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Completed

NCT Number: NCT03342495

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

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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Key information

Conditions

Diabetes Alcohol-Induced Disorders Alcohol-Related Disorders Autism Spectrum Disorder Autoimmune Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiac Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chemically-Induced Disorders Child Development Disorders, Pervasive Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Epilepsy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Diseases Gastro-Intestinal Disorder Genetic Diseases, Inborn Glucose Metabolism Disorders Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Kidney Diseases Male Urogenital Diseases Mental Disorders Metabolic Disease Metabolic Diseases Nervous System Diseases Neuro-Degenerative Disease Neurodevelopmental Disorders Nutritional and Metabolic Diseases Pregnancy Complications Renal Disease Respiration Disorders Respiratory Disease Respiratory Tract Diseases Stroke Substance-Related Disorders Trauma, Nervous System Traumatic Brain Injury Urogenital Diseases Urologic Diseases Vascular Diseases Wounds and Injuries

Age range

16 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

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

  • 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
  • to obtain perceptions of stakeholders regarding the role of patient navigators in reducing barriers to adult-oriented ambulatory care
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. cost analysis

    Time frame: up to 24 months

    did the intervention save high cost service provision

  2. Variation in TRAQ (Transition Readiness Questionnaire) scores

    Time frame: Enrollment and 3 subsequent times in 24 months

    Variation in TRAQ scores; comparing intervention and non-intervention arm

  3. Variation in SF-12 Scores

    Time frame: Enrollment and 3 subsequent times in 24 months

    Participant reported mental and physical health

Other outcomes

  1. Youth/Caregiver Satisfaction

    Time frame: after 12 to 24 months

    Qualitative Interviews with sampling of participants from patient navigator intervention arm

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services
  • University of Alberta

Registry information

Acronym: TNT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2017
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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