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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06375369
Other study ID # Pro00127121
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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