Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

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Indiana University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Other: CHICA Type 2 Diabetes Module

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01814787
1R01DK092717 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Increasing rates of type 2 diabetes among children and adolescents has considerable long-term implications not only for the affected individuals, but also for society and the health system as a whole. Pediatricians have unique and important opportunities to screen for type 2 diabetes and to promote lifestyle modification for those children identified with pre-diabetes; yet implementation of these practices within the pediatric primary care setting is far from ideal. The purpose of this study is to implement the ADA screening guidelines for type 2 diabetes and clinical management prompts within a pediatric primary care setting using a computer decision support system (CDSS) developed by the investigators research group - the Child Health Improvement through Computer Automation (CHICA) system. The investigators hypothesize that the coupling of CDSS with ADA guidelines will result in greater compliance with ADA recommended screening procedures as well as better clinical management of children identified as having pre-diabetes or type 2 diabetes.

Full description

As the prevalence of obesity in the United States has risen, so too has the prevalence of type 2 diabetes, a disease typically associated with adults. The American Diabetes Association (ADA) has recommended screening children 10 years of age or older who are at substantial risk for the presence or development of type 2 diabetes. They also recommend that primary prevention efforts, such as lifestyle modification, be directed to high-risk children whose glucose levels are elevated but not yet diagnostic of diabetes. The choice of screening methodology remains controversial and implementation within the pediatric primary care setting is far from ideal. The purpose of this study is to implement the ADA screening guidelines for type 2 diabetes within pediatric primary care practices using a computer decision support system (CDSS) developed by the investigators research group - the Child Health Improvement through Computer Automation (CHICA) system. Using the CHICA system the investigators will also be implementing clinical management prompts for the pediatrician caring for children with risk factors for type 2 diabetes, with impaired fasting glucose (IFG), or with fasting glucose indicating the possibility of diabetes. One of the greatest strengths of the CHICA system is its ability to implement evidence-based recommendations from authoritative sources, in this case the ADA, in a format that integrates easily into routine pediatric care; the system can therefore overcome many of the barriers described by pediatricians to the screening of type 2 diabetes in children. While the use of CDSS is not new, its application within the pediatric population has not been as pervasive as in adult medicine. Moreover, the application of CDSS to the screening, diagnosis and management of type 2 diabetes in children is relatively unexplored. The specific aims for this study are to: (1) Expand and modify an existing computer-based decision support system (CHICA), to identify those children 10 years of age or older who are at increased risk for type 2 diabetes, to provide pediatric physicians guidelines to screen for type 2 diabetes, and to coordinate the diagnosis and long-term management of the condition and (2) Demonstrate both the feasibility and effectiveness of the CHICA Type 2 Diabetes Module to recognize those children in need of screening for type 2 diabetes and facilitate prompt diagnosis and management of the condition. Phase one (Aim 1) focuses on programming and enhancements to the CHICA system and will take 12 months to complete. Phase two consists of a randomized controlled trial conducted in four pediatric clinics in order to evaluate Aim 2. Randomization will be by clinic and the investigators hypothesize that the coupling of CDSS with ADA guidelines will result in greater compliance with ADA recommended screening procedures as well as better clinical management of children identified as having pre-diabetes or type 2 diabetes. Phase two will begin in year 2 and continue through quarter 2 of year 4. Phase three involves statistical analysis and manuscript preparation.

Enrollment

1,369 patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A patient's chart will be eligible for chart abstraction if the child is age 10 or older and is a patient at one of the four clinics involved in the study.

Exclusion criteria

  • None

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,369 participants in 2 patient groups

CHICA Type 2 Diabetes Module
Experimental group
Description:
Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
Treatment:
Other: CHICA Type 2 Diabetes Module
Usual Care
No Intervention group
Description:
Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child's BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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