Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

Dissemination and Implementation of Decision Support for the Management of Overweight and Obesity in Pediatric Primary Care - Improving Pediatric Obesity Practice Using Prompts

The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

Detailed Description

This study will evaluate iPOP-UP, a newly-optimized intervention to improve adherence to national guidelines for the management of childhood obesity, among 81 primary care practices, grouped into 71 clinic clusters, affiliated with three health systems serving children with racial and ethnic, socio-economic, rural-urban, and geographic diversity.

This multi-site, parallel 2-arm cluster randomized controlled "Hybrid Type 2" effectiveness-implementation trial will use mixed methods (electronic health record (EHR) data analysis, surveys, interviews, and focus groups) to simultaneously evaluate (1) the effectiveness of the iPOP-UP implementation package in improving clinical care and children's Body Mass Index (BMI) outcomes in pediatric primary care setting and (2) the impact of the implementation strategy on the reach, adoption, fidelity, cost, and maintenance of the intervention.

The unit of randomization in this study is pediatric primary care practice clusters. Within the participating 71 clusters, pediatric primary care clinicians working at the implementation sites will be invited to participate in pre- and post-intervention surveys assessing their practice behaviors, obesity-related attitudes, beliefs, and self-efficacy, EHR usage and attitudes, and training preferences. In addition, a limited data set of EHR from patients visits will be queried and analyzed to evaluate clinical care outcomes and children's BMI outcomes. Limited data (to include dates and geographic information but no facial identifiers) will be queried and analyzed for all children 1) age 2.0 to ≤18 years-old at baseline, 2) with a well-child visit, during which height and weight are measured, at one of the participating practices during the study period, and 3) with a BMI ≥85th percentile for age/sex (CDC criteria for overweight/obesity).

Outcomes include: (a) change in BMI, measured as the yearly change in BMI expressed as a percentage of the 95th percentile (%BMIp95); (b) Change in clinicians' objective practice around managing elevated BMI in primary care using EHR data; (c) Change in clinicians' self-reported knowledge, attitudes, and practice around managing elevated BMI in primary care; and (d) Utilization of Clinical Decision Support (CDS) tools. The investigators will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of the study team throughout the process of implementation.

• Study Type: Interventional
• Enrollment (Actual): 58364
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary Care Practices: all primary care practices using the EHR system of one of the 3 health systems participating in the study that agree to participate in the iPOP-UP trial;
• Clinician-participants: all clinicians who delivery pediatric primary care at the participating practices, including physicians and physicians-in-training (residents and fellows), physician assistants (PA), nurse practitioners (NP)/advanced practice registered nurses (APRNs);
• Patient-participants: all patients ages 2-18 with overweight/obesity seen during the study period may be impacted by the intervention. A limited dataset will be collected for the subset of these 2 to 18 years old patients with BMI ≥ 85th percentile for age and sex seen for a well or follow-up visit during the study period in a primary care department and conducted by a prescribing clinician (physician, NP, PA)

Exclusion Criteria:

