Recruiting

Digital Health Pathway

Sponsor:

University of Alberta

Code:

NCT06375369

Conditions

Tracheostomy

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)

Study Details

Brief summary:

The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program.

The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families.

Conditions

Tracheostomy

Study ID

NCT06375369

Start date

Sep 1, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age < 18 years
  • First tracheostomy placement

Exclusion Criteria:

\-

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Pre-implementation

Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T

active comparator: Post-implementation/Intervention

Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T

Interventions

Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)

The intervention involves developing a standardized clinical pathway for these children requiring tracheostomy. The pathway comprises of a hospital to home directive, incorporating digital health solutions to support family, caregivers, and healthcare professionals. These digital supports include but are not limited to a Connect Care pathway, resources to aid families to make informed choices during the clinical decision-making process, education modules and high-fidelity simulations to enhance family/caregiver education, an online parental resource center and access to peer support (spanning from hospital to community) and a telehealth post discharge program.

Primary outcome measure

  • Hospital length of stay [ Time Frame: 12 months ]
  • ICU length of stay [ Time Frame: 12 months ]
  • ICU readmission [ Time Frame: 12 months ]
  • Mortality [ Time Frame: 12 months ]
  • Decannulation [ Time Frame: 12 months ]
  • Duration of tracheostomy [ Time Frame: 12 months ]
  • Tracheostomy adverse events [ Time Frame: 12 months ]
  • Hospital cost [ Time Frame: 12 months ]
  • Hospital readmission [ Time Frame: 12 months ]
  • Net-monetary benefit of DECIDE-T [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Maria Castro Codesal, MD, PhD

7802485650castroco@ualberta.ca

Locations

Alberta Children&#39;s Hospital

Recruiting

Calgary, Alberta, Canada

Contacts

Principal Investigator:

Karen Kam, MD

Stollery Children&#39;s Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Michael van Manen, MD

michaelv@ualberta.ca

Principal Investigator:

Michael van Manen, MD

More Information

Sponsor

University of Alberta

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-01-06.