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Clinical Trials/NCT06375369
NCT06375369
Recruiting
Not Applicable

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

University of Alberta2 sites in 1 country180 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Pre-implementation
Conditions
Tracheostomy
Sponsor
University of Alberta
Enrollment
180
Locations
2
Primary Endpoint
Mortality
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
December 31, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \< 18 years
  • First tracheostomy placement

Exclusion Criteria

  • Not provided

Arms & Interventions

Pre-implementation

Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T

Post-implementation/Intervention

Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 12 months

All cause mortality during admission

Hospital cost

Time Frame: 12 months

Total cost of hospital stay

Hospital length of stay

Time Frame: 12 months

The total duration of patient stay in hospital

Hospital readmission

Time Frame: 12 months

Rate of hospital re-admissions after index hospital discharge

ICU length of stay

Time Frame: 12 months

The total duration of patient stay in ICU

ICU readmission

Time Frame: 12 months

Rate of ICU re-admissions during the index hospitalization

Decannulation

Time Frame: 12 months

Successful decannulation during admission

Duration of tracheostomy

Time Frame: 12 months

Time between tracheostomy placement and successful decannulation

Tracheostomy adverse events

Time Frame: 12 months

Tracheostomy related adverse events during admission

Net-monetary benefit of DECIDE-T

Time Frame: 12 months

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

Secondary Outcomes

  • Caregivers mental stress(12 months)

Study Sites (2)

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