Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy

Tracheostomy Clinical Trial

— DECIDE-T  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375369
• Other study ID #: Pro00127121
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: Maria Castro Codesal, MD, PhD
• Phone: 7802485650
• Email: castroco[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age < 18 years

• First tracheostomy placement

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Tracheostomy

Intervention

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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	The total duration of patient stay in hospital	12 months
Primary	ICU length of stay	The total duration of patient stay in ICU	12 months
Primary	ICU readmission	Rate of ICU re-admissions during the index hospitalization	12 months
Primary	Mortality	All cause mortality during admission	12 months
Primary	Decannulation	Successful decannulation during admission	12 months
Primary	Duration of tracheostomy	Time between tracheostomy placement and successful decannulation	12 months
Primary	Tracheostomy adverse events	Tracheostomy related adverse events during admission	12 months
Primary	Hospital cost	Total cost of hospital stay	12 months
Primary	Hospital readmission	Rate of hospital re-admissions after index hospital discharge	12 months
Primary	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	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