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Clinical Trials/NCT03342495
NCT03342495
Completed
N/A

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

University of Calgary3 sites in 1 country337 target enrollmentFebruary 6, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Calgary
Enrollment
337
Locations
3
Primary Endpoint
Health services utilization
Status
Completed
Last Updated
2 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
February 6, 2018
End Date
September 7, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • cost analysis(up to 24 months)
  • Variation in SF-12 Scores(Enrollment and 3 subsequent times in 24 months)
  • Variation in TRAQ (Transition Readiness Questionnaire) scores(Enrollment and 3 subsequent times in 24 months)

Study Sites (3)

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