Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population

NCT04308109 | Active Not Recruiting

• 1 other identifier: 979984
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheostomy Complication; Simulation of Physical Illness; Teach-Back Communication

Keywords

Simulation; Teach-back; Caregiver

Outcome Measures

Primary Outcomes (5)

• Teach-back session performance

  Difference in Teach-back performance between active study and control groups. Measured from 0-24, with higher scores being better.

  Within 4 weeks of hospital discharge

• Independent Care session performance

  Independent Care performance between active study and control groups.

  Within 4 weeks of hospital discharge

• Hospital length of stay

  Difference in hospital length of stay between active study and active control groups. Measured from 0-7, with higher scores being better.

  First teaching session to discharge, an average of 4 weeks

• Phone Calls

  Difference in number of Phone Calls (from participants to medical providers/home care company) between active and control groups.

  1 year after initial discharge

• Number of Hospital Re-admissions/Emergency Room (ER) visits

  Difference in the number of Hospital Re-admissions/ER visit counts between active and control groups.

  1 year after initial discharge

Secondary Outcomes (2)

• Quality of discharge teaching scores

  Within 48 hours of initial hospital discharge

• Caregiver post-discharge coping scores

  Scale administered 24 hours after discharge and about 1 month after discharge

Study Arms (3)

Control

NO 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.

Active study

EXPERIMENTAL

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.

Behavioral: Simulation

Active control

ACTIVE COMPARATOR

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.

Behavioral: Simulation

Interventions

Simulation BEHAVIORAL

Simulation 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. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.

Active control; Active study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Can not have cared for a child with a tracheostomy in the last 10 years

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Teach-Back Communication

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Jennifer Henningfeld, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized control trial

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: March 13, 2020
• Study Start: September 22, 2017
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)