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

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ClinicalTrials.gov Identifier: NCT03342495
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : September 24, 2021
Sponsor:
Collaborators:
Alberta Health services
University of Alberta
Information provided by (Responsible Party):
University of Calgary

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date September 24, 2021
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • cost analysis [ Time Frame: up to 24 months ]
    did the intervention save high cost service provision
  • 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
  • Variation in SF-12 Scores [ Time Frame: Enrollment and 3 subsequent times in 24 months ]
    Participant reported mental and physical health
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 9, 2017)
Youth/Caregiver Satisfaction [ Time Frame: after 12 to 24 months ]
Qualitative Interviews with sampling of participants from patient navigator intervention arm
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Official Title  ICMJE Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups of participants will be randomized by primary clinical area
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Diabetes
  • Endocrine System Diseases
  • Gastro-Intestinal Disorder
  • Neuro-Degenerative Disease
  • Epilepsy
  • Autoimmune Diseases
  • Renal Disease
  • Cardiac Disease
  • Metabolic Disease
  • Genetic Diseases, Inborn
  • Respiratory Disease
  • Hematologic Diseases
  • Autism Spectrum Disorder
  • Fetal Alcohol Spectrum Disorders
  • Traumatic Brain Injury
  • Stroke
Intervention  ICMJE
  • 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
    Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics
Study Arms  ICMJE
  • 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.

    Intervention: Other: Patient Navigator
  • 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.

    Intervention: Other: Usual Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 22, 2021)
337
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2017)
600
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03342495
Other Study ID Numbers  ICMJE REB16-2561
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Calgary
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Calgary
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Alberta Health services
  • University of Alberta
Investigators  ICMJE
Principal Investigator: Susan Samuel, MD, MSc University of Calgary
Principal Investigator: Gina Dimitropoulos, PhD University of Calgary
Principal Investigator: Andrew Mackie, MD University of Alberta
PRS Account University of Calgary
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP