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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Digital Health Pathway for Pediatric Tracheostomy?

Research on similar clinical pathways, like those for tracheostomy and other medical procedures, shows that standardized care pathways can reduce hospital stay lengths and maintain quality care. This suggests that the Digital Health Pathway for Pediatric Tracheostomy might also improve care efficiency and outcomes. ^{1 2 3 4 5}

What makes the DECIDE-T Pathway treatment unique for children with tracheostomy?

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 outcomes to improve care quality and reduce hospital stays, unlike traditional methods that may not use digital tools for comprehensive care management. ^{1 2 4 6 7}

What is the purpose of this trial?

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.

Research Team

Maria Castro Codesal, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The path to a clinical pathway: collaborative care for the patient with an ostomy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The Trach Trail: A Systems-Based Pathway to Improve Quality of Tracheostomy Care and Interdisciplinary Collaboration. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Strategy for the Renovation of a Clinical Pathways Program. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Changing practice and improving care using a low-risk tracheotomy clinical pathway. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Clinical pathway for the Fontan patient to standardise care and improve outcomes. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Healthcare Trajectories and Outcomes in the First Year After Tracheostomy Based on Patient Characteristics. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

"New Trach Mom Here…": A qualitative study of internet-based resources by caregivers of children with tracheostomy. [2021]