Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial (TNT)
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| ClinicalTrials.gov Identifier: NCT03342495 |
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Recruitment Status :
Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : September 24, 2021
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | November 3, 2017 | |||||||||
| First Posted Date ICMJE | November 17, 2017 | |||||||||
| Last Update Posted Date | September 24, 2021 | |||||||||
| Actual Study Start Date ICMJE | February 6, 2018 | |||||||||
| Actual Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Health services utilization [ Time Frame: 12 to 24 months ] 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)
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
Youth/Caregiver Satisfaction [ Time Frame: after 12 to 24 months ] Qualitative Interviews with sampling of participants from patient navigator intervention arm
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| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial | |||||||||
| Official Title ICMJE | Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial | |||||||||
| Brief Summary | 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:
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| Detailed Description | 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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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Two groups of participants will be randomized by primary clinical area Masking: None (Open Label)Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | 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. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Actual Enrollment ICMJE |
337 | |||||||||
| Original Estimated Enrollment ICMJE |
600 | |||||||||
| Estimated Study Completion Date ICMJE | December 31, 2022 | |||||||||
| Actual Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 16 Years to 21 Years (Child, Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Canada | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03342495 | |||||||||
| Other Study ID Numbers ICMJE | REB16-2561 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | University of Calgary | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | University of Calgary | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Calgary | |||||||||
| Verification Date | April 2021 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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