Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT06375369
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2024-04-13', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': '12 months', 'description': 'The total duration of patient stay in hospital'}, {'measure': 'ICU length of stay', 'timeFrame': '12 months', 'description': 'The total duration of patient stay in ICU'}, {'measure': 'ICU readmission', 'timeFrame': '12 months', 'description': 'Rate of ICU re-admissions during the index hospitalization'}, {'measure': 'Mortality', 'timeFrame': '12 months', 'description': 'All cause mortality during admission'}, {'measure': 'Decannulation', 'timeFrame': '12 months', 'description': 'Successful decannulation during admission'}, {'measure': 'Duration of tracheostomy', 'timeFrame': '12 months', 'description': 'Time between tracheostomy placement and successful decannulation'}, {'measure': 'Tracheostomy adverse events', 'timeFrame': '12 months', 'description': 'Tracheostomy related adverse events during admission'}, {'measure': 'Hospital cost', 'timeFrame': '12 months', 'description': 'Total cost of hospital stay'}, {'measure': 'Hospital readmission', 'timeFrame': '12 months', 'description': 'Rate of hospital re-admissions after index hospital discharge'}, {'measure': 'Net-monetary benefit of DECIDE-T', 'timeFrame': '12 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Caregivers mental stress', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tracheostomy']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': "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.\n\nDIGITAL 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.\n\nPRIMARY OBJECTIVE: Reduce hospital stay and costs by 40%; SECONDARY OBJECTIVE: decrease families-caregivers mental stress and HCPs moral distress using validated measures.\n\nAPPROACHES: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 18 years\n* First tracheostomy placement\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06375369', 'acronym': 'DECIDE-T', 'briefTitle': 'Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Adoption and Enhancement of a Care Pathway for Children With Medical Complexity: an Implementation Evaluation Project for Tracheostomy in Pediatrics', 'orgStudyIdInfo': {'id': 'Pro00127121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre-implementation', 'description': 'Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Post-implementation/Intervention', 'description': 'Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T', 'interventionNames': ['Procedure: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)']}], 'interventions': [{'name': 'Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Post-implementation/Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Karen Kam, MD', 'role': 'CONTACT', 'email': 'karen.kam@albertahealthservices.ca'}, {'name': 'Karen Kam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alberta Children's Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michael van Manen, MD', 'role': 'CONTACT', 'email': 'michaelv@ualberta.ca'}, {'name': 'Michael van Manen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stollery Children's Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Maria Castro Codesal, MD, PhD', 'role': 'CONTACT', 'email': 'castroco@ualberta.ca', 'phone': '7802485650'}, {'name': 'Daniel Ofosu, MPhil', 'role': 'CONTACT', 'email': 'dofosu@ualberta.ca', 'phone': '7802485650'}], 'overallOfficials': [{'name': 'Maria Castro Codesal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Innovates Health Solutions', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}