Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240772 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-12-14

Brief Summary

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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.

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Detailed Description

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This study will evaluate iPOP-UP, a newly-optimized intervention to improve adherence to national guidelines for the management of childhood obesity, among 84 primary care practices 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 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 practices. Within the participating 84 practices, 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.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multi-site, parallel 2-arm cluster randomized controlled trial "Hybrid Type 2" effectiveness-implementation study to simultaneously evaluate (1) the effectiveness of iPOP-UP in improving clinical care and child weight 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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

Intervention Type BEHAVIORAL

EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No