• None - exclusion criteria are purposefully limited in this real-world implementation study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical Decision Support Tool; Practices assigned to iPOP-UP intervention which involves EHR-based CDS tools refined through a formative evaluation and user-centered design.	Behavioral: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP); EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study.
No Intervention: Control; Practices assigned to usual care that will not have access to the iPOP-UP CDS tool but will have access to many opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in BMI as Percentage of 95th Percentile	Calculated as a percentage of the participant's BMI (m/kg2) divided by the BMI (m/kg2) at the 95th percentile for the participant's age and sex based on CDC growth curves. A negative percentage indicates that the participant's BMI has decreased since trial launch.	Up to 15 months after first primary care visit following trial launch
Percent Adherence in Composite Measure of Clinician's Adherence to Clinical Guidelines, for Visits Completed Among Children 2-18 Years-old With BMI ≥85th Percentile.	Percent change in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period: Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list; Recommended lab orders for obesity related comorbidities, if eligible; Appropriate blood pressure (BP) measurement in children 3 years and older; Counseling diagnosis codes or structured documentation (every visit); Follow-up visit requested at visit or active referral order for further management of obesity A score of 1 indicates that a clinician followed all evidence of recommended obesity-related care; a score of 0 indicates that a clinician did not follow at least one recommendation for obesity-related care.	6 months after trial launch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines	Percent adherent visits at 12 and 18 months in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period: Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list; Recommended lab orders for obesity related comorbidities, if eligible; Appropriate BP measurement in children 3 years and older; Counseling diagnosis codes or structured documentation (every visit); Follow-up visit requested at visit or active referral order for further management of obesity A score of 1 indicates that a clinician followed all evidence of recommended obesity-.related care; a score of 0 indicates that a clinician did not follow at least one recommendation.	12 and 18 months after trial launch
Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI in problem list, queried from the electronic health record at baseline, 6, 12, and 18 months to see change at 6 months and how it's sustained at 12 and 18 months. A higher proportion of visits with relevant diagnosis code is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI queried from the electronic health record. A higher proportion of visits with relevant diagnosis code is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of screening lab orders for obesity-related comorbidities recommended by the American Academy of Pediatrics clinical practice guideline for obesity based on age and BMI percentile, queried from the electronic health record. A higher proportion of visits with recommended screening lab orders is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Adherent Visits in Appropriate Blood Pressure Screening	Percent adherent visits completed among children 3-18 years with BMI ≥85th percentile during the study period with evidence of appropriate blood pressure screening queried from the electronic health record. A higher proportion of visits with blood pressure screening is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Adherent Visits in Structured Documentation of Counseling	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of counseling structured documentation queried from the electronic health record. A higher proportion of visits with counseling structured documentation is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Visits With Follow-up Visit Requested	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of follow-up visit requested, queried from the electronic health record. A higher proportion of visits with follow-up visit requested is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Visits With Referral for Further Management of Obesity	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of referral for further management of obesity queried from the electronic health record. A higher proportion of visits with follow-up or referral for further management of obesity is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Visits With Weight Loss Medication Orders, if Eligible	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of weight loss medication orders, if eligible, queried from the electronic health record. A higher proportion of visits with weight loss medication orders, when eligible, is consistent with recommended care.	6, 12 and 18 months after trial post intervention launch
Percent Visits With Bariatric Surgery Program Referrals, if Eligible	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of bariatric surgery program referrals, if eligible queried from the electronic health record. A higher proportion of referrals to bariatric surgery programs, when eligible, is consistent with recommended care.	6, 12 and 18 months after trial launch
Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of insulin or thyroid lab orders, not routinely recommended for evaluation of children with obesity, queried from the electronic health record. A lower proportion indicates better adherence to recommended care.	6, 12 and 18 months after trial launch
Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools	Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of clinician use of the clinical decision support tools in the electronic health record developed for this trial, calculated from electronic health record query. Measure= % of visits at intervention sites at which the clinicians' uses clinical decision support tools through18 months A higher proportion indicates greater utilization of clinical decision support tools.	6, 12 and 18 months following trial launch
Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care	Mean change in clinician's attitudes and practice around management of elevated BMI measured using survey questions. Five factors will be assessed: Practice, Treatment self-efficacy, Counseling self-efficacy, Expectations, and Technology. Possible responses range from 1 (strongly disagree) to 5 (strongly agree) for attitudes or 1 (never) to 5 (almost always). Negative values indicate higher disagreement.	baseline and 6 months post intervention launch
Total Cost and Cost-effectiveness of iPOP-UP	Total cost of design, build, implementation of the tools, and other implementation strategies of iPOP-UP incurred by the clinics. Using a healthcare sector perspective, a micro-costing approach was utilized to estimate costs associated with the design, build, and implementation of EHR-based CDS for the management of pediatric overweight/obesity in primary care.	From 6 months before trial launch and up to 15 months after first primary care visit following trial launch

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Mahnoosh (Mona) Sharifi, MD, MPH, Yale University

Publications and helpful links

General Publications

• Ray J, Finn EB, Tyrrell H, Aloe CF, Perrin EM, Wood CT, Miner DS, Grout R, Michel JJ, Damschroder LJ, Sharifi M. User-Centered Framework for Implementation of Technology (UFIT): Development of an Integrated Framework for Designing Clinical Decision Support Tools Packaged With Tailored Implementation Strategies. J Med Internet Res. 2024 May 21;26:e51952. doi: 10.2196/51952.
• Nugent JT, Maciejewski KR, Finn EB, Grout RW, Wood CT, Esserman D, Michel JJ, Lu Y, Sharifi M. High Blood Pressure in Children Aged 3 to 12 Years Old With Overweight or Obesity. Child Obes. 2024 Dec;20(8):581-589. doi: 10.1089/chi.2023.0143. Epub 2024 May 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): December 14, 2024
• Study Completion (Actual): December 14, 2024

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Implementation Science; Pediatric Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 2000033551; 5R01MD014853 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No