Dissemination and Implementation of Decision Support for the Management of Overweight and Obesity in Pediatric Primary Care - Improving Pediatric Obesity Practice Using Prompts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 58,364
- Locations
- 6
- Primary Endpoint
- Mean Change in BMI as Percentage of 95th Percentile
Study Overview
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 81 primary care practices, grouped into 71 clinic clusters, 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 Body Mass Index (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 practice clusters. Within the participating 71 clusters, 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mean Change in BMI as Percentage of 95th Percentile
Time Frame: Up to 15 months after first primary care visit following trial launch
Calculated as a percentage of the participant's BMI (m/kg2) divided by the BMI (m/kg2) at the 95th percentile for the participant's age and sex based on CDC growth curves. A negative percentage indicates that the participant's BMI has decreased since trial launch.
Percent Adherence in Composite Measure of Clinician's Adherence to Clinical Guidelines, for Visits Completed Among Children 2-18 Years-old With BMI ≥85th Percentile.
Time Frame: 6 months after trial launch
Percent change in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period: 1. Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list 2. Recommended lab orders for obesity related comorbidities, if eligible 3. Appropriate blood pressure (BP) measurement in children 3 years and older 4. Counseling diagnosis codes or structured documentation (every visit) 5. Follow-up visit requested at visit or active referral order for further management of obesity A score of 1 indicates that a clinician followed all evidence of recommended obesity-related care; a score of 0 indicates that a clinician did not follow at least one recommendation for obesity-related care.
Secondary Outcomes
- Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines(12 and 18 months after trial launch)
- Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List(6, 12 and 18 months after trial launch)
- Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis(6, 12 and 18 months after trial launch)
- Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible(6, 12 and 18 months after trial launch)
- Percent Adherent Visits in Appropriate Blood Pressure Screening(6, 12 and 18 months after trial launch)
- Percent Adherent Visits in Structured Documentation of Counseling(6, 12 and 18 months after trial launch)
- Percent Visits With Follow-up Visit Requested(6, 12 and 18 months after trial launch)
- Percent Visits With Referral for Further Management of Obesity(6, 12 and 18 months after trial launch)
- Percent Visits With Weight Loss Medication Orders, if Eligible(6, 12 and 18 months after trial post intervention launch)
- Percent Visits With Bariatric Surgery Program Referrals, if Eligible(6, 12 and 18 months after trial launch)
- Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered(6, 12 and 18 months after trial launch)
- Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools(6, 12 and 18 months following trial launch)
- Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care(baseline and 6 months post intervention launch)
- Total Cost and Cost-effectiveness of iPOP-UP(From 6 months before trial launch and up to 15 months after first primary care visit following trial launch)