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

NCT02354820 | Completed Results

• 2 other identifiers: CHICA-GI ConstipationK23DK098235
• Study Type: interventional
• Target: 16,264
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation; Encopresis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Other: Evidence Based Constipation Reminders

Interventions

Evidence Based Constipation Reminders OTHER

Experimental

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Constipation; Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Results Point of Contact

• Title: William E. Bennett, Jr. Principal Investigator
• Organization: Indiana University School of Medicine

webjr@iu.edu

3172786928

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 3, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 14, 2022
• Results First Posted: September 14, 2022

Record last verified: 2022-08