-Life ...
The simulation program used a manikin to improve skills for real-life scenarios, including dislodgement, plugging, cardiac arrest, and ...
The impact of simulation-based training in medical education
This article explores the impact of SBT, tracing its historical development and examining the various types of simulations utilized today, ...
Pediatric Tracheostomy Care Simulation: Real-Life ...
Emergency scenarios included accidental tracheostomy tube dislodgement, tracheostomy tube plugging, cardiac arrest, and ventilator failure. Classes were ...
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