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

NCT ID: NCT02354820

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Evidence Based Constipation Reminders

Intervention Type: OTHER

Interventions

Evidence Based Constipation Reminders

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

William E. Bennett, Jr.

OTHER

Sponsor Role: lead

Responsible Party

William E. Bennett, Jr.

Assistant Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

K23DK098235

Identifier Type: NIH

Identifier Source: secondary_id

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CHICA-GI Constipation

Identifier Type: -

Identifier Source: org_study_id