TracheostomyDECIDE-TNCT06375369
Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy
A study testing Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) in people with Tracheostomy, run by University of Alberta at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 18 years
- First tracheostomy placement
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
Karen Kam, MD, karen.kam@albertahealthservices.ca
Karen Kam, MD
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta
Michael van Manen, MD, michaelv@ualberta.ca
Michael van Manen, MD
About this study
Official title: Adoption and Enhancement of a Care Pathway for Children With Medical Complexity: an Implementation Evaluation Project for Tracheostomy in Pediatrics
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.
Read the 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.
- Conditions
- Tracheostomy
- Being tested
- Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)Procedure or surgery
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 family/caregiver education, an online parental resource center and access to peer support (spanning from hospital to community) and a telehealth post discharge program.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation | No intervention | Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T |
| Post-implementation/Intervention | Active comparator | Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T Receives: Procedure: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
The total duration of patient stay in hospital
Measured: 12 months
ICU length of stay
The total duration of patient stay in ICU
Measured: 12 months
ICU readmission
Rate of ICU re-admissions during the index hospitalization
Measured: 12 months
Mortality
All cause mortality during admission
Measured: 12 months
Decannulation
Successful decannulation during admission
Measured: 12 months
Duration of tracheostomy
Time between tracheostomy placement and successful decannulation
Measured: 12 months
Tracheostomy adverse events
Tracheostomy related adverse events during admission
Measured: 12 months
Hospital cost
Total cost of hospital stay
Measured: 12 months
Hospital readmission
Rate of hospital re-admissions after index hospital discharge
Measured: 12 months
Net-monetary benefit of DECIDE-T
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
Measured: 12 months
Secondary outcomes (1)
Caregivers mental stress
The mental distress and burnout of caregivers/families of children requiring tracheostomy using the Pediatric Inventory for Parents (PIP). The PIP is a questionnaire comprising 42 items, grouped into four domains or subscales (Communication (CM), Emotional Distress (ED), Medical Care (MC), and Role Function (RF)). Its purpose is to measure the levels of stress suffered by parents caring for a child with a chronic illness or requires prolonged medical monitoring. Responses are provided using a five-point Likert scale, ranging from 1 ("never/not at all") to 5 ("very often/extremely"). Higher scores indicate higher levels of stress.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Sponsor
- Investigators
- Maria Castro Codesal, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375369
- Sponsor's protocol ID
- Pro00127121
- Acronym
- DECIDE-T
- Status last verified
- Jan 2026
- First submitted
- 13 Apr 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 with medical complexity - an implementation evaluation project for paediatric tracheostomy. BMJ Open. 2026 Jul 30;16(7):e117688. doi: 10.1136/bmjopen-2026-117688.
PubMed 42532566
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoption and Enhancement of a Care Pathway for Children With Medical Complexity: an Implementation Evaluation Project for Tracheostomy in Pediatrics
- ClinicalTrials.gov ID
- NCT06375369
- Acronym / sponsor ID
- DECIDE-T / Pro00127121
- Conditions
- Tracheostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation | No intervention | –Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T |
| Post-implementation/Intervention | Active comparator | Procedure: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age < 18 years
- First tracheostomy placement
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 family/caregiver education, an online parental resource center and access to peer support (spanning from hospital to community) and a telehealth post discharge program. | Procedure or surgery | Post-implementation/Intervention |
Primary outcome
Hospital length of stay
Time frame: 12 months
The total duration of patient stay in hospital
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
Mortality
Time frame: 12 months
All cause mortality during admission
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
Hospital cost
Time frame: 12 months
Total cost of hospital stay
Hospital readmission
Time frame: 12 months
Rate of hospital re-admissions after index hospital discharge
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
1 secondary outcome
Caregivers mental stress
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 42532566Ofosu 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 with medical complexity - an implementation evaluation project for paediatric tracheostomy. BMJ Open. 2026 Jul 30;16(7):e117688. doi: 10.1136/bmjopen-2026-117688.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Castro Codesal, MD, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) in people with Tracheostomy, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Castro Codesal, MD, PhD (7802485650, castroco@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.