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Child Health Improvement Through Computer Automation of Constipation Management in Primary Care (CHICA-GI)

Primary Purpose

Constipation, Encopresis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evidence Based Constipation Reminders
Sponsored by
William E. Bennett, Jr.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Experimental

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of Patients With Persistent Constipation Within 6 Months
    Parents are asked if constipation is still present at a subsequent visit within 6 months.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 26, 2015
    Last Updated
    August 19, 2022
    Sponsor
    William E. Bennett, Jr.
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02354820
    Brief Title
    Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
    Acronym
    CHICA-GI
    Official Title
    Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    William E. Bennett, Jr.
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    16264 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Evidence Based Constipation Reminders
    Primary Outcome Measure Information:
    Title
    Number of Patients With Persistent Constipation Within 6 Months
    Description
    Parents are asked if constipation is still present at a subsequent visit within 6 months.
    Time Frame
    All visits within 6 months of initial constipation complaint.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: None.

    12. IPD Sharing Statement

    Learn more about this trial

    Child Health Improvement Through Computer Automation of Constipation Management in Primary Care

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