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

Primary Purpose

Diabetes, Endocrine System Diseases, Gastro-Intestinal Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patient Navigator
Usual Care
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes focused on measuring transition, young adults, transfer

Eligibility Criteria

16 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's Hospital
  • Glenrose Rehabilitation Hospital
  • Stollery Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient Navigator Arm

Usual Care Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

cost analysis
did the intervention save high cost service provision
Variation in TRAQ (Transition Readiness Questionnaire) scores
Variation in TRAQ scores; comparing intervention and non-intervention arm
Variation in SF-12 Scores
Participant reported mental and physical health

Full Information

First Posted
November 3, 2017
Last Updated
June 9, 2023
Sponsor
University of Calgary
Collaborators
Alberta Health services, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03342495
Brief Title
Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Acronym
TNT
Official Title
Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services, University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Change care delivery Improve health outcomes 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 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 to obtain perceptions of stakeholders regarding the role of patient navigators in reducing barriers to adult-oriented ambulatory care 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of participants will be randomized by primary clinical area
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigator Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Arm
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Patient Navigator
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics
Primary Outcome Measure Information:
Title
Health services utilization
Description
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)
Time Frame
12 to 24 months
Secondary Outcome Measure Information:
Title
cost analysis
Description
did the intervention save high cost service provision
Time Frame
up to 24 months
Title
Variation in TRAQ (Transition Readiness Questionnaire) scores
Description
Variation in TRAQ scores; comparing intervention and non-intervention arm
Time Frame
Enrollment and 3 subsequent times in 24 months
Title
Variation in SF-12 Scores
Description
Participant reported mental and physical health
Time Frame
Enrollment and 3 subsequent times in 24 months
Other Pre-specified Outcome Measures:
Title
Youth/Caregiver Satisfaction
Description
Qualitative Interviews with sampling of participants from patient navigator intervention arm
Time Frame
after 12 to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Samuel, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gina Dimitropoulos, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Mackie, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Stollery Childrens Hospital
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31826899
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.
Results Reference
derived

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

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