Clinical trial NCT05627011: Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts
Official title: Dissemination and Implementation of Decision Support for the Management of Overweight and Obesity in Pediatric Primary Care - Improving Pediatric Obesity Practice Using Prompts
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: Clinical Decision Support
Implementation Science
Pediatric Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-11-25
Enrollment: 240772
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-site, parallel 2-arm cluster randomized controlled trial "Hybrid Type 2" effectiveness-implementation study to simultaneously evaluate (1) the effectiveness of iPOP-UP in improving clinical care and child weight outcomes in pediatric primary care setting and (2) the impact of the implementation strategy on the reach, adoption, fidelity, cost, and maintenance of the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.

Detailed description: This study will evaluate iPOP-UP, a newly-optimized intervention to improve adherence to national guidelines for the management of childhood obesity, among 84 primary care practices affiliated with three health systems serving children with racial and ethnic, socio-economic, rural-urban, and geographic diversity.

This multi-site, parallel 2-arm cluster randomized controlled "Hybrid Type 2" effectiveness-implementation trial will use mixed methods (electronic health record (EHR) data analysis, surveys, interviews, and focus groups) to simultaneously evaluate (1) the effectiveness of the iPOP-UP implementation package in improving clinical care and children's BMI outcomes in pediatric primary care setting and (2) the impact of the implementation strategy on the reach, adoption, fidelity, cost, and maintenance of the intervention.

The unit of randomization in this study is pediatric primary care practices. Within the participating 84 practices, pediatric primary care clinicians working at the implementation sites will be invited to participate in pre- and post-intervention surveys assessing their practice behaviors, obesity-related attitudes, beliefs, and self-efficacy, EHR usage and attitudes, and training preferences. In addition, a limited data set of EHR from patients visits will be queried and analyzed to evaluate clinical care outcomes and children's BMI outcomes. Limited data (to include dates and geographic information but no facial identifiers) will be queried and analyzed for all children 1) age 2.0 to ≤18 years-old at baseline, 2) with a well-child visit, during which height and weight are measured, at one of the participating practices during the study period, and 3) with a BMI ≥85th percentile for age/sex (CDC criteria for overweight/obesity).

Outcomes include: (a) change in BMI, measured as the yearly change in BMI expressed as a percentage of the 95th percentile (%BMIp95); (b) Change in clinicians' objective practice around managing elevated BMI in primary care using EHR data; (c) Change in clinicians' self-reported knowledge, attitudes, and practice around managing elevated BMI in primary care; and (d) Utilization of Clinical Decision Support (CDS) tools. The investigators will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of the study team throughout the process of implementation.

Eligibility criteria: Inclusion Criteria:

* Primary Care Practices: all primary care practices using the EHR system of one of the 3 health systems participating in the study that agree to participate in the iPOP-UP trial;
* Clinician-participants: all clinicians who delivery pediatric primary care at the participating practices, including physicians and physicians-in-training (residents and fellows), physician assistants (PA), nurse practitioners (NP)/advanced practice registered nurses (APRNs);
* Patient-participants: all patients ages 2-18 with overweight/obesity seen during the study period may be impacted by the intervention. A limited dataset will be collected for the subset of these 2 to 18 years old patients with BMI ≥ 85th percentile for age and sex seen for a well or follow-up visit during the study period in a primary care department and conducted by a prescribing clinician (physician, NP, PA)

Exclusion Criteria:

* None - exclusion criteria are purposefully limited in this real-world implementation study

Primary outcomes:
measure: Change in %BMIp95
timeFrame: Up to 15 months after first primary care visit following trial launch
measure: Change in composite measure of clinician's adherence to clinical guidelines, for visits completed among children 2-18 years-old with BMI ≥85th percentile.
timeFrame: Baseline through 6 months after trial launch
Secondary outcomes:
measure: Change in composite measure of clinician's adherence to clinical guidelines
timeFrame: Baseline through 18 months after trial launch
measure: Change in inclusion of diagnosis code indicating high BMI in problem list
timeFrame: Baseline through 18 months after trial launch
measure: Change in inclusion of diagnosis code indicating high BMI in visit diagnosis
timeFrame: Baseline through 18 months after trial launch
measure: Change in adherence to guideline recommended screening lab orders for obesity related comorbidities, if eligible
timeFrame: Baseline through 18 months after trial launch
measure: Change in appropriate blood pressure screening in children 3 and older
timeFrame: Baseline through 18 months after trial launch
measure: Change in structured documentation of counseling
timeFrame: Baseline through 18 months after trial launch
measure: Change in follow-up visit requested
timeFrame: Baseline through 18 months after trial launch
measure: Change in referral for further management of obesity
timeFrame: Baseline through 18 months after trial launch
measure: Change in weight loss medication orders, if eligible
timeFrame: Baseline through 18 months after trial post intervention launch
measure: Change in bariatric surgery program referrals, if eligible
timeFrame: Baseline through 18 months after trial launch
measure: Change in potentially unnecessary insulin or thyroid laboratory tests ordered
timeFrame: Baseline through 18 months after trial launch
measure: Clinicians' utilization of the clinical decision support tools
timeFrame: During the 18 months following trial launch
measure: Change in clinicians' attitudes and practice around managing elevated BMI in primary care
timeFrame: Pre-intervention and 6 months post intervention launch
measure: Cost and cost-effectiveness of iPOP-UP
timeFrame: 6 months before trial launch and up to 15 months after first primary care visit following trial launch
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Yale University
name: Mahnoosh (Mona) Sharifi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: