Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy (DECIDE-T)

Adoption and Enhancement of a Care Pathway for Children With Medical Complexity: an Implementation Evaluation Project for Tracheostomy in Pediatrics

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy
• Intervention / Treatment: Procedure: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)

Detailed Description

BACKGROUND: Medical advances have resulted in more children surviving critical illness and then living with medical complexity. Children discharged after critical illness with a tracheostomy-a surgical opening created through the neck to form an artificial airway that can be used for mechanical ventilation-are an example of this medically complex, technologically-dependent patient population. In Alberta, care for these children is centralized at the Stollery and Alberta Children's Hospitals. Fewer than 40 tracheostomized patients/year account for >50% of pediatric patients hospitalized for over 180 days and average $484.660/patient/year-more than 30% of Alberta's annual pediatric acute care budget. These tertiary centers, however, lack a provincial standardized tracheostomy care pathway and, based on current guidelines, have substantial variations in practice, program inefficiencies, and barriers to care. This causes: 1) compromised health and disease burden for patients; 2) inconsistent and poorly informed decision-making; 3) increased stay in intensive care and hospital; 4) systemic inequities for certain subpopulations; and 5) substantial burdens for families-caregivers and healthcare providers (HCPs), causing burnout and long-lasting mental health complications. These factors result in a high cost for the health system and potential detriment to the care of other pediatric patients.

DIGITAL SOLUTION: Investigators propose the adaptation, implementation, and assessment of a provincial Digital hEalth Pathway for ChIldren with MeDical ComplExity requiring Tracheostomy/LTV (DECIDE-T). The DECIDE-T model will comprise a hospital-to-home journey, education and peer support digital solutions and a telemedicine follow-up program to support families-caregivers and HCPs looking after tracheostomized children.

PRIMARY OBJECTIVE: Reduce hospital stay and costs by 40%; SECONDARY OBJECTIVE: decrease families-caregivers mental stress and HCPs moral distress using validated measures.

APPROACHES: The key components of DECIDE-T will be defined using evidence-based guidelines and consultation with families-caregivers, HCPs, and other stakeholders. Scientific methods will be used to evaluate outcomes after implementation of DECIDE-T.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Castro Codesal, MD, PhD; Phone Number: 7802485650; Email: castroco@ualberta.ca
• Study Contact Backup: Name: Daniel Ofosu, MPhil; Phone Number: 7802485650; Email: dofosu@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Alberta Children's Hospital
      • Contact: Karen Kam, MD; Email: karen.kam@albertahealthservices.ca
      • Principal Investigator: Karen Kam, MD
    • Edmonton, Alberta, Canada
      • Recruiting
      • Stollery Children's Hospital
      • Contact: Michael van Manen, MD; Email: michaelv@ualberta.ca
      • Principal Investigator: Michael van Manen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age < 18 years
• First tracheostomy placement

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers mental stress	The mental distress and burnout of caregivers/families of children requiring tracheostomy using the Pediatric Inventory for Parents (PIP). The PIP is a questionnaire comprising 42 items, grouped into four domains or subscales (Communication (CM), Emotional Distress (ED), Medical Care (MC), and Role Function (RF)). Its purpose is to measure the levels of stress suffered by parents caring for a child with a chronic illness or requires prolonged medical monitoring. Responses are provided using a five-point Likert scale, ranging from 1 ("never/not at all") to 5 ("very often/extremely"). Higher scores indicate higher levels of stress.	12 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Alberta Innovates Health Solutions
• Investigators: Principal Investigator: Maria Castro Codesal, MD, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 13, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00127121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No