Simulation Training for Tracheostomy Care in Children

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Experienced tracheostomy care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will develop, refine and pilot a highly-realistic simulation program that will allow caregivers opportunities to manage critical situations as it pertains to a medically complex child dependent on tracheostomy with or without home ventilation. The investigators hope to demonstrate that the use of highly realistic simulation training will improve hospital utilization as caregivers will have a more realistic understanding of clinical and equipment-related emergencies that may occur outpatient.

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 data supports the effectiveness of the treatment Simulation Training for Tracheostomy Care in Children?

Research shows that simulation training improves the knowledge, skills, and confidence of healthcare providers and caregivers in managing tracheostomies in children. This training provides a safe environment to practice without risking patient safety, leading to better preparedness for real-life scenarios. ^{1 2 3 4 5}

Is simulation training for tracheostomy care in children safe?

Simulation training for tracheostomy care is considered safe as it allows healthcare providers to practice and improve their skills without putting real patients at risk. It helps identify and address potential safety threats in a controlled environment, reducing the risk of complications in real-life scenarios. ^{1 5 6 7 8}

How is simulation training for tracheostomy care in children different from other treatments?

Simulation training for tracheostomy care is unique because it uses realistic practice scenarios with manikins to help healthcare providers and caregivers learn and improve their skills without risking patient safety. This approach focuses on building confidence and competence in managing tracheostomy care, especially in emergency situations, which is not typically addressed by traditional educational methods. ^{1 2 5 8 9}

Research Team

Jennifer Henningfeld, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

I am a caregiver for a patient with a tracheostomy leaving the NICU/PICU for the first time.

Exclusion Criteria

Caregivers cannot have cared for a child with a tracheostomy in the last 10 years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Simulation Training

Caregivers undergo bedside education, classroom-based skills class, and simulation training (high-fidelity or low-fidelity) to prepare for discharge.

4 weeks

Multiple sessions (in-person)

Independent Care Sessions

Caregivers demonstrate practical skills needed for home care, repeating sessions until all skills are passed.

Up to 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after discharge, including surveys and performance assessments.

1 year

Regular follow-up visits and surveys

Treatment Details

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.

Participant Groups

Group I: Active study Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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.

Group III: Active control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Children's Wisconsin

Collaborator

Trials

3

Recruited

500+

Children's Hospital and Health System Foundation, Wisconsin

Collaborator

Trials

56

Recruited

93,300+

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving knowledge, technical skills, and confidence among pediatric health care providers in the management of chronic tracheostomy using a simulation model. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of standardized tracheostomy training with a simulation model for healthcare providers: A study by ISPAT team. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Can human mannequin-based simulation provide a feasible and clinically acceptable method for training tracheostomy management skills for speech-language pathologists? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Simulation-Based Discharge Education Program for Caregivers of Children With Tracheostomies. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Pediatric Tracheostomy Care Simulation: Real-Life Scenarios in a Safe Learning Environment. [2023]

6. England pubmed.ncbi.nlm.nih.gov

In Situ Simulation to Assess Pediatric Tracheostomy Care Safety: A Novel Multicenter Quality Improvement Program. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

"When in Doubt, Change It out": A Case-Based Simulation for Pediatric Residents Caring for Hospitalized Tracheostomy-Dependent Children. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Utilization of Training Dolls to Enhance Caregiver Education for Pediatric Tracheostomy Care. [2023]