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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
| University of Alberta | OTHER |
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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.
The 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:
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.
Clinical 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.
Objectives/Methods
A 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Navigator Arm | Experimental | Patient Navigator (Social Worker) will assist youth adapt and attach to adult delivered healthcare for up to 24 months. Participants will receive 5 issues of a provincial generic newsletter on topics around transition. Participants will be asked to complete a health questionnaire at baseline and 4 more times during 24 months. Participants will be asked to complete a transition readiness questionnaire at baseline and 4 more times during 24 months. Participants will be provided the opportunity to journal online about their experiences. Up to 100 participants will be provided the opportunity to be interviewed at baseline and end of study about their transition experience. |
|
| Usual Care Arm | Other | Youth will receive usual care from their pediatric clinics in preparation and transfer to adult care. Participants will receive 5 issues of a provincial generic newsletter on topics around transition. Participants will be asked to complete a health questionnaire at baseline and 4 more times during 24 months. Participants will be asked to complete a transition readiness questionnaire at baseline and 4 more times during 24 months. Participants will be provided the opportunity to journal online about their experiences. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigator | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health services utilization | 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) | 12 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| cost analysis | did the intervention save high cost service provision | up to 24 months |
| Variation in TRAQ (Transition Readiness Questionnaire) scores | Variation in TRAQ scores; comparing intervention and non-intervention arm |
| Measure | Description | Time Frame |
|---|---|---|
| Youth/Caregiver Satisfaction | Qualitative Interviews with sampling of participants from patient navigator intervention arm | after 12 to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Samuel, MD, MSc | University of Calgary | Principal Investigator |
| Gina Dimitropoulos, PhD | University of Calgary | Principal Investigator |
| Andrew Mackie, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada | ||
| Glenrose Rehabilitation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39928304 | Derived | 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. | |
| 39382077 |
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Two groups of participants will be randomized by primary clinical area
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| Usual Care | Other | Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics |
|
| Enrollment and 3 subsequent times in 24 months |
| Variation in SF-12 Scores | Participant reported mental and physical health | Enrollment and 3 subsequent times in 24 months |
| Edmonton |
| Alberta |
| Canada |
| Stollery Childrens Hospital | Edmonton | Alberta | Canada |
| Derived |
| 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. |
| 31826899 | Derived | 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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D004066 | Digestive System Diseases |
| D004827 | Epilepsy |
| D001327 | Autoimmune Diseases |
| D007674 | Kidney Diseases |
| D006331 | Heart Diseases |
| D008659 | Metabolic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D012120 | Respiration Disorders |
| D006402 | Hematologic Diseases |
| D000067877 | Autism Spectrum Disorder |
| D063647 | Fetal Alcohol Spectrum Disorders |
| D000070642 | Brain Injuries, Traumatic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007154 | Immune System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002318 | Cardiovascular Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012140 | Respiratory Tract Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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