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

June 9, 2023 updated by: University of Calgary

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada
        • Glenrose Rehabilitation Hospital
      • Edmonton, Alberta, Canada
        • Stollery Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Navigator Arm

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
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
Other: Usual Care Arm

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost analysis
Time Frame: up to 24 months
did the intervention save high cost service provision
up to 24 months
Variation in TRAQ (Transition Readiness Questionnaire) scores
Time Frame: Enrollment and 3 subsequent times in 24 months
Variation in TRAQ scores; comparing intervention and non-intervention arm
Enrollment and 3 subsequent times in 24 months
Variation in SF-12 Scores
Time Frame: Enrollment and 3 subsequent times in 24 months
Participant reported mental and physical health
Enrollment and 3 subsequent times in 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Youth/Caregiver Satisfaction
Time Frame: after 12 to 24 months
Qualitative Interviews with sampling of participants from patient navigator intervention arm
after 12 to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Health services
University of Alberta

Investigators

  • Principal Investigator: Gina Dimitropoulos, PhD, University of Calgary
  • Principal Investigator: Andrew Mackie, MD, University of Alberta
  • Principal Investigator: Susan Samuel, MD, MSc, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2018

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 7, 2021

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB16-2561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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