Digital Health Pathway for Tracheostomy Care

(DECIDE-T Trial)

Recruiting at 3 trial locations

Overseen By Daniel Ofosu, MPhil

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing a digital health pathway to support children needing a tracheostomy (a surgical procedure to assist with breathing) and potentially long-term ventilation. The aim is to ease the transition from hospital to home for families and caregivers. The pathway, known as the Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy (DECIDE-T), includes digital tools such as education modules, decision-making resources, and telehealth support. Children receiving their first tracheostomy may be suitable candidates for this trial. The ultimate goal is to reduce hospital stays and alleviate the mental and emotional strain on caregivers. As an unphased trial, this study offers families a unique opportunity to contribute to innovative solutions that could significantly improve the quality of life for children with medical complexities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this digital health pathway is safe for pediatric tracheostomy care?

Research has shown that digital health programs like DECIDE-T aim to improve care for children with tracheostomies. These programs use digital tools to assist with education, decision-making, and support, making it easier for families and caregivers to manage care.

Studies have found that digital health solutions are safe and easy to use. They support, rather than replace, traditional care. With educational modules and telehealth programs, families often feel more confident and supported.

Digital health tools like DECIDE-T pose no medical risk. The goal is to provide better information and support for families and caregivers. By reducing the need for long hospital stays, these tools can also help lower stress and burnout for caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DECIDE-T digital health pathway because it aims to transform tracheostomy care for children with medical complexity. Unlike traditional methods that rely heavily on in-person healthcare visits and manual record-keeping, this digital approach leverages technology to streamline care and improve communication between families and healthcare providers. By implementing this digital pathway, there is potential for more personalized and efficient care, reducing the burden on families and enhancing the overall quality of life for these children. The hope is that this innovative approach will lead to better health outcomes and more effective management of tracheostomy care.

What evidence suggests that the Digital Health Pathway is effective for tracheostomy care?

Research shows that digital health tools can greatly improve care for children with tracheostomies. These tools provide essential education and support to families, helping caregivers make tough decisions about care. Studies have found that well-informed and supported families experience less stress and their children spend less time in the hospital. Additionally, digital tools can monitor the child's health to help prevent problems. The DECIDE-T project in this trial aims to use these digital solutions to improve health outcomes and lower costs for children with complex medical needs who require tracheostomies. Participants will be divided into two groups: those undergoing tracheostomy procedures before the implementation of DECIDE-T and those after its implementation. ^{1 2 4 5 6}

Who Is on the Research Team?

Maria Castro Codesal, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for children aged 0 to 18 who need a tracheostomy, which is a procedure that involves creating an opening in the neck to place a tube into a person's windpipe. There are no specific exclusion criteria, so all eligible children at participating sites can join.

Inclusion Criteria

My child, aged 0-18, had a tracheostomy at a participating hospital.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation of DECIDE-T

Implementation of the DECIDE-T digital health pathway for children with medical complexity requiring tracheostomy

12 months

Regular telehealth follow-ups

Follow-up

Participants are monitored for safety and effectiveness after the implementation of DECIDE-T

12 months

Telehealth follow-ups and in-person visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy (DECIDE-T)

Trial Overview The DECIDE-T project tests a digital health pathway designed for kids needing tracheostomy care. It includes hospital-to-home guidelines with digital tools like educational resources, simulations for training, online support centers, and telehealth services after leaving the hospital.

How Is the Trial Designed?

Group I: Post-implementation/Intervention Active Control 1 Intervention

Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T

Group II: Pre-implementation Active Control 1 Intervention

Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T

Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy (DECIDE-T) is already approved in Canada for the following indications:

Approved in Canada as DECIDE-T Pathway for:

• Support for pediatric patients requiring tracheostomy with or without long-term ventilation

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Published Research Related to This Trial

In a study of 4,274 adults who received a tracheostomy, older patients (65 years and older) had a median survival of less than 3 months, especially those with frailty, chronic organ dysfunction, cancer, or requiring dialysis.

Most patients spent the majority of their time alive in a healthcare facility (HCF) after tracheostomy, indicating that older adults and certain younger adults faced high rates of prolonged hospitalization with limited days spent outside of healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare Trajectories and Outcomes in the First Year After Tracheostomy Based on Patient Characteristics. Mehta, AB., Matlock, DD., Shorr, AF., et al.[2023]

Implementing an evidence-based clinical pathway for post-operative management of Fontan patients led to a significant reduction in hospital length of stay from 12 to 9 days, demonstrating improved efficiency in care.

