- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01281436
Health Information Technology to Support Clinical Decision Making in Obesity Care
The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health information technology (HIT) to improve health care decision making through the use of integrated data and knowledge management. The proposed study will evaluate the use of HIT for clinician decision support and tailored patient education on the implementation of the current guidelines for the prevention of obesity-related chronic conditions in health disparity populations of poor, minority youth who access care through SBHCs. The specific aims are:
To evaluate the effectiveness of web-based training with and without computerized clinical decision support on provider's process and outcome behaviors related to implementing the current guidelines for prevention of obesity and related conditions.
a. Process variables include the following: i. Provider knowledge, attitudes, and barriers to implementing the guidelines. ii. Parent perception of the interpersonal process of care (i.e., provider communication, collaborative decision making, and interpersonal style).
iii. Parent perception of provider support for their child's healthy eating and exercise.
b. Behavior outcomes include the following: i. Provider self-reported behaviors of identification and assessment of overweight, counseling on nutrition and physical activity, use of behavioral interventions, referrals, and cultural competency.
ii. Documentation by chart review of body mass index (BMI) percentile for age and sex; appropriate diagnosis when BMI > 85th percentile; blood pressure (BP) percentile for age, height, and sex; and ordering appropriate laboratory tests when indicated.
- To explore the role of HIT in the processes of system change for implementation of the guidelines for prevention of obesity and related conditions, including the facilitators, barriers, and impact of the care model on change.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85004
- Recruiting
- Arizona State University
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Contact:
- Danielle Dandreaux, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- School Based Health Centers who serve children 5-12 years
- sees a minimum of 20 children per month for well-child care or sports physicals
- has internet access and printer
- has space for a small computer in the waiting room or check-in area
- has a primary care provider who reads English.
Inclusion criteria for parents:
- read English or Spanish
Exclusion Criteria:
- centers that have implemented the HeartSmartKids program.
- children seen for immunizations, dental, or mental health care without a well-child visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Web-based Provider training
The training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity.
Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies.
|
The training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity.
Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies.
|
Active Comparator: HeartSmartKids with web-based training
The providers assigned to Group 2 will receive the web-based training described in the other arm, plus the HeartSmartKids™ (HSK) system.
HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education.
|
The training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity.
Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies.
The providers assigned to Group 2 will receive the web-based training described in the web-based training arm, plus the HeartSmartKids™ (HSK) system.
HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Life Science Institute(ILSI)Research Foundation Assessment of Overweight in Children and Adolescents
Time Frame: every 9-12 months
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The 35-item survey asks providers to rate themselves using a Likert-type scale on the following: (a) definitions of overweight in various age groups, (b) calculation and documentation of BMI percentile, (c) routine counseling on nutrition, physical activity, and screen time, (d) assessment of overweight children, and (e) resources and barriers that providers encounter in dealing with childhood overweight.
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every 9-12 months
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Chronic Care Model Elements Survey (CCMES)
Time Frame: every 9-12 months
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A 9-item survey that assesses the extent to which elements of the chronic care model are used in the routine care of patients in a practice.
It was originally designed for patients with diabetes and was adapted for use in overweight/obesity.
The total score is created as the mean of the 9 items, with the higher indicative of greater use of the elements of the CCM.
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every 9-12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interpersonal Process of Care (IPC)
Time Frame: every 9-12 months
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A 29-item survey available in English and Spanish.
It is a 5-point Likert-type scale that measures the patient-clinician relationship, quality, and satisfaction with care on three domains: communication, decision making, and interpersonal style.
Health disparities may be attributable to differences between minorities and their counterparts in the interpersonal processes between the patients and clinicians.
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every 9-12 months
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Health-Care Climate Questionnaire (HCCQ)
Time Frame: every 9-12 months
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A measure with 6 items for eating and 6 items for regular exercise that assesses the degree of support from healthcare providers for healthy behaviors.
The HCCQ for diet and exercise are scored by combining the items on each scale.
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every 9-12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bonnie M Gance-Cleveland, Ph.D., Arizona State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHRQ (HHSA29032001T)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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