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CompletedNCT03371875Updated Aug 23, 2022

Automated Youth-To-Adult Transition Planning Using Health Information ...

An interventional study of Automated transition care reminders in Transition and Adolescent Behavior, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-08-23.

Sponsored by Indiana University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study summary

This study seeks to automate the process of youth to adult transition using an existing computerized decision support system in primary care. Subjects will complete the TRAQ readiness questionnaire after the age of 14, and then their responses will be flagged for the physician to review and provide additional transition related educational materials. Once transition is necessary, the system sends an automated email to the responsible party in the office.

Read the detailed description

This proposal seeks to improve transition care using health information technology. The process of transition from a pediatric to adult provider is a universal need across both primary care and subspecialties. Little work has been done specifically within pediatric gastroenterology to address the needs of patients with chronic gastrointestinal disease. The investigators propose to use an existing computerized clinical decision support system (CHICA - the Child Health Improvement through Computer Automation system) to pilot a youth-to-adult Transition module within a large primary care network. This will be accomplished by automating the "Six Core Elements of Healthcare Transition" set forth by the National Health Care Transition Center. These core elements consist of: (1) sharing the transition policy with families, (2) providing transition tracking and monitoring, (3) assessing transition readiness using a standardized tool (the TRAQ - Transition Readiness Assessment Questionnaire), (4) transition planning through iterative preparation of all necessary transition skills and documents, (5) accomplishing the transfer of care itself, and (6) assessing transfer completion. Each of these core elements will be accomplished using a combination of patient-facing (tablets) and providerfacing (webforms alongside the electronic medical record). Once these software rules are written and tested, they will be piloted in the existing primary care decision support system. The investigators will iteratively assess the following goals: (1) each patient's transition readiness as appropriate for their age, and (2) provider and patient satisfaction with the transition process. These outcomes will be compared in a prepost design, data will be collected during the first 6 months prior to the Transition module being implemented in CHICA. Following this 6-month period, the Transition module will be turned on, and a repeat assessment made of these outcomes. If this pilot test is successful, the investigators will then be ready to launch this module in a similar system (CHICA-GI) that will be live in the pediatric gastroenterology clinic. Once this system has a transition module active, the investigators will be able to test if it accomplishes similar goals for gastroenterology subspecialty patients, including disease-specific transition goals, in future R21 and R01 applications.

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Conditions studied

  • Transition
  • Adolescent Behavior

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03

In context

Adolescent Behavior

305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.

This study's enrollment of 96 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.

Browse Adolescent Behavior studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 14-18 (those who need transition) and seen at an Eskenaki pediatrics clinic in past month.

Exclusion criteria

Exclusion Criteria:

  • None.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Transition Clinics

    Clinics in this arm will assess the adolescent's readiness for youth-to-adult transition using the TRAQ questionnaire. Physicians will then be given reminders based on the subject's deficiencies in transition management, and given the opportunity to intervene.

    Behavioral: Automated transition care reminders

  • No intervention
    Control Clinics

    Clinics in this arm will assess the adolescent's readiness for youth-to-adult transition using the TRAQ questionnaire. No reminders will be provided to providers for care transition.

Interventions

  • BehavioralAutomated transition care reminders

    The CHICA system will gather the elements of the TRAQ questionnaire and report the specific areas of deficiency to the physician. If a patient reaches the point of care transition (18 years), then an automated email is sent to a clinic nurse.

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What researchers measure

Primary outcomes

  1. Patient transition satisfaction (Pre)

    Families will be called by study RA and asked the following questions: Has your pediatrician shared with you (your child) their clinic's approach to transitioning you from pediatric to adult health care? Have you (or your child) ever been asked to complete a survey at your pediatrician's office regarding your health and how to use health care? Did you and your pediatric provider talk about you being more in charge of your health? Did you and this provider talk about you scheduling your own appointments with this provider instead of your parent or guardian? Did you and this provider talk about how your health insurance might change as you get older? Did you and this provider talk about whether you may need to change to a new provider who treats mostly adults? Did this provider ask if you had any questions or concerns about changing to a new provider who treats mostly adults?

    Time frame: Baseline

  2. Patient transition satisfaction (Post)

    Families will be called by study RA and asked the following questions: Has your pediatrician shared with you (your child) their clinic's approach to transitioning you from pediatric to adult health care? Have you (or your child) ever been asked to complete a survey at your pediatrician's office regarding your health and how to use health care? Did you and your pediatric provider talk about you being more in charge of your health? Did you and this provider talk about you scheduling your own appointments with this provider instead of your parent or guardian? Did you and this provider talk about how your health insurance might change as you get older? Did you and this provider talk about whether you may need to change to a new provider who treats mostly adults? Did this provider ask if you had any questions or concerns about changing to a new provider who treats mostly adults?

    Time frame: 1 month after appointment

Secondary outcomes

  1. Provider satisfaction

    A Likert scale is administered twice yearly determining the provider satisfaction with each CHICA module

    Time frame: 6 months

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Study locations

1 site
  • Eskenazi Health
    Indianapolis, Indiana 46202, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jun 2019, 18 months.

Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 18 months is below that.

Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2017
First posted
Dec 13, 2017
StartActual
Dec 15, 2017
Primary completionActual
Jun 30, 2019
CompletionActual
Jun 30, 2019
Last update
Aug 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03371875
Lead sponsor
Indiana University
Responsible party
William E. Bennett, Jr. (Assistant Professor of Pediatrics, Indiana University) — Principal investigator
First posted
Dec 13, 2017
Start date
Dec 15, 2017
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Aug 23, 2022

Study contacts

William E Bennett, MD
principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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