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OpenTrials
Completed

NCT Number: NCT03648242

Improving Pediatric Obesity Practice Using Prompts

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interruptive Clinical Decision Support

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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 outcomes

  1. 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

  2. System usability scale (SUS) score

    Time frame: 6 months post-implementation

    the system usability scale is a validated 10-item measure of system usability

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Boston Children's Hospital

Registry information

Official study title

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

Acronym: iPOP-UP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2018
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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