Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population (NCT04308109) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population
United States64 participantsStarted 2017-09-22
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Anticipated count of 90 participants includes 30 patients and 60 caregivers (2 per patient). Caregivers are the primary subjects, and patients are enrolled so the investigators can use their medical records.
Caregivers:
Inclusion Criteria
* Must be able to read and speak English
* Caring for a patient with a tracheostomy being discharged from the NICU/PICU for the first time
Exclusion Criteria
\- Can not have cared for a child with a tracheostomy in the last 10 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Teach-back session performance
Timeframe: Within 4 weeks of hospital discharge
2
Independent Care session performance
Timeframe: Within 4 weeks of hospital discharge
3
Hospital length of stay
Timeframe: First teaching session to discharge, an average of 4 weeks
4
Phone Calls
Timeframe: 1 year after initial discharge
5
Number of Hospital Re-admissions/Emergency Room (ER) visits