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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 : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborators:
Alberta Health Services
University of Alberta
Information provided by (Responsible Party):
University of Calgary

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

Condition or disease Intervention/treatment Phase
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 Other: Patient Navigator Other: Usual Care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Official Title: Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Patient Navigator Arm
Patient Navigator (Social Worker) will assist youth adapt and attach to adult oriented healthcare
Other: Patient Navigator
Social worker will be assigned to follow youth in adult care for up to 24 months
Usual Care Arm
Youth will receive usual care from their clinics, and periodic generic resources regarding transition.
Other: Usual Care
Whatever processes are in place to support transfer from pediatric to adult care



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. cost analysis [ Time Frame: up to 24 months ]
    did the intervention save high cost service provision

  2. 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

  3. Variation in SF-12 Scores [ Time Frame: Enrollment and 3 subsequent times in 24 months ]
    Participant reported mental and physical health


Other Outcome Measures:
  1. Youth/Caregiver Satisfaction [ Time Frame: after 12 to 24 months ]
    Qualitative Interviews with sampling of participants from patient navigator intervention arm



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342495


Contacts
Contact: Laurel A Ryan, MFA 403-955-7160 tnt@ucalgary.ca
Contact: Gurkeet Lalli, MBT 403-955-2769 tnt@ucalgary.ca

Locations
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Laurel Ryan, MFA    403-955-7160    tnt@ucalgary.ca   
Contact: Gurkeet Lalli, MBT    403-955-2769    tnt@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Alberta Health Services
University of Alberta
Investigators
Principal Investigator: Susan Samuel, MD, MSc University of Calgary

Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03342495     History of Changes
Other Study ID Numbers: REB16-2561
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Calgary:
transition, young adults, transfer

Additional relevant MeSH terms:
Disease
Brain Injuries
Brain Injuries, Traumatic
Autism Spectrum Disorder
Autoimmune Diseases
Metabolic Diseases
Respiration Disorders
Respiratory Tract Diseases
Genetic Diseases, Inborn
Hematologic Diseases
Heart Diseases
Endocrine System Diseases
Fetal Alcohol Spectrum Disorders
Neurodegenerative Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Immune System Diseases
Cardiovascular Diseases
Fetal Diseases