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

Last updated: June 9, 2023
Sponsor: University of Calgary
Overall Status: Completed

Phase

N/A

Condition

Focal Segmental Glomerulosclerosis

Diabetic Macular Edema

Diabetic Foot Ulcers

Treatment

Usual Care

Patient Navigator

Clinical Study ID

NCT03342495
REB16-2561
  • Ages 16-21
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • has a chronic medical condition (defined as conditions which are >3 months in durationand/or lifelong with multiple morbidities and/or multi-organ/system manifestations orcondition with typically affect a single organ/system), who are expected to betransferred to adult specialty follow-up
  • Last planned pediatric visit within up to 12 months after assessment of eligibility

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 337
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
February 06, 2018
Estimated Completion Date:
September 07, 2021

Study 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.

Connect with a study center

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Glenrose Rehabilitation Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • Stollery Childrens Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

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