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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03648242
Other study ID # 2000026382
Secondary ID 1K08HS024332-01A
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2020

Study information

Verified date May 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 31, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Yale University Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Change in proportion of patients with obesity with follow-up or referral orders 1-year pre-implementation compared to 1-year post-implementation
Secondary 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
Secondary System usability scale (SUS) score the system usability scale is a validated 10-item measure of system usability 6 months post-implementation
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