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Clinical Trials/NCT03342495
NCT03342495CompletedNot Applicable

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

University of Calgary3 sites in 1 country337 target enrollmentStarted: February 6, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
337
Locations
3
Primary Endpoint
Health services utilization

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
16 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Patient Navigator (Other)

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.

Intervention: Usual Care (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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