Clinical trial NCT03342495: Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Official title: Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: transition, young adults, transfer
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: University of Alberta
First posted: 2017-11-17
Enrollment: 337
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of participants will be randomized by primary clinical area
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Health services utilization
timeFrame: 12 to 24 months
Secondary outcomes:
measure: cost analysis
timeFrame: up to 24 months
measure: Variation in TRAQ (Transition Readiness Questionnaire) scores
timeFrame: Enrollment and 3 subsequent times in 24 months
measure: Variation in SF-12 Scores
timeFrame: Enrollment and 3 subsequent times in 24 months
Other outcomes:
measure: Youth/Caregiver Satisfaction
timeFrame: after 12 to 24 months
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Childrens Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Susan Samuel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Gina Dimitropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Andrew Mackie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.