ConstipationCHICA-GINCT02354820
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
A study testing Evidence Based Constipation Reminders in people with Constipation and Encopresis, run by William E. Bennett, Jr..
Trial summary
This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Constipation, Encopresis
- What is being tested?
- Evidence Based Constipation Reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,264 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN.
- Patients given a pre-screener form as part of the existing CHICA decision support system.
- Age between 2 years and 12 years, inclusive.
Who cannot join
- None.
About this study
This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.
- Conditions
- Constipation, Encopresis
- Being tested
- Evidence Based Constipation Reminders
- Medical subject headings
- Constipation, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence Based Constipation RemindersOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management. |
| Experimental | Experimental | Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management. Receives: Other: Evidence Based Constipation Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Persistent Constipation Within 6 Months
Parents are asked if constipation is still present at a subsequent visit within 6 months.
Measured: All visits within 6 months of initial constipation complaint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16,264 participants (actual)
Sponsor and investigators
- Lead sponsor
- William E. Bennett, Jr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William E. Bennett, Jr., Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354820
- Sponsor's protocol ID
- CHICA-GI Constipation
- Other IDs
- K23DK098235
- Acronym
- CHICA-GI
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2015
- Last updated
- 14 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
- ClinicalTrials.gov ID
- NCT02354820
- Acronym / sponsor ID
- CHICA-GI / CHICA-GI Constipation
- Conditions
- Constipation, Encopresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,264 participants (actual)
- Lead sponsor
- William E. Bennett, Jr.University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 14 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management. |
| Experimental | Experimental | Other: Evidence Based Constipation RemindersPatients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN.
- Patients given a pre-screener form as part of the existing CHICA decision support system.
- Age between 2 years and 12 years, inclusive.
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 |
|---|---|---|
| Evidence Based Constipation Reminders | Other | Experimental |
Primary outcome
Number of Patients With Persistent Constipation Within 6 Months
Time frame: All visits within 6 months of initial constipation complaint.
Parents are asked if constipation is still present at a subsequent visit within 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence Based Constipation Reminders in people with Constipation and Encopresis, run by William E. Bennett, Jr..
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 3 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 14 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Persistent Constipation Within 6 Months (time frame: All visits within 6 months of initial constipation complaint.). 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 14 Sep 2022.