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Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03342495
Acronym
TNT
Enrollment
337
Registered
2017-11-17
Start date
2018-02-06
Completion date
2021-09-07
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Autoimmune Diseases, Cardiac Disease, Diabetes, Endocrine System Diseases, Epilepsy, Fetal Alcohol Spectrum Disorders, Gastro-Intestinal Disorder, Genetic Diseases, Inborn, Hematologic Diseases, Metabolic Disease, Neuro-Degenerative Disease, Renal Disease, Respiratory Disease, Stroke, Traumatic Brain Injury

Keywords

transition, young adults, transfer

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: 1. Change care delivery 2. Improve health outcomes 3. Improve the experiences of young adult transition to adult care

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 1. 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 2. to obtain perceptions of stakeholders regarding the role of patient navigators in reducing barriers to adult-oriented ambulatory care 3. to determine the net health care cost impact attributable to the navigator intervention 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.

Interventions

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

OTHERUsual Care

Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics

Sponsors

Alberta Health services
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Two groups of participants will be randomized by primary clinical area

Eligibility

Sex/Gender
ALL
Age
16 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

* 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 * Last planned pediatric visit within up to 12 months after assessment of eligibility

Exclusion criteria

* cannot consent in English * moving out of province within 24 months * enrolled in another transition navigator study

Design outcomes

Primary

MeasureTime frameDescription
Health services utilization12 to 24 monthsverification 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)

Secondary

MeasureTime frameDescription
cost analysisup to 24 monthsdid the intervention save high cost service provision
Variation in TRAQ (Transition Readiness Questionnaire) scoresEnrollment and 3 subsequent times in 24 monthsVariation in TRAQ scores; comparing intervention and non-intervention arm
Variation in SF-12 ScoresEnrollment and 3 subsequent times in 24 monthsParticipant reported mental and physical health

Other

MeasureTime frameDescription
Youth/Caregiver Satisfactionafter 12 to 24 monthsQualitative Interviews with sampling of participants from patient navigator intervention arm

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026