Evaluating Innovations in Transition From Pediatric to Adult Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2021-09-07

Brief Summary

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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:

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

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of participants will be randomized by primary clinical area

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient Navigator Arm

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.

Group Type EXPERIMENTAL

Patient Navigator

Intervention Type 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

Usual Care Arm

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.

Group Type OTHER

Usual Care

Intervention Type OTHER

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

Interventions

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Patient Navigator

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

Intervention Type OTHER

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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