Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

May 13, 2021 updated by: Yale University

Improving Pediatric Obesity Practice Using Prompts (iPOP-UP): Using Electronic Health Records to Support Decision-Making in Pediatric Obesity Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary specific aims of this study are to:

  1. 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.
  2. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Interruptive Clinical Decision Support
Behavioral: 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:

  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000026382
  • 1K08HS024332-01A1 (AHRQ)

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

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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