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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
58,364
EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study.
Eskenazi Health
Indianapolis, Indiana, United States
Duke University
Durham, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Mean Change in BMI as Percentage of 95th Percentile
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.
Time frame: Up to 15 months after first primary care visit following 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.
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.
Time frame: 6 months after trial launch
Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines
Percent adherent visits at 12 and 18 months 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 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.
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Time frame: 12 and 18 months after trial launch
Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI in problem list, queried from the electronic health record at baseline, 6, 12, and 18 months to see change at 6 months and how it's sustained at 12 and 18 months. A higher proportion of visits with relevant diagnosis code is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI queried from the electronic health record. A higher proportion of visits with relevant diagnosis code is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of screening lab orders for obesity-related comorbidities recommended by the American Academy of Pediatrics clinical practice guideline for obesity based on age and BMI percentile, queried from the electronic health record. A higher proportion of visits with recommended screening lab orders is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Adherent Visits in Appropriate Blood Pressure Screening
Percent adherent visits completed among children 3-18 years with BMI ≥85th percentile during the study period with evidence of appropriate blood pressure screening queried from the electronic health record. A higher proportion of visits with blood pressure screening is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Adherent Visits in Structured Documentation of Counseling
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of counseling structured documentation queried from the electronic health record. A higher proportion of visits with counseling structured documentation is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Follow-up Visit Requested
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of follow-up visit requested, queried from the electronic health record. A higher proportion of visits with follow-up visit requested is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Referral for Further Management of Obesity
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of referral for further management of obesity queried from the electronic health record. A higher proportion of visits with follow-up or referral for further management of obesity is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Weight Loss Medication Orders, if Eligible
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of weight loss medication orders, if eligible, queried from the electronic health record. A higher proportion of visits with weight loss medication orders, when eligible, is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial post intervention launch
Percent Visits With Bariatric Surgery Program Referrals, if Eligible
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of bariatric surgery program referrals, if eligible queried from the electronic health record. A higher proportion of referrals to bariatric surgery programs, when eligible, is consistent with recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of insulin or thyroid lab orders, not routinely recommended for evaluation of children with obesity, queried from the electronic health record. A lower proportion indicates better adherence to recommended care.
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools
Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of clinician use of the clinical decision support tools in the electronic health record developed for this trial, calculated from electronic health record query. Measure= % of visits at intervention sites at which the clinicians' uses clinical decision support tools through18 months A higher proportion indicates greater utilization of clinical decision support tools.
Time frame: 6, 12 and 18 months following trial launch
Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care
Mean change in clinician's attitudes and practice around management of elevated BMI measured using survey questions. Five factors will be assessed: Practice, Treatment self-efficacy, Counseling self-efficacy, Expectations, and Technology. Possible responses range from 1 (strongly disagree) to 5 (strongly agree) for attitudes or 1 (never) to 5 (almost always). Negative values indicate higher disagreement.
Time frame: baseline and 6 months post intervention launch
Total Cost and Cost-effectiveness of iPOP-UP
Total cost of design, build, implementation of the tools, and other implementation strategies of iPOP-UP incurred by the clinics. Using a healthcare sector perspective, a micro-costing approach was utilized to estimate costs associated with the design, build, and implementation of EHR-based CDS for the management of pediatric overweight/obesity in primary care.
Time frame: From 6 months before trial launch and up to 15 months after first primary care visit following trial launch