- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648242
Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
Improving Pediatric Obesity Practice Using Prompts (iPOP-UP): Using Electronic Health Records to Support Decision-Making in Pediatric Obesity Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary specific aims of this study are to:
- To assess the impact of EHR-based tools for pediatric obesity in primary care. Hypotheses: EHR-based clinical decision support tools that interrupt but support clinical workflow will (1) improve measures of pediatric obesity care quality delivered by clinicians (e.g., addition of obesity to the problem list, recommended screening for comorbidities, and follow-up/referral plans) and (2) result in a reduced rate of BMI increase over one year among children with obesity.
- To utilize a mixed methods approach with surveys and semi-structured qualitative interviews with clinicians to (1) examine the extent to which the EHR tools positively impact clinicians' awareness, knowledge and adherence to expert guidelines for pediatric obesity management, and (2) to explore the barriers to and facilitators of clinicians' use of the EHR tools and factors that influence adoption.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Interruptive Clinical Decision Support
|
An interruptive, "soft-stop" alert will pop up when a pediatric primary care provider open a child's electronic health record (i.e., a new window in the forefront of the screen interrupting workflow and requiring the clinician to take an action) alerting them that the child meets criteria for obesity based on their age/sex-specific BMI percentile. The pop-up alert includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body mass index (BMI)
Time Frame: 1 year pre-intervention, baseline, and 1 year post-intervention
|
change in BMI, calculated from height and weight measured as part of routine clinical practice during primary care clinic visits and documented in the EHR
|
1 year pre-intervention, baseline, and 1 year post-intervention
|
|
Change in percent BMI above the 95th percentile (%BMIp95)
Time Frame: 1 year pre-intervention, baseline, and 1 year post-intervention
|
Change in percentage of age/sex-adjusted BMI above the 95th percentile (%BMIp95), calculated from height and weight measured as part of routine clinical practice during primary care clinic visits and documented in the EHR
|
1 year pre-intervention, baseline, and 1 year post-intervention
|
|
Change in documentation of elevated BMI diagnosis
Time Frame: 1-year pre-implementation compared to 1-year post-implementation
|
Change in proportion of patients with obesity who have elevated BMI documented in the EHR
|
1-year pre-implementation compared to 1-year post-implementation
|
|
Change in proportion of patients with obesity
Time Frame: 1-year pre-implementation compared to 1-year post-implementation
|
Change in proportion of patients with obesity who receive age-appropriate screening for comorbidities (blood measure measurement and age-appropriate laboratory screening)
|
1-year pre-implementation compared to 1-year post-implementation
|
|
Change in proportion of patients with obesity who have counseling for obesity-related behavior change documented in the EHR
Time Frame: 1-year pre-implementation compared to 1-year post-implementation
|
1-year pre-implementation compared to 1-year post-implementation
|
|
|
Change in proportion of patients with obesity with follow-up or referral orders
Time Frame: 1-year pre-implementation compared to 1-year post-implementation
|
1-year pre-implementation compared to 1-year post-implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in provider knowledge, attitudes and practice around obesity management in primary care assessed via an electronic surveys and qualitative interviews of clinicians
Time Frame: baseline compared to 6 months post-implementation
|
baseline compared to 6 months post-implementation
|
|
|
System usability scale (SUS) score
Time Frame: 6 months post-implementation
|
the system usability scale is a validated 10-item measure of system usability
|
6 months post-implementation
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000026382
- 1K08HS024332-01A1 (AHRQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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