Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interruptive Clinical Decision Support
Sponsored by
About this trial
This is an interventional health services research trial for Pediatric Obesity focused on measuring pediatric obesity, electronic health record, clinical decision support
Eligibility Criteria
All pediatric primary care providers providing well child care for patients ages 2-17 years-old in the Boston Children's Hospital primary care practices will be eligible for the study. There are no exclusion criteria.
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interruptive Clinical Decision Support
Arm Description
Outcomes
Primary Outcome Measures
Change in body mass index (BMI)
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
Change in percent BMI above the 95th percentile (%BMIp95)
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
Change in documentation of elevated BMI diagnosis
Change in proportion of patients with obesity who have elevated BMI documented in the EHR
Change in proportion of patients with obesity
Change in proportion of patients with obesity who receive age-appropriate screening for comorbidities (blood measure measurement and age-appropriate laboratory screening)
Change in proportion of patients with obesity who have counseling for obesity-related behavior change documented in the EHR
Change in proportion of patients with obesity with follow-up or referral orders
Secondary Outcome Measures
Change in provider knowledge, attitudes and practice around obesity management in primary care assessed via an electronic surveys and qualitative interviews of clinicians
System usability scale (SUS) score
the system usability scale is a validated 10-item measure of system usability
Full Information
NCT ID
NCT03648242
First Posted
August 21, 2018
Last Updated
May 13, 2021
Sponsor
Yale University
Collaborators
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03648242
Brief Title
Improving Pediatric Obesity Practice Using Prompts
Acronym
iPOP-UP
Official Title
Improving Pediatric Obesity Practice Using Prompts (iPOP-UP): Using Electronic Health Records to Support Decision-Making in Pediatric Obesity Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares the effectiveness of electronic health record (EHR)-based tools to support the management of pediatric obesity in primary care. All clinicians will receive an interruptive "pop-up" alert We will examine the impact -- the added value versus unintended consequences -- of the interruptive alert on the quality of obesity management in pediatric primary care.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
pediatric obesity, electronic health record, clinical decision support
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interruptive Clinical Decision Support
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Interruptive Clinical Decision Support
Intervention Description
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:
One-click addition of elevated BMI to problem list
Reminder to utilize Suggested PowerPlan
One-click access to a patient handout on evidence-based behavior change goals (screen time, sugary drinks, physical activity, sleep) and link to additional handouts and resources
Tables displaying trends in growth measures, blood pressure and relevant laboratory tests
Links to existing, evidence-based childhood obesity screening and management guidelines
Primary Outcome Measure Information:
Title
Change in body mass index (BMI)
Description
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
Time Frame
1 year pre-intervention, baseline, and 1 year post-intervention
Title
Change in percent BMI above the 95th percentile (%BMIp95)
Description
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
Time Frame
1 year pre-intervention, baseline, and 1 year post-intervention
Title
Change in documentation of elevated BMI diagnosis
Description
Change in proportion of patients with obesity who have elevated BMI documented in the EHR
Time Frame
1-year pre-implementation compared to 1-year post-implementation
Title
Change in proportion of patients with obesity
Description
Change in proportion of patients with obesity who receive age-appropriate screening for comorbidities (blood measure measurement and age-appropriate laboratory screening)
Time Frame
1-year pre-implementation compared to 1-year post-implementation
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
System usability scale (SUS) score
Description
the system usability scale is a validated 10-item measure of system usability
Time Frame
6 months post-implementation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
All pediatric primary care providers providing well child care for patients ages 2-17 years-old in the Boston Children's Hospital primary care practices will be eligible for the study. There are no exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinna Rea, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Pediatric Obesity Practice Using Prompts
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