TransitionNCT03371875
Automated Youth-To-Adult Transition Planning Using Health Information ...
A study testing Automated transition care reminders in people with Transition and Adolescent Behavior, run by Indiana University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Transition, Adolescent Behavior
- What is being tested?
- Automated transition care reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 14-18 (those who need transition) and seen at an Eskenaki pediatrics clinic in past month.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Transition, Adolescent Behavior
- Being tested
- Automated transition care reminders
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated transition care remindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transition Clinics | Experimental | 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. Receives: Behavioral: Automated transition care reminders |
| Control Clinics | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Baseline
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?
Measured: 1 month after appointment
Secondary outcomes (1)
Provider satisfaction
A Likert scale is administered twice yearly determining the provider satisfaction with each CHICA module
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start15 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransitionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William E. Bennett, Jr., Indiana University
- Investigators
- William E Bennett, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371875
- Sponsor's protocol ID
- 1704015932
- Status last verified
- Aug 2022
- First submitted
- 17 Nov 2017
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Youth-To-Adult Transition Planning Using Health Information ...
- ClinicalTrials.gov ID
- NCT03371875
- Acronym / sponsor ID
- 1704015932
- Conditions
- Transition, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition Clinics | Experimental | Behavioral: Automated transition care remindersClinics 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. |
| Control Clinics | No intervention | –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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged 14-18 (those who need transition) and seen at an Eskenaki pediatrics clinic in past month.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated transition care remindersThe 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. | Behavioural | Transition Clinics |
Primary outcome
Patient transition satisfaction (Pre)
Time frame: Baseline
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?
Patient transition satisfaction (Post)
Time frame: 1 month after appointment
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 secondary outcome
Provider satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Bennett, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated transition care reminders in people with Transition and Adolescent Behavior, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient transition satisfaction (Pre) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.