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

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 Overview

• Status: Completed
• Conditions: Constipation; Encopresis
• Intervention / Treatment: Other: Evidence Based Constipation Reminders

• Study Type: Interventional
• Enrollment (Actual): 16264
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.	Other: Evidence Based Constipation Reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Persistent Constipation Within 6 Months	Parents are asked if constipation is still present at a subsequent visit within 6 months.	All visits within 6 months of initial constipation complaint.

Collaborators and Investigators

• Sponsor: William E. Bennett, Jr.
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Signs and Symptoms, Digestive; Elimination Disorders; Constipation; Encopresis
• Other Study ID Numbers: CHICA-GI Constipation; K23DK098235 (U.S. NIH Grant/Contract)