The pathway was adhered to nearly 100% of the time and did not result in an increase in readmissions, indicating that standardizing care can enhance clinical outcomes without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pathway for the Fontan patient to standardise care and improve outcomes. Lagergren, SM., Jensen, M., Beaven, B., et al.[2021]

Caregivers of children with tracheostomy and chronic ventilation often turn to online resources for support, revealing four main themes: uncertainty, lived experiences, seeking context, and sharing advice.

The study identified two coping pathways among caregivers: the 'Acceptance pathway,' which leads to mastery and satisfaction, and the 'Resignation pathway,' characterized by feelings of frustration and lack of control, highlighting the emotional complexities of their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"New Trach Mom Here…": A qualitative study of internet-based resources by caregivers of children with tracheostomy. Meyer-Macaulay, CB., Graham, RJ., Williams, D., et al.[2021]

Implementing the standardized Trach Trail pathway significantly reduced the intensive care unit length of stay for patients undergoing tracheostomy, from an average of 21 days to 10 days, without increasing adverse events.

The study involved a comparison of 21 patients on the Trach Trail against 117 control patients, highlighting the effectiveness of coordinated care and education in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trach Trail: A Systems-Based Pathway to Improve Quality of Tracheostomy Care and Interdisciplinary Collaboration. Cherney, RL., Pandian, V., Ninan, A., et al.[2020]

The implementation of a low-risk tracheotomy clinical pathway significantly reduced the average time to decannulation from 15.5 days to 5.74 days in the pilot cohort, demonstrating its efficacy in improving patient outcomes.

The pathway was found to be safe, as there was no increase in adverse events associated with its use, indicating that it can be a reliable tool for clinicians managing tracheotomy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing practice and improving care using a low-risk tracheotomy clinical pathway. Smith, KA., Matthews, TW., Dubé, M., et al.[2014]

The implementation of a multidisciplinary clinical pathway for colostomy and ileostomy patients at a southeastern teaching hospital significantly reduced both the length of hospital stays and associated costs, while maintaining quality care indicators.

The success of the colostomy and ileostomy pathway led to the development of a similar pathway for urostomy/urinary diversion patients, demonstrating the effectiveness of this approach in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The path to a clinical pathway: collaborative care for the patient with an ostomy. Lovejoy, L., Bussey, C., Sherer, AP.[2019]

The renovation of the clinical pathways (CP) program at a children's hospital significantly improved efficiency, reducing the time to complete pathways from a median of 15 months to just 5 months, which is a 70% increase in efficiency.

Following the program's improvements, the hospital saw a 78% increase in the total number of clinical pathways developed, indicating enhanced multidisciplinary participation and better integration into the electronic health record.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Strategy for the Renovation of a Clinical Pathways Program. Pugh-Bernard, A., Nickels, S., Melendez, J., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-tracheostomy-care-8-2024-a500e

Digital Health Pathway for Tracheostomy Care The DECIDE-T Pathway is unique because it uses a digital health approach to coordinate care for children with tracheostomy, focusing on education and tracking ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9950280/

Tracheostomy decision-making for children with medical ... Abstract. Objectives. Caregivers of children with medical complexity (CMC) face decisions about life-sustaining interventions, such as tracheostomy.

3. researchgate.net researchgate.net/publication/342147798_Decision-Making_About_Tracheostomy_for_Children_With_Medical_Complexity_Caregiver_and_Health_Care_Provider_Perspectives

Decision-Making About Tracheostomy for Children With ... OBJECTIVE Caregivers of children with medical complexity (CMC) face decisions about tracheostomy. The objectives of this paper are to identify ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11272989/

Equitable Care for Children With a Tracheostomy: Addressing ... This study facilitates a nuanced inquiry into the experiences and systemic challenges encountered by medical professionals and primary caregivers managing CMC

5. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.1020

Pediatric Tracheostomy Education Program Structures ... In 26 out of 37 (70%) institutions, family availability and reluctance to participate were significant obstacles to tracheostomy education.

6. trachjournal.scholasticahq.com trachjournal.scholasticahq.com/article/133583-tracheostomy-in-the-digital-age-how-artificial-intelligence-and-immersive-technologies-are-redefining-airway-care

Tracheostomy in the Digital Age: How Artificial Intelligence ... This article explores the integration of AI-driven technologies in tracheostomy education, workforce development, telehealth, predictive analytics, and robotic ...