Obesity, Childhood
Conditions
Keywords
Clinical Decision Support, Implementation Science, Pediatric Obesity
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.
Interventions
BEHAVIORALImproving Pediatric Obesity Practice Using Prompts (iPOP-UP)
EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study.
Sponsors
Yale University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Mean Change in BMI as Percentage of 95th Percentile | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines | 12 and 18 months after trial launch | 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. |
| Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List | 6, 12 and 18 months after trial launch | 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. |
| Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis | 6, 12 and 18 months after trial launch | 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. |
| Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible | 6, 12 and 18 months after trial launch | 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. |
| Percent Adherent Visits in Appropriate Blood Pressure Screening | 6, 12 and 18 months after trial launch | 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. |
| Percent Adherent Visits in Structured Documentation of Counseling | 6, 12 and 18 months after trial launch | 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. |
| Percent Visits With Follow-up Visit Requested | 6, 12 and 18 months after trial launch | 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. |
| Percent Visits With Referral for Further Management of Obesity | 6, 12 and 18 months after trial launch | 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. |
| Percent Visits With Weight Loss Medication Orders, if Eligible | 6, 12 and 18 months after trial post intervention launch | 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. |
| Percent Visits With Bariatric Surgery Program Referrals, if Eligible | 6, 12 and 18 months after trial launch | 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. |
| Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered | 6, 12 and 18 months after trial launch | 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. |
| Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care | baseline and 6 months post intervention launch | 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. |
| 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 | 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. |
| Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools | 6, 12 and 18 months following trial launch | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMahnoosh (Mona) Sharifi, MD, MPH
Yale University
Participant flow
Recruitment details
Participating primary care practices (n=81) were recruited and enrolled prior to the study start and grouped into a total of 71 clusters to account for clinician crossover between some participating practices. During an 18-month observation period (February 2023 through December 2024), clinicians and children were observed for any completed visit in participating practices among children aged 2-18 years old with BMI ≥85th percentile via the electronic health record.
Pre-assignment details
Only clinics were enrolled and randomized; no individual participants were directly consented/randomized. Of 92 clinics invited to participate in the trial, 81 clinics agreed/enrolled and were grouped into 71 clinic clusters and cluster-randomized to iPOP-UP vs usual care using covariate constrained randomization based on site, % patients publicly insured, % non-Hispanic White, geographic location (urban vs not), practice size, practice volume, and academic vs non-academic.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 4.7 |
| BMI as percentage of 95th Percentile | 107 percentage points STANDARD_DEVIATION 18 |
| BMI z-score | 1.78 z-score STANDARD_DEVIATION 0.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12931 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41996 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2020 Participants |
| Financial class Other/Self-pay/Not reported | 1,585 Participants |
| Financial class Private | 9,762 Participants |
| Financial class Public | 15,559 Participants |
| Mean BMI | 24.8 kg/m^2 STANDARD_DEVIATION 6.3 |
| Mean BMI percentile | 94.2 percentile STANDARD_DEVIATION 4.3 |
| Number of participants seen in an academic setting | 19208 Participants |
| Practice Setting Not Urban | 249 Participants |
| Practice Setting Urban | 54541 Participants |
| Primary language English | 27,726 Participants |
| Primary language Other/ not reported | 666 Participants |
| Primary language Spanish | 5,910 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 50 Participants |
| Race/Ethnicity, Customized Race Asian | 1707 Participants |
| Race/Ethnicity, Customized Race Black or African American | 6710 Participants |
| Race/Ethnicity, Customized Race Middle Eastern or North African | 4 Participants |
| Race/Ethnicity, Customized Race More than one race | 1115 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 74 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 5845 Participants |
| Race/Ethnicity, Customized Race White | 10715 Participants |
| Region of Enrollment United States | 56947 Participants |
| Sex: Female, Male Female | 28002 Participants |
| Sex: Female, Male Male | 13895 Participants |
| Site Health System 1 | 18789 Participants |
| Site Health System 2 | 8781 Participants |
| Site Health System 3 | 2471 Participants |
| Visits at clinics above Median Clinicians | 32,401 visits |
| Visits at clinics above Median Medicaid | 14,589 visits |
| Visits at clinics above Median Non-Hispanic White (NHW) | 26,574 visits |
| Visits at clinics above Median Patients | 21,340 visits |
| Weight class Class 1 Obesity | 19470 Participants |
| Weight class Class 2 Obesity | 6954 Participants |
| Weight class Class 3 Obesity | 1,910 Participants |
| Weight class Overweight | 26964 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed