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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03371875
Other study ID # 1704015932
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date June 30, 2019

Study information

Verified date August 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - Patients aged 14-18 (those who need transition) and seen at an Eskenaki pediatrics clinic in past month. Exclusion Criteria: - None.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Automated 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.

Locations

Country Name City State
United States Eskenazi Health Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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?
Baseline
Primary 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?
1 month after appointment
Secondary Provider satisfaction A Likert scale is administered twice yearly determining the provider satisfaction with each CHICA module 6 months
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