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Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

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ClinicalTrials.gov Identifier: NCT03648242
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Interruptive Clinical Decision Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP): Using Electronic Health Records to Support Decision-Making in Pediatric Obesity Care
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648242


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Yale University
Boston Children’s Hospital
Investigators
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Principal Investigator: Corinna Rea, MD, MPH Boston Children’s Hospital

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03648242     History of Changes
Other Study ID Numbers: IRB-P00029050
1K08HS024332-01A1 ( U.S. AHRQ Grant/Contract )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
pediatric obesity
electronic health record
clinical decision support

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms