Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375369
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-13
Brief Title:
Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Adoption and Enhancement of a Care Pathway for Children With Medical Complexity an Implementation Evaluation Project for Tracheostomy in Pediatrics
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECIDE-T
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 tracheostomyLTV These patients represent a small portion of Albertas 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 tracheostomyLTV as well as to decrease mental distress and burnout experienced by their caregivers and families
The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomyLTV 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 Childrens Hospitals Fewer than 40 tracheostomized patientsyear account for 50 of pediatric patients hospitalized for over 180 days and average 484660patientyear-more than 30 of Albertas 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 TracheostomyLTV 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
DIGITAL SOLUTION Investigators propose the adaptation implementation and assessment of a provincial Digital hEalth Pathway for ChIldren with MeDical ComplExity requiring TracheostomyLTV 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None