Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06375369

Adoption and Enhancement of a Care Pathway for Children With Medical Complexity Requiring Tracheostomy: An Implementation Evaluation Project

Led by University of Alberta · Updated on 2026-01-06

180

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

A

Alberta Innovates Health Solutions

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to develop and evaluate a standardized clinical pathway called DECIDE-T for children with medical complexity who require a tracheostomy, with or without long-term ventilation. These children represent a small group but account for more than half of pediatric patients hospitalized for extended periods in Alberta. The project seeks to reduce hospital stays and associated costs while also addressing mental distress and burnout among caregivers and families. The DECIDE-T pathway includes a hospital-to-home directive supported by various digital health tools. These tools consist of a Connect Care pathway, educational modules, high-fidelity simulations for family and caregiver training, an online parental resource center, peer support within hospital and community settings, and a telehealth follow-up program after discharge. The study compares outcomes before and after implementing this pathway. Participants will be children under 18 years undergoing their first tracheostomy procedure. Researchers will monitor hospital and ICU length of stay, ICU readmission, mortality, decannulation, tracheostomy duration, adverse events, hospital costs, and readmissions over 12 months. They will also assess caregivers' mental stress. The study runs from September 2024 to December 2027, aiming to improve care efficiency and support for these families.

CONDITIONS

Brief Title

Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is younger than 18 years old
  • Undergoing first tracheostomy placement
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 months

Participants undergo a tracheostomy procedure and receive care through the DECIDE-T digital health pathway, which includes hospital-to-home support, education modules, peer support, and telehealth follow-up.

Trial Site Locations

Total: 2 locations

1

Alberta Children's Hospital

Calgary, Alberta, Canada

Actively Recruiting

2

Stollery Children's Hospital

Edmonton, Alberta, Canada

Actively Recruiting

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Research Team

M

Maria Castro Codesal, MD, PhD

D

Daniel Ofosu, MPhil

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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