Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT03342495
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D063647', 'term': 'Fetal Alcohol Spectrum Disorders'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of participants will be randomized by primary clinical area'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2017-11-03', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Youth/Caregiver Satisfaction', 'timeFrame': 'after 12 to 24 months', 'description': 'Qualitative Interviews with sampling of participants from patient navigator intervention arm'}], 'primaryOutcomes': [{'measure': 'Health services utilization', 'timeFrame': '12 to 24 months', 'description': 'verification of health services utilized by up to 600 participants collected via personal health numbers (e.g. National Ambulatory Care Reporting System; Alberta Ambulatory Care Reporting System; Discharge Abstract Database; Physician Claims)'}], 'secondaryOutcomes': [{'measure': 'cost analysis', 'timeFrame': 'up to 24 months', 'description': 'did the intervention save high cost service provision'}, {'measure': 'Variation in TRAQ (Transition Readiness Questionnaire) scores', 'timeFrame': 'Enrollment and 3 subsequent times in 24 months', 'description': 'Variation in TRAQ scores; comparing intervention and non-intervention arm'}, {'measure': 'Variation in SF-12 Scores', 'timeFrame': 'Enrollment and 3 subsequent times in 24 months', 'description': 'Participant reported mental and physical health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transition, young adults, transfer'], 'conditions': ['Diabetes', 'Endocrine System Diseases', 'Gastro-Intestinal Disorder', 'Neuro-Degenerative Disease', 'Epilepsy', 'Autoimmune Diseases', 'Renal Disease', 'Cardiac Disease', 'Metabolic Disease', 'Genetic Diseases, Inborn', 'Respiratory Disease', 'Hematologic Diseases', 'Autism Spectrum Disorder', 'Fetal Alcohol Spectrum Disorders', 'Traumatic Brain Injury', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '39928304', 'type': 'DERIVED', 'citation': 'Samuel S, Punjwani Z, San Martin-Feeney D, Allemang B, Guilcher GMT, Lang E, Pacaud D, Pinzon J, Andrew G, Zwaigenbaum L, Perrott C, Andersen J, Hamiwka L, Nettel-Aguirre A, Klarenbach S, McBrien K, Scott SD, Patton M, Samborn S, Pfister K, Ryan L, Dimitropoulos G, Mackie AS. Effectiveness of Patient Navigation During Transition to Adult Care: A Randomized Clinical Trial. JAMA Pediatr. 2025 Apr 1;179(4):375-382. doi: 10.1001/jamapediatrics.2024.6192.'}, {'pmid': '39382077', 'type': 'DERIVED', 'citation': 'Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.'}, {'pmid': '31826899', 'type': 'DERIVED', 'citation': 'Samuel S, Dimitropoulos G, Schraeder K, Klarenbach S, Nettel-Aguirre A, Guilcher G, Pacaud D, Pinzon J, Lang E, Andrew G, Zwaigenbaum L, Scott S, McBrien K, Hamiwka L, Mackie A. Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol. BMJ Open. 2019 Dec 10;9(12):e034309. doi: 10.1136/bmjopen-2019-034309.'}]}, 'descriptionModule': {'briefSummary': 'The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care.\n\nThe study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to:\n\n1. Change care delivery\n2. Improve health outcomes\n3. Improve the experiences of young adult transition to adult care', 'detailedDescription': 'Transition is the purposeful, planned movement of adolescent and young adults with chronic health conditions from child-centered to adult-oriented health systems. Transition includes, but is not limited to transfer to adult care. Transfer of care, which occurs during a vulnerable developmental period around age 18 introduces gaps in continuity of care that can lead to detrimental health outcomes in young adults. Therefore, provision of coordinated and developmentally appropriate care during the transition period is necessary to maintain health and to sustain investments made in pediatric health care.\n\nClinical practice guidelines for transition to adult care recommend the use of patient navigators to coordinate the entry of patients into a complex and unfamiliar adult health care system. Patient navigators provide individualized supports to facilitate medical follow-up and adherence. A limited number of studies have shown that access to a patient navigator during transition decreases drop-out from medical care and disease specific adverse events. No study to date has evaluated the benefits of a patient navigator to improve patient and or health system outcomes, when implemented across multiple chronic disease settings.\n\nObjectives/Methods\n\n1. to evaluate the impact of a patient navigator intervention compared to treatment as usual for 16 to 21 year olds living with chronic health conditions who are transferring to adult care with respect to healthcare utilization and patient reported outcomes\n2. to obtain perceptions of stakeholders regarding the role of patient navigators in reducing barriers to adult-oriented ambulatory care\n3. to determine the net health care cost impact attributable to the navigator intervention\n\nA qualitative study sampling participants randomized into the intervention arm at the beginning and end of the trial will also be undertaken to understand the patient experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* has a chronic medical condition (defined as conditions which are \\>3 months in duration and/or lifelong with multiple morbidities and/or multi-organ/system manifestations or condition with typically affect a single organ/system), who are expected to be transferred to adult specialty follow-up\n* Last planned pediatric visit within up to 12 months after assessment of eligibility\n\nExclusion Criteria:\n\n* cannot consent in English\n* moving out of province within 24 months\n* enrolled in another transition navigator study'}, 'identificationModule': {'nctId': 'NCT03342495', 'acronym': 'TNT', 'briefTitle': 'Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial', 'orgStudyIdInfo': {'id': 'REB16-2561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Navigator Arm', 'description': 'Patient Navigator (Social Worker) will assist youth adapt and attach to adult delivered healthcare for up to 24 months.\n\nParticipants will receive 5 issues of a provincial generic newsletter on topics around transition.\n\nParticipants will be asked to complete a health questionnaire at baseline and 4 more times during 24 months.\n\nParticipants will be asked to complete a transition readiness questionnaire at baseline and 4 more times during 24 months.\n\nParticipants will be provided the opportunity to journal online about their experiences.\n\nUp to 100 participants will be provided the opportunity to be interviewed at baseline and end of study about their transition experience.', 'interventionNames': ['Other: Patient Navigator']}, {'type': 'OTHER', 'label': 'Usual Care Arm', 'description': 'Youth will receive usual care from their pediatric clinics in preparation and transfer to adult care.\n\nParticipants will receive 5 issues of a provincial generic newsletter on topics around transition.\n\nParticipants will be asked to complete a health questionnaire at baseline and 4 more times during 24 months.\n\nParticipants will be asked to complete a transition readiness questionnaire at baseline and 4 more times during 24 months.\n\nParticipants will be provided the opportunity to journal online about their experiences.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Patient Navigator', 'type': 'OTHER', 'description': 'Social worker/Patient Navigator will be assigned to follow youth in adult care for up to 24 months to assist youth adapt and attach to adult delivered healthcare', 'armGroupLabels': ['Patient Navigator Arm']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics', 'armGroupLabels': ['Usual Care Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Glenrose Rehabilitation Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Stollery Childrens Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Susan Samuel, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Gina Dimitropoulos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Andrew Mackie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Health services', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}