Health TrialsbyHealthPanel

Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy

ConditionTracheostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age < 18 years

First tracheostomy placement

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Pre-implementationNo intervention 0 interventions
Group B: Post-implementation/InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital length of stay

The total duration of patient stay in hospital

Time frame
12 months
2

ICU length of stay

The total duration of patient stay in ICU

Time frame
12 months
3

ICU readmission

Rate of ICU re-admissions during the index hospitalization

Time frame
12 months
4

Mortality

All cause mortality during admission

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Alberta Innovates Health Solutions

Collaborator

Source ClinicalTrials.gov
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