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

NCT03342495 | Completed

• 1 other identifier: REB16-2561
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 3

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

Conditions

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

Keywords

transition, young adults, transfer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• cost analysis

  up to 24 months

• Variation in TRAQ (Transition Readiness Questionnaire) scores

  Enrollment and 3 subsequent times in 24 months

• Variation in SF-12 Scores

  Enrollment and 3 subsequent times in 24 months

Other Outcomes (1)

• Youth/Caregiver Satisfaction

  after 12 to 24 months

Study Arms (2)

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.

Other: Patient Navigator

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.

Other: Usual Care

Interventions

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

Patient Navigator Arm

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

Usual Care Arm

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator
• University of Alberta: collaborator

Study Sites (3)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Location

Stollery Childrens Hospital

Edmonton, Alberta, Canada

Location

Related Publications (3)

• 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.

  PMID: 39928304 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.

  PMID: 39382077 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.

  PMID: 31826899 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Endocrine System Diseases; Digestive System Diseases; Epilepsy; Autoimmune Diseases; Kidney Diseases; Heart Diseases; Metabolic Diseases; Genetic Diseases, Inborn; Respiration Disorders; Hematologic Diseases; Autism Spectrum Disorder; Fetal Alcohol Spectrum Disorders; Brain Injuries, Traumatic; Stroke

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Tract Diseases; Hemic and Lymphatic Diseases; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of participants will be randomized by primary clinical area

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 17, 2017
• Study Start: February 6, 2018
• Primary Completion: August 31, 2021
• Study Completion: September 7, 2021
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)