Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Hospital length of stay [Time frame: 12 months]
• ICU length of stay [Time frame: 12 months]
• ICU readmission [Time frame: 12 months]
• Mortality [Time frame: 12 months]
• Decannulation [Time frame: 12 months]
• Duration of tracheostomy [Time frame: 12 months]
• Tracheostomy adverse events [Time frame: 12 months]
• Hospital cost [Time frame: 12 months]
• Hospital readmission [Time frame: 12 months]
• Net-monetary benefit of DECIDE-T [Time frame: 12 months]

Secondary outcome measures (1)

• Caregivers mental stress [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• Age < 18 years
• First tracheostomy placement

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 2 centers

• Alberta Children&#39;s Hospital — Calgary
• Stollery Children&#39;s Hospital — Edmonton

Publications

• Ofosu D, Qureshi N, Kammerer E, Lecona L, Thomson-Kai P, Nitschke S, Gibson K, Schellenberg C, Wilkes S, Duke D, Schaab K, Davis J, Bonn N, Mahon K, Deus A, Doran T, Wiens S, Platt JM, Garros D, Jamal SM, Majaesic C, Soril L, Kam K, Walton J, Round J, Zimmermann GL, Mack C, Stickland MK, van Manen M, Castro Codesal ML. The DECIDE-T protocol: adoption and enhancement of a care pathway for children PMID 42532566

Identifiers

NCT: NCT06375369 · Pro00127121

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