Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy

NCT06375369 | Recruiting

• 1 other identifier: Pro00127121
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (10)

• Hospital length of stay

  The total duration of patient stay in hospital

  12 months

• ICU length of stay

  The total duration of patient stay in ICU

  12 months

• ICU readmission

  Rate of ICU re-admissions during the index hospitalization

  12 months

• Mortality

  All cause mortality during admission

  12 months

• Decannulation

  Successful decannulation during admission

  12 months

• Duration of tracheostomy

  Time between tracheostomy placement and successful decannulation

  12 months

• Tracheostomy adverse events

  Tracheostomy related adverse events during admission

  12 months

• Hospital cost

  Total cost of hospital stay

  12 months

• Hospital readmission

  Rate of hospital re-admissions after index hospital discharge

  12 months

• Net-monetary benefit of DECIDE-T

  The healthcare cost-savings attributable to DECIDE-T as the difference between the mean cost per index admission for patients treated before and after DECIDE-T implementation. The costs will include costs of hospitalizations, outpatient visits, physician claims, home care costs where available, readmissions after index discharge

  12 months

Secondary Outcomes (1)

• Caregivers mental stress

  12 months

Study Arms (2)

Pre-implementation

NO INTERVENTION

Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T

Post-implementation/Intervention

ACTIVE COMPARATOR

Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T

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

Interventions

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

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.

Post-implementation/Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \< 18 years
• First tracheostomy placement

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator

Study Sites (2)

Alberta Children&#39;s Hospital

Calgary, Alberta, Canada

RECRUITING

Stollery Children&#39;s Hospital

Edmonton, Alberta, Canada

RECRUITING

Study Officials

• Maria Castro Codesal, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Castro Codesal, MD, PhD

CONTACT

7802485650; castroco@ualberta.ca

Daniel Ofosu, MPhil

CONTACT

7802485650; dofosu@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)