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DiabetesTNTNCT03342495

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

A study testing Patient Navigator in people with Diabetes and Endocrine System Diseases, run by University of Calgary at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 21 years
What is being tested?
Patient Navigator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
337 participants
Where
3 sitesCanada
Study dates
6 Feb 2018to 7 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

  • Glenrose Rehabilitation Hospital

    Edmonton, Alberta

  • Stollery Childrens Hospital

    Edmonton, Alberta

Other trials in Canada

About this study

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
Read the 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.

Being tested
Patient Navigator, Usual Care
Keywords
transition, young adults, transfer
Medical subject headings
Diabetes Mellitus, Endocrine System Diseases, Digestive System Diseases, Epilepsy, Autoimmune Diseases, Kidney Diseases, Heart Diseases, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient NavigatorOther

    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 CareOther

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

Study groups in NCT03342495
Study groupRoleWhat they receive
Patient Navigator ArmExperimentalPatient 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.
Receives: Other: Patient Navigator
Usual Care ArmOtherYouth 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.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 to 24 months

Secondary outcomes (3)

  1. cost analysis

    did the intervention save high cost service provision

    Measured: up to 24 months

  2. Variation in TRAQ (Transition Readiness Questionnaire) scores

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

    Measured: Enrollment and 3 subsequent times in 24 months

  3. Variation in SF-12 Scores

    Participant reported mental and physical health

    Measured: Enrollment and 3 subsequent times in 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start6 Feb 2018
  3. Primary completion31 Aug 2021
  4. Study completion7 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups of participants will be randomized by primary clinical area
Masking
None (open label)
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03342495
Sponsor's protocol ID
REB16-2561
Acronym
TNT
Status last verified
Jun 2023
First submitted
3 Nov 2017
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39928304

  • 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.

    PubMed 39382077

  • 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.

    PubMed 31826899

Questions about this trial

What is this clinical trial studying?

A study testing Patient Navigator in people with Diabetes and Endocrine System Diseases, run by University of Calgary at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health services utilization (time frame: 12 to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03342495, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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