NCT03648242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

August 21, 2018

Last Update Submit

May 13, 2021

Conditions

Keywords

pediatric obesityelectronic health recordclinical decision support

Outcome Measures

Primary Outcomes (6)

  • 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

    1 year pre-intervention, baseline, and 1 year post-intervention

  • 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

    1 year pre-intervention, baseline, and 1 year post-intervention

  • Change in documentation of elevated BMI diagnosis

    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

    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

    1-year pre-implementation compared to 1-year post-implementation

  • Change in proportion of patients with obesity with follow-up or referral orders

    1-year pre-implementation compared to 1-year post-implementation

Secondary Outcomes (2)

  • Change in provider knowledge, attitudes and practice around obesity management in primary care assessed via an electronic surveys and qualitative interviews of clinicians

    baseline compared to 6 months post-implementation

  • System usability scale (SUS) score

    6 months post-implementation

Study Arms (1)

Interruptive Clinical Decision Support

EXPERIMENTAL
Behavioral: Interruptive Clinical Decision Support

Interventions

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

Interruptive Clinical Decision Support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Corinna Rea, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 27, 2018

Study Start

September 1, 2018

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations