Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT01814787
• Recruitment Status: Completed
• First Posted: March 20, 2013
• Results First Posted: March 23, 2017
• Last Update Posted: May 15, 2017
• Sponsor: Indiana University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Aaron Carroll, Indiana University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Other: CHICA Type 2 Diabetes Module	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1369 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Screening
• Official Title: Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
• Study Start Date: October 2013
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: CHICA Type 2 Diabetes Module; 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.	Other: CHICA Type 2 Diabetes Module; Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician whether the child might have insulin resistance. All information will then be analyzed to determine whether the child has 2 or more risk factors for the development of type 2 diabetes. If at least 2 risk factors are present, then the CHICA system goes on to coordinate the diagnosis and long-term management of type 2 diabetes.
No Intervention: Usual Care; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Children With Documented Risk Factors for Type 2 Diabetes [ Time Frame: 12 months ]
   Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

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

Investigators

• Principal Investigator: Aaron E Carroll, MD, MS; Indiana University School of Medicine
• Principal Investigator: Tamara Hannon, MD, MS; Indiana University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hannon TS, Dugan TM, Saha CK, McKee SJ, Downs SM, Carroll AE. Effectiveness of Computer Automation for the Diagnosis and Management of Childhood Type 2 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):327-334. doi: 10.1001/jamapediatrics.2016.4207.

• Responsible Party: Aaron Carroll, Professor of Pediatrics, Indiana University
• ClinicalTrials.gov Identifier: NCT01814787
• Other Study ID Numbers: 1R01DK092717 ( U.S. NIH Grant/Contract ); 1R01DK092717 ( U.S. NIH Grant/Contract )
• First Posted: March 20, 2013
• Results First Posted: March 23, 2017
• Last Update Posted: May 15, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Aaron Carroll, Indiana University:

Type 2 Diabetes; Pediatrics; Computerized Decision Support System

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases