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

Stroke Clinical Trial

— TNT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342495
• Other study ID #: REB16-2561
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: September 7, 2021

Study information

• Verified date: June 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: September 7, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autoimmune Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Cardiac Disease
• Diabetes
• Digestive System Diseases
• Endocrine System Diseases
• Epilepsy
• Fetal Alcohol Spectrum Disorders
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Genetic Diseases, Inborn
• Heart Diseases
• Hematologic Diseases
• Intestinal Diseases
• Metabolic Disease
• Metabolic Diseases
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Renal Disease
• Respiratory Disease
• Respiratory Tract Diseases
• Stroke
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Glenrose Rehabilitation Hospital	Edmonton	Alberta
Canada	Stollery Childrens Hospital	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Youth/Caregiver Satisfaction	Qualitative Interviews with sampling of participants from patient navigator intervention arm	after 12 to 24 months
Primary	Health services utilization	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	cost analysis	did the intervention save high cost service provision	up to 24 months
Secondary	Variation in TRAQ (Transition Readiness Questionnaire) scores	Variation in TRAQ scores; comparing intervention and non-intervention arm	Enrollment and 3 subsequent times in 24 months
Secondary	Variation in SF-12 Scores	Participant reported mental and physical health	Enrollment and 3 subsequent times in 24 months