Clinical trial NCT06375369: Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy
Official title: Adoption and Enhancement of a Care Pathway for Children With Medical Complexity: an Implementation Evaluation Project for Tracheostomy in Pediatrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheostomy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2024-04-19
Enrollment: 180
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age \< 18 years
* First tracheostomy placement

Exclusion Criteria:

-

Primary outcomes:
measure: Hospital length of stay
timeFrame: 12 months
measure: ICU length of stay
timeFrame: 12 months
measure: ICU readmission
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Decannulation
timeFrame: 12 months
measure: Duration of tracheostomy
timeFrame: 12 months
measure: Tracheostomy adverse events
timeFrame: 12 months
measure: Hospital cost
timeFrame: 12 months
measure: Hospital readmission
timeFrame: 12 months
measure: Net-monetary benefit of DECIDE-T
timeFrame: 12 months
Secondary outcomes:
measure: Caregivers mental stress
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children&#39;s Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children&#39;s Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Maria Castro Codesal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: