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Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01814787
First received: March 18, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention
Type 2 Diabetes
Other: CHICA Type 2 Diabetes Module

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Percent of children with documented risk factors for type 2 diabetes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)


Secondary Outcome Measures:
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes scheduled for FPG [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes completing FPG [ Time Frame: 12 monthes ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes scheduled for follow-up appointment with pediatrician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes attending follow-up appointment with pediatrician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes with "Positive" FPG Lab results (FPG>125) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes "Borderline" FPG Lab results (125>= FPG > 100) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes with "Positive" HbA1C (HbA1C >= 6.5%) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes with "Borderline" HbA1C (6.5% > HbA1C >= 5.7%) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs scheduled for OGTT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs completing OGTT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs scheduled for follow-up appointment with pediatrician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs attending follow-up appointment with pediatrician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs with "Positive" OGTT (OGTT > 199) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Positive" FPG or HbA1C Lab results (FPG > 125) or HbA1C ≥ 6.5%) referred to pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Positive" FPG or HbA1C Lab results (FPG > 125) or HbA1C ≥ 6.5%) attending appointment with pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with "Positive" FPG or HbA1C Lab results (FPG > 125) or HbA1C ≥ 6.5%) with follow-up letter sent to pediatrician by pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with OGTT > 199 referred to pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with OGTT > 199 attending appointment with pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with OGTT > 199 with follow-up letter sent to pediatrician by pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with OGTT between 140 and 199) referred to pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with OGTT between 140 and 199) attending appointment with pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of children (ages 10 and older) with OGTT between 140 and 199) with follow-up letter sent to pediatrician by pediatric endocrinologist [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: October 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, by asking these questions of parents on the pre-screener form. 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 is greater than the 85th percentile, a prompt will appear on the provider worksheet asking the clinician whether the child has any symptoms or conditions associated with insulin resistance. This information along with the data gathered previously from the pre-screener form will 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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814787

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01814787     History of Changes
Other Study ID Numbers: 1R01DK092717
Study First Received: March 18, 2013
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Type 2 Diabetes
Pediatrics
Computerized Decision Support System

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014