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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02354820
Other study ID # CHICA-GI Constipation
Secondary ID K23DK098235
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date December 2016

Study information

Verified date August 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 16264
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Evidence Based Constipation Reminders


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
William E. Bennett, Jr. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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